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Antwort auf Beitrag Nr.: 16.813.097 von zenman am 06.06.05 09:03:17Mitschrift aus dem CC
By: JBWIN
Unfiltered Notes from ELN 1Q2007 Earnings CC
* Reynold, VP IR
* Welcome to 1Q2007 earnings CC
* Kelly Martin, CEO, Shane Cooke, CFO, Lars Ekman, VP R&D
* Safe harbor
* KM
* Thank you for joining us
* Joining me is EVP, CFO Shane Cooke, President R&D Lars Ekman
* 3 points
* First, first and foremost rev growth, up 30%, costs up a bit, mainly in R&D making progress
* If take out special 2006, $63M taken out
* Expect to continue to make progress in each subseq qtr
* Tysabri build foundation re patient acq, globally
* As described in 4Q2007 earnings, moved from risk mgt to efficacy and patient benefit
* W/depth and breadth of efficacy 68% decr relapse, patient benefit is overwhelming
* Expect continued gain in mkt share
* Given all we know, expect Tysabri become leading MS therapy given choices
* Lastly, pipeline moves forward, Lars will describe
* Re aab-001, lead program w/WYE in AD, on track as prev stated, take admin look at mid-yr 2007, fully expect will provide clues re precise dose and P III trial design
* Continue to protect P II, it could in and of itself be a pivotal trial, cont to protect
* Further re aab-001. fully understand imp to multiple constit incl investors, patients, pract, WYE
* Shane Cooke
* First, metrics re T in TOUCH as of mid-Apr2007
* This data further 9 weeks of data since last reported
* In Appendix 1, Tysabri and rest of business
* Analysis of adj EBITDA
* Incl of 2006 gain of 44.2M from EU Prialt and incl in 2007 of net charge of Athena notes ($615M retirement)
* Adj net EBITDA decr 2/3
* Pos EBITDA 13.8M, reduced T losses
* Expect 2007 EBITDA loss under 50M
* Rev from ROB 9%, hospital up 13%, drug tech up 13%
* Generic maxipime intentions noted if allowed
* No generic appr re Azactem
* Rev ex-T >500M
* If generic Maxipime appr in 2008 may look at guidance again
* Change in prod mix, growth in
* GM 60-65
* Costs 122M, incr R&D, primarily AD
* Collab ELND-005
* Total SG&A incl T, 150M
* Comfortable FY2007 600-650M
* Re T in MS
* As of mid-Apr 12.5K enrolled in Touch or infused, growth of 30% since last update 9 weeks ago
* 10K infused
* 150 docs enrolled
* Expect high conversion of enrollment
* ¾ switchers from CRAB
* In US, good progress re infusion centers and reimb
* In EU, 2.5K primarily Germany and Nordics
* Now have sales in Germany and Italy, bring on France and
* Avg #patients per week 325
* Expect w/more safety profile, incr
* Compr safety and efficacy at upcoming AAN
* As prev guided, 15K covers 300M cost of T
* Accts for only 3% of market
* Almost 9.1K on therapy, hope to reach 3% level mid-3Q2007
* Next milestone 7-9%, become profitable
* W/favorable tax sitn, very attractive
* Expect T could ecipse all MS therapies, treating 100K+ patients
* 48.4K ww, 12.7 in EU
* 1Q2007 net loss of T 21.2M, slight reduction, incr sales, ELN’s share of EU, cost of open label study
* Collab w/BIIB diff in US and EU
* In US, purchase from BIIB and we distr, we record rev
* Cost of prod plus BIIB’s share
* In EU, BIIB distr, we get share of net profit
* Neg rev of 5M, our share of loss, net sales 12.7M after EU expenses
* To conclude, pleased strong start, advance towards prof
* Lars Ekman
* Spend next 2 mins 5 topics
* 1. AN1792 4 yr follow-up presented in Salzburg
* 2. Update immunotherapeutic w/WYE
* 3. Update of fast track re AD program ELND-005, share w/Transition Thera
* 4. Key T data presenting at AAN
* 5. Short update T in Crohn’s
* AN1792 4 yr updated at ADPD conf in Salzburg
* Short recap of trial first
* Immun of ?? patients, randomized trial, discont after 2 infusions, due to enceph stopped
* 1 yr data impr in cogn endpts
* Recnet 4.5 yrs safety and efficacy of 201 patients
* Results analyzed using treatment assignment
* Based on 159 patients, responder patients, sign lower decl on dementia score than placebo
* This is commonly used to assess QoL by caregiver
* Data also revealed stat sign in responders re dependency on caregiver
* In summar, most imp takeaway, 4.5 yrs after immunized w/AN1792 impr on cogn and dep
* All aspects presented ADPD on website
* Turn to other AIP program
* Aab-001 on track, interim analysis around mid-yr
* Data used to help det timing and design of P III
* Trial complete 1H2008
* Aac-001, active conjugate
* Aab-002 on track, obj to move into clin trials
* New addition, sub-cutaneous of BAP
* Rationale for new formulation to broaden and deepen commercial opp of BAP
* ACD103 3Apr2007, fast track for ELND-005, collab w/Transition Thera
* Encouraging news, eval in P I, anticipate start P II by end of 2007
* Tysabri
* Highlight AAN MS data (28Apr-5May2007 in Boston)
* 7 Tysabri presentations ranging from health-rel QofL, efficacy 3 yr data RR MS, safety data from TOUCH and TIGRIS trials
* ELN/BIIB periodic safety updates
* Encourage to stop by ELN/BIIB booths
* T in Crohn’s
* In Eur, EMEA, exp reg action in next couple of months
* In US, BLA under review by FDA, anticipate action in 2007
* # of T Crohn’s data at upcoming DDW in May2007
* Focus of presentations, ENCORE results, maintains remissions in CD longer than 2 yrs
* T does not req concom use of immunosuppressives
* Also investigated addit indications for Tysabri
* Hope to update last part of 2007
* Happy to answer any Q
* KM
* Thank you for joining us
* Committed to themes
* Moving forward fin qtr by qtr, ult move to prof
* Alloc resources to biggest opps
* Bread of AD in R&D as P/F loves forward, allocate more resources
* AAN mtg next week encourage people to stop by ELN/BIIB booth
* Interesting posters re T
* Read thoroughly
* Q&A
* Q1: Orla Hartford
* Re T, conversion of patients, why more not converted? Weekly run-rate 320 over last 8-9 weeks, what is it now? Price increase? Avg price in Europe?
* A1: Re TOUCH forms, received 10K, prev 8K. Not all patients who completed go on to therapy. You will get net #. Some dropouts. Affects that # re TOUCH form and on therapy. Better to look at # on therapy. # given, avg new Rx, TOUCH enrollment forms+new patients in Europe, avg in 325 and higher at end of qte. Cont to see strengthening. Same price, 28.4K.
* Q2: Avg time from enrollment to treatment?
* A2: 4-5 wks, same, reimb not a prob
* Q3: Ian Hunter, Goodbody
* Maxipime and generic, will BMS petition patent infringement. Timeline for pot generic to mkt?
* A3: 2 patents might protect until 2Q2008. Looking at options w/BMS. Understand made an application to FDA. They think appr coming soon. We expect Maximpime will go generic. Plan to respond.
* Q4: NICE and UK, where is process? Gut feel?
* A4: KM, re NICE, series of steps. Working w/BIIB on steps, first apply, hear init thoughts re their pharmacoeconomic, several other steps. Working closely w/NICE, to find way can be made avail thru UK nat ins. Heard loud and clear from patient interest to get access to T re efficacy. Re timeline, run thru 2-3Q2007, decision by YE2007
* Q5: Corey Davis
* Ask first about AD. Not micro analyze, what constitutes look? Does look compromise integrity?
* A5: KM: Try to fram answer. What compromises in disc w/WYE and FDA, some combo of what you mentioned, most optimal is completely unblended, as descry and discussed w/FDA. Want to start P III and preserve P II. Least # people know dat and least freq looking better. Will be need to roll out P III trial design. That is confidential process. Way to do it and construct P III w/o tipping off, contaminating P II. Lars: We have disclosed process to FDA and they are comfortable w/way dealing w/data. Process in place to protect trial. KM: State publicly hope data in P II provide clarity that we would like to fine tune dose and exact P III trial design. Our view immunotherapeutic platforms works and completely address pathology of AD. Finetune next step. Understand persp of many group, incl 10M AD patients. Move aac-001, aab-002 forward. Broaden and depen w/WYE immunthera program. Aab-001 as stand-alone and other programs.
* Q6: Lilly and gamma secr program
* A6: Understand in PII, move to P III in 2007 plan. Option to up to 50% of gamma compound for 7 yrs upon either filing or appr.
* Q7: Not opt in until after P III?
* A7: Yes
* Q8: Timing of compl aab-001?
* A8: On track, on sched. If use as pivotal trial, on filing, del top line data. Totality not released. If not pivotal (aab-001), share in neuro or other med trial.
* Q9: Erin Bloom, GS
* Tysabri supplies, any centers having issues. What rate causes supply disruptions?
* A9: Not aware of any centers where short of supply. Capacity from BIIB sufficient for 100K patients, work on high tier, go to 3x that level
* Q10: Not prod at that level, will need to ramp up?
* A10: We have fair amt of inventory when off mkt. Not an issue.
* Q11: Brigette, ML
* One questions, given expect EMEA resp, have you recruited T CD sales force?
* A11: Still working w/Euro regs. Comm infrastructure can be assembled rather quickly betw ourselves and some potential BIIB resources. Don’t put in place too soon. Not CD I/S in place yet in Europe. When further clarity from EMEA, position w/specific target. At DDW upcoming, # of posters that will be presented from KOLs and its positioning.
* Q12: Bill Tanner, Leerink Swann
* KM, re NICE discussions. Perhaps risk-sharing scheme like beta-interferons. Issues re cost?
* A12: Don’t want to publicly go into detail. Their model drives decision. Fair to say, ELN/BIIB have sign thoughts on best way to look at T and other thera, what should be in model. Having dialogue w?NICE what is in model, assumptions. Given efficacy and patient benefit, we feel MS UK should be approvable from reimb standpt and made avail. Re other routes premature. Focus on Round 2/3, that model driving decision more accur reflect reality.
* Q13: 1500 phsyicians enr in US TOUCH. Targeting top 2000. Is 1500 disprop of Rx docs?
* A13: Init target of 2.5K, every wk, every qtr, more physicians enroll. Wide dispersion. Other docs have milestones. Very hard to give answer descry beh in mktplace. Imp to reach 2.5K docs, where patients come from. 75% switchers, very imp pt of equation, help build patient # and momentum.
* Q14: Re CD, risk map program planning for FDA disc? How about Europe?
* A14: For Europe have note discussed risk map, assume there will be in US.
* Q15: Orla, NCB
* Aab-001, P II extension study, how long run. # of cohorts?
* A15: Patients have rights. Have not given details re #of cohorts leaving. Vast majority opt in to extension study. Classical open label study.
* Q16: Present aac-001 P I in 2007?
* A16: Yes, anticipate will be presented and published.
* Q17: P II design?
* A17: aac-001 will not be presented this yr. No aac-001 data this yr. Design of P II, randomized, double blind, primary var safety, tol, secondary immunogenicity. Efficacy, usual suspects. Approx same size as aab-001.
* Q18: Multiple concentrations?
* A18: Of course, look at concentration of anti-body for P III.
* Q19: Annie Chang
* Driver of reimb in Germany, Nordic vs UK. What they not considering? New formulation re aab-001, use in P III?
* A19: KM: Reimb, no strict nat process. Focus init on hospitals and their budgets. That is why started launch there. In diff Nordic countries, some are diff in processes, gen accepted UK process is unique re cost/benefit, patient benefit, soc pt of view. UK one of leading thinkers of multi-dimensional pharmacoec. Often don’t approve novel therapies. Working on assumption in T for MS. Fairly large # of patients in UK, should have access to T. Re sub-cutaneous, as Lars stated, could have sign comm. Opps for WYE/ELN globally. Not all countries, locations have infusion facilities. AD pop close to 10M., imp that we have follow on formulations that allow breadth and depth of access. Not use in P III trial.
* Q20: Think of as follow-on product (A: Yes). Interim analysis of aab-001, trigger.
* A20: Given broad guidelines from what we learned re AN1792. Know timeline re dosing cohorts from trial. Pick out time pts where reasonably expect certain things happen in cohorts. Combo of endpts classify BAP as disease-modifying therapy. Provide clarity re starting P III, choosing rt dose, rt P III design and protect P II. Not shared P II endpts, but over the disease-modifying hurdle.
* Q21: Barry Gallagher, Davies
* Pricing US vs Europe for T? Run rate spend?
* A21: Roughly same price. Run rate same going forward.
* Q22: Large?
* A22: Settlement w/King brought in 50M
* Q23: Paribas
* What % of T ever on T before?
* A23: Less than 40%
* Q24: Good results on Maxipime, can I extrapolate forward or one-off?
* A24: Continue growing at that level.
Thank everyone, replay on website.
By: JBWIN
Unfiltered Notes from ELN 1Q2007 Earnings CC
* Reynold, VP IR
* Welcome to 1Q2007 earnings CC
* Kelly Martin, CEO, Shane Cooke, CFO, Lars Ekman, VP R&D
* Safe harbor
* KM
* Thank you for joining us
* Joining me is EVP, CFO Shane Cooke, President R&D Lars Ekman
* 3 points
* First, first and foremost rev growth, up 30%, costs up a bit, mainly in R&D making progress
* If take out special 2006, $63M taken out
* Expect to continue to make progress in each subseq qtr
* Tysabri build foundation re patient acq, globally
* As described in 4Q2007 earnings, moved from risk mgt to efficacy and patient benefit
* W/depth and breadth of efficacy 68% decr relapse, patient benefit is overwhelming
* Expect continued gain in mkt share
* Given all we know, expect Tysabri become leading MS therapy given choices
* Lastly, pipeline moves forward, Lars will describe
* Re aab-001, lead program w/WYE in AD, on track as prev stated, take admin look at mid-yr 2007, fully expect will provide clues re precise dose and P III trial design
* Continue to protect P II, it could in and of itself be a pivotal trial, cont to protect
* Further re aab-001. fully understand imp to multiple constit incl investors, patients, pract, WYE
* Shane Cooke
* First, metrics re T in TOUCH as of mid-Apr2007
* This data further 9 weeks of data since last reported
* In Appendix 1, Tysabri and rest of business
* Analysis of adj EBITDA
* Incl of 2006 gain of 44.2M from EU Prialt and incl in 2007 of net charge of Athena notes ($615M retirement)
* Adj net EBITDA decr 2/3
* Pos EBITDA 13.8M, reduced T losses
* Expect 2007 EBITDA loss under 50M
* Rev from ROB 9%, hospital up 13%, drug tech up 13%
* Generic maxipime intentions noted if allowed
* No generic appr re Azactem
* Rev ex-T >500M
* If generic Maxipime appr in 2008 may look at guidance again
* Change in prod mix, growth in
* GM 60-65
* Costs 122M, incr R&D, primarily AD
* Collab ELND-005
* Total SG&A incl T, 150M
* Comfortable FY2007 600-650M
* Re T in MS
* As of mid-Apr 12.5K enrolled in Touch or infused, growth of 30% since last update 9 weeks ago
* 10K infused
* 150 docs enrolled
* Expect high conversion of enrollment
* ¾ switchers from CRAB
* In US, good progress re infusion centers and reimb
* In EU, 2.5K primarily Germany and Nordics
* Now have sales in Germany and Italy, bring on France and
* Avg #patients per week 325
* Expect w/more safety profile, incr
* Compr safety and efficacy at upcoming AAN
* As prev guided, 15K covers 300M cost of T
* Accts for only 3% of market
* Almost 9.1K on therapy, hope to reach 3% level mid-3Q2007
* Next milestone 7-9%, become profitable
* W/favorable tax sitn, very attractive
* Expect T could ecipse all MS therapies, treating 100K+ patients
* 48.4K ww, 12.7 in EU
* 1Q2007 net loss of T 21.2M, slight reduction, incr sales, ELN’s share of EU, cost of open label study
* Collab w/BIIB diff in US and EU
* In US, purchase from BIIB and we distr, we record rev
* Cost of prod plus BIIB’s share
* In EU, BIIB distr, we get share of net profit
* Neg rev of 5M, our share of loss, net sales 12.7M after EU expenses
* To conclude, pleased strong start, advance towards prof
* Lars Ekman
* Spend next 2 mins 5 topics
* 1. AN1792 4 yr follow-up presented in Salzburg
* 2. Update immunotherapeutic w/WYE
* 3. Update of fast track re AD program ELND-005, share w/Transition Thera
* 4. Key T data presenting at AAN
* 5. Short update T in Crohn’s
* AN1792 4 yr updated at ADPD conf in Salzburg
* Short recap of trial first
* Immun of ?? patients, randomized trial, discont after 2 infusions, due to enceph stopped
* 1 yr data impr in cogn endpts
* Recnet 4.5 yrs safety and efficacy of 201 patients
* Results analyzed using treatment assignment
* Based on 159 patients, responder patients, sign lower decl on dementia score than placebo
* This is commonly used to assess QoL by caregiver
* Data also revealed stat sign in responders re dependency on caregiver
* In summar, most imp takeaway, 4.5 yrs after immunized w/AN1792 impr on cogn and dep
* All aspects presented ADPD on website
* Turn to other AIP program
* Aab-001 on track, interim analysis around mid-yr
* Data used to help det timing and design of P III
* Trial complete 1H2008
* Aac-001, active conjugate
* Aab-002 on track, obj to move into clin trials
* New addition, sub-cutaneous of BAP
* Rationale for new formulation to broaden and deepen commercial opp of BAP
* ACD103 3Apr2007, fast track for ELND-005, collab w/Transition Thera
* Encouraging news, eval in P I, anticipate start P II by end of 2007
* Tysabri
* Highlight AAN MS data (28Apr-5May2007 in Boston)
* 7 Tysabri presentations ranging from health-rel QofL, efficacy 3 yr data RR MS, safety data from TOUCH and TIGRIS trials
* ELN/BIIB periodic safety updates
* Encourage to stop by ELN/BIIB booths
* T in Crohn’s
* In Eur, EMEA, exp reg action in next couple of months
* In US, BLA under review by FDA, anticipate action in 2007
* # of T Crohn’s data at upcoming DDW in May2007
* Focus of presentations, ENCORE results, maintains remissions in CD longer than 2 yrs
* T does not req concom use of immunosuppressives
* Also investigated addit indications for Tysabri
* Hope to update last part of 2007
* Happy to answer any Q
* KM
* Thank you for joining us
* Committed to themes
* Moving forward fin qtr by qtr, ult move to prof
* Alloc resources to biggest opps
* Bread of AD in R&D as P/F loves forward, allocate more resources
* AAN mtg next week encourage people to stop by ELN/BIIB booth
* Interesting posters re T
* Read thoroughly
* Q&A
* Q1: Orla Hartford
* Re T, conversion of patients, why more not converted? Weekly run-rate 320 over last 8-9 weeks, what is it now? Price increase? Avg price in Europe?
* A1: Re TOUCH forms, received 10K, prev 8K. Not all patients who completed go on to therapy. You will get net #. Some dropouts. Affects that # re TOUCH form and on therapy. Better to look at # on therapy. # given, avg new Rx, TOUCH enrollment forms+new patients in Europe, avg in 325 and higher at end of qte. Cont to see strengthening. Same price, 28.4K.
* Q2: Avg time from enrollment to treatment?
* A2: 4-5 wks, same, reimb not a prob
* Q3: Ian Hunter, Goodbody
* Maxipime and generic, will BMS petition patent infringement. Timeline for pot generic to mkt?
* A3: 2 patents might protect until 2Q2008. Looking at options w/BMS. Understand made an application to FDA. They think appr coming soon. We expect Maximpime will go generic. Plan to respond.
* Q4: NICE and UK, where is process? Gut feel?
* A4: KM, re NICE, series of steps. Working w/BIIB on steps, first apply, hear init thoughts re their pharmacoeconomic, several other steps. Working closely w/NICE, to find way can be made avail thru UK nat ins. Heard loud and clear from patient interest to get access to T re efficacy. Re timeline, run thru 2-3Q2007, decision by YE2007
* Q5: Corey Davis
* Ask first about AD. Not micro analyze, what constitutes look? Does look compromise integrity?
* A5: KM: Try to fram answer. What compromises in disc w/WYE and FDA, some combo of what you mentioned, most optimal is completely unblended, as descry and discussed w/FDA. Want to start P III and preserve P II. Least # people know dat and least freq looking better. Will be need to roll out P III trial design. That is confidential process. Way to do it and construct P III w/o tipping off, contaminating P II. Lars: We have disclosed process to FDA and they are comfortable w/way dealing w/data. Process in place to protect trial. KM: State publicly hope data in P II provide clarity that we would like to fine tune dose and exact P III trial design. Our view immunotherapeutic platforms works and completely address pathology of AD. Finetune next step. Understand persp of many group, incl 10M AD patients. Move aac-001, aab-002 forward. Broaden and depen w/WYE immunthera program. Aab-001 as stand-alone and other programs.
* Q6: Lilly and gamma secr program
* A6: Understand in PII, move to P III in 2007 plan. Option to up to 50% of gamma compound for 7 yrs upon either filing or appr.
* Q7: Not opt in until after P III?
* A7: Yes
* Q8: Timing of compl aab-001?
* A8: On track, on sched. If use as pivotal trial, on filing, del top line data. Totality not released. If not pivotal (aab-001), share in neuro or other med trial.
* Q9: Erin Bloom, GS
* Tysabri supplies, any centers having issues. What rate causes supply disruptions?
* A9: Not aware of any centers where short of supply. Capacity from BIIB sufficient for 100K patients, work on high tier, go to 3x that level
* Q10: Not prod at that level, will need to ramp up?
* A10: We have fair amt of inventory when off mkt. Not an issue.
* Q11: Brigette, ML
* One questions, given expect EMEA resp, have you recruited T CD sales force?
* A11: Still working w/Euro regs. Comm infrastructure can be assembled rather quickly betw ourselves and some potential BIIB resources. Don’t put in place too soon. Not CD I/S in place yet in Europe. When further clarity from EMEA, position w/specific target. At DDW upcoming, # of posters that will be presented from KOLs and its positioning.
* Q12: Bill Tanner, Leerink Swann
* KM, re NICE discussions. Perhaps risk-sharing scheme like beta-interferons. Issues re cost?
* A12: Don’t want to publicly go into detail. Their model drives decision. Fair to say, ELN/BIIB have sign thoughts on best way to look at T and other thera, what should be in model. Having dialogue w?NICE what is in model, assumptions. Given efficacy and patient benefit, we feel MS UK should be approvable from reimb standpt and made avail. Re other routes premature. Focus on Round 2/3, that model driving decision more accur reflect reality.
* Q13: 1500 phsyicians enr in US TOUCH. Targeting top 2000. Is 1500 disprop of Rx docs?
* A13: Init target of 2.5K, every wk, every qtr, more physicians enroll. Wide dispersion. Other docs have milestones. Very hard to give answer descry beh in mktplace. Imp to reach 2.5K docs, where patients come from. 75% switchers, very imp pt of equation, help build patient # and momentum.
* Q14: Re CD, risk map program planning for FDA disc? How about Europe?
* A14: For Europe have note discussed risk map, assume there will be in US.
* Q15: Orla, NCB
* Aab-001, P II extension study, how long run. # of cohorts?
* A15: Patients have rights. Have not given details re #of cohorts leaving. Vast majority opt in to extension study. Classical open label study.
* Q16: Present aac-001 P I in 2007?
* A16: Yes, anticipate will be presented and published.
* Q17: P II design?
* A17: aac-001 will not be presented this yr. No aac-001 data this yr. Design of P II, randomized, double blind, primary var safety, tol, secondary immunogenicity. Efficacy, usual suspects. Approx same size as aab-001.
* Q18: Multiple concentrations?
* A18: Of course, look at concentration of anti-body for P III.
* Q19: Annie Chang
* Driver of reimb in Germany, Nordic vs UK. What they not considering? New formulation re aab-001, use in P III?
* A19: KM: Reimb, no strict nat process. Focus init on hospitals and their budgets. That is why started launch there. In diff Nordic countries, some are diff in processes, gen accepted UK process is unique re cost/benefit, patient benefit, soc pt of view. UK one of leading thinkers of multi-dimensional pharmacoec. Often don’t approve novel therapies. Working on assumption in T for MS. Fairly large # of patients in UK, should have access to T. Re sub-cutaneous, as Lars stated, could have sign comm. Opps for WYE/ELN globally. Not all countries, locations have infusion facilities. AD pop close to 10M., imp that we have follow on formulations that allow breadth and depth of access. Not use in P III trial.
* Q20: Think of as follow-on product (A: Yes). Interim analysis of aab-001, trigger.
* A20: Given broad guidelines from what we learned re AN1792. Know timeline re dosing cohorts from trial. Pick out time pts where reasonably expect certain things happen in cohorts. Combo of endpts classify BAP as disease-modifying therapy. Provide clarity re starting P III, choosing rt dose, rt P III design and protect P II. Not shared P II endpts, but over the disease-modifying hurdle.
* Q21: Barry Gallagher, Davies
* Pricing US vs Europe for T? Run rate spend?
* A21: Roughly same price. Run rate same going forward.
* Q22: Large?
* A22: Settlement w/King brought in 50M
* Q23: Paribas
* What % of T ever on T before?
* A23: Less than 40%
* Q24: Good results on Maxipime, can I extrapolate forward or one-off?
* A24: Continue growing at that level.
Thank everyone, replay on website.
Und wieder warten wir 3 weitere Monate ... oh mein Gott, wie ich das hasse.
Dieses beschissene Gehangel von CC zu CC ...
Dieses beschissene Gehangel von CC zu CC ...
Antwort auf Beitrag Nr.: 28.972.887 von Holgus am 24.04.07 16:11:08es ist wie ein Geburtstag, an dem man immer das Geschenk bekommt das man nicht will...
Antwort auf Beitrag Nr.: 28.972.925 von Birgit.Tersteegen am 24.04.07 16:12:55obwohl ich den Abverkauf überhaupt nicht verstehe!
Na schaut mal, wie schön der Kurs in den Keller semmelt.
14:41 grad eben.
Diese Schrottaktie will bald keiner mehr haben.
14:41 grad eben.
Diese Schrottaktie will bald keiner mehr haben.
Glaubt denn im ernst wirklich noch jemand, das irgendwelche positiven Alzheimer-Nachrichten den Kurs von Elan in die Höhe treiben wird ?
Zumindest merklich ?
Na gut, die glauben dann aber auch noch an den Weihnachtsmann.
Zumindest merklich ?
Na gut, die glauben dann aber auch noch an den Weihnachtsmann.
Wir sehen uns in den 13nern ... und im Mai sind dann die 12,50er Optionen wieder dran ... dann gehts noch weiter den Bach runter.
By: pinvestment2
ty on track to be a billion dollar drug 18 months from release
and could do it even sooner when sales growth accelerates
i am not sure what exactly folks are looking for - looks great to me and with aab-001 at a news point - with AAN safety report in a week - canadian approval etc - AGM - looksl ike a busy month coming up - i will be curious to see BIIB give its tysabri numbers in about 10 days
just a sit back and watch it grow
FWIW tysabri is selling 400% more than last time the price was 15 - and sitting right close to a phase III start possible for aab-001
ty on track to be a billion dollar drug 18 months from release
and could do it even sooner when sales growth accelerates
i am not sure what exactly folks are looking for - looks great to me and with aab-001 at a news point - with AAN safety report in a week - canadian approval etc - AGM - looksl ike a busy month coming up - i will be curious to see BIIB give its tysabri numbers in about 10 days
just a sit back and watch it grow
FWIW tysabri is selling 400% more than last time the price was 15 - and sitting right close to a phase III start possible for aab-001
.test.
Hilfe..
..die posting gehen raus, werden auch zeitmäßig unter meinen Favos angezeigt......aber im Thread selber ist das letzte posting von #15008 ( Birgit )....uuuuaaaahhhh.....
..MODS, haut mal in die Tasten...
..die posting gehen raus, werden auch zeitmäßig unter meinen Favos angezeigt......aber im Thread selber ist das letzte posting von #15008 ( Birgit )....uuuuaaaahhhh.....
..MODS, haut mal in die Tasten...
test
Guten Morgen;
haben sie gestern unser Schätzchen wieder geknebelt....m.A.n. völlig übertrieben;mal sehen ob Biogens CC etwas mehr für die Stimmung tun kann....
haben sie gestern unser Schätzchen wieder geknebelt....m.A.n. völlig übertrieben;mal sehen ob Biogens CC etwas mehr für die Stimmung tun kann....
..nochmal test..
Antwort auf Beitrag Nr.: 28.981.899 von Birgit.Tersteegen am 25.04.07 08:42:33die Wartezeit ist natürlich nicht so schön. Allerdings benötige ich das Geld zur Zeit nicht "so dringend".
(wenn der Kurs bei $50,- stehen würde, hätte ich wahrscheinlich schon die Aktien verkauft und die Kohle ausgegeben. So habe ich immer noch die Vorfreude)
(wenn der Kurs bei $50,- stehen würde, hätte ich wahrscheinlich schon die Aktien verkauft und die Kohle ausgegeben. So habe ich immer noch die Vorfreude)
!
Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an feedback@wallstreet-online.de
..auch, wenn WO aktuell noch nicht funzt, setze ich diesen Artikel schon mal rein..
NCB
With Q1 US Tysabri revenues falling short of our forecasts (on a lower number ofpatients treated than expected and a slower than anticipated rate of conversion in theUS from enrolment to infusion), we have revised downwards our FY2007 US Tysabrirevenue estimate leaving our EU/ROW revenue estimate unchanged.
• For the quarter, we had assumed that the 3,000 patients enrolled in the TOUCHprogram in the US in mid-February would convert to infused patients by the end of thequarter. By mid-April only c.50% of these TOUCH enrolled patients had converted to revenue generating patients. Elan confirmed that the average time from enrolment toinfusion remains unchanged at 4-5 weeks (for those enrollees who want to progress to Tysabri. It therefore appears that a significant proportion of new enrollees in TOUCHdo so with the intention of moving to Tysabri at some time in the future and notimmediately (i.e. beyond a 4-5 week timeframe). With patient conversion from TOUCHto infusion slower than anticipated due to a high percentage of patients not convertingto infused patients, we have revised our US Tysabri forecasts for the remainder of the
year. Our revised forecasts assume that at year end c.16,000 patients will be infused with Tysabri in the US (this compares to our previous estimate of c.19,000 patients ontreatment by year-end).
Our EU/RoW Tysabri forecasts are unchanged with c.6000
patients on treatment by year-end. Our revised US revenues are c.$260m (from $346m previously) and EU/RoW revenues are unchanged at $104m.
• Since last quarter, the uptick in momentum for Tysabri has improved with the average weekly number of patients enrolled in TOUCH and treated in EU increasing from 300 new patients to 325 new patients. At the end of the quarter the weekly run rate was
higher than the average number of 325 reported but no further details were provided.
We have revised our patient numbers upwards for 2008 with our full year revenue forecasts remaining broadly unchanged.
• Overall as Tysabri continues to gain momentum with the prescriber base expanding(15% increase in the quarter) and as safety data is presented at scientific conferences over the coming quarters, the penetration of Tysabri among MS patients should be
underpinned. Currently, c.75% of patients are switching from an existing ABCR treatment (c.70% switching level reported at Q4 2006) which continues to be a very encouraging sign opening up more of the MS market for penetration.
Our peak target of global revenues for Tysabri of $2bn is unchanged.
• Elsewhere, management remains upbeat on commentary around Alzheimer’s Diseaseconfirming an interim analysis of the Phase II data with AAB-001 in H1 2007. In the Q&A session, management also confirmed that a pathway had been established whereby the data from the Phase II interim analysis could trigger progression of AAB-001 to Phase III without compromising the integrity of the Phase II study. Further investments are been made in the immunotherapeutic approaches to Alzheimer’s
Disease with plans to start an additional clinical study in Q2 2007 with an injectableformulation of AAB-001.
http://www.rte.ie/business/2007/morningrep/download/0425ncb.…
NCB
With Q1 US Tysabri revenues falling short of our forecasts (on a lower number ofpatients treated than expected and a slower than anticipated rate of conversion in theUS from enrolment to infusion), we have revised downwards our FY2007 US Tysabrirevenue estimate leaving our EU/ROW revenue estimate unchanged.
• For the quarter, we had assumed that the 3,000 patients enrolled in the TOUCHprogram in the US in mid-February would convert to infused patients by the end of thequarter. By mid-April only c.50% of these TOUCH enrolled patients had converted to revenue generating patients. Elan confirmed that the average time from enrolment toinfusion remains unchanged at 4-5 weeks (for those enrollees who want to progress to Tysabri. It therefore appears that a significant proportion of new enrollees in TOUCHdo so with the intention of moving to Tysabri at some time in the future and notimmediately (i.e. beyond a 4-5 week timeframe). With patient conversion from TOUCHto infusion slower than anticipated due to a high percentage of patients not convertingto infused patients, we have revised our US Tysabri forecasts for the remainder of the
year. Our revised forecasts assume that at year end c.16,000 patients will be infused with Tysabri in the US (this compares to our previous estimate of c.19,000 patients ontreatment by year-end).
Our EU/RoW Tysabri forecasts are unchanged with c.6000
patients on treatment by year-end. Our revised US revenues are c.$260m (from $346m previously) and EU/RoW revenues are unchanged at $104m.
• Since last quarter, the uptick in momentum for Tysabri has improved with the average weekly number of patients enrolled in TOUCH and treated in EU increasing from 300 new patients to 325 new patients. At the end of the quarter the weekly run rate was
higher than the average number of 325 reported but no further details were provided.
We have revised our patient numbers upwards for 2008 with our full year revenue forecasts remaining broadly unchanged.
• Overall as Tysabri continues to gain momentum with the prescriber base expanding(15% increase in the quarter) and as safety data is presented at scientific conferences over the coming quarters, the penetration of Tysabri among MS patients should be
underpinned. Currently, c.75% of patients are switching from an existing ABCR treatment (c.70% switching level reported at Q4 2006) which continues to be a very encouraging sign opening up more of the MS market for penetration.
Our peak target of global revenues for Tysabri of $2bn is unchanged.
• Elsewhere, management remains upbeat on commentary around Alzheimer’s Diseaseconfirming an interim analysis of the Phase II data with AAB-001 in H1 2007. In the Q&A session, management also confirmed that a pathway had been established whereby the data from the Phase II interim analysis could trigger progression of AAB-001 to Phase III without compromising the integrity of the Phase II study. Further investments are been made in the immunotherapeutic approaches to Alzheimer’s
Disease with plans to start an additional clinical study in Q2 2007 with an injectableformulation of AAB-001.
http://www.rte.ie/business/2007/morningrep/download/0425ncb.…
Msg: 101246 of 101253 4/25/2007 5:13:48 AM Recs: 6
By: winonefortheteam
My perspective
No use in trying to pretend that I was happy with the Tysabri sales. Solid, but no inflection point has been reached yet. It will probably take a few more quarters for this to happen.
Nanotech is not driving growth, and is more hype than anything else at this point. Prialt is a niche drug that won't see significant revenues in our investment lifetimes. Maxipime and Azactam are doing well but likely to hit generic competition in the next year. Tysabri for cancer is years away, and Tysabri for Crohn's is priced into the stock already (and given the trouble in gaining lift-off in MS sales, not expected to materially impact 2007 / 2008 anyway).
It is nice that KM is positive on Alzheimer's, but Wall Street is not going to get excited at this stage. Neurochem's CEO has been touting his treatment for years, and serious investors have not paid attention. Results are needed (i.e. move to PIII) for the stock price to move.
Despite the gloom and doom, Elan is coming up to an interesting dynamic -- the interim peek by 6/30 on AAB-001. Based on management's statements, we are all expecting this to be a sure thing. if they don't go to Phase III at that point, stockholders are going to assume that the drug is a failure. It may be unfair, but that is the way it is. And with Tysabri being a 12 month story now, rather than a next quarter story, and Nanotech/Prialt/Maxipime not worth a whole lot, Elan willl be very, very vulnerable and facing a lot of angry shareholders who will want to monetize their investment.
Here are the scenarios as I see them:
If we go to Phase III (and no filing), I see Elan staying independent and the stock moving to the $20s.
If we go to Phase III and Subpart E filing, I see Elan going to $40 immediately, and going up from there as Wyeth moves to buy the company.
If we DON'T go to Phase III, the stock will go to $10 and Fidelity and friends will push Elan into a marriage with Biogen which will probably be willing to pay anywhere from $15 to $20.
We are only a few months away from the peek. Biotech stocks tend to get a bid as they move closer to the release of test data. So I see our stock actually well supported at current levels after we get through this current wave of selling.
By: winonefortheteam
My perspective
No use in trying to pretend that I was happy with the Tysabri sales. Solid, but no inflection point has been reached yet. It will probably take a few more quarters for this to happen.
Nanotech is not driving growth, and is more hype than anything else at this point. Prialt is a niche drug that won't see significant revenues in our investment lifetimes. Maxipime and Azactam are doing well but likely to hit generic competition in the next year. Tysabri for cancer is years away, and Tysabri for Crohn's is priced into the stock already (and given the trouble in gaining lift-off in MS sales, not expected to materially impact 2007 / 2008 anyway).
It is nice that KM is positive on Alzheimer's, but Wall Street is not going to get excited at this stage. Neurochem's CEO has been touting his treatment for years, and serious investors have not paid attention. Results are needed (i.e. move to PIII) for the stock price to move.
Despite the gloom and doom, Elan is coming up to an interesting dynamic -- the interim peek by 6/30 on AAB-001. Based on management's statements, we are all expecting this to be a sure thing. if they don't go to Phase III at that point, stockholders are going to assume that the drug is a failure. It may be unfair, but that is the way it is. And with Tysabri being a 12 month story now, rather than a next quarter story, and Nanotech/Prialt/Maxipime not worth a whole lot, Elan willl be very, very vulnerable and facing a lot of angry shareholders who will want to monetize their investment.
Here are the scenarios as I see them:
If we go to Phase III (and no filing), I see Elan staying independent and the stock moving to the $20s.
If we go to Phase III and Subpart E filing, I see Elan going to $40 immediately, and going up from there as Wyeth moves to buy the company.
If we DON'T go to Phase III, the stock will go to $10 and Fidelity and friends will push Elan into a marriage with Biogen which will probably be willing to pay anywhere from $15 to $20.
We are only a few months away from the peek. Biotech stocks tend to get a bid as they move closer to the release of test data. So I see our stock actually well supported at current levels after we get through this current wave of selling.
Davy Flash from 24th
(sorry if already posted, some of the flashes don't make the board, some do)
(tables/charts not right)
Better EBITDA out-turn in Q1;
Tysabri momentum solid to date; FY
forecasts broadly unchanged
Solid progress from Tysabri
• Tysabri global revenues were $48.4m, some $8m below
our forecast but broadly in line with consensus.
• Enrolment totalled 12,500 by mid-April, equating to 325
per week since the last results. This number is accelerating
and needs to increase significantly (to c.450) to meet our
FY forecasts.
Little change to 2007 forecasts
• We were comfortable with the overall Q1 out-turn and will
make only minor changes to the P&L mix.
• We continue to anticipate that Elan can achieve positive
group EBITDA in Q4 of this year and positive group
earnings in early 2009.
Looking towards Alzheimer’s R&D in mid-year
• The next interim look at AAB-001 data will be conducted
before the end of June. This will help to determine the
timing and design of a prospective Phase III programme.
• Notably, a subcutaneous formulation of AAB-001 will also
be explored as a follow-on product. Trials begin in Q2.
• A Phase II programme for ACC-001 will start in the coming
months and will be of similar design to AAB-001.
Valuation
• The sell-off following the results should be viewed in light
of recent appreciation (+13% in the month pre-results),
supported by improved US biotech sector sentiment.
• As potential AD newsflow approaches, there may be
trading upside in the price as the market anticipates data.
• Elan’s AD programmes (at 30% success probability)
account for 30% of our $16.10 SOTP valuation. Each $1
movement in valuation is equivalent to a 6% movement in
probability estimates.
(sorry if already posted, some of the flashes don't make the board, some do)
(tables/charts not right)
Better EBITDA out-turn in Q1;
Tysabri momentum solid to date; FY
forecasts broadly unchanged
Solid progress from Tysabri
• Tysabri global revenues were $48.4m, some $8m below
our forecast but broadly in line with consensus.
• Enrolment totalled 12,500 by mid-April, equating to 325
per week since the last results. This number is accelerating
and needs to increase significantly (to c.450) to meet our
FY forecasts.
Little change to 2007 forecasts
• We were comfortable with the overall Q1 out-turn and will
make only minor changes to the P&L mix.
• We continue to anticipate that Elan can achieve positive
group EBITDA in Q4 of this year and positive group
earnings in early 2009.
Looking towards Alzheimer’s R&D in mid-year
• The next interim look at AAB-001 data will be conducted
before the end of June. This will help to determine the
timing and design of a prospective Phase III programme.
• Notably, a subcutaneous formulation of AAB-001 will also
be explored as a follow-on product. Trials begin in Q2.
• A Phase II programme for ACC-001 will start in the coming
months and will be of similar design to AAB-001.
Valuation
• The sell-off following the results should be viewed in light
of recent appreciation (+13% in the month pre-results),
supported by improved US biotech sector sentiment.
• As potential AD newsflow approaches, there may be
trading upside in the price as the market anticipates data.
• Elan’s AD programmes (at 30% success probability)
account for 30% of our $16.10 SOTP valuation. Each $1
movement in valuation is equivalent to a 6% movement in
probability estimates.
Diese ganzen Preisvorhersagungen sind allesamt einfach nur Bullshit.
Seit meinem ersten Tag in Elan sind alle möglichen Leute mit irgendwelchen Vorhersagungen um die Ecke gekommen, und keine Einzige hat bisher gestimmt.
Birgit, solche Sachen kann man bei Elan vergessen.
Der Markt macht was er will, die Börse auch ... und die Elan-Aktie erst recht.
Erwarte das Unerwartete ...
Seit meinem ersten Tag in Elan sind alle möglichen Leute mit irgendwelchen Vorhersagungen um die Ecke gekommen, und keine Einzige hat bisher gestimmt.
Birgit, solche Sachen kann man bei Elan vergessen.
Der Markt macht was er will, die Börse auch ... und die Elan-Aktie erst recht.
Erwarte das Unerwartete ...
Antwort auf Beitrag Nr.: 28.986.927 von Holgus am 25.04.07 13:01:58und....was folgerst Du aus dem Gesagten??
Antwort auf Beitrag Nr.: 28.987.584 von Birgit.Tersteegen am 25.04.07 13:33:25
Ich folger daraus erstmal gar nix, nur habe ich meine Entscheidungen,
auch hinsichtlich den Optionen, zu einem großen Teil aufgrund solcher Aussagen getroffen (Elmer ließ grüßen).
Mittlerweile hab ich gelernt, daß es ein großer Fehler war.
So ist das mit dem Lernen.
Und Du mußt mir doch Recht geben, daß solche Vorhersagen noch nie gestimmt haben, warum machen Leute die dann erst bzw. warum werden
die hierher übernommen ?
Damit noch mehr Neulinge sich Zeithorizonte erträumen und ihr Geld dann zersemmeln ??
Ich folger daraus erstmal gar nix, nur habe ich meine Entscheidungen,
auch hinsichtlich den Optionen, zu einem großen Teil aufgrund solcher Aussagen getroffen (Elmer ließ grüßen).
Mittlerweile hab ich gelernt, daß es ein großer Fehler war.
So ist das mit dem Lernen.
Und Du mußt mir doch Recht geben, daß solche Vorhersagen noch nie gestimmt haben, warum machen Leute die dann erst bzw. warum werden
die hierher übernommen ?
Damit noch mehr Neulinge sich Zeithorizonte erträumen und ihr Geld dann zersemmeln ??
Antwort auf Beitrag Nr.: 28.987.715 von Holgus am 25.04.07 13:40:28Hi Holgi kann dich verstehen, deshalb vertrau auch lieber auf deine innere Stimme als auf irgend welches gefasel und sei es noch so gut gemeint.
Meine Stimme sagte kürzlich zu mir geh da mal wieder rein und wart ab ob das W wie im meisten Falle nach oben ausbricht...
...habs glaube schon ma gepostet...
-auch rechne ich nochmals mit einen Rückseter -vielleicht sogar bis in die 13 hinein. Aber spätestens dann muß der Kram wieder drehen. Unter 12 siehts dann schon wieder traurig aus...und ich bin raus.
Auch habe ich keine Ahnung ob das so richtig ist wie ichs sehe, ist mir auch scheißegal hauptsache man hat sowas wie nen Plan und glaubt daran.
Mit Deinen Optionen ists natürlich schlimmer mit dem Schmerz.
wird schon werden
Meine Stimme sagte kürzlich zu mir geh da mal wieder rein und wart ab ob das W wie im meisten Falle nach oben ausbricht...
...habs glaube schon ma gepostet...
-auch rechne ich nochmals mit einen Rückseter -vielleicht sogar bis in die 13 hinein. Aber spätestens dann muß der Kram wieder drehen. Unter 12 siehts dann schon wieder traurig aus...und ich bin raus.
Auch habe ich keine Ahnung ob das so richtig ist wie ichs sehe, ist mir auch scheißegal hauptsache man hat sowas wie nen Plan und glaubt daran.
Mit Deinen Optionen ists natürlich schlimmer mit dem Schmerz.
wird schon werden
Antwort auf Beitrag Nr.: 28.988.719 von Nostarowie am 25.04.07 14:23:23
Hi Nosta,
das mit Deinem "W" ist ja irgendwie `ne prima Sache, aber verlassen kannst Du Dich da auch nicht drauf, oder ?
Elan wird sicherlich irgendwann ausbrechen und ev. auch abgehn wie `ne Rakete ... da ist alles drin zwischen 10 und 1000 Dollar.
Nur wann, wie schnell dann ... und wie hoch, das kann kein Mensch
vorhersagen (und wer es wagt, der lügt).
Ich hätte letztens auch niemals gedacht, daß DNDN da über Nacht mal eben Richtung 25 Dollar rennt, von 5 Dollar kommend.
Alles ist möglich ...
Hi Nosta,
das mit Deinem "W" ist ja irgendwie `ne prima Sache, aber verlassen kannst Du Dich da auch nicht drauf, oder ?
Elan wird sicherlich irgendwann ausbrechen und ev. auch abgehn wie `ne Rakete ... da ist alles drin zwischen 10 und 1000 Dollar.
Nur wann, wie schnell dann ... und wie hoch, das kann kein Mensch
vorhersagen (und wer es wagt, der lügt).
Ich hätte letztens auch niemals gedacht, daß DNDN da über Nacht mal eben Richtung 25 Dollar rennt, von 5 Dollar kommend.
Alles ist möglich ...
Was anderes ...
Hat gestern Abend jemand Kerner gesehn ?
Da war eine junge MS-Kranke zu Gast, die über ihre Krankheit
berichtete. Ich hab noch meinen Rekorder gestartet, aber als sie grad so erzählte, wie ihre Erkrankung entdeckt wurde, da war meine Platte voll ... Mist.
Tät mich ja mal interessieren, welche Medikation bei ihr angewendet wird oder ob sogar der Name Tysabri ins Gespräch gebracht wurde.
Hat gestern Abend jemand Kerner gesehn ?
Da war eine junge MS-Kranke zu Gast, die über ihre Krankheit
berichtete. Ich hab noch meinen Rekorder gestartet, aber als sie grad so erzählte, wie ihre Erkrankung entdeckt wurde, da war meine Platte voll ... Mist.
Tät mich ja mal interessieren, welche Medikation bei ihr angewendet wird oder ob sogar der Name Tysabri ins Gespräch gebracht wurde.
Antwort auf Beitrag Nr.: 28.988.988 von Holgus am 25.04.07 14:32:34Na ich sag ja man braucht einfach nen Wahn-Plan wo sich dran geklammert wird...wichtig ist nur bei scheitern desselben aufzugeben und loszulassen.
Im übrigen hast Du Dir eben selber Deine Einstellung zu elan gegeben.
Allso jammer nicht rum...
Im übrigen hast Du Dir eben selber Deine Einstellung zu elan gegeben.
Allso jammer nicht rum...
Antwort auf Beitrag Nr.: 28.989.550 von Nostarowie am 25.04.07 14:50:49
Bäääh ... ... ich jammer doch gar nich.
Ab und zu mal etwas Brechreiz ist gut für die schlanke Linie.
Wogegen ich mich wehre, sind diese blöden Postings mit Preisvorhersagungen (tschulligung, ich Knallkopf hab je gestern selber gesagt "wir sehen uns in den 13nern" ... kommt nich wieder vor).
... für Birgitigitt
Bäääh ... ... ich jammer doch gar nich.
Ab und zu mal etwas Brechreiz ist gut für die schlanke Linie.
Wogegen ich mich wehre, sind diese blöden Postings mit Preisvorhersagungen (tschulligung, ich Knallkopf hab je gestern selber gesagt "wir sehen uns in den 13nern" ... kommt nich wieder vor).
... für Birgitigitt
Antwort auf Beitrag Nr.: 28.989.748 von Holgus am 25.04.07 14:57:46OK Du Motzkopp!!Ich nehm`den Keks!
WYE tomorrow
as i have said before I love that ELN provides relatively undiluted and more leveraged investments in tysabri, drug delivery, and the immunotherapeutic approach for alzheimers disease - but I think they have not shown the ability to market a drug and gain acceptance and a proper valuation from wall street - their CC's are loaded with interesting info and promising angles but they seem to be unable to make wall street understand why what they are saying is important and how to value what they are doing
thus
I am going to rely on the BIIB analysis for tysabri (which I imagine will be much more upbeat and informative) and I am going to rely on WYE for the information on how aab-001 will move forward in the clinics
I have no choice but to rely on ELN for DD/nano information which by the way is almost zero call after call - of course we have heard about just how big it is going to be in the next year but without some granularity I don't think that the market knows how to value the DD/nano/manufacturing without info and without at least a separated structure
http://www.investorvillage.com/smbd.asp?mb=160&mn=101351&pt=…
...also, dann schauen wir mal, was WYETH morgen vom Stapel lässt....
as i have said before I love that ELN provides relatively undiluted and more leveraged investments in tysabri, drug delivery, and the immunotherapeutic approach for alzheimers disease - but I think they have not shown the ability to market a drug and gain acceptance and a proper valuation from wall street - their CC's are loaded with interesting info and promising angles but they seem to be unable to make wall street understand why what they are saying is important and how to value what they are doing
thus
I am going to rely on the BIIB analysis for tysabri (which I imagine will be much more upbeat and informative) and I am going to rely on WYE for the information on how aab-001 will move forward in the clinics
I have no choice but to rely on ELN for DD/nano information which by the way is almost zero call after call - of course we have heard about just how big it is going to be in the next year but without some granularity I don't think that the market knows how to value the DD/nano/manufacturing without info and without at least a separated structure
http://www.investorvillage.com/smbd.asp?mb=160&mn=101351&pt=…
...also, dann schauen wir mal, was WYETH morgen vom Stapel lässt....
Antwort auf Beitrag Nr.: 28.993.574 von Birgit.Tersteegen am 25.04.07 16:50:20OK Du Motzkopp!!Ich nehm`den Keks!
Frau Tersteegen, bitte mal bücken ...
Frau Tersteegen, bitte mal bücken ...
Wyeth Webcast information - 9:30am Eastern
Wyeth (NYSE: WYE) will webcast its Annual Meeting of Stockholders, which is being held on
Thursday, April 26, 2007, at 9:30 a.m. (EDT).
On that day, a live audio webcast of the Meeting will be available to all interested parties, which may be accessed by visiting the Wyeth website at http://www.wyeth.com and clicking on the "Investor Relations" icon.
Wyeth (NYSE: WYE) will webcast its Annual Meeting of Stockholders, which is being held on
Thursday, April 26, 2007, at 9:30 a.m. (EDT).
On that day, a live audio webcast of the Meeting will be available to all interested parties, which may be accessed by visiting the Wyeth website at http://www.wyeth.com and clicking on the "Investor Relations" icon.
Antwort auf Beitrag Nr.: 29.008.501 von bernie55 am 26.04.07 08:53:12
Title Wyeth's 2007 Annual Meeting of Stockholders
Date and Time Thursday, April 26, 2007 9:30 a.m. ET
Duration 1 Hour 30 Minutes
Location 3 Speedwell Avenue
Morristown, NJ
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetail…
Title Wyeth's 2007 Annual Meeting of Stockholders
Date and Time Thursday, April 26, 2007 9:30 a.m. ET
Duration 1 Hour 30 Minutes
Location 3 Speedwell Avenue
Morristown, NJ
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetail…
Interview with Wyeth R&D Chief
Long, rambling interview. The real item of interest is how Ruffolo focuses on the Alz program without any prompting. Wyeth has a lot going on this year with new drug applications, and yet the ONLY program which Ruffolo talks about in depth is the Alz program. Wyeth may not trumpet the Alz research at its quarterly conference calls because it is only Phase II (and the analysts don't care at this point), but the organization is obsessed with the program.
http://www.nj.com/business/ledger/index.ssf?/base/business-0…
Researcher makes his mark
By establishing goals, Robert Ruffolo helped Wyeth step up its R&D game
Wednesday, April 25, 2007
BY SUSAN TODD
Star-Ledger Staff
If Robert Ruffolo has his way, Wyeth's research labs never again will suffer through a dry spell.
Ruffolo, the drugmaker's chief researcher, stirred things up when he began setting quotas for his scientists seven years ago. Now, the Madison-based company is taking at least two potential new medicines to the Food and Drug Administration every year. Wyeth spent more than $3 billion on research and development last year. These days, Wyeth is making huge bets on Alzheimer's disease. At last count, the company had a dozen potential Alzheimer's drugs in its pipeline, as scientists continue to unravel the daunting, progressive brain disease.
Ruffolo, who previously worked as a researcher at SmithKline Beecham (now GlaxoSmithKline), sat down with The Star-Ledger re cently to reflect on Wyeth's new- found productivity.
No conversation with the 57-year-old scientist would be complete without mention of his guitar- playing, which evokes almost as much enthusiasm from him as all those new medicines Wyeth's labs are pushing out. His instrument of choice: a Fender Stratocaster.
When you arrived at Wyeth seven years ago, you set out to energize the labs. Have you finished your work?
We're never finished, but we've come a long way. I think once you think you're finished, that's the beginning of the end. I think large companies that have gotten themselves in trouble are the ones who thought they knew how to do this, how to discover and develop new drugs.
We set very aggressive metrics and objectives that scientists had to hit. We put their compensation at risk, so if they hit their objectives, they could enhance their compensation, and if they didn't, they could lose a significant part of their compensation. So their skin is in the game. We set up a system that values productivity. When you do that, when you have a metrics-based system, you also have to put in safeguards so the quality doesn't slip and the system can't be gamed.
The results have been significant. We made a commitment seven years ago to be the first company to file two new drug ap plications per year, every year. That's never been done, not even by companies that are three times bigger. They may submit two in a year, but not every year. We did two of them in 2005. We did four new drug applications in 2006. We already have one submitted this year. With the system we set up with all the metrics, we see this going into the future.
You can't plan a business around a couple of launches and then have a long dry spell. We are a business and that's how we get our R&D money. We were trying to set up a system that allowed us to provide a significant number of new products to sustain the growth of this company. That's exactly what we did. Some of your critics said the quality of research at Wyeth would be compromised by a system that relied on quotas. What have the results shown? I guess the proof is in the pudding: We're making new drugs. When we started this system, our success rate for getting a drug from discovery into phase one (the first phase of clinical trials) was 70 percent. That was also the industry norm. The in dustry norm has now fallen to 55 percent. Wyeth went from 70 percent to 83 percent. I would argue our quality went up. Tell us about Wyeth's work to find a treatment for Alzheimer's disease. Our CEO, Bob Essner, has declared a war against Alzheimer's disease. He considers it the next epidemic of our health-care system. It's not an epidemic that's spread such as the flu. It's an epidemic in that we're all living longer. The number of patients affected by the disease is going to increase, and it's going to put a burden on the health-care system that we've never, ever seen be fore.
Right now, Alzheimer's disease impacts the U.S. health-care system to a tune of over $100 billion (a year) in direct and indirect costs. There isn't adequate therapy; there are a couple of drugs that are palliative. One of the things we do at Wyeth is focus on areas of high, unmet medical need. That's why you don't see us making new drugs for high blood pressure or new drugs to lower cholesterol. We don't do that. Alzheimer's disease is an area with very high unmet medical need and a very high economic burden, and, of course, we believe if we're successful, we can get a return on the investment as well.
Having declared this war on Alzheimer's disease, Wyeth in vested heavily, not only in neu rosciences, but particularly in Alzheimer's disease. We have 11 drugs in development right now. We're putting another one into development in another week or two. How is Wyeth searching for these new drugs? The term I like to use is scorched earth. We have a common hypothesis (about Alzheim er's) based on amyloid deposits in the brain -- these plaques. We're looking at every way this plaque is formed, synthesized, comes together and is potentially eliminated. We know a lot about all of that now, so we can attack each one of these processes. It's not just 12 drugs working on one mechanism. It's 11 and soon to be 12 drugs working by probably six, seven mechanisms attacking different parts of this, because we don't know what is the best part to attack. ... That's what I mean by scorched earth. These drugs will all be new and heavy duty. What about the risks? My main hope is that they work. I'm a little bit different than the rest of the world right now, which is focused on safety, safety, safety. I worry a little less about the side effects because some of them, you may be able to deal with. Some of them, you may not. The drug has to work first; otherwise, nothing else matters. Some of the vaccines and biotech drugs, if they work, will have to be given by injection. The good news is, a vaccine might only have to be given a couple of times a year and that's it.
But the side effects ... I guess I'll get on my soapbox for a minute. Every drug should be prescribed based on its risk and its benefit. It's a ratio. What frustrates me right now is the almost obsessive focus on risk is only one part of that ratio. Did you ever take your calculator and put in a number and divide it by zero. Do you know what it will tell you? Does not compute. You can't divide by zero. When I see and read debates about risk, risk, risk, it doesn't mean anything unless you put it in context with the benefit.
We spent a great deal of time hearing about the risk of heart at tack with Vioxx. Heart attack is a pretty bad side effect. But we also know oral contraceptives have a risk of heart attack. It's very low. We as a society, women, have decided reproductive freedom is worth the risk. If you take the benefit out of there, we have a meaningless debate.
Yes, these drugs will have some side effects. We don't know what they are. That's what we measure in our clinical trials. You can imagine the tolerability of the side effects will be far greater for a horrible disease like this than they would be for a drug that lowers blood pressure. Our clinical trials are getting larger and larger as people's and regulators' expec tations for safety may be approaching the unachievable, which is my biggest fear and what I worry about in this office.
One of the reasons you can't just buy drugs is because they aren't meant to be totally and absolutely risk free. That's why you have to go to the doctor, get diagnosed and get a prescription. I don't know who promised the world that these things are risk- free, but I don't remember that promise. Like some of the other major drug companies, Wyeth is trying to reduce the time and expense involved in clinical trials -- an important phase of drug development. What's the status of your efforts? We waste a lot of time between phases. It can be two to three years in an already very long development process. It really does take 15 years to make a drug. If we could capture a few of those years, that would be terrific. The Food and Drug Administration was very positive. European regulators were very positive. We changed our whole system and put in place over 100 metrics. We agreed on the final metrics just this week. Will we cut time and save money? Will we get drugs to patients sooner? I don't know, but I'll know in a year or so. So, are you still playing the guitar? Yes. I would love to be a rock star. We're just a bunch of old R&D guys who want to play music. We have a solemn promise not to reveal the name of our band. We did play in public once, a year ago in September. We packed the place. We really didn't stink.
Long, rambling interview. The real item of interest is how Ruffolo focuses on the Alz program without any prompting. Wyeth has a lot going on this year with new drug applications, and yet the ONLY program which Ruffolo talks about in depth is the Alz program. Wyeth may not trumpet the Alz research at its quarterly conference calls because it is only Phase II (and the analysts don't care at this point), but the organization is obsessed with the program.
http://www.nj.com/business/ledger/index.ssf?/base/business-0…
Researcher makes his mark
By establishing goals, Robert Ruffolo helped Wyeth step up its R&D game
Wednesday, April 25, 2007
BY SUSAN TODD
Star-Ledger Staff
If Robert Ruffolo has his way, Wyeth's research labs never again will suffer through a dry spell.
Ruffolo, the drugmaker's chief researcher, stirred things up when he began setting quotas for his scientists seven years ago. Now, the Madison-based company is taking at least two potential new medicines to the Food and Drug Administration every year. Wyeth spent more than $3 billion on research and development last year. These days, Wyeth is making huge bets on Alzheimer's disease. At last count, the company had a dozen potential Alzheimer's drugs in its pipeline, as scientists continue to unravel the daunting, progressive brain disease.
Ruffolo, who previously worked as a researcher at SmithKline Beecham (now GlaxoSmithKline), sat down with The Star-Ledger re cently to reflect on Wyeth's new- found productivity.
No conversation with the 57-year-old scientist would be complete without mention of his guitar- playing, which evokes almost as much enthusiasm from him as all those new medicines Wyeth's labs are pushing out. His instrument of choice: a Fender Stratocaster.
When you arrived at Wyeth seven years ago, you set out to energize the labs. Have you finished your work?
We're never finished, but we've come a long way. I think once you think you're finished, that's the beginning of the end. I think large companies that have gotten themselves in trouble are the ones who thought they knew how to do this, how to discover and develop new drugs.
We set very aggressive metrics and objectives that scientists had to hit. We put their compensation at risk, so if they hit their objectives, they could enhance their compensation, and if they didn't, they could lose a significant part of their compensation. So their skin is in the game. We set up a system that values productivity. When you do that, when you have a metrics-based system, you also have to put in safeguards so the quality doesn't slip and the system can't be gamed.
The results have been significant. We made a commitment seven years ago to be the first company to file two new drug ap plications per year, every year. That's never been done, not even by companies that are three times bigger. They may submit two in a year, but not every year. We did two of them in 2005. We did four new drug applications in 2006. We already have one submitted this year. With the system we set up with all the metrics, we see this going into the future.
You can't plan a business around a couple of launches and then have a long dry spell. We are a business and that's how we get our R&D money. We were trying to set up a system that allowed us to provide a significant number of new products to sustain the growth of this company. That's exactly what we did. Some of your critics said the quality of research at Wyeth would be compromised by a system that relied on quotas. What have the results shown? I guess the proof is in the pudding: We're making new drugs. When we started this system, our success rate for getting a drug from discovery into phase one (the first phase of clinical trials) was 70 percent. That was also the industry norm. The in dustry norm has now fallen to 55 percent. Wyeth went from 70 percent to 83 percent. I would argue our quality went up. Tell us about Wyeth's work to find a treatment for Alzheimer's disease. Our CEO, Bob Essner, has declared a war against Alzheimer's disease. He considers it the next epidemic of our health-care system. It's not an epidemic that's spread such as the flu. It's an epidemic in that we're all living longer. The number of patients affected by the disease is going to increase, and it's going to put a burden on the health-care system that we've never, ever seen be fore.
Right now, Alzheimer's disease impacts the U.S. health-care system to a tune of over $100 billion (a year) in direct and indirect costs. There isn't adequate therapy; there are a couple of drugs that are palliative. One of the things we do at Wyeth is focus on areas of high, unmet medical need. That's why you don't see us making new drugs for high blood pressure or new drugs to lower cholesterol. We don't do that. Alzheimer's disease is an area with very high unmet medical need and a very high economic burden, and, of course, we believe if we're successful, we can get a return on the investment as well.
Having declared this war on Alzheimer's disease, Wyeth in vested heavily, not only in neu rosciences, but particularly in Alzheimer's disease. We have 11 drugs in development right now. We're putting another one into development in another week or two. How is Wyeth searching for these new drugs? The term I like to use is scorched earth. We have a common hypothesis (about Alzheim er's) based on amyloid deposits in the brain -- these plaques. We're looking at every way this plaque is formed, synthesized, comes together and is potentially eliminated. We know a lot about all of that now, so we can attack each one of these processes. It's not just 12 drugs working on one mechanism. It's 11 and soon to be 12 drugs working by probably six, seven mechanisms attacking different parts of this, because we don't know what is the best part to attack. ... That's what I mean by scorched earth. These drugs will all be new and heavy duty. What about the risks? My main hope is that they work. I'm a little bit different than the rest of the world right now, which is focused on safety, safety, safety. I worry a little less about the side effects because some of them, you may be able to deal with. Some of them, you may not. The drug has to work first; otherwise, nothing else matters. Some of the vaccines and biotech drugs, if they work, will have to be given by injection. The good news is, a vaccine might only have to be given a couple of times a year and that's it.
But the side effects ... I guess I'll get on my soapbox for a minute. Every drug should be prescribed based on its risk and its benefit. It's a ratio. What frustrates me right now is the almost obsessive focus on risk is only one part of that ratio. Did you ever take your calculator and put in a number and divide it by zero. Do you know what it will tell you? Does not compute. You can't divide by zero. When I see and read debates about risk, risk, risk, it doesn't mean anything unless you put it in context with the benefit.
We spent a great deal of time hearing about the risk of heart at tack with Vioxx. Heart attack is a pretty bad side effect. But we also know oral contraceptives have a risk of heart attack. It's very low. We as a society, women, have decided reproductive freedom is worth the risk. If you take the benefit out of there, we have a meaningless debate.
Yes, these drugs will have some side effects. We don't know what they are. That's what we measure in our clinical trials. You can imagine the tolerability of the side effects will be far greater for a horrible disease like this than they would be for a drug that lowers blood pressure. Our clinical trials are getting larger and larger as people's and regulators' expec tations for safety may be approaching the unachievable, which is my biggest fear and what I worry about in this office.
One of the reasons you can't just buy drugs is because they aren't meant to be totally and absolutely risk free. That's why you have to go to the doctor, get diagnosed and get a prescription. I don't know who promised the world that these things are risk- free, but I don't remember that promise. Like some of the other major drug companies, Wyeth is trying to reduce the time and expense involved in clinical trials -- an important phase of drug development. What's the status of your efforts? We waste a lot of time between phases. It can be two to three years in an already very long development process. It really does take 15 years to make a drug. If we could capture a few of those years, that would be terrific. The Food and Drug Administration was very positive. European regulators were very positive. We changed our whole system and put in place over 100 metrics. We agreed on the final metrics just this week. Will we cut time and save money? Will we get drugs to patients sooner? I don't know, but I'll know in a year or so. So, are you still playing the guitar? Yes. I would love to be a rock star. We're just a bunch of old R&D guys who want to play music. We have a solemn promise not to reveal the name of our band. We did play in public once, a year ago in September. We packed the place. We really didn't stink.
Wyeth - Alz presentation
...... need industry focus
......trying to show why Alz is an epedimic and so important.
..... apparently showing regular brain and brain on Alz.
..... wyeth wants to modify disease
..... decrease the rate of the disease is target. also doing symptomatic drugs.
.... ultimate goal to extend quality life and out of insititution.
..... talking about how a-beta is formed.
..... showing slides of plaque scans. explaining plaque
..... Wyeth has most expensive alz programs. more coming this year.
..... Vaccines, Proteins and small molecules, Wyeth only company with all three.
.... Manny - 12 in clinical development - attack disease process and symptoms
.... disease modifying vaccines
Lead product - AAB
AAB-002 is back up.
Vaccine approach - ACC-001 Lead program
Acc-002 phase behind that
Showing mice slides
A complete removal in animals and we think we can do this in humans.
AAB Lead program then ACC-001
-------- next small molecule
1st - Paz 417
2nd - gsi 953
(may have missed the names)
......... Back to huge impact of Alzheimers' summary perhaps. nothing new. hopefully some questions.
.................. Bob and Manny done............
That's seems to be it for now. Just a review of the products. Lots of beating of the message of the upcoming epidimic.
........... now to questions.....
http://www.investorvillage.com/smbd.asp?mb=160&mn=101767&pt=…
...... need industry focus
......trying to show why Alz is an epedimic and so important.
..... apparently showing regular brain and brain on Alz.
..... wyeth wants to modify disease
..... decrease the rate of the disease is target. also doing symptomatic drugs.
.... ultimate goal to extend quality life and out of insititution.
..... talking about how a-beta is formed.
..... showing slides of plaque scans. explaining plaque
..... Wyeth has most expensive alz programs. more coming this year.
..... Vaccines, Proteins and small molecules, Wyeth only company with all three.
.... Manny - 12 in clinical development - attack disease process and symptoms
.... disease modifying vaccines
Lead product - AAB
AAB-002 is back up.
Vaccine approach - ACC-001 Lead program
Acc-002 phase behind that
Showing mice slides
A complete removal in animals and we think we can do this in humans.
AAB Lead program then ACC-001
-------- next small molecule
1st - Paz 417
2nd - gsi 953
(may have missed the names)
......... Back to huge impact of Alzheimers' summary perhaps. nothing new. hopefully some questions.
.................. Bob and Manny done............
That's seems to be it for now. Just a review of the products. Lots of beating of the message of the upcoming epidimic.
........... now to questions.....
http://www.investorvillage.com/smbd.asp?mb=160&mn=101767&pt=…
akt up-schub auf 14,50
da muss doch grad was passiert sein ?
da muss doch grad was passiert sein ?
Antwort auf Beitrag Nr.: 29.018.142 von zenman am 26.04.07 17:49:30mal einige Postings aus dem IV zu Wyeth - Alz presentation
The "news in the not to distant future" backs up Kellys..."peek in H1 07" statement..
ACC-002 came up on the slide under ACC-001
If so this is new... a second vaccine candidate. (or mayvbe he said AAB002..??)
The slide showed two vaccines and two anti-bodies: acc-001, acc-002, aab-001, aab-002. All four compounds were marked with an asterisk to represent that they were in collaboration with Elan.
news is different than, and better than, a peek. Peek doesn't mean news, but news means success
The "news in the not to distant future" backs up Kellys..."peek in H1 07" statement..
ACC-002 came up on the slide under ACC-001
If so this is new... a second vaccine candidate. (or mayvbe he said AAB002..??)
The slide showed two vaccines and two anti-bodies: acc-001, acc-002, aab-001, aab-002. All four compounds were marked with an asterisk to represent that they were in collaboration with Elan.
news is different than, and better than, a peek. Peek doesn't mean news, but news means success
Artikel aus einer französischen Zeitung
Associated Press le 26/04/2007 18:54
auteur : Florence Sebaoun --
Sclérose en plaques: des avancées majeures
http://clubobs.nouvelobs.com/article/2007/04/26/20070426.FAP…
Überstzung mit Babbel-fish
In fünfzehn Jahren hat die Übernahme der multiplen Sklerose, eine Nervenkrankheit, die durch verbreitete Verletzungen des Gehirns und/oder des Rückenmarkmarkes charakterisiert wurde, beträchtlich gewechselt. Die sehr aktive Forschung, von der sie macht l'objet, ist für die 80.000 Personen Träger-, d'espoir, die in Frankreich erreicht wurden. Donnerstag in Paris durch l'ARSEP versammelte Spezialisten (Assoziation der Forschung zur multiplen Sklerose), haben eine detaillierte Bilanz der Vorsprünge aufgestellt neu erhalten sowohl im Bereich des Verständnisses ihrer Mechanismen als auch in jenem ihrer Diagnostik oder ihrer Behandlungen. Das zentrale Nervensystem wird von Zellen gemacht die Neurone, die nervöse l'influx befördern. L'axone, eines der Verlängerungen des Neurons ist umgeben d'une umhüllen schützend myéline, das sie eine schnelle l'influxleitung nährt, schützt und erlaubt nervös. Die multiple Sklerose wird durch einen Angriff der Muffen myéline des zentralen Nervensystems gefolgten charakterisiert d'une Entartung von axones. Ein Phänomen, das auf die Umwandlung der Lymphozyte zurückzuführen ist, die Immunzelle des Blutes in aggressiver aktivierter Lymphozyte. Umgewandelt geht die Lymphozyte sich auf das wuchernde zentrale Nervensystem (SNC) dort ein teilt, indem sie so eine entzündliche Reaktion verursacht. Er sondert Moleküle ab oder cytokines und bewirkt die Produktion d'anticorps, was zur Zerstörung von myéline und von l'axone führt. Für s'opposer an dieser Penetration ziehen die Wissenschaftler in Betracht aujourd'hui, auf der l'inflammation"kontrolle "d'agir;, Pr Alain Creange erklärt hat (Hôpital Henri Mondor, Créteil). "La wäre Wucherung der Lymphozyten auf einen Fehler der Kontrolle des entzündlichen Vorgangs durch Unzulänglichkeit der Zellen zurückzuführen régulatrices", hat er am Kurs d'une Pressekonferenz unterstrichen. An "moduler diesen Zellen erfolgreich sein könnte gut ein Weg sein thérapeutique" für morgen. Was Gehirnl'imagerie betrifft l'IRM bleibt grundlegendes l'outil im Bereich der Diagnostik. "On l'utilise au quotidien", unterstrich Dr. Bruno Stankoff (Krankenhausgroupe Pitié-Salpétrière). "Elle erlaubt, die entzündlichen Verletzungen und die démyélinisationsverletzungen zu veranschaulichen. Sie erlaubt sogar d'en zu datieren certaines", hat er hinzugefügt. "Avec konventionelles l'IRM messen wir l'étendue von l'atrophie anspruchsvollem, l'IRM nicht konventionell erlaubt uns, den Verlust der Fasern zu quantifizieren nerveuses". Morgen werden "l'arrivée d'IRM noch leistungsstärker an höherem Magnetfeld erlauben, Verletzungen zu sehen microscopiques". Anderes Forschungsgebiet, die Reparatur von myéline, von man weiß jetzt "qu'elle vorkommt oft, der Art und Weise spontanée", erklärte Pr Catherine Lubetzki (Krankenhausgroupe Pitié - Salpétrière). "Cette spontane Reparatur betrifft ungefähr zwei Drittel der Verletzungen, was viel mehr ist als, was l'on pensait", hat sie hinzugefügt. "Il besteht Bons und schlechte Handwerker cellulaires" und "actuellement, die Forschungswege beziehen sich auf das Verständnis dieses Phänomens. Man denkt qu'il besteht behindernde Faktoren des remyélinisation und d'autres, das im Gegenteil es favoriseraient". "En reformant schützt myéline l'axone und verhindert das neurodégénérescence", hat sie verfolgt. Die nervöse Leitung wird wiederhergestellt, was einen partiellen oder vollständigen Rückgang der Symptome bewirkt. Infolgedessen werden zwei Arten von Strategien erforscht: "celle, das dieses spontane remyélinisation begünstigt, indem es die Bons ausrichtet facteurs", und jene, die am "développer exogenen myélinisation mit Hilfe von Stammzellen immatures d'oligodendrocytes oder von Zellen von Schwann" spannt;. Was die Behandlungen betrifft noch nicht vorhanden gibt es etwa zehn d'années, sie erlauben aujourd'hui eine deutliche Verbesserung der nachlassenden Formen, c'est-à-dire von den Formen, die sich durch Schübe entwickeln: so die immuno- Modulationsröhren, die erlauben, um 30% die Häufigkeit dieser Schübe und den mittelfristigen Schwachpunkt wahrscheinlich zu vermindern. Ein um das natalizumab demnächst erweitertes therapeutisches Arsenal, vermenschlichte monoklonale Antikörper, dessen Vermarktung in Frankreich für den Monat Juni vorgesehen ist. "Le erlaubt Natalizumab eine Reduzierung der Schübe von 60% und verzögert den Schwachpunkt clinique", unterstrich Bruno Stankoff, der vor seinen Nebenwirkungen warnt, die davon ein Arzneimittel machen, das an den strengen Formen der Krankheit eingeschränkt wurde.
Associated Press le 26/04/2007 18:54
auteur : Florence Sebaoun --
Sclérose en plaques: des avancées majeures
http://clubobs.nouvelobs.com/article/2007/04/26/20070426.FAP…
Überstzung mit Babbel-fish
In fünfzehn Jahren hat die Übernahme der multiplen Sklerose, eine Nervenkrankheit, die durch verbreitete Verletzungen des Gehirns und/oder des Rückenmarkmarkes charakterisiert wurde, beträchtlich gewechselt. Die sehr aktive Forschung, von der sie macht l'objet, ist für die 80.000 Personen Träger-, d'espoir, die in Frankreich erreicht wurden. Donnerstag in Paris durch l'ARSEP versammelte Spezialisten (Assoziation der Forschung zur multiplen Sklerose), haben eine detaillierte Bilanz der Vorsprünge aufgestellt neu erhalten sowohl im Bereich des Verständnisses ihrer Mechanismen als auch in jenem ihrer Diagnostik oder ihrer Behandlungen. Das zentrale Nervensystem wird von Zellen gemacht die Neurone, die nervöse l'influx befördern. L'axone, eines der Verlängerungen des Neurons ist umgeben d'une umhüllen schützend myéline, das sie eine schnelle l'influxleitung nährt, schützt und erlaubt nervös. Die multiple Sklerose wird durch einen Angriff der Muffen myéline des zentralen Nervensystems gefolgten charakterisiert d'une Entartung von axones. Ein Phänomen, das auf die Umwandlung der Lymphozyte zurückzuführen ist, die Immunzelle des Blutes in aggressiver aktivierter Lymphozyte. Umgewandelt geht die Lymphozyte sich auf das wuchernde zentrale Nervensystem (SNC) dort ein teilt, indem sie so eine entzündliche Reaktion verursacht. Er sondert Moleküle ab oder cytokines und bewirkt die Produktion d'anticorps, was zur Zerstörung von myéline und von l'axone führt. Für s'opposer an dieser Penetration ziehen die Wissenschaftler in Betracht aujourd'hui, auf der l'inflammation"kontrolle "d'agir;, Pr Alain Creange erklärt hat (Hôpital Henri Mondor, Créteil). "La wäre Wucherung der Lymphozyten auf einen Fehler der Kontrolle des entzündlichen Vorgangs durch Unzulänglichkeit der Zellen zurückzuführen régulatrices", hat er am Kurs d'une Pressekonferenz unterstrichen. An "moduler diesen Zellen erfolgreich sein könnte gut ein Weg sein thérapeutique" für morgen. Was Gehirnl'imagerie betrifft l'IRM bleibt grundlegendes l'outil im Bereich der Diagnostik. "On l'utilise au quotidien", unterstrich Dr. Bruno Stankoff (Krankenhausgroupe Pitié-Salpétrière). "Elle erlaubt, die entzündlichen Verletzungen und die démyélinisationsverletzungen zu veranschaulichen. Sie erlaubt sogar d'en zu datieren certaines", hat er hinzugefügt. "Avec konventionelles l'IRM messen wir l'étendue von l'atrophie anspruchsvollem, l'IRM nicht konventionell erlaubt uns, den Verlust der Fasern zu quantifizieren nerveuses". Morgen werden "l'arrivée d'IRM noch leistungsstärker an höherem Magnetfeld erlauben, Verletzungen zu sehen microscopiques". Anderes Forschungsgebiet, die Reparatur von myéline, von man weiß jetzt "qu'elle vorkommt oft, der Art und Weise spontanée", erklärte Pr Catherine Lubetzki (Krankenhausgroupe Pitié - Salpétrière). "Cette spontane Reparatur betrifft ungefähr zwei Drittel der Verletzungen, was viel mehr ist als, was l'on pensait", hat sie hinzugefügt. "Il besteht Bons und schlechte Handwerker cellulaires" und "actuellement, die Forschungswege beziehen sich auf das Verständnis dieses Phänomens. Man denkt qu'il besteht behindernde Faktoren des remyélinisation und d'autres, das im Gegenteil es favoriseraient". "En reformant schützt myéline l'axone und verhindert das neurodégénérescence", hat sie verfolgt. Die nervöse Leitung wird wiederhergestellt, was einen partiellen oder vollständigen Rückgang der Symptome bewirkt. Infolgedessen werden zwei Arten von Strategien erforscht: "celle, das dieses spontane remyélinisation begünstigt, indem es die Bons ausrichtet facteurs", und jene, die am "développer exogenen myélinisation mit Hilfe von Stammzellen immatures d'oligodendrocytes oder von Zellen von Schwann" spannt;. Was die Behandlungen betrifft noch nicht vorhanden gibt es etwa zehn d'années, sie erlauben aujourd'hui eine deutliche Verbesserung der nachlassenden Formen, c'est-à-dire von den Formen, die sich durch Schübe entwickeln: so die immuno- Modulationsröhren, die erlauben, um 30% die Häufigkeit dieser Schübe und den mittelfristigen Schwachpunkt wahrscheinlich zu vermindern. Ein um das natalizumab demnächst erweitertes therapeutisches Arsenal, vermenschlichte monoklonale Antikörper, dessen Vermarktung in Frankreich für den Monat Juni vorgesehen ist. "Le erlaubt Natalizumab eine Reduzierung der Schübe von 60% und verzögert den Schwachpunkt clinique", unterstrich Bruno Stankoff, der vor seinen Nebenwirkungen warnt, die davon ein Arzneimittel machen, das an den strengen Formen der Krankheit eingeschränkt wurde.
Antwort auf Beitrag Nr.: 29.026.741 von bernie55 am 27.04.07 10:45:28bin beeindruckt, Bernie.
Ich habe schon Probleme bei den englischen Texten einen Bezug auf Tysabri (Natalizumab) zu finden. An französiche Texte brauche ich mich gar nicht erst versuchen.
Hört sich aber wieder einmal sehr gut an.
Ich habe schon Probleme bei den englischen Texten einen Bezug auf Tysabri (Natalizumab) zu finden. An französiche Texte brauche ich mich gar nicht erst versuchen.
Hört sich aber wieder einmal sehr gut an.
Nichts desto Trotz, habe ich heute einen Teil meiner ADRs in FFM veräußert.
Normalerweise dürfte in den nächsten Wochen nichts dramatisches bei ELAN passieren
(bei meinem Glück kommt morgen die SUPERMELDUNG, auf die wir seit Monaten warten)
Den Großteil meiner Aktien halte ich natürlich weiterhin.
Mal sehen ob ich in den nächsten Tagen noch einmal bei Dendreon nachlege, oder ein anderes Investment finde.
Normalerweise dürfte in den nächsten Wochen nichts dramatisches bei ELAN passieren
(bei meinem Glück kommt morgen die SUPERMELDUNG, auf die wir seit Monaten warten)
Den Großteil meiner Aktien halte ich natürlich weiterhin.
Mal sehen ob ich in den nächsten Tagen noch einmal bei Dendreon nachlege, oder ein anderes Investment finde.
Antwort auf Beitrag Nr.: 29.029.166 von Poppholz am 27.04.07 13:07:09Oha, das beunruhigt mich jetzt Poppi, echt. Du als Superlongie.
Hm das ist wie wenn der Flugkapitän einer Boing seinem Triebwerk nicht mehr traut.
Ich bin einigermaßen aufgewühlt und nervös nun....als Passagier.
Hm das ist wie wenn der Flugkapitän einer Boing seinem Triebwerk nicht mehr traut.
Ich bin einigermaßen aufgewühlt und nervös nun....als Passagier.
Antwort auf Beitrag Nr.: 29.029.654 von Nostarowie am 27.04.07 13:42:25dafür besteht kein Grund.
Wollte nur ein wenig "Spielgeld" locker machen, da mein Long-Depot (über ein Jahr alte Investments, die jetzt Steuerfrei sind) bei den ADRs am besten "sauber gehalten" werden kann, habe ich diese jetzt einfach genommen.
DELPHI wird in den nächsten Wochen nach oben gehen (glaube ich). Somit die Entscheidung für die ADRs.
Also alles in Ordnung.
Wollte nur ein wenig "Spielgeld" locker machen, da mein Long-Depot (über ein Jahr alte Investments, die jetzt Steuerfrei sind) bei den ADRs am besten "sauber gehalten" werden kann, habe ich diese jetzt einfach genommen.
DELPHI wird in den nächsten Wochen nach oben gehen (glaube ich). Somit die Entscheidung für die ADRs.
Also alles in Ordnung.
Antwort auf Beitrag Nr.: 29.029.654 von Nostarowie am 27.04.07 13:42:25als Passagier
..... nervös - und nun ???
flieg einfach weiter mit....
...Birgit ist doch unsere Stewardess und bringt dir einen " gekühlten Merlot ".....
..und im übrigen ist Poppie ja noch dabei....
ich mache mir viel mehr Gedanken über die neue Aktienstruktur unserer PBB Company.......
..... nervös - und nun ???
flieg einfach weiter mit....
...Birgit ist doch unsere Stewardess und bringt dir einen " gekühlten Merlot ".....
..und im übrigen ist Poppie ja noch dabei....
ich mache mir viel mehr Gedanken über die neue Aktienstruktur unserer PBB Company.......
Antwort auf Beitrag Nr.: 29.029.166 von Poppholz am 27.04.07 13:07:09Nichts desto Trotz, habe ich heute einen Teil meiner ADRs in FFM veräußert.
12:09:22 10,42 - 569
...das wird die PBB Company verkraften...
12:09:22 10,42 - 569
...das wird die PBB Company verkraften...
Antwort auf Beitrag Nr.: 29.029.761 von bernie55 am 27.04.07 13:52:22Naja bernie, weist ja wenn einer den anfang macht...dann rammeln alle anderen meist gleich hinterher.
Und dann auch noch Poppi....der Kapitän...
ich bin beunruhigt trotz kaltem Merlot.
Und dann auch noch Poppi....der Kapitän...
ich bin beunruhigt trotz kaltem Merlot.
Antwort auf Beitrag Nr.: 29.029.819 von Nostarowie am 27.04.07 13:56:35habe das Signal meines Verkaufs wohl ein wenig unterschätzt.
wenn der Kurs dadurch heute noch unter die € 5,- Grenze fallen sollte, werde ich sofort wieder kaufen, um den Kurs zu stützen.
Im Ernst:
Die 569 Stück sind wirklich meine gewesen und die gesamte Menge an ADRs in einem meiner Depots (insgesamt habe ich 5 verschiedene). Da ich in Zukunft bestimmt wieder ELAN ADRs kaufen werde, möchte ich nicht meine Steuerfreiheit der restlichen Aktien riskieren, da das Finanzamt ja nicht erkennen kann welche Aktien bereits im Depot gewesen sind und welche neu hinzu gekauft wurden und somit die Frist für alle Aktien von vorne anfängt zu laufen.
PBB ist weiterhin "Großaktionär" und könnte die SHORTIES schon ein wenig ärgern, wenn alle Aktien auf einmal zu einem Kurs von € 100,- zum Kauf angeboten werden.
wenn der Kurs dadurch heute noch unter die € 5,- Grenze fallen sollte, werde ich sofort wieder kaufen, um den Kurs zu stützen.
Im Ernst:
Die 569 Stück sind wirklich meine gewesen und die gesamte Menge an ADRs in einem meiner Depots (insgesamt habe ich 5 verschiedene). Da ich in Zukunft bestimmt wieder ELAN ADRs kaufen werde, möchte ich nicht meine Steuerfreiheit der restlichen Aktien riskieren, da das Finanzamt ja nicht erkennen kann welche Aktien bereits im Depot gewesen sind und welche neu hinzu gekauft wurden und somit die Frist für alle Aktien von vorne anfängt zu laufen.
PBB ist weiterhin "Großaktionär" und könnte die SHORTIES schon ein wenig ärgern, wenn alle Aktien auf einmal zu einem Kurs von € 100,- zum Kauf angeboten werden.
Antwort auf Beitrag Nr.: 29.030.054 von Poppholz am 27.04.07 14:12:53Ich bin wieder beruhigt.
Antwort auf Beitrag Nr.: 29.029.732 von bernie55 am 27.04.07 13:49:27interessant mein neuer Stewardessenjob--wo ich doch so gerne reise LONG + STRONG!!Der 1 $ den sie uns gedückt haben ist ärgerlich aber bald überholt....Schönes WE!
The 59th annual meeting of the American Academy of Neurology (AAN) has commenced with a number of relevant Tysabri abstracts to be presented on 3rd May.
Included in the abstracts is a safety update from the TOUCH prescribing program and the TYGRIS (Tysabri Global Observation Program in Safety) program which are to be presented this Thursday. We expect a clean safety profile from the TOUCH program as we believe that the TOUCH program and use of Tysabri monotherapy should mitigate a significant amount of risk associated with patients developing PML.
• As safety data is presented at scientific conferences over the coming quarters, we expect the penetration of Tysabri among neurologists/MS patients to improve. To date the number of physicians enrolling patients is at 1,500. We expect positive safety data from the TOUCH program to provide additional support for the product although reaching the first anniversary of Tysabri’s re-launch may be a more significant event for the more conservative neurologists.
• Additionally of interest at AAN on 3rd May is an update on the efficacy of Tysabri monotherapy over 3 years of treatment in patients with RRMS.
http://www.rte.ie/business/2007/morningrep/download/0430ncb.…
Included in the abstracts is a safety update from the TOUCH prescribing program and the TYGRIS (Tysabri Global Observation Program in Safety) program which are to be presented this Thursday. We expect a clean safety profile from the TOUCH program as we believe that the TOUCH program and use of Tysabri monotherapy should mitigate a significant amount of risk associated with patients developing PML.
• As safety data is presented at scientific conferences over the coming quarters, we expect the penetration of Tysabri among neurologists/MS patients to improve. To date the number of physicians enrolling patients is at 1,500. We expect positive safety data from the TOUCH program to provide additional support for the product although reaching the first anniversary of Tysabri’s re-launch may be a more significant event for the more conservative neurologists.
• Additionally of interest at AAN on 3rd May is an update on the efficacy of Tysabri monotherapy over 3 years of treatment in patients with RRMS.
http://www.rte.ie/business/2007/morningrep/download/0430ncb.…
Na Leute, kotzt Euch unsere Schrottaktie auch grad mal wieder so richtig an ?
Wenn dies Papier ein Hund wäre, man sollte ihn einschläfern ... ätz
Wenn dies Papier ein Hund wäre, man sollte ihn einschläfern ... ätz
Siehste, fluchen hilft ... rumms geht der Kurs wieder rauf
Biogen reports moderately higher earnings
Results fall short of Wall Street expectations
By Val Brickates Kennedy, MarketWatch
Last Update: 9:12 AM ET May 2, 2007
.............Revenue from sales of Tysabri, a new MS drug co-marketed with Elan Corp., was $30 million. Global sales of the medication reached $48 million during the quarter.
Tysabri was temporarily taken off the market in 2005 after some users developed an extremely rare but dangerous brain disease called PML. The drug was returned to the market last summer with tight prescribing restrictions.
As of mid-April, about 12,500 patients had been prescribed Tysabri worldwide, Biogen said...............
http://www.marketwatch.com/news/story/biogen-reports-moderat…
Results fall short of Wall Street expectations
By Val Brickates Kennedy, MarketWatch
Last Update: 9:12 AM ET May 2, 2007
.............Revenue from sales of Tysabri, a new MS drug co-marketed with Elan Corp., was $30 million. Global sales of the medication reached $48 million during the quarter.
Tysabri was temporarily taken off the market in 2005 after some users developed an extremely rare but dangerous brain disease called PML. The drug was returned to the market last summer with tight prescribing restrictions.
As of mid-April, about 12,500 patients had been prescribed Tysabri worldwide, Biogen said...............
http://www.marketwatch.com/news/story/biogen-reports-moderat…
Antwort auf Beitrag Nr.: 29.095.441 von bernie55 am 02.05.07 15:26:05Morgen soll es wohl Infos zu Tysabris Sicherheit geben...Der Kurs zieht schon mal ein bisschen an!
..Morgen..
little bigger piece of the nature article on alzheimer's
Elan/Wyeth could initially bring bapineuzumab to the market as a symptom-management drug and then secure disease-modifying claims in post-approval studies. In an 8-week Phase I study, bapineuzumab showed statistically significant improvement in cognitive function. If interim data from the ongoing Phase II trial, expected in mid 2007, confirm this result, Elan/Wyeth could initiate a short Phase III trial (3–6 months as opposed to an 18–month study required for a DMD) and file for a cognitive improvement/symptom-management label.
http://www.investorvillage.com/smbd.asp?mb=160&mn=104049&pt=…
little bigger piece of the nature article on alzheimer's
Elan/Wyeth could initially bring bapineuzumab to the market as a symptom-management drug and then secure disease-modifying claims in post-approval studies. In an 8-week Phase I study, bapineuzumab showed statistically significant improvement in cognitive function. If interim data from the ongoing Phase II trial, expected in mid 2007, confirm this result, Elan/Wyeth could initiate a short Phase III trial (3–6 months as opposed to an 18–month study required for a DMD) and file for a cognitive improvement/symptom-management label.
http://www.investorvillage.com/smbd.asp?mb=160&mn=104049&pt=…
Antwort auf Beitrag Nr.: 29.105.659 von bernie55 am 03.05.07 08:10:15@ männliche Aktionäre
“Buy Elan and Dendreon shares until my nuts hurt!"
“Buy Elan and Dendreon shares until my nuts hurt!"
goodybody on elan
Elan (Buy, Closing Price $14.17); Nothing new on Tysabri in Biogen Idec’s Q1’07 release.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Biogen Idec, Elan’s partners in the development and commercialisation of Tysabri for the treatment of MS reported a steady set of Q1’07 numbers yesterday afternoon. A 7% increase in earnings per share over Q1’06 to 59c was 2.5% behind market expectations of 60.5c. The 17% increase in revenue over the same period last year to $716m was also 2% behind consensus of $730m. As agreed by both companies when reporting separately (Elan reported Q1’07 numbers last Tuesday, 24th April), Biogen Idec provided the same numbers on patient enrolment as Elan, quoting from the same time period. There was, therefore, little take away for Elan shareholders from Biogen Idec’s results. Year to date 65% of those on Tysabri have switched from other therapies. Within the switchers 34% and 31% were on Copaxone and Avonex, respectively. The rollout over Europe continues with the majority of revenue being generated in Germany (2.0% of MS patients on Tysabri) and Sweden (5%). The drug has been launched and reimbursement is in place in Italy. It is hoped to launch the drug in France by the end of June.
http://www.investorvillage.com/smbd.asp?mb=160&mn=104062&pt=…
Elan (Buy, Closing Price $14.17); Nothing new on Tysabri in Biogen Idec’s Q1’07 release.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Biogen Idec, Elan’s partners in the development and commercialisation of Tysabri for the treatment of MS reported a steady set of Q1’07 numbers yesterday afternoon. A 7% increase in earnings per share over Q1’06 to 59c was 2.5% behind market expectations of 60.5c. The 17% increase in revenue over the same period last year to $716m was also 2% behind consensus of $730m. As agreed by both companies when reporting separately (Elan reported Q1’07 numbers last Tuesday, 24th April), Biogen Idec provided the same numbers on patient enrolment as Elan, quoting from the same time period. There was, therefore, little take away for Elan shareholders from Biogen Idec’s results. Year to date 65% of those on Tysabri have switched from other therapies. Within the switchers 34% and 31% were on Copaxone and Avonex, respectively. The rollout over Europe continues with the majority of revenue being generated in Germany (2.0% of MS patients on Tysabri) and Sweden (5%). The drug has been launched and reimbursement is in place in Italy. It is hoped to launch the drug in France by the end of June.
http://www.investorvillage.com/smbd.asp?mb=160&mn=104062&pt=…
Reuters - No new cases of brain disease seen with Tysabri
BOSTON, May 3 (Reuters) - Biogen Idec Inc. (BIIB.O: Quote, Profile , Research) said on Thursday there have been no new confirmed cases of a potentially fatal brain infection associated with its multiple sclerosis drug Tysabri.
Data presented at the annual meeting of the American Academy of Neurology showed no new confirmed cases of progressive multifocal leukoencephalopathy, or PML, a rare and potentially deadly brain disease, since the drug was reintroduced to the market last July.
Reuter did do a little bit of a negative spin or at least an uninformed comment
this is what they said
The news is positive for Biogen, but some analysts say it won't affect prescribing patterns any time soon as many doctors are likely to wait two years before prescribing the drug, which is currently taken by about 10,000 people worldwide.
****** actually BIIB said there surveys said that up to 75% of neurologists said they expect to prescribe tysabri this year and 25% said they would wait for 2 years of data - tysabri is being prescribed by 1500 neurologists right now - there are over 10,000 neurologists in the US -
that means BIIB is expecting # of prescribing neurologists to jump from 1500 to 7500 this year -
hard for reuters to say that 500% increase in number of prescribing neurologists wouldn't cause a rapid uptick in tysabri uptake
http://www.investorvillage.com/smbd.asp?mb=160&mn=104117&pt=…
BOSTON, May 3 (Reuters) - Biogen Idec Inc. (BIIB.O: Quote, Profile , Research) said on Thursday there have been no new confirmed cases of a potentially fatal brain infection associated with its multiple sclerosis drug Tysabri.
Data presented at the annual meeting of the American Academy of Neurology showed no new confirmed cases of progressive multifocal leukoencephalopathy, or PML, a rare and potentially deadly brain disease, since the drug was reintroduced to the market last July.
Reuter did do a little bit of a negative spin or at least an uninformed comment
this is what they said
The news is positive for Biogen, but some analysts say it won't affect prescribing patterns any time soon as many doctors are likely to wait two years before prescribing the drug, which is currently taken by about 10,000 people worldwide.
****** actually BIIB said there surveys said that up to 75% of neurologists said they expect to prescribe tysabri this year and 25% said they would wait for 2 years of data - tysabri is being prescribed by 1500 neurologists right now - there are over 10,000 neurologists in the US -
that means BIIB is expecting # of prescribing neurologists to jump from 1500 to 7500 this year -
hard for reuters to say that 500% increase in number of prescribing neurologists wouldn't cause a rapid uptick in tysabri uptake
http://www.investorvillage.com/smbd.asp?mb=160&mn=104117&pt=…
Antwort auf Beitrag Nr.: 29.111.718 von bernie55 am 03.05.07 13:52:10
that means BIIB is expecting # of prescribing neurologists to jump from 1500 to 7500 this year -
that means BIIB is expecting # of prescribing neurologists to jump from 1500 to 7500 this year -
Press Release Source: Biogen Idec and Elan Corporation, plc
Data Presented at the American Academy of Neurology's Annual Meeting Provide Update on Utilization and Safety of TYSABRI(R) in Patients with Multiple Sclerosis
Thursday May 3, 7:00 am ET
Additional Data From Extension Study Presented Show TYSABRI Benefit is Sustained Over Three Years
BOSTON--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that new data from the TOUCH Prescribing Program(TM) and TYGRIS safety study confirm the safety profile from previous clinical studies of TYSABRI® (natalizumab). Also presented at the 59th annual meeting of the American Academy of Neurology in Boston, MA were extension study data that showed that TYSABRI has a sustained treatment effect on clinical relapses and the risk of disability progression in multiple sclerosis (MS) patients treated for up to three years. The companies recently reported that as of mid-April 2007 approximately 12,500 patients have been prescribed TYSABRI worldwide. The companies estimate that in both commercial use and clinical trials, there are currently over 10,000 patients on TYSABRI therapy worldwide.
"The findings from the safety update combined with the data showing the sustained effect of TYSABRI in patients treated for up to three years, contribute to our evolving understanding of the utilization of this therapy as an important treatment option for people living with the debilitating effects of MS," said Paul O'Connor, MD, St. Michael's Hospital, Toronto, Ontario, Canada, lead investigator of the TYSABRI extension study.
TYSABRI Update
TYSABRI is available in the US through the TOUCH Prescribing Program. All prescribers, infusion sites and patients receiving TYSABRI are required to enroll in TOUCH. Safety information is also collected through ongoing clinical trials and registries, including STRATA, TYGRIS and the pregnancy registry. According to data available to the companies as of April 23, 2007, there have been no new reports of confirmed cases of progressive multifocal leukoencephalopathy (PML) or other serious opportunistic infections (OIs). The data confirm the safety profile from previous clinical studies of TYSABRI and will continue to expand the knowledge of the long-term safety and tolerability of TYSABRI.
The combination of TOUCH, TYGRIS and the pregnancy registry will be the largest long-term follow-up undertaken for an MS therapy, and the companies plan to continue to provide similar updates at upcoming medical meetings.
The companies recently announced that as of mid-April, approximately 12,500 patients have been prescribed TYSABRI worldwide. In both commercial use and clinical trials, there are currently over 10,000 patients on TYSABRI therapy worldwide.
In the US, approximately 6,600 patients are on TYSABRI therapy commercially. Approximately 10,000 patients have enrolled in the TOUCH program and 1,500 physicians have enrolled patients.
In the EU, approximately 2,500 patients internationally have received TYSABRI infusions commercially, mostly in Germany and the Nordic countries.
In clinical trial settings, over 1,000 patients are on TYSABRI therapy.
TYSABRI Efficacy Sustained through Three Years
Patients who participated in the Phase III TYSABRI program were eligible to enroll in an open-label extension study that evaluated the therapy's long-term effects. Included in this were patients from AFFIRM, a randomized, double-blind, placebo-controlled, two-year monotherapy study of TYSABRI that enrolled 942 patients (627 patients on TYSABRI, 315 on placebo). In AFFIRM, TYSABRI reduced the annualized relapse rate in patients with MS by 67% (p<0.001) and the risk of 12-week sustained disability progression by 42% (p<0.001) compared with placebo.
In the intent to treat analysis, the annualized relapse rate for patients treated with TYSABRI over the three-year period was 0.23, translating into an average of one relapse every 4.3 years. The relapse rate also continued to remain low over the three-year treatment period with TYSABRI: 0.27 during the first year; 0.20 during the second year; and 0.15 during the third year (based on 531 patients who entered the extension study, which includes approximately 250 patients with nearly three years of continuous therapy).
In addition, TYSABRI also decreased the cumulative probability of disability progression sustained for six months compared to placebo. The estimated proportion of patients who had 24-week sustained disability progression at two years was 11% in patients treated with TYSABRI compared to 23% in patients treated with placebo, a 54% relative reduction.
This effect was maintained in patients treated with TYSABRI for up to three years with 13% showing 24-week sustained disability progression.
About TOUCH and TYGRIS
Before initiating treatment, all US patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious OIs, including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit/risk discussions prior to initiating TYSABRI treatment. Physicians report on PML, serious OIs, deaths and discontinuation of therapy on an ongoing basis.
TYGRIS (TYSABRI Global ObseRvation Program In Safety) is expected enroll 5,000 patients worldwide, including approximately 3,000 patients from TOUCH. Patients in TYGRIS are evaluated at baseline and every six months thereafter for five years. Researchers will evaluate data including medical/MS history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs, and malignancies.
The information provided here is derived from voluntary adverse event reporting. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner.
About TYSABRI
In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms of MS. TYSABRI increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Patients should be monitored at regular intervals for any new or worsening signs or symptoms suggestive of PML Because of the increased risk of PML, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. It is available in the US only through a restricted distribution program called the TOUCH Prescribing Program. According to product labeling, after two years, TYSABRI treatment led to a 67% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42% (p<0.001). TYSABRI treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI. Changes in MRI findings often do not correlate with changes in the clinical status of patients (e.g., disability progression). The prognostic significance of the MRI findings in these studies has not been evaluated.
In the European Union, TYSABRI is indicated as a single disease-modifying therapy in highly active relapsing-remitting MS patients. Because of the increased risk of PML, it is for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing-remitting MS.
According to product labeling in the EU, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).
Serious adverse events that occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Herpes infections were slightly more common in patients treated with TYSABRI. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea
http://biz.yahoo.com/bw/070503/20070503005129.html?.v=1
Data Presented at the American Academy of Neurology's Annual Meeting Provide Update on Utilization and Safety of TYSABRI(R) in Patients with Multiple Sclerosis
Thursday May 3, 7:00 am ET
Additional Data From Extension Study Presented Show TYSABRI Benefit is Sustained Over Three Years
BOSTON--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that new data from the TOUCH Prescribing Program(TM) and TYGRIS safety study confirm the safety profile from previous clinical studies of TYSABRI® (natalizumab). Also presented at the 59th annual meeting of the American Academy of Neurology in Boston, MA were extension study data that showed that TYSABRI has a sustained treatment effect on clinical relapses and the risk of disability progression in multiple sclerosis (MS) patients treated for up to three years. The companies recently reported that as of mid-April 2007 approximately 12,500 patients have been prescribed TYSABRI worldwide. The companies estimate that in both commercial use and clinical trials, there are currently over 10,000 patients on TYSABRI therapy worldwide.
"The findings from the safety update combined with the data showing the sustained effect of TYSABRI in patients treated for up to three years, contribute to our evolving understanding of the utilization of this therapy as an important treatment option for people living with the debilitating effects of MS," said Paul O'Connor, MD, St. Michael's Hospital, Toronto, Ontario, Canada, lead investigator of the TYSABRI extension study.
TYSABRI Update
TYSABRI is available in the US through the TOUCH Prescribing Program. All prescribers, infusion sites and patients receiving TYSABRI are required to enroll in TOUCH. Safety information is also collected through ongoing clinical trials and registries, including STRATA, TYGRIS and the pregnancy registry. According to data available to the companies as of April 23, 2007, there have been no new reports of confirmed cases of progressive multifocal leukoencephalopathy (PML) or other serious opportunistic infections (OIs). The data confirm the safety profile from previous clinical studies of TYSABRI and will continue to expand the knowledge of the long-term safety and tolerability of TYSABRI.
The combination of TOUCH, TYGRIS and the pregnancy registry will be the largest long-term follow-up undertaken for an MS therapy, and the companies plan to continue to provide similar updates at upcoming medical meetings.
The companies recently announced that as of mid-April, approximately 12,500 patients have been prescribed TYSABRI worldwide. In both commercial use and clinical trials, there are currently over 10,000 patients on TYSABRI therapy worldwide.
In the US, approximately 6,600 patients are on TYSABRI therapy commercially. Approximately 10,000 patients have enrolled in the TOUCH program and 1,500 physicians have enrolled patients.
In the EU, approximately 2,500 patients internationally have received TYSABRI infusions commercially, mostly in Germany and the Nordic countries.
In clinical trial settings, over 1,000 patients are on TYSABRI therapy.
TYSABRI Efficacy Sustained through Three Years
Patients who participated in the Phase III TYSABRI program were eligible to enroll in an open-label extension study that evaluated the therapy's long-term effects. Included in this were patients from AFFIRM, a randomized, double-blind, placebo-controlled, two-year monotherapy study of TYSABRI that enrolled 942 patients (627 patients on TYSABRI, 315 on placebo). In AFFIRM, TYSABRI reduced the annualized relapse rate in patients with MS by 67% (p<0.001) and the risk of 12-week sustained disability progression by 42% (p<0.001) compared with placebo.
In the intent to treat analysis, the annualized relapse rate for patients treated with TYSABRI over the three-year period was 0.23, translating into an average of one relapse every 4.3 years. The relapse rate also continued to remain low over the three-year treatment period with TYSABRI: 0.27 during the first year; 0.20 during the second year; and 0.15 during the third year (based on 531 patients who entered the extension study, which includes approximately 250 patients with nearly three years of continuous therapy).
In addition, TYSABRI also decreased the cumulative probability of disability progression sustained for six months compared to placebo. The estimated proportion of patients who had 24-week sustained disability progression at two years was 11% in patients treated with TYSABRI compared to 23% in patients treated with placebo, a 54% relative reduction.
This effect was maintained in patients treated with TYSABRI for up to three years with 13% showing 24-week sustained disability progression.
About TOUCH and TYGRIS
Before initiating treatment, all US patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious OIs, including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit/risk discussions prior to initiating TYSABRI treatment. Physicians report on PML, serious OIs, deaths and discontinuation of therapy on an ongoing basis.
TYGRIS (TYSABRI Global ObseRvation Program In Safety) is expected enroll 5,000 patients worldwide, including approximately 3,000 patients from TOUCH. Patients in TYGRIS are evaluated at baseline and every six months thereafter for five years. Researchers will evaluate data including medical/MS history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs, and malignancies.
The information provided here is derived from voluntary adverse event reporting. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner.
About TYSABRI
In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms of MS. TYSABRI increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Patients should be monitored at regular intervals for any new or worsening signs or symptoms suggestive of PML Because of the increased risk of PML, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. It is available in the US only through a restricted distribution program called the TOUCH Prescribing Program. According to product labeling, after two years, TYSABRI treatment led to a 67% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42% (p<0.001). TYSABRI treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI. Changes in MRI findings often do not correlate with changes in the clinical status of patients (e.g., disability progression). The prognostic significance of the MRI findings in these studies has not been evaluated.
In the European Union, TYSABRI is indicated as a single disease-modifying therapy in highly active relapsing-remitting MS patients. Because of the increased risk of PML, it is for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing-remitting MS.
According to product labeling in the EU, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).
Serious adverse events that occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Herpes infections were slightly more common in patients treated with TYSABRI. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea
http://biz.yahoo.com/bw/070503/20070503005129.html?.v=1
na also!Haben W I R doch schon lange gesagt!Auf gehts!!
14,55$!Prima!
Link to BIIB webcast starting 10:30 ET today
http://phx.corporate-ir.net/phoenix.zhtml?c=128651&p=confere…
http://phx.corporate-ir.net/phoenix.zhtml?c=128651&p=confere…
Antwort auf Beitrag Nr.: 29.115.178 von Birgit.Tersteegen am 03.05.07 16:31:49 http://phx.corporate-ir.net/phoenix.zhtml?c=128651&p=confere…" target="_blank" rel="nofollow ugc noopener">http://phx.corporate-ir.net/phoenix.zhtml?c=128651&p=confere…
JPM - Biogen Idec - Overweight
Tysabri Safety Update: No New Cases of PML
http://pull.jpmorgan-research.com/cgi-bin/pull/DocPull/22-F9…
Biogen Idec and Elan announced new data from the TOUCH program and TYGRIS study. With over 12,500 MS patients prescribed Tysabri, no new cases of progressive multifocal leukoencephalopathy (PML) or other opportunistic infections have been reported. The median number of Tysabri infusions from the updated data is about 5 (range 1-10). The positive safety data suggest a lower PML risk for Tysabri than previously expected and clearly lower than the 1:1000 highlighted in the package insert. In our view, it will require longer duration of therapy to make neurologists comfortable with Tysabri's benefit/risk profile; however, today’s safety update is a step in the right direction.
· No PML Thus Far in TOUCH and TYGRIS. In a poster by Bozic et al (abstract P06.0895), no serious opportunistic infections (including JC virus/PML) were reported to have been observed in the post-marketing experience since re-launch of Tysabri. A relatively low rate of infusion reactions was reported (0.8%), in line to better than expected. With 7,600 patients having received Tysabri since the re-launch at the time of poster publication (2/23/07) and 12,500 to date, the rate of PML occurrence in appears to be markedly lower than the 1:1000 risk of PML assumed when the FDA granted marketing re-approval in 2006.
· Positive Safety Update Could Drive Inflection Point. Though it has best-in-class efficacy, the commercial opportunity for Tysabri for the next 12 months may be determined by the frequency of PML. Given a well-informed patient population hungry for drugs with disease-modifying efficacy, it appears to be conservatism by neurologists that is limiting its uptake thus far in the launch. Hence, a positive safety update (next one likely at ECTRIMS; Oct 11-14) could continue to drive comfort with Tysabri's benefit/risk profile, though 1-2 yr experience in at least 10,000 MS patients may be the minimum to convert these MS docs.
· Reiterate OW. Today's update is an important milestone in the Tysabri launch. At 19X our 07 EPS ests (peer group: 35X), we view BIIB shares as attractively valued ahead of expected acceleration of Tysabri sales.
Tysabri Safety Update: No New Cases of PML
http://pull.jpmorgan-research.com/cgi-bin/pull/DocPull/22-F9…
Biogen Idec and Elan announced new data from the TOUCH program and TYGRIS study. With over 12,500 MS patients prescribed Tysabri, no new cases of progressive multifocal leukoencephalopathy (PML) or other opportunistic infections have been reported. The median number of Tysabri infusions from the updated data is about 5 (range 1-10). The positive safety data suggest a lower PML risk for Tysabri than previously expected and clearly lower than the 1:1000 highlighted in the package insert. In our view, it will require longer duration of therapy to make neurologists comfortable with Tysabri's benefit/risk profile; however, today’s safety update is a step in the right direction.
· No PML Thus Far in TOUCH and TYGRIS. In a poster by Bozic et al (abstract P06.0895), no serious opportunistic infections (including JC virus/PML) were reported to have been observed in the post-marketing experience since re-launch of Tysabri. A relatively low rate of infusion reactions was reported (0.8%), in line to better than expected. With 7,600 patients having received Tysabri since the re-launch at the time of poster publication (2/23/07) and 12,500 to date, the rate of PML occurrence in appears to be markedly lower than the 1:1000 risk of PML assumed when the FDA granted marketing re-approval in 2006.
· Positive Safety Update Could Drive Inflection Point. Though it has best-in-class efficacy, the commercial opportunity for Tysabri for the next 12 months may be determined by the frequency of PML. Given a well-informed patient population hungry for drugs with disease-modifying efficacy, it appears to be conservatism by neurologists that is limiting its uptake thus far in the launch. Hence, a positive safety update (next one likely at ECTRIMS; Oct 11-14) could continue to drive comfort with Tysabri's benefit/risk profile, though 1-2 yr experience in at least 10,000 MS patients may be the minimum to convert these MS docs.
· Reiterate OW. Today's update is an important milestone in the Tysabri launch. At 19X our 07 EPS ests (peer group: 35X), we view BIIB shares as attractively valued ahead of expected acceleration of Tysabri sales.
--------------------------------------------------------------------------------
Ärzte Zeitung, 03.05.2007
--------------------------------------------------------------------------------
Progrediente MS: weniger Schübe durch Antikörper
Studiendaten zu Natalizumab
FRANKFURT AM MAIN (djb). Der monoklonale Antikörper Natalizumab verringert bei therapieresistenter oder rasch progredienter Multipler Sklerose (MS) die Zahl der jährlichen Schübe.
Das haben die Dreijahresdaten der Zulassungsstudie zu Natalizumab (Tysabri®) bestätigt, die Professor Ralf Gold aus Bochum präsentiert hat. In der Studie waren 627 Patienten mit schubförmiger remittierender MS mit Natalizumab und 315 mit Placebo behandelt worden. Die Therapie mit Placebo endete nach zwei Jahren.
In der Placebo-Gruppe traten in den zwei Jahren im Mittel 0,73 Schübe pro Jahr auf, in der Verum-Gruppe waren es im zweiten und im dritten Jahr je 0,23 Schübe. Die Schubrate war in der Verumgruppe also um 68 Prozent erniedrigt, so Gold bei einer Veranstaltung von Biogen Idec in Frankfurt am Main. Die Wahrscheinlichkeit einer anhaltenden Progression der Behinderungen war mit Natalizumab um 54 Prozent niedriger.
Natalizumab schützt auch vor neuen, MS-typischen Läsionen im ZNS. So war die Zahl der Läsionen, die das Kontrastmittel Gadolinium aufnehmen - ein Maß für die entzündliche Aktivität - nach zwei Jahren in der Verum-Gruppe um 92 Prozent niedriger als mit Placebo.
Natalizumab ist für die Monotherapie bei hochaktiver, schubförmig remittierender MS zugelassen, und zwar für Patienten mit hoher Krankheitsaktivität trotz Behandlung mit Interferon-beta und für Patienten mit rasch fortschreitender schubförmig remittierender MS. Bei zusätzlicher Immunsuppression sind in Studien drei Fälle einer progressiven multifokalen Leukoenzephalopathie (PML) aufgetreten. Unter der Natalizumab-Monotherapie wurde keine solche Komplikation beschrieben.
Ärzte Zeitung, 03.05.2007
--------------------------------------------------------------------------------
Progrediente MS: weniger Schübe durch Antikörper
Studiendaten zu Natalizumab
FRANKFURT AM MAIN (djb). Der monoklonale Antikörper Natalizumab verringert bei therapieresistenter oder rasch progredienter Multipler Sklerose (MS) die Zahl der jährlichen Schübe.
Das haben die Dreijahresdaten der Zulassungsstudie zu Natalizumab (Tysabri®) bestätigt, die Professor Ralf Gold aus Bochum präsentiert hat. In der Studie waren 627 Patienten mit schubförmiger remittierender MS mit Natalizumab und 315 mit Placebo behandelt worden. Die Therapie mit Placebo endete nach zwei Jahren.
In der Placebo-Gruppe traten in den zwei Jahren im Mittel 0,73 Schübe pro Jahr auf, in der Verum-Gruppe waren es im zweiten und im dritten Jahr je 0,23 Schübe. Die Schubrate war in der Verumgruppe also um 68 Prozent erniedrigt, so Gold bei einer Veranstaltung von Biogen Idec in Frankfurt am Main. Die Wahrscheinlichkeit einer anhaltenden Progression der Behinderungen war mit Natalizumab um 54 Prozent niedriger.
Natalizumab schützt auch vor neuen, MS-typischen Läsionen im ZNS. So war die Zahl der Läsionen, die das Kontrastmittel Gadolinium aufnehmen - ein Maß für die entzündliche Aktivität - nach zwei Jahren in der Verum-Gruppe um 92 Prozent niedriger als mit Placebo.
Natalizumab ist für die Monotherapie bei hochaktiver, schubförmig remittierender MS zugelassen, und zwar für Patienten mit hoher Krankheitsaktivität trotz Behandlung mit Interferon-beta und für Patienten mit rasch fortschreitender schubförmig remittierender MS. Bei zusätzlicher Immunsuppression sind in Studien drei Fälle einer progressiven multifokalen Leukoenzephalopathie (PML) aufgetreten. Unter der Natalizumab-Monotherapie wurde keine solche Komplikation beschrieben.
Jetzt ist quasi bewiesen ,was wir immer schon wussten :Tysabri wird ein Blockbuster weil es in Monotherapie sicher und absolut wirksam ist....
Msg: 104383 of 104431 5/3/2007 12:46:03 PM
By: bankonit
Shock & Awe
Nature (AAB-001) + Tysabri Safety/Efficacy/QOL = $15+
I think folks are still in shock... Wait until they wake up and understand the true impact of today's news. Shock & Awe. These stories are more than an incremental increase in the probability of rocket-ship-like growth for Elan. These are market-changers in my opinion; this run-up will take us over $15 and place us in the upper teens by OE in mid May.
Safety data is solid, but the efficacy data on Tysabri is truly spectacular. Chart out the relapse rate at year 1, 2, and 3 and you will see a nearly LINEAR progression downward. The effect of Tysabri practically halts progression for some patients, and for a certain percentage actually reverses symptoms based on QOL data. At this rate, by year 5 (as Pin postulated) we may see a relapse rate of less than 1 in 10 years, with an improved safety profile. The risk of PML is significantly less than 1:1000 on monotherapy, and neuros and their patients are now realizing that. As they do, Tysabri will creep up to 20% market share this year. At this point, mainstream neuros will become less risk-averse and hop on board. The trip from 25% to over 50% will be practically overnight - Tysabri will eclipse all other MS drugs on the market as management said. I wouldn't be surprised if we see this rapid adoption stage by early 2008.
The article in NATURE suggesting that AAB-001 might begin a short PIII, supplemented by a longer term PIII study cannot be dismissed as just speculation. This approach to approval is just too "out-of-the-box". Someone had to offer this possibilty to the writer - someone well-informed with the results of Phase I and on top of the Phase II situation. Think about it - the article went beyond whether a PIII is even warranted - it actually centered on how a PIII could be conducted to make it available to patients with AD quickly. To me (and I think influential others) - this is a clear tell-tale that something good is happening, the risk has to be diminishing, word is speading, and this is worthy of a larger investment.
Things for ELN look even better today than yesterday.
Msg: 104383 of 104431 5/3/2007 12:46:03 PM
By: bankonit
Shock & Awe
Nature (AAB-001) + Tysabri Safety/Efficacy/QOL = $15+
I think folks are still in shock... Wait until they wake up and understand the true impact of today's news. Shock & Awe. These stories are more than an incremental increase in the probability of rocket-ship-like growth for Elan. These are market-changers in my opinion; this run-up will take us over $15 and place us in the upper teens by OE in mid May.
Safety data is solid, but the efficacy data on Tysabri is truly spectacular. Chart out the relapse rate at year 1, 2, and 3 and you will see a nearly LINEAR progression downward. The effect of Tysabri practically halts progression for some patients, and for a certain percentage actually reverses symptoms based on QOL data. At this rate, by year 5 (as Pin postulated) we may see a relapse rate of less than 1 in 10 years, with an improved safety profile. The risk of PML is significantly less than 1:1000 on monotherapy, and neuros and their patients are now realizing that. As they do, Tysabri will creep up to 20% market share this year. At this point, mainstream neuros will become less risk-averse and hop on board. The trip from 25% to over 50% will be practically overnight - Tysabri will eclipse all other MS drugs on the market as management said. I wouldn't be surprised if we see this rapid adoption stage by early 2008.
The article in NATURE suggesting that AAB-001 might begin a short PIII, supplemented by a longer term PIII study cannot be dismissed as just speculation. This approach to approval is just too "out-of-the-box". Someone had to offer this possibilty to the writer - someone well-informed with the results of Phase I and on top of the Phase II situation. Think about it - the article went beyond whether a PIII is even warranted - it actually centered on how a PIII could be conducted to make it available to patients with AD quickly. To me (and I think influential others) - this is a clear tell-tale that something good is happening, the risk has to be diminishing, word is speading, and this is worthy of a larger investment.
Things for ELN look even better today than yesterday.
Msg: 104526 of 104535 5/3/2007 4:09:17 PM Recs: 3 Sentiment: Not Disclosed
By: vagaosp
Westfield added 1,477,585 last quarter
according to nasdaq.com
http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&timeframe…
By: vagaosp
Westfield added 1,477,585 last quarter
according to nasdaq.com
http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&timeframe…
habe ich es Euch nicht gesagt: Wenn ich mit einer kleinen Position raus gehe, dann kommt endlich eine gute News und der Kurs steigt.
Ich sitze jetzt auf meiner Kohle und schaue den steigenden Kursen von DENDREON und ELAN hinterher.
(zum Glück habe ich nur ein wenig Spielgeld raus gezogen)
Ich sitze jetzt auf meiner Kohle und schaue den steigenden Kursen von DENDREON und ELAN hinterher.
(zum Glück habe ich nur ein wenig Spielgeld raus gezogen)
Msg: 104643 of 104660 5/4/2007 4:20:22 AM
By: smellybadger2003
NCB
Data presented yesterday at AAN confirmed that there are no new confirmed PML
cases or other serious opportunistic infections from the TOUCH program (data
available from re-launch until 23rd April) and the TYGRIS* safety study. Although early
in the TOUCH process, the Tysabri safety update is very positive.
• The risk of developing PML was established by the FDA as 1 in 1000 patients treated
for 18 months of treatment. The TOUCH program (which should prevent
immunosuppressed patients from treatment) and use of Tysabri as a monotherapy
should significantly reduce the risk of patients developing PML. To date PML has not
been confirmed in any MS patients treated with Tysabri monotherapy.
• Additionally at AAN 3 year efficacy data was presented which showed that Tysabri had
a sustained effect on relapse rate and risk of disability progression. The annualised
relapse rate for patients treated with Tysabri over the 3 year period was 0.23 translating
into 1 relapse every 4.3 years. Importantly, this data shows that the longer patients are
on treatment the greater the effect with Tysabri - the relapse rate at year one translated
to one relapse every 3.7 years compared to one relapse every 6.7 years after 3 years
of treatment. This data is very impressive and confirms once again the strong efficacy
profile of the product. No safety update has been provided from this study.
• The Tysabri safety update and the 3-year efficacy data is very positive. A number of
other safety updates are expected throughout the year. We expect the positive safety
data from the TOUCH program today to provide additional support for the product and
to help convince a proportion of the non-prescribing neurologists. To date the number
of physicians enrolling patients is at 1,500. Of the neurologists that are not prescribing
Tysabri, c.70% say that they intend to do so over the next 12 months with the remaining
neurologists planning to wait until the two year data is available (source: market
research conducted by BiogenIdec). Reaching the first and second anniversary of
Tysabri’s re-launch would therefore appear to be a more significant event for the more
conservative neurologists.
• Over the next 6-8 weeks the catalyst for the stock is the potential for AAB-001 to
progress to Phase III studies. AAB-001 has the potential to transform Elan’s investment
case and progress of AAB-001 to Phase III could potentially add c.30% to our SOTPs
valuation range ($16.66-$18.80). With the potential for positive newsflow over the
coming weeks, we are maintaining our Buy recommendation. See attachment for
" target="_blank" rel="nofollow ugc noopener">http://ftp.ncb.ie/equities/NCBLatestIrishEquities.pdf
By: smellybadger2003
NCB
Data presented yesterday at AAN confirmed that there are no new confirmed PML
cases or other serious opportunistic infections from the TOUCH program (data
available from re-launch until 23rd April) and the TYGRIS* safety study. Although early
in the TOUCH process, the Tysabri safety update is very positive.
• The risk of developing PML was established by the FDA as 1 in 1000 patients treated
for 18 months of treatment. The TOUCH program (which should prevent
immunosuppressed patients from treatment) and use of Tysabri as a monotherapy
should significantly reduce the risk of patients developing PML. To date PML has not
been confirmed in any MS patients treated with Tysabri monotherapy.
• Additionally at AAN 3 year efficacy data was presented which showed that Tysabri had
a sustained effect on relapse rate and risk of disability progression. The annualised
relapse rate for patients treated with Tysabri over the 3 year period was 0.23 translating
into 1 relapse every 4.3 years. Importantly, this data shows that the longer patients are
on treatment the greater the effect with Tysabri - the relapse rate at year one translated
to one relapse every 3.7 years compared to one relapse every 6.7 years after 3 years
of treatment. This data is very impressive and confirms once again the strong efficacy
profile of the product. No safety update has been provided from this study.
• The Tysabri safety update and the 3-year efficacy data is very positive. A number of
other safety updates are expected throughout the year. We expect the positive safety
data from the TOUCH program today to provide additional support for the product and
to help convince a proportion of the non-prescribing neurologists. To date the number
of physicians enrolling patients is at 1,500. Of the neurologists that are not prescribing
Tysabri, c.70% say that they intend to do so over the next 12 months with the remaining
neurologists planning to wait until the two year data is available (source: market
research conducted by BiogenIdec). Reaching the first and second anniversary of
Tysabri’s re-launch would therefore appear to be a more significant event for the more
conservative neurologists.
• Over the next 6-8 weeks the catalyst for the stock is the potential for AAB-001 to
progress to Phase III studies. AAB-001 has the potential to transform Elan’s investment
case and progress of AAB-001 to Phase III could potentially add c.30% to our SOTPs
valuation range ($16.66-$18.80). With the potential for positive newsflow over the
coming weeks, we are maintaining our Buy recommendation. See attachment for
" target="_blank" rel="nofollow ugc noopener">http://ftp.ncb.ie/equities/NCBLatestIrishEquities.pdf
Antwort auf Beitrag Nr.: 29.124.307 von Poppholz am 03.05.07 23:45:35habe ich es Euch nicht gesagt: Wenn ich mit einer kleinen Position raus gehe, dann kommt endlich eine gute News und der Kurs steigt.
..na dann weiter so, Poppie...
..na dann weiter so, Poppie...
Antwort auf Beitrag Nr.: 29.132.174 von bernie55 am 04.05.07 14:42:32das kann ich mir vorstellen, dass Euch dies gefallen würde.
Antwort auf Beitrag Nr.: 29.132.174 von bernie55 am 04.05.07 14:42:32da bin ich aber EGOIST.
Ich will auch Gewinne haben.
Ich will auch Gewinne haben.
Antwort auf Beitrag Nr.: 29.132.494 von Poppholz am 04.05.07 14:58:55ECHT?? Frisst Dir der Nachwuchs schon die Haare vom Kopf??
Antwort auf Beitrag Nr.: 29.137.706 von Birgit.Tersteegen am 04.05.07 18:37:45mit dem Nachwuchs läuft alles super.
Allerdings hat er wirklich einen guten Appetit. Er möchte halt auch ordenlich wachsen.
Allerdings hat er wirklich einen guten Appetit. Er möchte halt auch ordenlich wachsen.
Antwort auf Beitrag Nr.: 29.145.830 von Poppholz am 04.05.07 23:39:35Hi Popp, wie gesagt, in die 13 dippen wir noch.
Zu Deinem Sohn fällt mir spontan als Maßstab zur Größe Nicolai Walujew ein.
Zu Deinem Sohn fällt mir spontan als Maßstab zur Größe Nicolai Walujew ein.
Promising New Approach To Treating Alzheimer's
Dr. Boxer on AAB001 Clinical Trial
@ UCSF see video
May 3 - KGO - Alzheimer's disease can take a terrible toll on families, and although there are drugs on the market to relieve the symptoms, there is no known treatment to prevent or halt the disease. But local researchers are now eyeing a promising new approach.
Alheimer's disease is a thief, stealing thoughts and memories, fends and families, dignity and ultimately human life.
Letta McMillen is still in the early stages of Alzheimer's, but the disease is progressing relentlessly.
Leeta McMillen, Alzheimer's Patient: "I don't remember time, I don't remember what I'm supposed to do unless if have it written down, stuff like that."
Sara McMillen, Leeta's Daughter: "Mom has a hard time remembering where she is and what day it is and what you're supposed to be doing that day and where home is and sometimes even trouble where the food's going to be coming."
A few months ago she had to move into assisted living. Now Leeta is part of a UCSF clinical trial on a new Alzheimer's treatment.
Adam Boxer, M.D., Ph.D, UCSF Neurologist: "I think the really exciting thing about this type of treatment is that it really targets the toxin, the thing that damages your brain in Alzheimer's disease."
The brains of Alzheimer's patients' often show a rapid buildup of toxic substances called amyloid proteins, which damage the brain and interfere with neurological connections.
Adam Boxer, M.D., Ph.D, UCSF Neurologist: "So one way to measure the shrinkage is to take brain scans over time."
As a brain scan shows, ultimately the patient's brain begins to shrink and the spaces between the brain folds increase. Researchers at UCSF are hoping a genetically-engineered antibody given as an IV infusion will trigger the immune system to attack these toxic amyloid proteins.
Adam Boxer, M.D., Ph.D, UCSF Neurologist: "There's a type of immune cell in the brain that's sort of like of a Pac Man for infectious agents and so when we mark something with an antibody it may help it to clear this protein out of the brain."
Study patients like Leeta get an infusion every three months of either the real drug or a placebo. Taking part in this trial is important to Leeta since she lost both her brother and sister to Alzheimer's disease.
Sara McMillen, Leeta's Daughter: "It would be great to have a cure, to be able to prevent this disease, but we know that this is just a trial and we just want do try to do our part, do whatever we can, to help find some answers for the disease."
The answers are still months or years away, but progressive brain scans taken a year apart may be able to show if brain shrinkage is slowing in study patients and Dr. Boxer is hopeful about the research.
Adam Boxer, M.D., Ph.D, UCSF Neurologist: "We think that this new type of therapy that we're testing really has great potential to act to protect the brain from some of the damage that occurs, and possibly prolong people's lives or at least prolong people's ability to remember and to function independently. That's the real hope."
A hope that Leeta shares.
http://abclocal.go.com/kgo/story?section=drive_to_discover&i…
Dr. Boxer on AAB001 Clinical Trial
@ UCSF see video
May 3 - KGO - Alzheimer's disease can take a terrible toll on families, and although there are drugs on the market to relieve the symptoms, there is no known treatment to prevent or halt the disease. But local researchers are now eyeing a promising new approach.
Alheimer's disease is a thief, stealing thoughts and memories, fends and families, dignity and ultimately human life.
Letta McMillen is still in the early stages of Alzheimer's, but the disease is progressing relentlessly.
Leeta McMillen, Alzheimer's Patient: "I don't remember time, I don't remember what I'm supposed to do unless if have it written down, stuff like that."
Sara McMillen, Leeta's Daughter: "Mom has a hard time remembering where she is and what day it is and what you're supposed to be doing that day and where home is and sometimes even trouble where the food's going to be coming."
A few months ago she had to move into assisted living. Now Leeta is part of a UCSF clinical trial on a new Alzheimer's treatment.
Adam Boxer, M.D., Ph.D, UCSF Neurologist: "I think the really exciting thing about this type of treatment is that it really targets the toxin, the thing that damages your brain in Alzheimer's disease."
The brains of Alzheimer's patients' often show a rapid buildup of toxic substances called amyloid proteins, which damage the brain and interfere with neurological connections.
Adam Boxer, M.D., Ph.D, UCSF Neurologist: "So one way to measure the shrinkage is to take brain scans over time."
As a brain scan shows, ultimately the patient's brain begins to shrink and the spaces between the brain folds increase. Researchers at UCSF are hoping a genetically-engineered antibody given as an IV infusion will trigger the immune system to attack these toxic amyloid proteins.
Adam Boxer, M.D., Ph.D, UCSF Neurologist: "There's a type of immune cell in the brain that's sort of like of a Pac Man for infectious agents and so when we mark something with an antibody it may help it to clear this protein out of the brain."
Study patients like Leeta get an infusion every three months of either the real drug or a placebo. Taking part in this trial is important to Leeta since she lost both her brother and sister to Alzheimer's disease.
Sara McMillen, Leeta's Daughter: "It would be great to have a cure, to be able to prevent this disease, but we know that this is just a trial and we just want do try to do our part, do whatever we can, to help find some answers for the disease."
The answers are still months or years away, but progressive brain scans taken a year apart may be able to show if brain shrinkage is slowing in study patients and Dr. Boxer is hopeful about the research.
Adam Boxer, M.D., Ph.D, UCSF Neurologist: "We think that this new type of therapy that we're testing really has great potential to act to protect the brain from some of the damage that occurs, and possibly prolong people's lives or at least prolong people's ability to remember and to function independently. That's the real hope."
A hope that Leeta shares.
http://abclocal.go.com/kgo/story?section=drive_to_discover&i…
CHMP Meeting Dates For May And June
May
21 - 24
Committee for Medicinal Products for Human Use (CHMP)
June
18 - 21
Committee for Medicinal Products for Human Use (CHMP)
http://www.investorvillage.com/smbd.asp?mb=160&pt=msg&mn=105…
May
21 - 24
Committee for Medicinal Products for Human Use (CHMP)
June
18 - 21
Committee for Medicinal Products for Human Use (CHMP)
http://www.investorvillage.com/smbd.asp?mb=160&pt=msg&mn=105…
PRESS RELEASE
EMBARGOED FOR RELEASE UNTIL 4 PM ET, MAY 7, 2007
Media Contacts: Angela Babb, (651) 695-2789, ababb@aan.com or Robin Stinnett, (651) 695-2763, rstinnett@aan.com.
Brain Scans Show Early Alzheimer’s Disease in People with Memory Problems
ST. PAUL, Minn – Brain scans of people with mild cognitive impairment (MCI) show signs of early Alzheimer’s disease, according to a study published in the May 8, 2007, issue of Neurology®, the scientific journal of the American Academy of Neurology.
For the study, PET scans were performed on the brains of 13 elderly men and women with mild cognitive impairment (MCI) and 14 elderly people without memory problems. The scans were used to measure uptake of PIB, which is an imaging agent that allows doctors to see and measure abnormal protein aggregation growth, otherwise known as amyloid plaque, in the brain. Abnormal protein aggregation growth is a signature of Alzheimer’s disease. Until recently, Alzheimer’s disease couldn’t be officially diagnosed until after death with an autopsy.
The study found people with MCI had as much as 39 percent more PIB uptake in some parts of the brain than people without MCI. And about half of the MCI patients had PIB uptake in the Alzheimer’s disease range.
“This pattern of increased PIB in patients with MCI resembles what’s seen in Alzheimer’s disease and is suggestive of an early Alzheimer’s disease process,” said study author Juha O. Rinne, MD, PhD, with the University of Turku in Turku, Finland, and Fellow of the American Academy of Neurology. “Our findings are similar to what’s seen in post-mortem studies in which abnormal protein aggregation growth is found in people who had been diagnosed with probable Alzheimer’s disease.”
Rinne says larger studies and extended follow-up is needed since identifying people with MCI who have abnormal protein aggregation growth will become increasingly important as treatments affecting such plaque amyloid accumulation become available.
The study was supported by Turku University Hospital, the Finnish Medical Society Duodecim, the Finnish Cultural Foundation, the Research Foundation of Orion Corporation, the Research Council for Health of the Academy of Finland, and the Sigrid Juselius Foundation.
The American Academy of Neurology, an association of more than 20,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as epilepsy, dystonia, migraine, Huntington’s disease, and dementia. For more information about the American Academy of Neurology, visit www.aan.com.
http://www.investorvillage.com/smbd.asp?mb=160&mn=105851&pt=…
EMBARGOED FOR RELEASE UNTIL 4 PM ET, MAY 7, 2007
Media Contacts: Angela Babb, (651) 695-2789, ababb@aan.com or Robin Stinnett, (651) 695-2763, rstinnett@aan.com.
Brain Scans Show Early Alzheimer’s Disease in People with Memory Problems
ST. PAUL, Minn – Brain scans of people with mild cognitive impairment (MCI) show signs of early Alzheimer’s disease, according to a study published in the May 8, 2007, issue of Neurology®, the scientific journal of the American Academy of Neurology.
For the study, PET scans were performed on the brains of 13 elderly men and women with mild cognitive impairment (MCI) and 14 elderly people without memory problems. The scans were used to measure uptake of PIB, which is an imaging agent that allows doctors to see and measure abnormal protein aggregation growth, otherwise known as amyloid plaque, in the brain. Abnormal protein aggregation growth is a signature of Alzheimer’s disease. Until recently, Alzheimer’s disease couldn’t be officially diagnosed until after death with an autopsy.
The study found people with MCI had as much as 39 percent more PIB uptake in some parts of the brain than people without MCI. And about half of the MCI patients had PIB uptake in the Alzheimer’s disease range.
“This pattern of increased PIB in patients with MCI resembles what’s seen in Alzheimer’s disease and is suggestive of an early Alzheimer’s disease process,” said study author Juha O. Rinne, MD, PhD, with the University of Turku in Turku, Finland, and Fellow of the American Academy of Neurology. “Our findings are similar to what’s seen in post-mortem studies in which abnormal protein aggregation growth is found in people who had been diagnosed with probable Alzheimer’s disease.”
Rinne says larger studies and extended follow-up is needed since identifying people with MCI who have abnormal protein aggregation growth will become increasingly important as treatments affecting such plaque amyloid accumulation become available.
The study was supported by Turku University Hospital, the Finnish Medical Society Duodecim, the Finnish Cultural Foundation, the Research Foundation of Orion Corporation, the Research Council for Health of the Academy of Finland, and the Sigrid Juselius Foundation.
The American Academy of Neurology, an association of more than 20,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as epilepsy, dystonia, migraine, Huntington’s disease, and dementia. For more information about the American Academy of Neurology, visit www.aan.com.
http://www.investorvillage.com/smbd.asp?mb=160&mn=105851&pt=…
Antwort auf Beitrag Nr.: 29.146.312 von Nostarowie am 05.05.07 03:15:40ganz so groß braucht er aber nicht zu werden.
Tysabri abstracts to be presented on May 22 at DDW
Efficacy of Natalizumab in Crohn's Patients With Disease Duration Less Than Three Years
S. Schreiber1; S. R. Targan2
1. Christian Albrechts University, Kiel, Germany.
2. Cedars Sinai, Los Angeles, CA, USA.
Purpose: The phase 3 ENCORE and ENACT-2 trials demonstrated that natalizumab was an effective induction and maintenance therapy for Crohn’s disease (CD) patients. More than half of the patients in either trial had a disease duration >7 years. This post-hoc analysis examined remission rates with natalizumab in patients with disease duration ?3 years in these trials. Methods: In the ENCORE trial, patients (N=509) with Crohn’s Disease Activity Index (CDAI) scores ?220 and ?450 and C-reactive protein levels >2.87 mg/L were randomized 1:1 and received natalizumab (300 mg; n=259) or placebo (n=250) infusions at Weeks 0, 4, and 8. Twenty-four percent (120/509) of ENCORE patients had a mean disease duration ?3 years. In the ENACT-2 maintenance trial, adult patients with CD who responded (?70-point reduction in baseline CDAI score and CDAI score <220) to natalizumab induction therapy in the ENACT-1 trial were re-randomized 1:1 to natalizumab (300 mg; n=168) or placebo (n=171) and received up to 12 monthly infusions. Nearly 20% (67/339) of ENACT-2 patients had a mean disease duration ?3 years. Remission rates were analyzed at the various endpoints of both trials (Table). Results: Natalizumab was significantly superior to placebo (p<0.05) at all assessments in both groups studied (1 exception noted). Remission induction rates with natalizumab were consistently higher for patients with short disease duration than in the overall population of the ENCORE study, while placebo rates were similar. Natalizumab was equally efficacious for long-term maintenance of remission in both groups. Conclusions: Natalizumab was effective in inducing and sustaining remission in CD patients with short disease duration (?3 years) and in the overall population, despite the fact that a large proportion of patients in natalizumab phase 3 trials had extended disease duration. There were trends for higher induction remission rates for patients with short disease duration compared to the overall population, while maintenance therapy with natalizumab was efficacious irrespective of disease duration.
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Natalizumab Induces Sustained Response and Remission in Patients With Crohn’s Disease Activity Index Scores ?330: Results From the ENCORE Trial
R. Panaccione1; B. G. Feagan2; R. Fedorak3; B. Lashner4; D. H. Present5; P. Rutgeerts6; W. J. Sandborn7; M. E. Spehlmann8; Z. Tulassay9; M. Volfova10; D. C. Wolf11; S. R. Targan12
1. University of Calgary, Calgary, AB, Canada.
2. Robarts Research Institute, University of Western Ontario, London, ON, Canada.
3. University of Alberta, Edmonton, AB, Canada.
4. Cleveland Clinic, Cleveland, OH, USA.
5. Mount Sinai School of Medicine, New York, NY, USA.
6. University Hospital Gasthuisberg, Leuven, Belgium.
7. Mayo Clinic, Rochester, MN, USA.
8. Asklepios Westklinikum, Hamburg, Germany.
9. Semmelweis University, Budapest, Hungary.
10. Hepato-Gastroenterology, Hradec Králové, Czech Republic.
11. Atlanta Gastroenterology Associates, Atlanta, GA, USA.
12. Cedars Sinai, Los Angeles, CA, USA.
Purpose: Natalizumab has been shown to be effective in inducing response and remission (by Week 8 and through Week 12) in patients with moderate to severely active Crohn’s disease in a large phase 3 randomized controlled trial: ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission).1 Approximately 30% (155/509) of these patients entered the ENCORE trial with a baseline Crohn’s Disease Activity Index (CDAI) score ? 330; this post-hoc analysis assessed the efficacy of natalizumab in this subpopulation. Methods: Patients (N=509) with CDAI scores ?220 and ?450 and CRP >2.87 mg/L were randomized 1:1 and received natalizumab (300 mg; n=259) or placebo (n=250) infusions at Weeks 0, 4, and 8. Efficacy and safety were assessed at Weeks 4, 8 and 12. The primary endpoint was the ability of natalizumab to induce a clinical response (?70 point decrease in baseline CDAI score) by Week 8 that was sustained through Week 12. Results: Of the patients who entered the trial with a baseline CDAI score ? 330 (n=155), 51% had a sustained response to natalizumab through Weeks 8 and 12 compared with 27% of patients treated with placebo (p=0.002). Approximately 60% of patients with baseline CDAI ?330 were in response at either time point (62% at Week 8 and 60% at Week 12, p?0.005 for both comparisons with placebo). The response to natalizumab was demonstrated early, with 57% responding after the first infusion of natalizumab (Week 4) compared with 39% in the placebo group (p=0.029). Remission was sustained through Weeks 8 and 12 in 14% of patients treated with natalizumab compared with 3% of patients in the placebo group (p=0.025); remission rates at the Week 8 and 12 time-points were 21% and 23% in the natalizumab-treated patients, compared with 7% and 10% in placebo-treated patients (p?0.039 for both comparisons with placebo). The mean change in CDAI score from baseline exceeded 100 points at each time point in the natalizumab group and was statistically significant compared with placebo (-103 vs -55 at Week 4, p=0.002; -135 vs -69 at Week 8, p<0.001; -146 vs -66 at Week 12, p<0.001). Conclusions: In patients whose baseline CDAI score was ?330 natalizumab induced rapid, statistically significant, and durable response and remission (at Weeks 8 and 12) compared with placebo. Durable remission in this patient population is particularly impressive due to the magnitude of the decrease in CDAI scores necessary to achieve and sustain this endpoint.
-----------------------------------------------------------------
Natalizumab Induces Sustained Response and Remission in Crohn’s Patients After Previous Infliximab Failure: Results From the ENCORE Trial
D. H. Present1; B. G. Feagan2; R. N. Fedorak3; B. Lashner4; R. Panaccione5; P. Rutgeerts6; W. J. Sandborn7; M. E. Spehlmann8; Z. Tulassay9; M. Volfova10; D. C. Wolf11; S. R. Targan12
1. Mount Sinai School of Medicine, New York , NY, USA.
2. Robarts Research Institute, University of Western Ontario, London , ON, Canada.
3. University of Alberta, Edmonton, AB, Canada.
4. Cleveland Clinic, Cleveland, OH, USA.
5. University of Calgary, Calgary , AB, Canada.
6. University Hospital Gasthuisberg, Leuven, Belgium.
7. Mayo Clinic, Rochester, MN, USA.
8. Asklepios Westklinikum, Hamburg, Germany.
9. Semmelweis University, Budapest, Hungary.
10. Hepato-Gastroenterology, Hradec Králové, Czech Republic.
11. Atlanta Gastroenterology Associates, Atlanta, GA, USA.
12. Cedars Sinai, Los Angeles, CA, USA.
Purpose: The phase 3 ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission) trial demonstrated that natalizumab was effective in inducing durable response and remission in Crohn’s patients with active disease and evidence of inflammation. Forty-eight percent of patients sustained response through Weeks 8 and 12, and 26% sustained remission compared with 32% and 16% in the placebo groups (p?0.002). Nearly 50% (242/509) of patients in the ENCORE trial had been previously exposed to infliximab, and over two-thirds of these patients (71%; 172/242) were considered by the study investigators to have failed this anti-TNF therapy. This post-hoc analysis assessed the efficacy of natalizumab in the ENCORE subpopulation of patients with prior infliximab failure. Methods: Patients (N=509) with Crohn’s Disease Activity Index (CDAI) scores ?220 and ?450 and C-reactive protein leves >2.87 mg/L were randomized 1:1 and received natalizumab (300 mg; n=259) or placebo (n=250) infusions at Weeks 0, 4, and 8. Efficacy and safety were assessed at Weeks 4, 8 and 12. The primary endpoint was the ability of natalizumab to induce a clinical response (?70 point decrease in baseline CDAI score) by Week 8 that was sustained through Week 12. Results: Of the patients who had previously failed therapy with infliximab (N=172), 38% had a sustained response to natalizumab through Weeks 8 and 12 compared with 15% of patients treated with placebo (p<0.001). Approximately 50% of natalizumab-treated patients with prior infliximab failure were in response at either time point (52% at Week 8 and 49% at Week 12) compared with 22% and 29% in the placebo group (p?0.006). Patients treated with natalizumab also had higher sustained remission rates. Remission was sustained through Weeks 8 and 12 in 17% of patients treated with natalizumab compared with 5% of patients in the placebo group (p=0.012). The incidence and types of adverse events were similar between groups and were comparable to the overall treatment population. Conclusions: Natalizumab induced durable response and remission in patients who had previously failed infliximab therapy. A statistically greater proportion of natalizumab-treated patients achieved response or remission by Week 8 that was sustained through Week 12 compared with patients receiving placebo. Natalizumab was well tolerated in this sub-population of patients, with adverse events not significantly different than placebo or the overall ENCORE population
http://www.investorvillage.com/smbd.asp?mb=160&mn=105858&pt=…
Ich bedaure alle DNDN-Aktionäre, zumal ich einen noch tieferen Fall mit Elan schon hinter mir habe und von daher weiß, wie man sich fühlt. posimist
Antwort auf Beitrag Nr.: 29.231.429 von posimist am 09.05.07 14:35:57
DNDN war die letzten Wochen aber auch künstlich aufgepumpt worden und was jetzt passiert, ist mehr als normal.
Was wir bei Elan die letzten 1 1/4 Jahre erleben, ist im Grunde
viel schlimmer.
DNDN war die letzten Wochen aber auch künstlich aufgepumpt worden und was jetzt passiert, ist mehr als normal.
Was wir bei Elan die letzten 1 1/4 Jahre erleben, ist im Grunde
viel schlimmer.
Business Wire
Auf der Jahresversammlung der American Academy of Neurology präsentierte Daten liefern neue Informationen zur Anwendung und Verträglichkeit von TYSABR
Mittwoch 9. Mai 2007, 17:46 Uhr
BOSTON Biogen Idec (NASDAQ: BIIB) und die Elan Corporation PLC (NYSE: ELN) teilten heute mit, dass neue Daten des TOUCH Prescribing Program(TM) und der Sicherheitsstudie TYGRIS das Sicherheitsprofil aus früheren klinischen Studien zu TYSABRI(R) (natalizumab) bestätigen. Zudem wurden auf der 59. Jahresversammlung der American Academy of Neurology in Boston, Massachusetts, Daten einer Anschlussstudie präsentiert, die zeigen, dass TYSABRI einen anhaltenden Behandlungseffekt auf klinische Rückfälle und das Risiko der Behinderungsprogression bei Patienten mit multipler Sklerose (MS) hat, die bis zu drei Jahre lang behandelt werden. Die Unternehmen meldeten vor kurzem, dass mit Stand Mitte April 2007 ca. 12.500 Patienten weltweit TYSABRI verschrieben wurde. Schätzungen der beiden Unternehmen zufolge wenden gegenwärtig mehr als 10.000 Patienten TYSABRI in klinischen Studien und im kommerziellen Rahmen an.
,,Die neuen Ergebnisse hinsichtlich der Sicherheit des Mittels zusammen mit den Daten, die den anhaltenden Behandlungseffekt bei Patienten zeigen, die bis zu drei Jahre lang mit TYSABRI behandelt wurden, liefern aufschlussreiche Informationen darüber, wie diese Therapie als Behandlungsmöglichkeit für Patienten eingesetzt werden kann, die mit den Folgen multipler Sklerose leben müssen", sagte Dr. med. Paul O'Connor, St. Michael's Hospital, Toronto, Ontario, Kanada, Hauptversuchsleiter der TYSABRI-Anschlussstudie.
Aktuelle Informationen zu TYSABRI
TYSABRI ist in den USA über das TOUCH Prescribing Program erhältlich. Alle Verordner, Infusionsstellen und Patienten, die TYSABRI erhalten, müssen sich für das TOUCH-Programm registrieren. Informationen über die Sicherheit des Mittels werden zudem anhand von laufenden klinischen Studien und Registern zusammengetragen, darunter STRATA, TYGRIS und das Schwangerschaftsregister. Laut den Daten, die den Unternehmen zum 23. April 2007 vorlagen, gab es keine neuen Berichte über bestätigte Fälle von progressiver multifokaler Leukoenzephalopathie (PML) oder andere schwere opportunistische Infektionen (OIs). Die Daten bestätigen das Sicherheitsprofil aus früheren klinischen Studien zu TYSABRI und werden die Kenntnisse in Bezug auf die langfristige Sicherheit und Verträglichkeit von TYSABRI erweitern.
TOUCH, TYGRIS und das Schwangerschaftsregister bilden das umfassendste jemals durchgeführte Programm zur langfristigen Nachkontrolle einer MS-Therapie und die Unternehmen planen, auf kommenden medizinischen Veranstaltungen weiterhin aktuelle Informationen dieser Art bereit zu stellen.
Den Unternehmen zufolge wurde mit Stand Mitte April ca. 12.500 Patienten weltweit TSBARI verschrieben. Gegenwärtig werden mehr als 10.000 Patienten weltweit sowohl im kommerziellen Rahmen als auch in klinischen Studien mit TYSABRI behandelt.
-- In den USA wenden gegenwärtig ca. 6.600 Patienten TYSABRI im kommerziellen Rahmen an. Ungefähr 10.000 Patienten haben sich für das TOUCH-Programm registriert und 1.500 Mediziner haben registrierte Patienten.
-- In der EU haben etwa 2.500 Patienten TYSABRI-Infusionen im kommerziellen Rahmen erhalten, hauptsächlich in Deutschland und den nordischen Ländern.
-- Mehr als 1.000 Patienten unterziehen sich im Rahmen klinischer Studien einer TYSABRI-Therapie.
Anhaltende Wirksamkeit von TYSABRI über drei Jahre
Patienten, die an dem Phase-III-TYSABRI-Programm teilgenommen hatten, waren zur Anmeldung für eine Open-Label-Anschlussstudie berechtigt, in deren Rahmen die Langzeitwirkung der Behandlung evaluiert wurde. Dazu gehörten Patienten von AFFIRM, einer randomisierten, doppelblinden, Placebo-kontrollierten, zweijährigen Monotherapiestudie zu TYSABRI, an der 942 Patienten teilnahmen (von denen 627 Patienten TYSABRI und 315 ein Placebo erhielten). In der AFFIRM-Studie reduzierte TYSABRI im Vergleich zur Placebogruppe die auf das Jahr bezogene Rückfallrate bei MS-Patienten um 67 % (p<0,001) und das Risiko der über 12 Wochen anhaltenden Behinderungsprogression um 42 % (p<0,001).
In der Intent-to-Treat-Analyse lag die auf das Jahr bezogene Rückfallrate für mit TYSABRI behandelte Patienten über den Zeitraum von drei Jahren bei 0,23, was im Durchschnitt einem Rückfall aller 4,3 Jahre entspricht. Die Rückfallrate blieb während der dreijährigen Behandlung mit TYSABRI zudem weiterhin niedrig: 0,27 im ersten Jahr; 0,20 im zweiten Jahr und 0,15 im dritten Jahr (basierend auf 531 Patienten, die an der Anschlussstudie teilnahmen, darunter ca. 250 Patienten mit fast drei Jahren fortlaufender Therapie).
Des Weiteren reduzierte TYSABRI die kumulative Wahrscheinlichkeit der über sechs Monate anhaltenden Behinderungsprogression im Vergleich zur Placebogruppe. Der geschätzte Anteil von Patienten mit einer über 24 Wochen anhaltenden Behinderungsprogression lag bei mit TYSABRI behandelten Patienten nach zwei Jahren bei 11 % gegenüber 23 % bei Patienten, die ein Placebo erhielten. Dies entspricht einer relativen Reduktion von 54 %.
Dieser Effekt wurde bei mit TYSABRI behandelten Patienten bis zu drei Jahre lang aufrechterhalten. 13 % von ihnen zeigten eine über 24 Wochen andauernde Behinderungsprogression.
Über TOUCH und TYGRIS
Vor Behandlungsbeginn müssen alle Patienten, Verordner und Infusionsstellen beim TOUCH Prescribing Program (Abk. f. TYSABRI Outreach: Unified Commitment to Health) registriert sein. TOUCH dient der Bestimmung des Auftretens von schweren OIs sowie von Risikofaktoren für diese, darunter PML, sowie der Überwachung von Patienten, um PML-Symptome zu erkennen, und fördert sachkundige Nutzen-/Risiko-Diskussionen vor dem Beginn einer Behandlung mit TYSABRI. Ärzte berichten auf fortlaufender Basis über PML, schwere OIs, Todesfälle und Therapieabbrüche.
Für TYGRIS (Abk. f. TYSABRI Global ObseRvation Program In Safety) werden sich voraussichtlich 5.000 Patienten weltweit anmelden, darunter ca. 3.000 Patienten von TOUCH. Patienten, die an TYGRIS teilnehmen, werden zu Beginn der Studie und danach fünf Jahre lang alle sechs Monate untersucht. Die Forscher werden u. a. folgende Daten auswerten: medizinische/MS-Vorgeschichte; frühere Anwendung von TYSABRI; frühere Anwendung von immunmodulatorischen, antineoplastischen oder immunsuppressiven Wirkstoffen und sämtliche schwerwiegende unerwünschte Ereignisse, darunter PML und andere schwere OIs und bösartige Tumore.
Die hier bereitgestellten Informationen beruhen auf freiwilligen Meldungen unerwünschter Ereignisse. Es besteht die Möglichkeit, dass nicht alle Reaktionen gemeldet wurden oder dass einige Reaktionen Biogen Idec oder Elan nicht rechtzeitig gemeldet werden.
Über TYSABRI
In den USA ist TYSABRI als Monotherapie für die Behandlung der in Schüben verlaufenden multiplen Sklerose zugelassen. TYSABRI erhöht das Risiko einer PML, einer opportunistischen Virusinfektion des Gehirns, die in der Regel tödlich verläuft oder zu schweren Behinderungen führt. Die Patienten müssen daher regelmäßig auf neue bzw. sich verschlechternde Symptome untersucht werden, die eine PML vermuten lassen. Wegen des erhöhten PML-Risikos empfiehlt sich TYSABRI nur für Patienten, die auf alternative MS-Therapien nicht ansprechen oder diese nicht vertragen. TYSABRI unterliegt in den USA strengen Auflagen und ist nur über das sogenannte TOUCH Prescribing Program erhältlich. Laut Produktbeschriftung führte die Behandlung mit TYSABRI gegenüber der Vergleichstherapie mit einem Placebo zu einer relativen Verminderung der auf das Jahr bezogenen Rückfallrate um 67 % (p<0,001) und reduzierte das relative Risiko der Behinderungsprogression um 42 % (p<0,001). Die Behandlung mit TYSABRI resultierte zudem in einer anhaltenden und statistisch signifikanten Reduzierung der mittels MRT gemessenen Hirnverletzungsaktivität. Veränderungen der MRT-Ergebnisse korrelieren oft nicht mit den Veränderungen des klinischen Status von Patienten (z. B. Behinderungsprogression). Die prognostische Bedeutung der MRT-Ergebnisse in diesen Studien wurde nicht evaluiert.
In der Europäischen Union wird TYSABRI als krankheitsmodifizierende Einzeltherapie bei Patienten mit hochaktiver schubförmig-remittierender MS eingesetzt. Wegen des erhöhten Risikos einer PML wird TYSABRI nur bei hoher Krankheitsaktivität trotz Behandlung mit einem Beta-Interferon oder bei schnell fortschreitender schwerer schubförmig-remittierender MS verabreicht.
Laut Produktbeschriftung in der EU führte die Behandlung mit TYSABRI gegenüber der Vergleichstherapie mit einem Placebo zu einer relativen Verminderung der auf das Jahr bezogenen Rückfallrate um 68 % (p<0,001) und reduzierte das relative Risiko der Behinderungsprogression um 42-54 % (p<0,001).
Zu den schweren Nebenwirkungen, die bei mit TYSABRI behandelten MS-Patienten auftraten, zählen u. a. Überempfindlichkeitsreaktionen (z. B. allergische Reaktionen), Infektionen, Depressionen und Gallensteine. Das Auftreten anderer schwerer oder häufiger Nebenwirkungen wie auch die Gesamtrate der Infektionen war bei den Behandlungsgruppen ausgeglichen. Bei den Patienten, die mit TYSABRI behandelt wurden, kam es etwas häufiger zu Herpesinfektionen. Schwere opportunistische und andere atypische Infektionen wurden bei mit TYSABRI behandelten Patienten beobachtet, von denen einige gleichzeitig Immunsuppressiva erhielten. Häufige Nebenwirkungen, über die von Patienten berichtet wurde, die mit TYSABRI behandelt wurden, sind Kopfschmerzen, Müdigkeit, Infusionsreaktionen, Harnwegsinfektionen, Gelenk- und Gliederschmerzen, Infektionen der unteren Atemwege, Ausschlag, Gastroenteritis, Vaginitis, Depressionen, Bauchbeschwerden und Diarrhö.
Weitere Informationen zu TYSABRI erhalten Sie unter www.tysabri.com, www.biogenidec.com oder www.elan.com oder telefonisch unter +1-800-456-2255.
Über Biogen Idec
Biogen Idec setzt in therapeutischen Bereichen mit erheblichen medizinischen Versorgungslücken neue Standards. Das Unternehmen wurde 1978 gegründet und ist bei der Entwicklung, Herstellung und Kommerzialisierung innovativer Therapien weltweit führend. Patienten in mehr als 90 Ländern profitieren von Biogen Idecs leistungsfähigen Produkten für die Behandlung von Lymphknotenerkrankungen und Krankheiten wie multipler Sklerose und Gelenkrheumatismus. Produktinformationen, Pressemitteilungen und zusätzliche Informationen über das Unternehmen finden Sie unter http://www.biogenidec.com.
Über Elan
Die Elan Corporation, plc ist ein Biotechnologie-Unternehmen mit neurowissenschaftlicher Ausrichtung und strebt danach, das Leben der Patienten und ihrer Familien zu verbessern. Das Unternehmen setzt sich dafür ein, wissenschaftliche Innovationen für ernste, nicht gelöste medizinische Probleme nutzbar zu machen, da diese nach wie vor weltweit anzutreffen sind. Die Aktien von Elan werden an den Börsen in New York, London und Dublin gehandelt. Weitere Informationen über das Unternehmen sind unter www.elan.com abrufbar.
Safe-Harbor/Zukunftsbezogene Aussagen
Diese Pressemitteilung enthält zukunftsbezogene Aussagen in Bezug auf TYSABRI. Diese Aussagen beruhen auf den gegenwärtigen Überzeugungen und Erwartungen der Unternehmen. Das kommerzielle Potential von TYSABRI ist einer Reihe von Risiken und Unsicherheiten ausgesetzt. Zu den Faktoren, die dazu führen können, dass die tatsächlichen Ergebnisse erheblich von den derzeitigen Erwartungen der Unternehmen abweichen, gehört das Risiko, dass wir möglicherweise nicht in der Lage sind, in angemessenen Maße auf die Bedenken oder Fragen der FDA oder anderer Zulassungsbehörden zu reagieren, dass sich aus den zusätzlichen Daten Bedenken ergeben könnten, dass das Auftreten und/oder das Risiko von PML oder anderer opportunistischer Infektionen bei mit TYSABRI behandelten Patienten häufiger bzw. größer ist als in klinischen Studien beobachtet wurde, oder dass die Unternehmen auf andere unerwartete Hindernisse stoßen. Die Entwicklung und Vermarktung von Medikamenten ist mit zahlreichen Risiken behaftet.
Ausführlichere Informationen über die Risiken und Unsicherheiten in Verbindung mit der Medikamentenentwicklung und anderen Aktivitäten der Unternehmen sind in den regelmäßigen und aktuellen Berichten enthalten, die Biogen Idec und Elan bei der US-Börsenaufsichtsbehörde SEC eingereicht haben. Die Unternehmen übernehmen keine Verpflichtung, zukunftsbezogene Aussagen zu aktualisieren, sollten sich neue Informationen, Ereignisse o. ä. ergeben.
Kontakt
Ansprechpartner Medien:
Biogen Idec
Amy Brockelman, 617 914 6524
oder
Elan
Matt Dallas, 212 850 5664
Elizabeth Headon, 353 1 498 0300
oder
Ansprechpartner Investoren:
Biogen Idec
Eric Hoffman, 617 679 2812
oder
Elan
Chris Burns, 353 1 709 4444
800 252 3526
http://de.biz.yahoo.com/09052007/240/jahresversammlung-ameri…
Auf der Jahresversammlung der American Academy of Neurology präsentierte Daten liefern neue Informationen zur Anwendung und Verträglichkeit von TYSABR
Mittwoch 9. Mai 2007, 17:46 Uhr
BOSTON Biogen Idec (NASDAQ: BIIB) und die Elan Corporation PLC (NYSE: ELN) teilten heute mit, dass neue Daten des TOUCH Prescribing Program(TM) und der Sicherheitsstudie TYGRIS das Sicherheitsprofil aus früheren klinischen Studien zu TYSABRI(R) (natalizumab) bestätigen. Zudem wurden auf der 59. Jahresversammlung der American Academy of Neurology in Boston, Massachusetts, Daten einer Anschlussstudie präsentiert, die zeigen, dass TYSABRI einen anhaltenden Behandlungseffekt auf klinische Rückfälle und das Risiko der Behinderungsprogression bei Patienten mit multipler Sklerose (MS) hat, die bis zu drei Jahre lang behandelt werden. Die Unternehmen meldeten vor kurzem, dass mit Stand Mitte April 2007 ca. 12.500 Patienten weltweit TYSABRI verschrieben wurde. Schätzungen der beiden Unternehmen zufolge wenden gegenwärtig mehr als 10.000 Patienten TYSABRI in klinischen Studien und im kommerziellen Rahmen an.
,,Die neuen Ergebnisse hinsichtlich der Sicherheit des Mittels zusammen mit den Daten, die den anhaltenden Behandlungseffekt bei Patienten zeigen, die bis zu drei Jahre lang mit TYSABRI behandelt wurden, liefern aufschlussreiche Informationen darüber, wie diese Therapie als Behandlungsmöglichkeit für Patienten eingesetzt werden kann, die mit den Folgen multipler Sklerose leben müssen", sagte Dr. med. Paul O'Connor, St. Michael's Hospital, Toronto, Ontario, Kanada, Hauptversuchsleiter der TYSABRI-Anschlussstudie.
Aktuelle Informationen zu TYSABRI
TYSABRI ist in den USA über das TOUCH Prescribing Program erhältlich. Alle Verordner, Infusionsstellen und Patienten, die TYSABRI erhalten, müssen sich für das TOUCH-Programm registrieren. Informationen über die Sicherheit des Mittels werden zudem anhand von laufenden klinischen Studien und Registern zusammengetragen, darunter STRATA, TYGRIS und das Schwangerschaftsregister. Laut den Daten, die den Unternehmen zum 23. April 2007 vorlagen, gab es keine neuen Berichte über bestätigte Fälle von progressiver multifokaler Leukoenzephalopathie (PML) oder andere schwere opportunistische Infektionen (OIs). Die Daten bestätigen das Sicherheitsprofil aus früheren klinischen Studien zu TYSABRI und werden die Kenntnisse in Bezug auf die langfristige Sicherheit und Verträglichkeit von TYSABRI erweitern.
TOUCH, TYGRIS und das Schwangerschaftsregister bilden das umfassendste jemals durchgeführte Programm zur langfristigen Nachkontrolle einer MS-Therapie und die Unternehmen planen, auf kommenden medizinischen Veranstaltungen weiterhin aktuelle Informationen dieser Art bereit zu stellen.
Den Unternehmen zufolge wurde mit Stand Mitte April ca. 12.500 Patienten weltweit TSBARI verschrieben. Gegenwärtig werden mehr als 10.000 Patienten weltweit sowohl im kommerziellen Rahmen als auch in klinischen Studien mit TYSABRI behandelt.
-- In den USA wenden gegenwärtig ca. 6.600 Patienten TYSABRI im kommerziellen Rahmen an. Ungefähr 10.000 Patienten haben sich für das TOUCH-Programm registriert und 1.500 Mediziner haben registrierte Patienten.
-- In der EU haben etwa 2.500 Patienten TYSABRI-Infusionen im kommerziellen Rahmen erhalten, hauptsächlich in Deutschland und den nordischen Ländern.
-- Mehr als 1.000 Patienten unterziehen sich im Rahmen klinischer Studien einer TYSABRI-Therapie.
Anhaltende Wirksamkeit von TYSABRI über drei Jahre
Patienten, die an dem Phase-III-TYSABRI-Programm teilgenommen hatten, waren zur Anmeldung für eine Open-Label-Anschlussstudie berechtigt, in deren Rahmen die Langzeitwirkung der Behandlung evaluiert wurde. Dazu gehörten Patienten von AFFIRM, einer randomisierten, doppelblinden, Placebo-kontrollierten, zweijährigen Monotherapiestudie zu TYSABRI, an der 942 Patienten teilnahmen (von denen 627 Patienten TYSABRI und 315 ein Placebo erhielten). In der AFFIRM-Studie reduzierte TYSABRI im Vergleich zur Placebogruppe die auf das Jahr bezogene Rückfallrate bei MS-Patienten um 67 % (p<0,001) und das Risiko der über 12 Wochen anhaltenden Behinderungsprogression um 42 % (p<0,001).
In der Intent-to-Treat-Analyse lag die auf das Jahr bezogene Rückfallrate für mit TYSABRI behandelte Patienten über den Zeitraum von drei Jahren bei 0,23, was im Durchschnitt einem Rückfall aller 4,3 Jahre entspricht. Die Rückfallrate blieb während der dreijährigen Behandlung mit TYSABRI zudem weiterhin niedrig: 0,27 im ersten Jahr; 0,20 im zweiten Jahr und 0,15 im dritten Jahr (basierend auf 531 Patienten, die an der Anschlussstudie teilnahmen, darunter ca. 250 Patienten mit fast drei Jahren fortlaufender Therapie).
Des Weiteren reduzierte TYSABRI die kumulative Wahrscheinlichkeit der über sechs Monate anhaltenden Behinderungsprogression im Vergleich zur Placebogruppe. Der geschätzte Anteil von Patienten mit einer über 24 Wochen anhaltenden Behinderungsprogression lag bei mit TYSABRI behandelten Patienten nach zwei Jahren bei 11 % gegenüber 23 % bei Patienten, die ein Placebo erhielten. Dies entspricht einer relativen Reduktion von 54 %.
Dieser Effekt wurde bei mit TYSABRI behandelten Patienten bis zu drei Jahre lang aufrechterhalten. 13 % von ihnen zeigten eine über 24 Wochen andauernde Behinderungsprogression.
Über TOUCH und TYGRIS
Vor Behandlungsbeginn müssen alle Patienten, Verordner und Infusionsstellen beim TOUCH Prescribing Program (Abk. f. TYSABRI Outreach: Unified Commitment to Health) registriert sein. TOUCH dient der Bestimmung des Auftretens von schweren OIs sowie von Risikofaktoren für diese, darunter PML, sowie der Überwachung von Patienten, um PML-Symptome zu erkennen, und fördert sachkundige Nutzen-/Risiko-Diskussionen vor dem Beginn einer Behandlung mit TYSABRI. Ärzte berichten auf fortlaufender Basis über PML, schwere OIs, Todesfälle und Therapieabbrüche.
Für TYGRIS (Abk. f. TYSABRI Global ObseRvation Program In Safety) werden sich voraussichtlich 5.000 Patienten weltweit anmelden, darunter ca. 3.000 Patienten von TOUCH. Patienten, die an TYGRIS teilnehmen, werden zu Beginn der Studie und danach fünf Jahre lang alle sechs Monate untersucht. Die Forscher werden u. a. folgende Daten auswerten: medizinische/MS-Vorgeschichte; frühere Anwendung von TYSABRI; frühere Anwendung von immunmodulatorischen, antineoplastischen oder immunsuppressiven Wirkstoffen und sämtliche schwerwiegende unerwünschte Ereignisse, darunter PML und andere schwere OIs und bösartige Tumore.
Die hier bereitgestellten Informationen beruhen auf freiwilligen Meldungen unerwünschter Ereignisse. Es besteht die Möglichkeit, dass nicht alle Reaktionen gemeldet wurden oder dass einige Reaktionen Biogen Idec oder Elan nicht rechtzeitig gemeldet werden.
Über TYSABRI
In den USA ist TYSABRI als Monotherapie für die Behandlung der in Schüben verlaufenden multiplen Sklerose zugelassen. TYSABRI erhöht das Risiko einer PML, einer opportunistischen Virusinfektion des Gehirns, die in der Regel tödlich verläuft oder zu schweren Behinderungen führt. Die Patienten müssen daher regelmäßig auf neue bzw. sich verschlechternde Symptome untersucht werden, die eine PML vermuten lassen. Wegen des erhöhten PML-Risikos empfiehlt sich TYSABRI nur für Patienten, die auf alternative MS-Therapien nicht ansprechen oder diese nicht vertragen. TYSABRI unterliegt in den USA strengen Auflagen und ist nur über das sogenannte TOUCH Prescribing Program erhältlich. Laut Produktbeschriftung führte die Behandlung mit TYSABRI gegenüber der Vergleichstherapie mit einem Placebo zu einer relativen Verminderung der auf das Jahr bezogenen Rückfallrate um 67 % (p<0,001) und reduzierte das relative Risiko der Behinderungsprogression um 42 % (p<0,001). Die Behandlung mit TYSABRI resultierte zudem in einer anhaltenden und statistisch signifikanten Reduzierung der mittels MRT gemessenen Hirnverletzungsaktivität. Veränderungen der MRT-Ergebnisse korrelieren oft nicht mit den Veränderungen des klinischen Status von Patienten (z. B. Behinderungsprogression). Die prognostische Bedeutung der MRT-Ergebnisse in diesen Studien wurde nicht evaluiert.
In der Europäischen Union wird TYSABRI als krankheitsmodifizierende Einzeltherapie bei Patienten mit hochaktiver schubförmig-remittierender MS eingesetzt. Wegen des erhöhten Risikos einer PML wird TYSABRI nur bei hoher Krankheitsaktivität trotz Behandlung mit einem Beta-Interferon oder bei schnell fortschreitender schwerer schubförmig-remittierender MS verabreicht.
Laut Produktbeschriftung in der EU führte die Behandlung mit TYSABRI gegenüber der Vergleichstherapie mit einem Placebo zu einer relativen Verminderung der auf das Jahr bezogenen Rückfallrate um 68 % (p<0,001) und reduzierte das relative Risiko der Behinderungsprogression um 42-54 % (p<0,001).
Zu den schweren Nebenwirkungen, die bei mit TYSABRI behandelten MS-Patienten auftraten, zählen u. a. Überempfindlichkeitsreaktionen (z. B. allergische Reaktionen), Infektionen, Depressionen und Gallensteine. Das Auftreten anderer schwerer oder häufiger Nebenwirkungen wie auch die Gesamtrate der Infektionen war bei den Behandlungsgruppen ausgeglichen. Bei den Patienten, die mit TYSABRI behandelt wurden, kam es etwas häufiger zu Herpesinfektionen. Schwere opportunistische und andere atypische Infektionen wurden bei mit TYSABRI behandelten Patienten beobachtet, von denen einige gleichzeitig Immunsuppressiva erhielten. Häufige Nebenwirkungen, über die von Patienten berichtet wurde, die mit TYSABRI behandelt wurden, sind Kopfschmerzen, Müdigkeit, Infusionsreaktionen, Harnwegsinfektionen, Gelenk- und Gliederschmerzen, Infektionen der unteren Atemwege, Ausschlag, Gastroenteritis, Vaginitis, Depressionen, Bauchbeschwerden und Diarrhö.
Weitere Informationen zu TYSABRI erhalten Sie unter www.tysabri.com, www.biogenidec.com oder www.elan.com oder telefonisch unter +1-800-456-2255.
Über Biogen Idec
Biogen Idec setzt in therapeutischen Bereichen mit erheblichen medizinischen Versorgungslücken neue Standards. Das Unternehmen wurde 1978 gegründet und ist bei der Entwicklung, Herstellung und Kommerzialisierung innovativer Therapien weltweit führend. Patienten in mehr als 90 Ländern profitieren von Biogen Idecs leistungsfähigen Produkten für die Behandlung von Lymphknotenerkrankungen und Krankheiten wie multipler Sklerose und Gelenkrheumatismus. Produktinformationen, Pressemitteilungen und zusätzliche Informationen über das Unternehmen finden Sie unter http://www.biogenidec.com.
Über Elan
Die Elan Corporation, plc ist ein Biotechnologie-Unternehmen mit neurowissenschaftlicher Ausrichtung und strebt danach, das Leben der Patienten und ihrer Familien zu verbessern. Das Unternehmen setzt sich dafür ein, wissenschaftliche Innovationen für ernste, nicht gelöste medizinische Probleme nutzbar zu machen, da diese nach wie vor weltweit anzutreffen sind. Die Aktien von Elan werden an den Börsen in New York, London und Dublin gehandelt. Weitere Informationen über das Unternehmen sind unter www.elan.com abrufbar.
Safe-Harbor/Zukunftsbezogene Aussagen
Diese Pressemitteilung enthält zukunftsbezogene Aussagen in Bezug auf TYSABRI. Diese Aussagen beruhen auf den gegenwärtigen Überzeugungen und Erwartungen der Unternehmen. Das kommerzielle Potential von TYSABRI ist einer Reihe von Risiken und Unsicherheiten ausgesetzt. Zu den Faktoren, die dazu führen können, dass die tatsächlichen Ergebnisse erheblich von den derzeitigen Erwartungen der Unternehmen abweichen, gehört das Risiko, dass wir möglicherweise nicht in der Lage sind, in angemessenen Maße auf die Bedenken oder Fragen der FDA oder anderer Zulassungsbehörden zu reagieren, dass sich aus den zusätzlichen Daten Bedenken ergeben könnten, dass das Auftreten und/oder das Risiko von PML oder anderer opportunistischer Infektionen bei mit TYSABRI behandelten Patienten häufiger bzw. größer ist als in klinischen Studien beobachtet wurde, oder dass die Unternehmen auf andere unerwartete Hindernisse stoßen. Die Entwicklung und Vermarktung von Medikamenten ist mit zahlreichen Risiken behaftet.
Ausführlichere Informationen über die Risiken und Unsicherheiten in Verbindung mit der Medikamentenentwicklung und anderen Aktivitäten der Unternehmen sind in den regelmäßigen und aktuellen Berichten enthalten, die Biogen Idec und Elan bei der US-Börsenaufsichtsbehörde SEC eingereicht haben. Die Unternehmen übernehmen keine Verpflichtung, zukunftsbezogene Aussagen zu aktualisieren, sollten sich neue Informationen, Ereignisse o. ä. ergeben.
Kontakt
Ansprechpartner Medien:
Biogen Idec
Amy Brockelman, 617 914 6524
oder
Elan
Matt Dallas, 212 850 5664
Elizabeth Headon, 353 1 498 0300
oder
Ansprechpartner Investoren:
Biogen Idec
Eric Hoffman, 617 679 2812
oder
Elan
Chris Burns, 353 1 709 4444
800 252 3526
http://de.biz.yahoo.com/09052007/240/jahresversammlung-ameri…
Antwort auf Beitrag Nr.: 29.234.952 von Holgus am 09.05.07 16:56:14Es lag nicht am "Aufgepumptsein" sondern an der Macht des Geldes,dem sich auch ein integerer FDA-Vorsitzende nicht widersetzen durfte....es leben die Chemoindustrie und die Hedgefunds eben sehr gut...
Antwort auf Beitrag Nr.: 29.237.753 von Birgit.Tersteegen am 09.05.07 19:09:05Na komm Birgit, über Nacht von 5 auf 25 (vorbörslich), da waren
verdammt welche am Pumpen. So groß war die Nachricht, die das auslöste, nun auch wieder nicht.
Dann müßte Elan bei solch einer Nachricht zu Alz locker auf 70ig hüpfen, das wird aber nicht passieren.
Bei Elan sind andere "Mächte" am Drücker :O
verdammt welche am Pumpen. So groß war die Nachricht, die das auslöste, nun auch wieder nicht.
Dann müßte Elan bei solch einer Nachricht zu Alz locker auf 70ig hüpfen, das wird aber nicht passieren.
Bei Elan sind andere "Mächte" am Drücker :O
Antwort auf Beitrag Nr.: 29.240.327 von Holgus am 09.05.07 21:21:46Dann müßte Elan bei solch einer Nachricht zu Alz locker auf 70ig hüpfen,
..genau Hoger...endlich hast du die Börse begriffen...
..Guten Morgen, " alter " Schwede....ich hoffe ., dir geht es gut ....
Grüße bernie55
..genau Hoger...endlich hast du die Börse begriffen...
..Guten Morgen, " alter " Schwede....ich hoffe ., dir geht es gut ....
Grüße bernie55
Antwort auf Beitrag Nr.: 29.244.209 von bernie55 am 10.05.07 09:09:18Guten Morgen, " alter " Schwede...
Moin Bernie, Schweden liegt aber noch´n büschen weiter nördlich.
Noch wohn ich in Schleswig-Holstein.
Das ist das Land mit den 2 Meeren, ähnlich wie Afrika, allerdings
ohne Elefanten und dicke schwarze Frauen.
Auch ist es bei uns nicht ganz so heiß, obwohl es bei "Einfall"
von genügend Schwedinnen garantiert heißer zugeht.
Soviel zum Thema "Erdkunde und Sexualwissenschaften"
Moin Bernie, Schweden liegt aber noch´n büschen weiter nördlich.
Noch wohn ich in Schleswig-Holstein.
Das ist das Land mit den 2 Meeren, ähnlich wie Afrika, allerdings
ohne Elefanten und dicke schwarze Frauen.
Auch ist es bei uns nicht ganz so heiß, obwohl es bei "Einfall"
von genügend Schwedinnen garantiert heißer zugeht.
Soviel zum Thema "Erdkunde und Sexualwissenschaften"
damit wir hier mal wieder bessere Laune bekommen:
Oh man Poppi geh mir weg mit dem Mäusekinochart.
Im Dendreonthread kommen jetzt die ganzen Kartoffelkäfer und streiten sich über die Restkrümel vom Dropskuchen. Hab das Thema abgehakt und nu müss mer ma gucken wo Kohle anderswo herkommt.
Mal sehen ob sich eln hält falls der Dow-Zirkus weiterfällt.
Im Dendreonthread kommen jetzt die ganzen Kartoffelkäfer und streiten sich über die Restkrümel vom Dropskuchen. Hab das Thema abgehakt und nu müss mer ma gucken wo Kohle anderswo herkommt.
Mal sehen ob sich eln hält falls der Dow-Zirkus weiterfällt.
Antwort auf Beitrag Nr.: 29.237.753 von Birgit.Tersteegen am 09.05.07 19:09:05hi birgit,
hattest was von einer party gesagt, sollte hier stattfinden!
hab da ein bischen was auf der hohen kante
erzähl mir doch kurz was über die story hier ( stichpunkte reichen ), bitte verlang nicht das ich den mörderthread durchlese.
hattest was von einer party gesagt, sollte hier stattfinden!
hab da ein bischen was auf der hohen kante
erzähl mir doch kurz was über die story hier ( stichpunkte reichen ), bitte verlang nicht das ich den mörderthread durchlese.
Antwort auf Beitrag Nr.: 29.255.248 von Nostarowie am 10.05.07 17:50:00bin mit DNDN noch nicht ganz durch.
Werde wohl auch alle Aktien behalten und bis 2008 bzw. 2010 warten.
Habe aber auch gelernt, wenigstens einen Teil meiner Gewinne in Zukunft zu realisieren und nicht generell auf das Überschreiten der Jahresfrist zu warten.
Werde wohl auch alle Aktien behalten und bis 2008 bzw. 2010 warten.
Habe aber auch gelernt, wenigstens einen Teil meiner Gewinne in Zukunft zu realisieren und nicht generell auf das Überschreiten der Jahresfrist zu warten.
Msg: 106422 of 106446 5/10/2007 9:07:16 PM Recs: 30 Sentiment: Strong Buy
By: elmer92692 Send PM Profile Ignore Recommend Add To Favorites
Gee.....
JP Morgan doubled their position last quarter. Now 2.1 million. Go figure. cheers
By: elmer92692 Send PM Profile Ignore Recommend Add To Favorites
Gee.....
JP Morgan doubled their position last quarter. Now 2.1 million. Go figure. cheers
Antwort auf Beitrag Nr.: 29.267.120 von Birgit.Tersteegen am 11.05.07 12:19:14JP Morgan doubled their position last quarter. Now 2.1 million. Go figure.
..nicht schlecht für den Anfang, da können wir ja locker mit unserer PBB (n) * Company locker mithalten.....
* Nosta auf Warteliste
..nicht schlecht für den Anfang, da können wir ja locker mit unserer PBB (n) * Company locker mithalten.....
* Nosta auf Warteliste
Antwort auf Beitrag Nr.: 29.259.721 von GuHu1 am 10.05.07 21:59:49Hi Guhu!Zwinkern(auch als BM);Hi Neuinteressierte!
Cyberhexe hat einen Thread zu Elan(871331) damals aufgemacht,wo alles Fundamentale zu MS und der Behandlung mit Tysabri steht.Ty ist dabei, ein Blockbuster zu werden--es reduziert die Schübe um 68%--die Sicherheit wird durch das "Touch-Programm"gewährleistet, um pml-Fälle zu verhindern,die am Anfang von TY-Vermarktung auftraten,allerdings NUR in Verabreichung mit Avonex(von Biogen,unserem Partner der gerne doppelt verdienen wollte....)Diese Fälle hatten dazu geführt,dass Elan damals das Medikament vom Markt genommen hatte um es dann in Monotherapie wieder einzuführen.Untersuchungen von vor 2 Wochen haben die Sicherheit des Medikaments noch einmal bestätigt!
Der andere grosse Deal ist die Forschung mit Wyeth zu Alzheimer.Diese Forschung ist a.d. Alz-Gebiet am erfolgsversprechendsten.Im Sommer gibt es Zwischenergebnisse und evtl.den Eintritt in Phase 3.Wenn Elan hier auch erfolgreich ist,wäre das Potential unermesslich.
Gruss + Alles Gute!Birgit
Cyberhexe hat einen Thread zu Elan(871331) damals aufgemacht,wo alles Fundamentale zu MS und der Behandlung mit Tysabri steht.Ty ist dabei, ein Blockbuster zu werden--es reduziert die Schübe um 68%--die Sicherheit wird durch das "Touch-Programm"gewährleistet, um pml-Fälle zu verhindern,die am Anfang von TY-Vermarktung auftraten,allerdings NUR in Verabreichung mit Avonex(von Biogen,unserem Partner der gerne doppelt verdienen wollte....)Diese Fälle hatten dazu geführt,dass Elan damals das Medikament vom Markt genommen hatte um es dann in Monotherapie wieder einzuführen.Untersuchungen von vor 2 Wochen haben die Sicherheit des Medikaments noch einmal bestätigt!
Der andere grosse Deal ist die Forschung mit Wyeth zu Alzheimer.Diese Forschung ist a.d. Alz-Gebiet am erfolgsversprechendsten.Im Sommer gibt es Zwischenergebnisse und evtl.den Eintritt in Phase 3.Wenn Elan hier auch erfolgreich ist,wäre das Potential unermesslich.
Gruss + Alles Gute!Birgit
Hi Leute,
bitte einmal kurz eure meinung:
wie hoch schätzt ihr die möglichkeit eines buyouts von tysabri an biogen (nur MS) und was könnte dies in der konsequenz für das pps von elan bedeuten ?
was könnte elan dazu bewegen, sich von tysabri zu trennen (ohne allerdings auf royalties zu verzichten) ?
danke für eure meinungen
gruß
mega
bitte einmal kurz eure meinung:
wie hoch schätzt ihr die möglichkeit eines buyouts von tysabri an biogen (nur MS) und was könnte dies in der konsequenz für das pps von elan bedeuten ?
was könnte elan dazu bewegen, sich von tysabri zu trennen (ohne allerdings auf royalties zu verzichten) ?
danke für eure meinungen
gruß
mega
Antwort auf Beitrag Nr.: 29.262.590 von Poppholz am 11.05.07 08:32:31Naja Poppi manchmal is besser zu werfen...lieber paar% Steuern zahlen als ewig zu hoffen und zu Beten.
Meiner Steuerberaterin fallen immer fast die Haare aus wenn ich mit meinem Zettelkram anmarschiere. Da sammelt sich nämlich bei dem hin und hergehüpf einiges an, zum glück kenn ich Sie gut...sonst würde ich
vielleicht auch über ein Jahr warten.
Deshalb bleib ich wohl auf der Warteliste bei der PBB-Company.
Übrigens hab ich 200Stk Dendrops behalten...als andenken an gute Zeiten.
Meiner Steuerberaterin fallen immer fast die Haare aus wenn ich mit meinem Zettelkram anmarschiere. Da sammelt sich nämlich bei dem hin und hergehüpf einiges an, zum glück kenn ich Sie gut...sonst würde ich
vielleicht auch über ein Jahr warten.
Deshalb bleib ich wohl auf der Warteliste bei der PBB-Company.
Übrigens hab ich 200Stk Dendrops behalten...als andenken an gute Zeiten.
Antwort auf Beitrag Nr.: 29.268.522 von megadax am 11.05.07 13:36:02Hi, denke das kann am besten Birgit oder Cyberhexe beantworten.
Fachlich hab ich null durchblick-darum klappts auch so gut mit der spekuliererei.
Fachlich hab ich null durchblick-darum klappts auch so gut mit der spekuliererei.
Antwort auf Beitrag Nr.: 29.262.590 von Poppholz am 11.05.07 08:32:31bin mit DNDN noch nicht ganz durch
Von 460% runter auf 2% und raus
auch ich muss noch lernen Gewinne mitzunehmen
Noogmann
Von 460% runter auf 2% und raus
auch ich muss noch lernen Gewinne mitzunehmen
Noogmann
Antwort auf Beitrag Nr.: 29.267.527 von Birgit.Tersteegen am 11.05.07 12:42:56hi birgit,
danke für die kurze zusammenfassung.
werde den wert jetzt mal intensiver beobachten.
bin auch noch bei dndn aktiv, hab da noch was laufen
danke für die kurze zusammenfassung.
werde den wert jetzt mal intensiver beobachten.
bin auch noch bei dndn aktiv, hab da noch was laufen
Antwort auf Beitrag Nr.: 29.252.676 von Poppholz am 10.05.07 15:56:35mein lieber schwan
denen ihre blaue linie ändert sich aber in TAGEN rasant
vorher straight up
und nu
seitwärts bis mitte juni
echte profis halt
denen ihre blaue linie ändert sich aber in TAGEN rasant
vorher straight up
und nu
seitwärts bis mitte juni
echte profis halt
Msg: 106764 of 106768 5/12/2007
By: ridge303
According to this post there will be a Tysabri Documentary
Leben mit ms ICH BIN GLÜCKLICH!!! I am happy ! ( ..and I am happy to relate these posts with you ! :o) Ridge )
Jackie:
Heute war eine Filmcrew bei mir und hat mich bzw mein leben/meine Geschichte aufgezeichnet. Für einen Tysabri Film!!!
All die schlimmen und schönen Dinge mit und wegen der ms habe ich revue passieren lassen...
Meint ihr nicht auch das die ms, so schrecklich wie sie zu uns sein kann uns auch viel positives bringt??
Haben wir nicht viel durch die ms gelernt?? Hilft uns die ms nicht in unserem Leben weiter wie andere zu kommen??
Ich habe so viel positives über mich gehört. So eine Ehrfurcht vor unserer situation...
Ich habe auch sehr viel dazu gelernt. Wir sind einfach zu oft zu unfair unseren lieben gegenüber... Wir sollten ihnen viel öfter unserern dank und liebe zollen. Was wären wir nur in vielen Situationen ohne sie gewesen. Ich weiß es nicht!!!
Life with MS - I'm happy
Today a film crew was with me and made a documentary about my life with ms for a Tysabri film!!!
I remembered all the bad and beautiful things that had happened to me with and because of the ms .
Don`t you think that we have learned a lot through our illness ? Doesn`t the MS sometimes help us to get further in life?
I have heard so many positive things about myself. Such a respect for our situation ....
I have also learned a lot about being unfair to our loved ones. We should more often show them that we are grateful
to them. What would have become of us in so many situations without our loved ones ? I don't know !""
Sarah: " What, a documentary ? an advertising film for Tysabri ? are you taking Ty yourself ?
Excuse me but I am nosy here !"
Jackie: " It was a wonderful day! They filmed me the whole day in different situations. It's going to be a patients`film
with three patients and two experts. It was a great day ! And they were all soo nice ! The movie will be on TV some time later.
I`ll let you all know when ! It was just great ! "
Then Jackie writes how she is going to be in Hamburg on the 31.May for a press conference...and
""The physicians have given up on me more or less. Had so many terrible relapses!!!
In the end I was in a wheelchair and they were already looking for a place for me in a home for disabled because I needed very much assistance in the everyday life ! I receive Tysabri now for 8 months.
Can dance again, can jump around! Can work again, can meet with friends again. That is nearly like being born again..:o) much fun! ""
By: ridge303
According to this post there will be a Tysabri Documentary
Leben mit ms ICH BIN GLÜCKLICH!!! I am happy ! ( ..and I am happy to relate these posts with you ! :o) Ridge )
Jackie:
Heute war eine Filmcrew bei mir und hat mich bzw mein leben/meine Geschichte aufgezeichnet. Für einen Tysabri Film!!!
All die schlimmen und schönen Dinge mit und wegen der ms habe ich revue passieren lassen...
Meint ihr nicht auch das die ms, so schrecklich wie sie zu uns sein kann uns auch viel positives bringt??
Haben wir nicht viel durch die ms gelernt?? Hilft uns die ms nicht in unserem Leben weiter wie andere zu kommen??
Ich habe so viel positives über mich gehört. So eine Ehrfurcht vor unserer situation...
Ich habe auch sehr viel dazu gelernt. Wir sind einfach zu oft zu unfair unseren lieben gegenüber... Wir sollten ihnen viel öfter unserern dank und liebe zollen. Was wären wir nur in vielen Situationen ohne sie gewesen. Ich weiß es nicht!!!
Life with MS - I'm happy
Today a film crew was with me and made a documentary about my life with ms for a Tysabri film!!!
I remembered all the bad and beautiful things that had happened to me with and because of the ms .
Don`t you think that we have learned a lot through our illness ? Doesn`t the MS sometimes help us to get further in life?
I have heard so many positive things about myself. Such a respect for our situation ....
I have also learned a lot about being unfair to our loved ones. We should more often show them that we are grateful
to them. What would have become of us in so many situations without our loved ones ? I don't know !""
Sarah: " What, a documentary ? an advertising film for Tysabri ? are you taking Ty yourself ?
Excuse me but I am nosy here !"
Jackie: " It was a wonderful day! They filmed me the whole day in different situations. It's going to be a patients`film
with three patients and two experts. It was a great day ! And they were all soo nice ! The movie will be on TV some time later.
I`ll let you all know when ! It was just great ! "
Then Jackie writes how she is going to be in Hamburg on the 31.May for a press conference...and
""The physicians have given up on me more or less. Had so many terrible relapses!!!
In the end I was in a wheelchair and they were already looking for a place for me in a home for disabled because I needed very much assistance in the everyday life ! I receive Tysabri now for 8 months.
Can dance again, can jump around! Can work again, can meet with friends again. That is nearly like being born again..:o) much fun! ""
Antwort auf Beitrag Nr.: 29.287.690 von Birgit.Tersteegen am 13.05.07 00:13:16WOW, eindrucksvolles posting.
Msg: 106925 of 106934 5/14/2007 7:06:06 AM
By: stockhound4
Bellvue Asset & MFS Investment Both Added Over 1 M Shares In Q1
Link: http://www.adrbny.com/dr_ownership.jsp?cusip=284131208&LSP=2…
Hound
By: stockhound4
Bellvue Asset & MFS Investment Both Added Over 1 M Shares In Q1
Link: http://www.adrbny.com/dr_ownership.jsp?cusip=284131208&LSP=2…
Hound
Msg: 106980 of 106993 5/14/2007 11:21:59 AM Recs: 24 Sentiment: Not Disclosed
By: luvnanotech Send PM Profile Ignore Recommend Add To Favorites
ELN/WYE: Alzheimer's Drug Could Save U.S. Trillions, New Study Says
By Mike Huckman | 14 May 2007 | 11:06 AM ET Font size: A new study says if a drug is quickly developed that delays the onset of Alzheimer's Disease it would save the U.S. economy trillions of dollars.
The group, which goes by the acronym ACT-AD, claims this is the first economic estimate of the impact new drugs could have.
The results show that if an Alzheimer's treatment were to come to market by 2010--and if the drug delayed the onset of the disease by up to five years--the American economy could save nearly $4 trillion by 2050.
Nearly five million people in the U.S. have Alzheimer's but that number is forecast to possibly triple by mid-century.
The group that did the study gets some of its funding from Wyeth, Elan and Myriad Genetics, all of which are working on Alzheimer's treatments. Many other companies also have Alzheimer's drugs in development.
© 2007 CNBC.com http://www.cnbc.com/id/18654307
By: luvnanotech Send PM Profile Ignore Recommend Add To Favorites
ELN/WYE: Alzheimer's Drug Could Save U.S. Trillions, New Study Says
By Mike Huckman | 14 May 2007 | 11:06 AM ET Font size: A new study says if a drug is quickly developed that delays the onset of Alzheimer's Disease it would save the U.S. economy trillions of dollars.
The group, which goes by the acronym ACT-AD, claims this is the first economic estimate of the impact new drugs could have.
The results show that if an Alzheimer's treatment were to come to market by 2010--and if the drug delayed the onset of the disease by up to five years--the American economy could save nearly $4 trillion by 2050.
Nearly five million people in the U.S. have Alzheimer's but that number is forecast to possibly triple by mid-century.
The group that did the study gets some of its funding from Wyeth, Elan and Myriad Genetics, all of which are working on Alzheimer's treatments. Many other companies also have Alzheimer's drugs in development.
© 2007 CNBC.com http://www.cnbc.com/id/18654307
Antwort auf Beitrag Nr.: 29.301.245 von Birgit.Tersteegen am 14.05.07 14:32:51... folgende Message sollte man allerdings auch Beachtung schenken
By: Fixer13605
INVUS Public Equities liquidates ELN holdings
Looks like they reported dumping their entire 9.3 million shares, dropping our institutional ownership down to 49.57%.
That SUCKS
JMO / GLTA
By: Fixer13605
INVUS Public Equities liquidates ELN holdings
Looks like they reported dumping their entire 9.3 million shares, dropping our institutional ownership down to 49.57%.
That SUCKS
JMO / GLTA
Tysabri erfreut sich wohl steigender Nachfrage und wurde (s.Cyberhexes Thread)jetzt auch in der Schweiz zugelassen----also muss wohl mehr produziert werden...GUT für UNS und für die PATIENTEN!
Msg: 107152 of 107177 5/15/2007 7:49:09 AM
By: donewithpunting
TY Manufactoring NEWS
Jacobs Receives Contract From Biogen Idec for Biotechnology Project in Denmark
via COMTEX
May 15, 2007
PASADENA, Calif., May 15, 2007 /PRNewswire-FirstCall via COMTEX News Network/ --
Jacobs Engineering Group Inc. (NYSE: JEC) announced today that they received a contract from Biogen Idec (Nasdaq: BIIB) to provide engineering, procurement, validation, and site support services for the first cell culture manufacturing facility at the greenfield biotechnology plant in Hillerod, Denmark. The manufacturing facility is expected to produce TYSABRI(R) (natalizumab), which is used in the treatment of multiple sclerosis.
Officials did not disclose the contract details, but noted that the plant is scheduled to be completed in 2009.
Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. The company creates new standards of care in therapeutic areas with high unmet medical needs and has significant products serving patients in more than 90 countries. This will be their first manufacturing facility in Europe. Jacobs performed conceptual design for the facility and will execute this new scope of work from their office in Reading, England.
In making the announcement, Jacobs Group Vice President Phil Stassi said, "We are very enthusiastic about continuing our collaboration with Biogen Idec to help them bring this important drug treatment to market. This award strengthens our position as the leading engineering contractor for large European biotech projects."
Jacobs, with over 46,000 employees and revenues exceeding $8.0 billion, provides technical, professional, and construction services globally.
Any statements made in this release that are not based on historical fact are forward-looking statements. Although such statements are based on management's current estimates and expectations, and currently available competitive, financial, and economic data, forward-looking statements are inherently uncertain. We, therefore, caution the reader that there are a variety of factors that could cause business conditions and results to differ materially from what is contained in our forward-looking statements. For a description of some of the factors which may occur that could cause actual results to differ from our forward-looking statements please refer to our 2006 Form 10-K, and in particular the discussions contained under Items 1 - Business, 1A - Risk Factors, 3 - Legal Proceedings, and 7 - Management's Discussion and Analysis of Financial Condition and Results of Operations. We also caution the readers of this release that we do not undertake to update any forward-looking statements made herein.
For additional information contact: Mary Bloom 626.578.6992 (Logo: http://www.newscom.com/cgi-bin/prnh/20051021/LAJACOBSEGLOGO )
SOURCE Jacobs Engineering Group Inc.
Mary Bloom of Jacobs Engineering Group Inc., +1-626-578-6992 http://www.jacobs.com
Copyright (C) 2007 PR Newswire. All rights reserved
Msg: 107152 of 107177 5/15/2007 7:49:09 AM
By: donewithpunting
TY Manufactoring NEWS
Jacobs Receives Contract From Biogen Idec for Biotechnology Project in Denmark
via COMTEX
May 15, 2007
PASADENA, Calif., May 15, 2007 /PRNewswire-FirstCall via COMTEX News Network/ --
Jacobs Engineering Group Inc. (NYSE: JEC) announced today that they received a contract from Biogen Idec (Nasdaq: BIIB) to provide engineering, procurement, validation, and site support services for the first cell culture manufacturing facility at the greenfield biotechnology plant in Hillerod, Denmark. The manufacturing facility is expected to produce TYSABRI(R) (natalizumab), which is used in the treatment of multiple sclerosis.
Officials did not disclose the contract details, but noted that the plant is scheduled to be completed in 2009.
Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. The company creates new standards of care in therapeutic areas with high unmet medical needs and has significant products serving patients in more than 90 countries. This will be their first manufacturing facility in Europe. Jacobs performed conceptual design for the facility and will execute this new scope of work from their office in Reading, England.
In making the announcement, Jacobs Group Vice President Phil Stassi said, "We are very enthusiastic about continuing our collaboration with Biogen Idec to help them bring this important drug treatment to market. This award strengthens our position as the leading engineering contractor for large European biotech projects."
Jacobs, with over 46,000 employees and revenues exceeding $8.0 billion, provides technical, professional, and construction services globally.
Any statements made in this release that are not based on historical fact are forward-looking statements. Although such statements are based on management's current estimates and expectations, and currently available competitive, financial, and economic data, forward-looking statements are inherently uncertain. We, therefore, caution the reader that there are a variety of factors that could cause business conditions and results to differ materially from what is contained in our forward-looking statements. For a description of some of the factors which may occur that could cause actual results to differ from our forward-looking statements please refer to our 2006 Form 10-K, and in particular the discussions contained under Items 1 - Business, 1A - Risk Factors, 3 - Legal Proceedings, and 7 - Management's Discussion and Analysis of Financial Condition and Results of Operations. We also caution the readers of this release that we do not undertake to update any forward-looking statements made herein.
For additional information contact: Mary Bloom 626.578.6992 (Logo: http://www.newscom.com/cgi-bin/prnh/20051021/LAJACOBSEGLOGO )
SOURCE Jacobs Engineering Group Inc.
Mary Bloom of Jacobs Engineering Group Inc., +1-626-578-6992 http://www.jacobs.com
Copyright (C) 2007 PR Newswire. All rights reserved
Na alle noch am leben?
Der Kurs erzeut Brechreizsymptome, immer anner 15 entlang es ist zum verwelken...
Der Kurs erzeut Brechreizsymptome, immer anner 15 entlang es ist zum verwelken...
Antwort auf Beitrag Nr.: 29.348.878 von Nostarowie am 16.05.07 19:25:14----da gibts Schlimmeres---
Antwort auf Beitrag Nr.: 29.351.138 von Birgit.Tersteegen am 16.05.07 22:10:49auf jeden Fall.
Aber wir können den Kurs ja mal ein wenig nach oben treiben, so für das allgemeine Wohlgefühl.
Aber wir können den Kurs ja mal ein wenig nach oben treiben, so für das allgemeine Wohlgefühl.
Antwort auf Beitrag Nr.: 29.367.134 von Poppholz am 18.05.07 09:15:00Moin!
Gestern war der Anfang....-heute machen wir weiter,OK??!!
Ich bin übers WE mit Freunden in Amsterdam--werde von Ferne die Kräfte wirken lassen...
Till monday! Birgit
Gestern war der Anfang....-heute machen wir weiter,OK??!!
Ich bin übers WE mit Freunden in Amsterdam--werde von Ferne die Kräfte wirken lassen...
Till monday! Birgit
Antwort auf Beitrag Nr.: 29.367.609 von Birgit.Tersteegen am 18.05.07 09:41:32BID und ASK gehen schön nach oben. Jetzt muss nur noch einer verkaufen, bzw. kaufen.
Antwort auf Beitrag Nr.: 29.367.609 von Birgit.Tersteegen am 18.05.07 09:41:32na Birgit, wie machen wir das heute wieder?
Und dann kommt natürlich keiner vorbei und sagt, dass wir das gut gemacht haben.
PBB
(Großaktionär)
Und dann kommt natürlich keiner vorbei und sagt, dass wir das gut gemacht haben.
PBB
(Großaktionär)
Antwort auf Beitrag Nr.: 29.348.878 von Nostarowie am 16.05.07 19:25:14gleich haben wir den Kurs über die $16,00 gehoben.
Sollte das schon reichen?
Sollte das schon reichen?
Antwort auf Beitrag Nr.: 29.374.052 von Poppholz am 18.05.07 16:10:07natürlich nicht !!!!!
Kurs auf die $16,20
Kurs auf die $16,20
Antwort auf Beitrag Nr.: 29.375.352 von Poppholz am 18.05.07 17:15:29
jedesmal wenn Biggi verreist, steigt der Kurs
Sie sollte öfter verreisen, damit unser ELAN auf 20$ zu geht
jedesmal wenn Biggi verreist, steigt der Kurs
Sie sollte öfter verreisen, damit unser ELAN auf 20$ zu geht
Antwort auf Beitrag Nr.: 29.375.352 von Poppholz am 18.05.07 17:15:29DRX ist um über 11% gestiegen und ich bin der einzige, der davon etwas mitbekommt?
Wo seit Ihr alle?
Wo seit Ihr alle?
Antwort auf Beitrag Nr.: 29.375.552 von Poppholz am 18.05.07 17:28:28reg Dich ab, Poppi. Ich bin auch noch da
Antwort auf Beitrag Nr.: 29.375.778 von surga am 18.05.07 17:41:34sehr schön.
Hatte schon bedenken, dass Ihr alle noch eine andere Aktie beobachtet, die noch stärker am steigen ist und ich davon nichts mitbekommen habe.
RT $16,50 = €12,22)
Hatte schon bedenken, dass Ihr alle noch eine andere Aktie beobachtet, die noch stärker am steigen ist und ich davon nichts mitbekommen habe.
RT $16,50 = €12,22)
Antwort auf Beitrag Nr.: 29.375.813 von Poppholz am 18.05.07 17:43:43Wie war es mit DNDN, ich hoffe , Du hattest Dein Gewinn mitgenommen?
Antwort auf Beitrag Nr.: 29.375.552 von Poppholz am 18.05.07 17:28:28
Das habt ihr gut gemacht
Gruß Noogmann
Das habt ihr gut gemacht
Gruß Noogmann
Antwort auf Beitrag Nr.: 29.376.976 von noogmann am 18.05.07 18:55:39ups gähnen streichen und
Noogmann
Noogmann
Antwort auf Beitrag Nr.: 29.376.006 von surga am 18.05.07 17:55:05leider nicht.
Hatte schon die Jahresfrist in die Planung mit aufgenommen.
Das Hauptärgernis ist allerdings gewesen, dass ich bei €12.xx noch einmal nachgekauft habe. Somit bin ich in der Summe jetzt auch im Minus.
Noch ärgerlicher ist dabei sogar noch, dass ich für den Nachkauf ELAN beim Kurs von €10,xx verkauft habe.
Geschieht mir ganz recht: "Gier frisst Hirn".
Mal sollte seinen Prinzipien treu bleiben. Ich habe daraus gelernt und werde in Zukunft (hoffentlich) nicht erneut so handeln.
Hatte schon die Jahresfrist in die Planung mit aufgenommen.
Das Hauptärgernis ist allerdings gewesen, dass ich bei €12.xx noch einmal nachgekauft habe. Somit bin ich in der Summe jetzt auch im Minus.
Noch ärgerlicher ist dabei sogar noch, dass ich für den Nachkauf ELAN beim Kurs von €10,xx verkauft habe.
Geschieht mir ganz recht: "Gier frisst Hirn".
Mal sollte seinen Prinzipien treu bleiben. Ich habe daraus gelernt und werde in Zukunft (hoffentlich) nicht erneut so handeln.
Antwort auf Beitrag Nr.: 29.375.552 von Poppholz am 18.05.07 17:28:28Hi Popp, heut ist ein Tach nach Männertach da bekommt man nix mit im normalfall...
Leute, was ist bloß mit Elan los.
Ich hab bei dem Wert knapp 25.000 Dollar in Optionen investiert,
die standen bis gestern mit über 20.000 im Minus und es wäre
eigentlich ein riesiger Anstieg nötig (+ 5 Dollar schätze ich),
um wieder in die schwarzen Zahlen zu kommen.
Nun haben wir gestern grad mal 1,20 zugelegt, aber meine
Options stehen mit über 7.000 im Plus ... ich fass es nich.
Da geht irgendwas ab, was ganz Gewaltiges ... ich schätze Mal
Alzheimer, sonst würde bei den Optionen nicht soviel Zukunft
eingepreist werden.
Geht hoffentlich so weiter ... nich das ich auch noch
dendrongeschädigt werde
Ich hab bei dem Wert knapp 25.000 Dollar in Optionen investiert,
die standen bis gestern mit über 20.000 im Minus und es wäre
eigentlich ein riesiger Anstieg nötig (+ 5 Dollar schätze ich),
um wieder in die schwarzen Zahlen zu kommen.
Nun haben wir gestern grad mal 1,20 zugelegt, aber meine
Options stehen mit über 7.000 im Plus ... ich fass es nich.
Da geht irgendwas ab, was ganz Gewaltiges ... ich schätze Mal
Alzheimer, sonst würde bei den Optionen nicht soviel Zukunft
eingepreist werden.
Geht hoffentlich so weiter ... nich das ich auch noch
dendrongeschädigt werde
Antwort auf Beitrag Nr.: 29.379.784 von Poppholz am 18.05.07 21:44:53Geschieht mir ganz recht: "Gier frisst Hirn".
Das ist echt ein Thema, das wir lernen müssen umzugehen.
Ich versuche zumindest mein Einsatz zurück zu bekommen, so dass ich unbeschadet rauskomme, oder alles verkaufen und mit dem Gewinn zufrieden sein, unbeachtet davon, was die anderen WO-ler sagen.
Besser einmischen Gewinn einfahren als Verluste, die wir später tragen müssen.
Denn keine weiß genau, was auf der Börse passieren kann (ich war auch sehr davon überzeugt, dass DNDN eine Zulassung bekämme).
Bei NBIX hatte ich mein Prinzip verletzt, siehe da, jetzt habe ich -15% . Ich muss wieder abwarten, oder ganz auf Jahresfrist warten.
Im Leben lernen nie aus.
Wir hoffen, dass wir bessere Trading machen. Schönes Wochende wünsche ich Dir aus Berlin.
Das ist echt ein Thema, das wir lernen müssen umzugehen.
Ich versuche zumindest mein Einsatz zurück zu bekommen, so dass ich unbeschadet rauskomme, oder alles verkaufen und mit dem Gewinn zufrieden sein, unbeachtet davon, was die anderen WO-ler sagen.
Besser einmischen Gewinn einfahren als Verluste, die wir später tragen müssen.
Denn keine weiß genau, was auf der Börse passieren kann (ich war auch sehr davon überzeugt, dass DNDN eine Zulassung bekämme).
Bei NBIX hatte ich mein Prinzip verletzt, siehe da, jetzt habe ich -15% . Ich muss wieder abwarten, oder ganz auf Jahresfrist warten.
Im Leben lernen nie aus.
Wir hoffen, dass wir bessere Trading machen. Schönes Wochende wünsche ich Dir aus Berlin.
...dies liest sich ausserordentlich gut:
http://www.thepost.ie/post/pages/p/story.aspx-qqqt=MARKETS-q…
http://www.thepost.ie/post/pages/p/story.aspx-qqqt=MARKETS-q…
ja, sie sind in Bezug auf ihre Geschäftsentwicklung sehr positiv gestimmt..aber das sind wir ja auch
Ich hatte aber gedacht, das Alzheimer-Projekt wäre schon in Phase 3.
Ich hatte aber gedacht, das Alzheimer-Projekt wäre schon in Phase 3.
Antwort auf Beitrag Nr.: 29.381.887 von Holgus am 19.05.07 08:21:51SOOOOOOOOOOOOOOOOOOOOOO HOLGI..............................
NIENIENIE WIEDER WILL ICH JETZT DEPRESSIVES GEJAMMER über unser Schätzchen HÖREN--
UUUUUUUUUUUUUND;wenn´s so weitergeht zahlst Du das BIER auf unserer Party....
---------------------------------------------------------------
Ansonsten war ich jetzt 3 Tage in Amsterdam und hab an Elan auch "gut"
verdient... DAS HABT IHR GUT GEMACHT
NIENIENIE WIEDER WILL ICH JETZT DEPRESSIVES GEJAMMER über unser Schätzchen HÖREN--
UUUUUUUUUUUUUND;wenn´s so weitergeht zahlst Du das BIER auf unserer Party....
---------------------------------------------------------------
Ansonsten war ich jetzt 3 Tage in Amsterdam und hab an Elan auch "gut"
verdient... DAS HABT IHR GUT GEMACHT
Antwort auf Beitrag Nr.: 29.396.523 von Birgit.Tersteegen am 20.05.07 20:12:38@alle
...tja..da bin ich auch mal on the road...( diesmal war ich Nürnberg - Seminar geleitet - ...natürlich, wie immer , voller ELAN.........und dann dieser elanvolle Aufschwung....
ELAN .....mach weiter so.....
Birgit......das nächste Mal fahren wir noch einmal zu selben Zeit los, , dann wird sich ELAN nicht mehr unter 20 halten können....
..und Holgie....du bist nun im Plus...
..also, es geht doch voran, Holger.....sogar ohne und und
...bestens....es kann also nur noch up gehen....
Grüße bernie55, bis morgen...
...tja..da bin ich auch mal on the road...( diesmal war ich Nürnberg - Seminar geleitet - ...natürlich, wie immer , voller ELAN.........und dann dieser elanvolle Aufschwung....
ELAN .....mach weiter so.....
Birgit......das nächste Mal fahren wir noch einmal zu selben Zeit los, , dann wird sich ELAN nicht mehr unter 20 halten können....
..und Holgie....du bist nun im Plus...
..also, es geht doch voran, Holger.....sogar ohne und und
...bestens....es kann also nur noch up gehen....
Grüße bernie55, bis morgen...
Tysabri Video---Anschauen!
http://kutv.com/healthyliving/local_story_120193850.html
After watching this video ....
comment from German ms board -
" If this Tysabri is really that good - a miracle - why can`t we all get it ? "
Apr 30, 2007 5:37 pm US/Mountain
Healthy Living: Miracle Drug For MS Sufferers
200 new cases of multiple sclerosis are diagnosed each week in the U.S. it’s a debilitating disease but now there’s new hope for patients.
In this Healthy Living report, a brand new drug that some are calling a miracle.
It was a diagnosis that hit the Rydalch family out of the blue. The day before Thanksgiving 2006, Clint Rydalch was diagnosed with multiple sclerosis.
Just a few months ago, he was so ill, he couldn’t move.
“I was in bed, couldn’t move, talk to anything. I couldn’t even eat,” says Clint.
“He had to get a feeding tube, he had no memory and couldn’t remember me, the kids, the family,” says Clint’s wife Cindy.
But thanks to a brand new drug for MS called Tysabri Clint is making his way back.
In patients with MS, the protective shield surrounding nerves is attacked by cells and damaged, causing a short circuit in the nervous system. That leads to problems with vision, movement and energy among other things.
Tysabri works by blocking these damaging cells. Doctor John Foley specializes in MS and says results of this drug are very promising.
“In a fairly large number we’re seeing a reversal or improvement of symptoms, in some cases to a fairly dramatic degree,” says Dr Foley.
The drug is given once a month by IV, clint says he noticed immediate results.
Clint says, “my first day after Tysabri I could talk again, move and even sit up in bed with a little help.”
And after four treatments, he’s even back to work part time. This drug is only for certain patients with MS and it can’t be taken with other treatments because a severe brain virus can occur. But for the Rydalch family, it’s been nothing short of a miracle.
Cindy says, “From day one we started noticing miracles, really.”
Tysabri is usually given after patients don’t respond to other drug treatments.
(© MMVII, CBS Broadcasting Inc. All Rights Reserved.)
http://kutv.com/healthyliving/local_story_120193850.html
After watching this video ....
comment from German ms board -
" If this Tysabri is really that good - a miracle - why can`t we all get it ? "
Apr 30, 2007 5:37 pm US/Mountain
Healthy Living: Miracle Drug For MS Sufferers
200 new cases of multiple sclerosis are diagnosed each week in the U.S. it’s a debilitating disease but now there’s new hope for patients.
In this Healthy Living report, a brand new drug that some are calling a miracle.
It was a diagnosis that hit the Rydalch family out of the blue. The day before Thanksgiving 2006, Clint Rydalch was diagnosed with multiple sclerosis.
Just a few months ago, he was so ill, he couldn’t move.
“I was in bed, couldn’t move, talk to anything. I couldn’t even eat,” says Clint.
“He had to get a feeding tube, he had no memory and couldn’t remember me, the kids, the family,” says Clint’s wife Cindy.
But thanks to a brand new drug for MS called Tysabri Clint is making his way back.
In patients with MS, the protective shield surrounding nerves is attacked by cells and damaged, causing a short circuit in the nervous system. That leads to problems with vision, movement and energy among other things.
Tysabri works by blocking these damaging cells. Doctor John Foley specializes in MS and says results of this drug are very promising.
“In a fairly large number we’re seeing a reversal or improvement of symptoms, in some cases to a fairly dramatic degree,” says Dr Foley.
The drug is given once a month by IV, clint says he noticed immediate results.
Clint says, “my first day after Tysabri I could talk again, move and even sit up in bed with a little help.”
And after four treatments, he’s even back to work part time. This drug is only for certain patients with MS and it can’t be taken with other treatments because a severe brain virus can occur. But for the Rydalch family, it’s been nothing short of a miracle.
Cindy says, “From day one we started noticing miracles, really.”
Tysabri is usually given after patients don’t respond to other drug treatments.
(© MMVII, CBS Broadcasting Inc. All Rights Reserved.)
Antwort auf Beitrag Nr.: 29.397.424 von Birgit.Tersteegen am 20.05.07 22:30:00Tysabri Video---Anschauen!
http://kutv.com/healthyliving/local_story_120193850.html
http://kutv.com/healthyliving/local_story_120193850.html
Elan and Wyeth to Initiate Phase 3 Clinical Trial of Bapineuzumab (AAB-001) in Alzheimer's Disease
Monday May 21, 2:00 am ET
DUBLIN, Ireland & Madison, N.J.--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), today announced the decision to initiate a Phase 3 clinical program of their lead immunotherapeutic candidate, Bapineuzumab (AAB-001), for the treatment of patients with mild to moderate Alzheimer's Disease. This decision was based on the seriousness of the disease and the totality of what the companies have learned from their immunotherapy programs, including a scheduled Interim look at data from an ongoing Phase 2 study, which remains blinded. No conclusion about the Phase 2 study can be drawn until the study is completed and the final data are analyzed and released in 2008. Phase 3 clinical trial design will be finalized with regulatory agencies, and subject to regulatory approval, it is intended for the trial to begin in the second half of 2007.
ADVERTISEMENT
It is important to remember that Alzheimer's disease is a complex and formidable challenge, and our immunotherapeutic programs still contain inherent risks.
About Bapineuzumab
Bapineuzumab (AAB-001) is a humanized monoclonal antibody that received Fast Track designation from the United States Food and Drug Administration (FDA) for treatment of mild to moderate Alzheimer's disease. Fast Track designation facilitates development and may expedite regulatory review of drugs that the FDA recognizes as potentially addressing an unmet medical need for serious or life threatening conditions.
There are two ongoing Phase 2 studies with Bapineuzumab. The first Phase 2 trial is a randomized, double-blind, placebo controlled, multiple ascending dose study of 4 cohorts of the approximately 240 total patients with mild to moderate Alzheimer's disease. The primary objective of the trial is to assess the safety of bapineuzumab. Assessments of cognitive and functional status are also being made in the trail, and each patient's participation lasts approximately 18 months. The key end-points include: ADAS-Cog (assesses cognition), Neuropsychological Test Battery (NTB) and DAD score (measures quality of life). The second Phase 2 trial is an Alzheimer's beta-amyloid imaging study in 30 patients and is being conducted in Europe. The companies do not expect that any Phase 2 data will be released into the public domain until the completion of the Phase 2 trials in 2008.
About Alzheimer's Disease
Alzheimer's disease is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As Alzheimer's progresses, individuals may also experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations. It is currently estimated that more than 5 million Americans and more than 24 million people worldwide have Alzheimer's disease (Source: Alzheimer's Association and Alzheimer's Disease International)
About the Elan and Wyeth Collaboration
The Elan and Wyeth Alzheimer's Immunotherapy Program (AIP) is a 50:50 collaboration to research, develop and commercialize an immunotherapeutic approach that may be used for the treatment of mild to moderate AD and possibly to prevent the onset of the disease. Current AIP programs include bapineuzumab (AAB-001), AAB-001 SubQ, ACC-001 and AAB-002. Wyeth and Elan equally share all costs and potential revenues from this collaboration.
About Elan
Elan Corporation (NYSE: ELN - News), plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com
About Wyeth
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. For additional information about the company, please visit https://www.wyeth.com.
Safe Harbor / Forward-Looking Statements
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties and include, without limitation, the risks associated with the inherent uncertainty of the clinical development of AAB-001 for Alzheimer's disease and whether AAB-001 will ever be approved for commercialization. Factors which could cause actual results to differ materially from the companies' current expectations include the risks that problems or delays may arise during preparations for the proposed Phase 3 trial or, if the proposed Phase 3 trial is initiated, during the course of the Phase 3 trial, that the Phase 2 trials may not be successfully completed, and even if the Phase 2 trials are successfully completed, that results in the proposed Phase 3 trial may not show that AAB-001 is safe and effective, as well as the other risks and uncertainties described from time to time in the companies' periodic and other reports filed with the Securities and Exchange Commission.
http://biz.yahoo.com/bw/070521/20070520005042.html?.v=1
Antwort auf Beitrag Nr.: 29.381.887 von Holgus am 19.05.07 08:21:51das freut mich für Dich Holgus.
Dann sollte Deine Laune ja auch wieder ein wenig besser sein.
Die +$5,00 sollte beim Aktienkurs auch bald drin sein.
Dann sollte Deine Laune ja auch wieder ein wenig besser sein.
Die +$5,00 sollte beim Aktienkurs auch bald drin sein.
Die Meldung schnallt hier noch niemand.........aber ich hab´schon soo viele....aber kann frau je genug haben??
Antwort auf Beitrag Nr.: 29.399.070 von Birgit.Tersteegen am 21.05.07 09:10:10Guten Morgen
Hat jemand RT Kurs von Irland ?
Dankeeeeeeeeee
Hat jemand RT Kurs von Irland ?
Dankeeeeeeeeee
Antwort auf Beitrag Nr.: 29.399.338 von YoungRich am 21.05.07 09:30:46Leute---die 13 € Party....... sie rückt näher....
NCB
Elan and Wyeth are to initiate a Phase III study with AAB-001 in patients with mild to moderate Alzheimer’s Disease. This decision to initiate Phase III studies was based on the “seriousness of the disease and the totality of what the companies have learned
from their immunotherapy programs” included the interim data from the on-going Phase II study. The Phase II data is not expected to be released until the Phase II studies complete in 2008.
• The Phase II interim analysis data, the Phase I AAB-001 data and the follow-on study with the AN-1792 treated patients likely supported Elan/Wyeth’s decision to progress to a Phase III study. The Phase I study with AAB-001 showed that patients (6 treated patients) treated with 1.5mg/kg of AAB-001 showed an statistically significant improvement in the MMSE (mini-mental state examination (assess short term memory)) compared to the placebo treated patients at week 16. This memory improvement trend continued through 12 months. A 4.5 yr follow-up study of patients (c.160) that participated in the AN-1792 study showed that the high antibody responder patients in this study were 40% less dependent on caregivers than patients treated with placebo.
• Our AAB-001 forecasts assume a launch of the drug in 2010, pricing of $15k (at the low end of the biologics range), peak market share of c.10% in the US and 1.5% in EU/RoW and 50% profit split with Wyeth. Our NPV assessment was based on a 25% probability of success which we will be increasing to reflect the progress of AAB-001 to Phase III. At this point, however, it is difficult to assess the real market potential of this
news in the absence of detail on the actual Phase II data and the label the data supports (disease modifying versus symptomatic). What we can assume is that Elan has seen clinically meaningful trends (no interpretation on statistical significance of the
Phase II data can be made) in the Phase II study that has lead to the decision on initiating a Phase III study.
The Phase III study is expected to begin in H2 2007 and is likely to be an 18-month study. Data dependent, the earliest that Elan could file for US approval could be H2 2008/H1 2009.
Our SOTPs is under review.
• Click Here to access the Elan page on NCB’s online Irish Equity Stock Guide
Orla Hartford +353 1 611 5844 orla.hartford@ncb.
http://www.investorvillage.com/smbd.asp?mb=160&mn=109205&pt=…
Elan and Wyeth are to initiate a Phase III study with AAB-001 in patients with mild to moderate Alzheimer’s Disease. This decision to initiate Phase III studies was based on the “seriousness of the disease and the totality of what the companies have learned
from their immunotherapy programs” included the interim data from the on-going Phase II study. The Phase II data is not expected to be released until the Phase II studies complete in 2008.
• The Phase II interim analysis data, the Phase I AAB-001 data and the follow-on study with the AN-1792 treated patients likely supported Elan/Wyeth’s decision to progress to a Phase III study. The Phase I study with AAB-001 showed that patients (6 treated patients) treated with 1.5mg/kg of AAB-001 showed an statistically significant improvement in the MMSE (mini-mental state examination (assess short term memory)) compared to the placebo treated patients at week 16. This memory improvement trend continued through 12 months. A 4.5 yr follow-up study of patients (c.160) that participated in the AN-1792 study showed that the high antibody responder patients in this study were 40% less dependent on caregivers than patients treated with placebo.
• Our AAB-001 forecasts assume a launch of the drug in 2010, pricing of $15k (at the low end of the biologics range), peak market share of c.10% in the US and 1.5% in EU/RoW and 50% profit split with Wyeth. Our NPV assessment was based on a 25% probability of success which we will be increasing to reflect the progress of AAB-001 to Phase III. At this point, however, it is difficult to assess the real market potential of this
news in the absence of detail on the actual Phase II data and the label the data supports (disease modifying versus symptomatic). What we can assume is that Elan has seen clinically meaningful trends (no interpretation on statistical significance of the
Phase II data can be made) in the Phase II study that has lead to the decision on initiating a Phase III study.
The Phase III study is expected to begin in H2 2007 and is likely to be an 18-month study. Data dependent, the earliest that Elan could file for US approval could be H2 2008/H1 2009.
Our SOTPs is under review.
• Click Here to access the Elan page on NCB’s online Irish Equity Stock Guide
Orla Hartford +353 1 611 5844 orla.hartford@ncb.
http://www.investorvillage.com/smbd.asp?mb=160&mn=109205&pt=…
Data dependent, the earliest that Elan could file for US approval could be H2 2008/H1 2009.
Hauptsache die Börse erhoffte sich nicht auch gleichzeitig ein Filing
und der ganze Salat geht dann doch nach hinten los.
Wir haben sowas schon beim Tysabri-Approval erlebt.
Hauptsache die Börse erhoffte sich nicht auch gleichzeitig ein Filing
und der ganze Salat geht dann doch nach hinten los.
Wir haben sowas schon beim Tysabri-Approval erlebt.
Antwort auf Beitrag Nr.: 29.401.643 von Holgus am 21.05.07 12:15:25..zumindest bist du mit deinen Optionen jetzt doch schon im Plus, oder ???....
Antwort auf Beitrag Nr.: 29.401.643 von Holgus am 21.05.07 12:15:25wenn Du auf Nummer sicher gehen willst, dann verkaufe doch Deine Optionen.
Antwort auf Beitrag Nr.: 29.401.696 von Poppholz am 21.05.07 12:19:06wenn Du auf Nummer sicher gehen willst, dann verkaufe doch Deine Optionen.
....macht Holger doch nicht...
..vielmehr wird er bald seinen Antrag für eine Beteiligung an der PBBn Company stellen...
....macht Holger doch nicht...
..vielmehr wird er bald seinen Antrag für eine Beteiligung an der PBBn Company stellen...
Antwort auf Beitrag Nr.: 29.401.696 von Poppholz am 21.05.07 12:19:06Nö, werd ich nicht tun. Auf Nummer "Sicher" ... das hat man nie
an der Börse, ist mir schon klar. Wer will das auch ... wär
doch langweilig.
Ab und zu ein wenig ärgern würzt doch auch das Leben
an der Börse, ist mir schon klar. Wer will das auch ... wär
doch langweilig.
Ab und zu ein wenig ärgern würzt doch auch das Leben
Antwort auf Beitrag Nr.: 29.401.674 von bernie55 am 21.05.07 12:17:19..zumindest bist du mit deinen Optionen jetzt doch schon im Plus
Das ist ja das, was mir so Sorgen bereitet ... der Sprung bei den Optionen war viiiiiieeeel zu hoch ... absolut unrealistisch.
Nun kann ich nur hoffen, das es tatsächlich real ist und bleibt.
Das ist ja das, was mir so Sorgen bereitet ... der Sprung bei den Optionen war viiiiiieeeel zu hoch ... absolut unrealistisch.
Nun kann ich nur hoffen, das es tatsächlich real ist und bleibt.
Apropos Drogen ... wo iss´n Birgit ?
Was sind das denn für Zahlen heute?!
Broad Intelligence +11%
Worldwater +14%
Meine mit Abstand größte Position Elan +11%! Haben die in Irland das Kursziel von 16 auf 21 USD erhöht, recht so - da läßt sich auf die in 1,5 Jahren anstehenden Phase III Ergebnisse leichter warten.
posimist
Broad Intelligence +11%
Worldwater +14%
Meine mit Abstand größte Position Elan +11%! Haben die in Irland das Kursziel von 16 auf 21 USD erhöht, recht so - da läßt sich auf die in 1,5 Jahren anstehenden Phase III Ergebnisse leichter warten.
posimist
Antwort auf Beitrag Nr.: 29.401.943 von Holgus am 21.05.07 12:35:44hier!--musste mal kurz ein wenig arbeiten.....(Elan steht ja NOCH NICHT bei 100€....)---Kinder,ist der Anstieg nicht schon mal KLASSE!!!!
Wo ist denn Nosta??
Wo ist denn Nosta??
Msg: 109260 of 109263 5/21/2007 6:58:22 AM Sentiment: Not Disclosed
By: sing
LONDON, May 21 (Reuters) - Ireland's Elan Corp
LONDON, May 21 (Reuters) - Ireland's Elan Corp (ELN.I: Quote, Profile , Research) and U.S. partner Wyeth (WYE.N: Quote, Profile , Research) plan to start final-stage clinical tests of a new antibody drug to fight Alzheimer's disease, offering new hope to patients and boosting shares in Elan.
Bapineuzumab, also known as AAB-001, will begin Phase III trials in treating patients with mild to moderate Alzheimer's in the second half of this year, once clinical trial design is finalised with regulatory agencies, the firms said on Monday.
The development is encouraging, since Alzheimer's research has been a graveyard of failed drugs, but the project remains high risk.
The decision to push ahead with Phase III tests was reached taking into account the seriousness of the disease and a review of interim data from Phase II studies, Elan and Wyeth said.
"No conclusion about the Phase II study can be drawn until the study is completed and the final data are analysed and released in 2008," they added.
Despite the companies' caution, industry analysts said the decision to push ahead with late-stage testing suggested Elan and Wyeth had a promising new technology to tackle one of the world's most intractable diseases. Continued... This is a very positive development for both Elan and Wyeth, given that the acceleration of the drug into a Phase III study was only going to be considered if the interim data showed a significant improvement in patient progress," Ian Hunter of Goodbody Stockbrokers said in a note.
Shares in Elan were 13.7 percent higher at a 10-month high of 13.3 euros by 1015 GMT.
Orla Hartford of NCB Stockbrokers said there was a possibility the new drug could be submitted for regulatory approval based on Phase II data alone, if the results were good enough.
A filing based on Phase II would increase the chance of the the product's success to 60 percent from 25 percent and add around 50 percent to the stock's valuation, she added.
"AAB-001 has the potential to transform Elan's investment case," Hartford said.
TOUGH DISEASE
Alzheimer's, which destroys memory and eventually leads to death, has been a focus of research for years but it is a very tough disease to fight and there are so far no very effective treatments. Continued... Drugs approved since the 1990s, including Pfizer Inc. (PFE.N: Quote, Profile , Research) and Eisai Co. Ltd's (4523.T: Quote, NEWS , Research) market-leading Aricept, provide only modest symptomatic relief.
Elan and Wyeth's new drug could be the first disease-modifying treatment, making it a potential multibillion-dollar product -- if it works.
Bapineuzumab is a humanised monoclonal antibody designed to attack the A-beta peptide, which is one component of amyloid plaque that builds up in the brain and is thought to be responsible for damaging brain cells.
Elan and Wyeth are also working on a vaccine called ACC-001 designed to coax the body to make its own antibodies against A-beta peptide, which is in early-stage human trials.
An earlier experimental Alzheimer's vaccine from the two partners was abandoned in 2002 after it caused dangerous brain inflammation in some patients, although later research suggested it did help clear some brain-destroying plaques.
The World Health Organisation estimates there are about 18 million people worldwide with Alzheimer's disease and this figure is projected to reach 34 million by 2025, due to ageing populations.
(Additional reporting by Paul Hoskins in Dublin)
© Reuters 2007. All Rights Reserved.
By: sing
LONDON, May 21 (Reuters) - Ireland's Elan Corp
LONDON, May 21 (Reuters) - Ireland's Elan Corp (ELN.I: Quote, Profile , Research) and U.S. partner Wyeth (WYE.N: Quote, Profile , Research) plan to start final-stage clinical tests of a new antibody drug to fight Alzheimer's disease, offering new hope to patients and boosting shares in Elan.
Bapineuzumab, also known as AAB-001, will begin Phase III trials in treating patients with mild to moderate Alzheimer's in the second half of this year, once clinical trial design is finalised with regulatory agencies, the firms said on Monday.
The development is encouraging, since Alzheimer's research has been a graveyard of failed drugs, but the project remains high risk.
The decision to push ahead with Phase III tests was reached taking into account the seriousness of the disease and a review of interim data from Phase II studies, Elan and Wyeth said.
"No conclusion about the Phase II study can be drawn until the study is completed and the final data are analysed and released in 2008," they added.
Despite the companies' caution, industry analysts said the decision to push ahead with late-stage testing suggested Elan and Wyeth had a promising new technology to tackle one of the world's most intractable diseases. Continued... This is a very positive development for both Elan and Wyeth, given that the acceleration of the drug into a Phase III study was only going to be considered if the interim data showed a significant improvement in patient progress," Ian Hunter of Goodbody Stockbrokers said in a note.
Shares in Elan were 13.7 percent higher at a 10-month high of 13.3 euros by 1015 GMT.
Orla Hartford of NCB Stockbrokers said there was a possibility the new drug could be submitted for regulatory approval based on Phase II data alone, if the results were good enough.
A filing based on Phase II would increase the chance of the the product's success to 60 percent from 25 percent and add around 50 percent to the stock's valuation, she added.
"AAB-001 has the potential to transform Elan's investment case," Hartford said.
TOUGH DISEASE
Alzheimer's, which destroys memory and eventually leads to death, has been a focus of research for years but it is a very tough disease to fight and there are so far no very effective treatments. Continued... Drugs approved since the 1990s, including Pfizer Inc. (PFE.N: Quote, Profile , Research) and Eisai Co. Ltd's (4523.T: Quote, NEWS , Research) market-leading Aricept, provide only modest symptomatic relief.
Elan and Wyeth's new drug could be the first disease-modifying treatment, making it a potential multibillion-dollar product -- if it works.
Bapineuzumab is a humanised monoclonal antibody designed to attack the A-beta peptide, which is one component of amyloid plaque that builds up in the brain and is thought to be responsible for damaging brain cells.
Elan and Wyeth are also working on a vaccine called ACC-001 designed to coax the body to make its own antibodies against A-beta peptide, which is in early-stage human trials.
An earlier experimental Alzheimer's vaccine from the two partners was abandoned in 2002 after it caused dangerous brain inflammation in some patients, although later research suggested it did help clear some brain-destroying plaques.
The World Health Organisation estimates there are about 18 million people worldwide with Alzheimer's disease and this figure is projected to reach 34 million by 2025, due to ageing populations.
(Additional reporting by Paul Hoskins in Dublin)
© Reuters 2007. All Rights Reserved.
Pre-Market Last: $ 18.15
Pre-Market High: $ 18.25
Pre-Market Volume: 8,800
Pre-Market Low: $ 17.75
Pre-Market High: $ 18.25
Pre-Market Volume: 8,800
Pre-Market Low: $ 17.75
Pre-Market Trade Reporting Monday May 21
Pre-Market Last: $ 18.21
Pre-Market High: $ 18.30
Pre-Market Last: $ 18.21
Pre-Market High: $ 18.30
premarket akt 18,60
Antwort auf Beitrag Nr.: 29.403.392 von zenman am 21.05.07 14:18:08..nicht mehr...
Pre-Market Trade Reporting Monday May 21
Pre-Market Last: $ 18.80
Pre-Market High: $ 18.85
Pre-Market Trade Reporting Monday May 21
Pre-Market Last: $ 18.80
Pre-Market High: $ 18.85
..heute 20 USD ????
..die Shorties könnten heute bestimmt einen Teil dazu beitragen....
..die Shorties könnten heute bestimmt einen Teil dazu beitragen....
Antwort auf Beitrag Nr.: 29.403.617 von bernie55 am 21.05.07 14:37:28$18,90 haben wir auch schon hinter uns gelassen.
..in D aktuell zwischen 13,69 und 14,00....
Antwort auf Beitrag Nr.: 29.403.643 von Poppholz am 21.05.07 14:39:32das war die $19,00
Antwort auf Beitrag Nr.: 29.403.651 von Poppholz am 21.05.07 14:39:58rechnerisch sind wir somit bei €14,00 angekommen.
Antwort auf Beitrag Nr.: 29.403.651 von Poppholz am 21.05.07 14:39:58$19,20.
Anscheinend ist nicht die Frage, ob wir die $20,00 heute erreichen, sondern ob wir dieses noch im PREMARKED schaffen.
Anscheinend ist nicht die Frage, ob wir die $20,00 heute erreichen, sondern ob wir dieses noch im PREMARKED schaffen.
Antwort auf Beitrag Nr.: 29.403.669 von Poppholz am 21.05.07 14:42:01..nicht schlecht für den Anfang...
Antwort auf Beitrag Nr.: 29.403.707 von bernie55 am 21.05.07 14:45:17..ach, wie lieb ich diese Farbe...
Antwort auf Beitrag Nr.: 29.403.712 von bernie55 am 21.05.07 14:45:50vielleicht ist der Knoten jetzt ja endlich geplatzt.
Der Kurs pendelt sich bei $19,00 ein (vorbörslich).
Der Kurs pendelt sich bei $19,00 ein (vorbörslich).
Elan auf Bloomberg
Elan gains on alzheimers new trial
Elan gains on alzheimers new trial
KM said: "if we move to phase 3, it validates the whole program"
Hi, na denn erstmal herzlichen GW allen die Elanies die Treue
gehalten haben. Über 700K vorbörslich klingt nicht schlecht.
gehalten haben. Über 700K vorbörslich klingt nicht schlecht.
Antwort auf Beitrag Nr.: 29.403.772 von mikel_ann am 21.05.07 14:50:20ELANITES - ELANIACS - ELANNIES
...egal, hauptsache LONGIES....
...egal, hauptsache LONGIES....
Das 52w Hoch liegt bei 19.42$ darüber müsste es noch
etwas Schub geben. Sieht wirklich gut aus.
etwas Schub geben. Sieht wirklich gut aus.
Mittagsscchlaf beendet uuuuuuuuuuuuund:SUPI.....
Antwort auf Beitrag Nr.: 29.403.898 von Birgit.Tersteegen am 21.05.07 15:00:31an solchen Tagen könnte ich keinen Mittagsschlaf machen. Da bin ich noch nicht "abgebrüht" genug.
Ei was is hier los.
Das W bekommt Kinder...
Sk über 19 wäre nicht zu verachten.
Das W bekommt Kinder...
Sk über 19 wäre nicht zu verachten.
Antwort auf Beitrag Nr.: 29.403.906 von Poppholz am 21.05.07 15:01:26....und dann schlaf ich besonders gut---wegen den reichwerden im Schlaf-Traum....
Die 4000 bei 14,38 war wohl sell on good news----Zeni:Warst Du das etwa....??
My shares are not for sell.....
Die 4000 bei 14,38 war wohl sell on good news----Zeni:Warst Du das etwa....??
My shares are not for sell.....
Antwort auf Beitrag Nr.: 29.404.140 von Birgit.Tersteegen am 21.05.07 15:19:10meine waren das auch nicht.
(einen solchen Fehler mache ich nicht noch einmal)
(einen solchen Fehler mache ich nicht noch einmal)
Antwort auf Beitrag Nr.: 29.404.140 von Birgit.Tersteegen am 21.05.07 15:19:10Hi Biggi, vergiss mal ganz schnell meine theorie über ABN wieder
Und gleich geht's los...
http://www.rallymonkey.com/video/kenindex.swf
P.S.: Bernie, danke mal wieder für den Tipp
http://www.rallymonkey.com/video/kenindex.swf
P.S.: Bernie, danke mal wieder für den Tipp
Antwort auf Beitrag Nr.: 29.404.221 von Nostarowie am 21.05.07 15:24:24Mach ich!
jetzt heben wir uns auch mal ein wenig von BIIB ab:
Antwort auf Beitrag Nr.: 29.404.280 von Poppholz am 21.05.07 15:28:26Echt,mit den Loosern wollen WIR doch nix zu tun haben...ich sach nur Avonex (die PML-Droge.....:laughiiiiiiiiiiiiiiihhhhh
Antwort auf Beitrag Nr.: 29.404.254 von philippf am 21.05.07 15:26:32Bernie, danke mal wieder für den Tipp
...not worth mentioning...
...not worth mentioning...
Shorties wieder aktiv------ich hoffe,das wird ein KURZES Vergnügen für sie....
wäre nicht schlecht für den weiteren Verlauf wenndas gap heut dichtgemacht wird. Sieht auch danach aus.
Antwort auf Beitrag Nr.: 29.404.467 von Nostarowie am 21.05.07 15:39:24wie meinen?
Antwort auf Beitrag Nr.: 29.404.507 von Birgit.Tersteegen am 21.05.07 15:41:51Weis nich
Antwort auf Beitrag Nr.: 29.404.536 von Nostarowie am 21.05.07 15:43:41wohin soll denn der Kurs damit das Gap zu ist und danach alles noch hübscher wird????Nosta???
Ich fände eigentlich 20 $ heute ganz fein...
Ich fände eigentlich 20 $ heute ganz fein...
Antwort auf Beitrag Nr.: 29.404.592 von Birgit.Tersteegen am 21.05.07 15:46:46Ich habe nur laut gedacht. Aktien können steigen und fallen.
Na und guck wenn ein Loch offen bleibt dann ziehts den Kurs früher oder später meist wieder dorthin, deshalb....lieber heut als später.
Na und guck wenn ein Loch offen bleibt dann ziehts den Kurs früher oder später meist wieder dorthin, deshalb....lieber heut als später.
Msg: 109545 of 109546 5/21/2007 10:01:32 AM
By: elanguru
Remember we have only added a billion to market cap for a drug conservatively in 2 years will have a billion in sales
By: elanguru
Remember we have only added a billion to market cap for a drug conservatively in 2 years will have a billion in sales
19$
übrigens Bernie ,die" 15000"(Nr. in diesem Thread )hatte:I C H !!!!!!
Msg: 109597 of 109598 5/21/2007 10:22:01 AM
By: ipar4s2
***Advertisement*** Free whale watching tours from your desktop. Show begins in 7 minutes!!
Get your popcorn and a cold beverage.
The fine wine "rx" speaks of will be required reading later today.----schauen wir mal----
By: ipar4s2
***Advertisement*** Free whale watching tours from your desktop. Show begins in 7 minutes!!
Get your popcorn and a cold beverage.
The fine wine "rx" speaks of will be required reading later today.----schauen wir mal----
Antwort auf Beitrag Nr.: 29.405.237 von Birgit.Tersteegen am 21.05.07 16:23:09übrigens Bernie ,die" 15000"(Nr. in diesem Thread )hatte:I C H !!!!!!
....ich bin wie ich bin.....selbstlos......
....ich bin wie ich bin.....selbstlos......
Antwort auf Beitrag Nr.: 29.405.364 von bernie55 am 21.05.07 16:30:04kein Stück;Du hast einfach "gepennt"......
Antwort auf Beitrag Nr.: 29.405.517 von Nostarowie am 21.05.07 16:39:34super....
Antwort auf Beitrag Nr.: 29.405.448 von Birgit.Tersteegen am 21.05.07 16:35:10kein Stück;Du hast einfach " gepennt "......
...nö......ich habe Rasen gemäht...
...nö......ich habe Rasen gemäht...
Antwort auf Beitrag Nr.: 29.405.517 von Nostarowie am 21.05.07 16:39:34...von jedem ein bisschen....
sie möchten es unter 19$ halten....
Antwort auf Beitrag Nr.: 29.405.592 von Birgit.Tersteegen am 21.05.07 16:45:21schaffen Sie aber nicht.
Antwort auf Beitrag Nr.: 29.405.626 von Poppholz am 21.05.07 16:47:40...wollte ich auch gerade schreiben....(GRRRRRRRRRRRRH,ich Dussel hätte heute Morgen noch zuschlagen sollen----SCHLUCHZ)
Jetzt haben wir´s geknackt ... das 52-Wiik-Hei
Antwort auf Beitrag Nr.: 29.405.686 von Birgit.Tersteegen am 21.05.07 16:51:39...BIGGIE....sei nicht so gierig...
..die " kleinen " Pfunde, die wir jetzt mittlerweile in unserem PBBn Company Depot haben, sind doch wirklich nicht von schlechten Eltern....
..die " kleinen " Pfunde, die wir jetzt mittlerweile in unserem PBBn Company Depot haben, sind doch wirklich nicht von schlechten Eltern....
Press Release Source: Wyeth
Wyeth to Present at the Citigroup Health Care Conference
Tuesday May 15, 3:40 pm ET
MADISON, N.J., May 15 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE - News) announced today that it will present at the Citigroup Health Care Conference on Tuesday, May 22, 2007 at 2:00 p.m. Eastern Time. Presenting for Wyeth will be Robert R. Ruffolo, Jr., Ph.D., Senior Vice President, Wyeth and President, Wyeth Research.
Wyeth's presentation will be webcast live for investors at www.wyeth.com and available for replay following the conference.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products, and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
Wyeth to Present at the Citigroup Health Care Conference
Tuesday May 15, 3:40 pm ET
MADISON, N.J., May 15 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE - News) announced today that it will present at the Citigroup Health Care Conference on Tuesday, May 22, 2007 at 2:00 p.m. Eastern Time. Presenting for Wyeth will be Robert R. Ruffolo, Jr., Ph.D., Senior Vice President, Wyeth and President, Wyeth Research.
Wyeth's presentation will be webcast live for investors at www.wyeth.com and available for replay following the conference.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products, and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
Antwort auf Beitrag Nr.: 29.405.701 von Holgus am 21.05.07 16:52:53HOLGIEU SCHREIBST DAS S O F O R T NOCHMAL MIT EINEM O P T I M I S T I S C H E N SMILY.....
Mensch, meine Options stehen mit über 15 TSD im Plus ... heut früh waren es "nur" 6.500 ...
Wenn ich `n Klempner wäre, würd ich jetzt `n Rohr kriegen
Wenn ich `n Klempner wäre, würd ich jetzt `n Rohr kriegen
19,25 - 19,26
= 14,25 €
= 14,25 €
Antwort auf Beitrag Nr.: 29.405.768 von Holgus am 21.05.07 16:56:33DU zahlst das Bier----als therapeutische Ausgleichszahlung für uns.....:O
... SCHREIBST DAS S O F O R T NOCHMAL MIT EINEM O P T I M I S T I S C H E N SMILY
Mach ich glatt ...
Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ...
Mach ich glatt ...
Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ... Rohr kriegen ...
Antwort auf Beitrag Nr.: 29.405.768 von Holgus am 21.05.07 16:56:33Wenn ich `n Klempner wäre, würd ich jetzt `n Rohr kriegen
..ich fass es nicht...Holger mit ROHR...
..ich fass es nicht...Holger mit ROHR...
Antwort auf Beitrag Nr.: 29.405.816 von bernie55 am 21.05.07 16:59:35
Wie sang schon der berühmte Würgen Marcus ?
Mir wächst ein Rohr aus´m Ohr ... trallala
Wie sang schon der berühmte Würgen Marcus ?
Mir wächst ein Rohr aus´m Ohr ... trallala
Antwort auf Beitrag Nr.: 29.405.815 von Holgus am 21.05.07 16:59:35...ich kann nicht mehr....der Rohrkrieger...
Sieht nicht nach schließung aus.Nix mit kauflimit.
Und Holger kippt vorne über.
Und Holger kippt vorne über.
Antwort auf Beitrag Nr.: 29.405.815 von Holgus am 21.05.07 16:59:35:O:O:O:O:O:O:O:O:O:O:Owehe wir sehen uns mal live:O:O:O:O:O:O:O:O:O
Thema verfehlt
"Jetzt haben wir´s geknackt ... das 52-Wiik-Hei" HIER fehlt der passende Smilie---versuchs noch einmal Sam.....
Thema verfehlt
"Jetzt haben wir´s geknackt ... das 52-Wiik-Hei" HIER fehlt der passende Smilie---versuchs noch einmal Sam.....
Antwort auf Beitrag Nr.: 29.405.904 von Birgit.Tersteegen am 21.05.07 17:04:54Na gut ...
Jetzt haben wir´s geknackt ... das 52-Wiik-Hei
Jetzt haben wir´s geknackt ... das 52-Wiik-Hei
eben die $19,30 Grenze überwunden und nun wird der Kurs wieder gedrückt.
Für die SHORTIES entwickelt sich ELAN zu einem Teufelskreis.
Für die SHORTIES entwickelt sich ELAN zu einem Teufelskreis.
Komme von der arbeit und sehe ne 14
super muß jetzt aber noch mal weg ich hoffe wenn ich zurück komme ist die 14 noch da
gruß Noogmann
super muß jetzt aber noch mal weg ich hoffe wenn ich zurück komme ist die 14 noch da
gruß Noogmann
Antwort auf Beitrag Nr.: 29.405.928 von Poppholz am 21.05.07 17:06:36
Für die SHORTIES entwickelt sich ELAN zu einem Teufelskreis
Bis Donnerstag war ich da noch mitten drin ... in dem Teufelskreis ... so´n Scheiß.
Aber heute ... hmm ... gut das ich kein Klempner bin
Für die SHORTIES entwickelt sich ELAN zu einem Teufelskreis
Bis Donnerstag war ich da noch mitten drin ... in dem Teufelskreis ... so´n Scheiß.
Aber heute ... hmm ... gut das ich kein Klempner bin
Birgit ha´m wir´s zu verdanken
am Weekend war sie mächtig tanken
Den Kofferraumi voller Drogen
kam ratzfatz nach Haus geflogen
Verteilt das Zeug an Investoren
worauf die Jungs dann unverfroren
Total bekifft in alten Lumpen
Elan in den Himmel pumpen
Amen
Doch durch das Kiffen
und das saufen
hat man meist dann ein Rad am laufen
und gurkt benommen durch die Nebel
durch Wiese,Wald mit Megahebel
und dann zuhause angekommen sieht man sich unverhofft-benommen
vor diesem edlen Kasten sitzen...
verdammt die Leber fängt schon an zu Schwitzen
und das saufen
hat man meist dann ein Rad am laufen
und gurkt benommen durch die Nebel
durch Wiese,Wald mit Megahebel
und dann zuhause angekommen sieht man sich unverhofft-benommen
vor diesem edlen Kasten sitzen...
verdammt die Leber fängt schon an zu Schwitzen
Antwort auf Beitrag Nr.: 29.406.133 von Nostarowie am 21.05.07 17:19:05... verdammt die Leber fängt schon an zu Schwitzen
Ist die Leber schlecht am Laufen
mußt Du halt Tysabri saufen
Rülps
Ist die Leber schlecht am Laufen
mußt Du halt Tysabri saufen
Rülps
Antwort auf Beitrag Nr.: 29.406.041 von Holgus am 21.05.07 17:12:47---- OK!
Antwort auf Beitrag Nr.: 29.406.197 von Holgus am 21.05.07 17:22:34Tysabri zu bekommen ist schwer
drum sammle Giftge Pilze sehr
die haun auf gleiche weise rein
nur nebenwirkung wird wohl sein
was bei Tysabri gänzlich fehlt
jedoch der Teufel Fliegen zählt
und in der Not auch diese frisst
wenn er schon kein Tysabri kriegt
drum sammle Giftge Pilze sehr
die haun auf gleiche weise rein
nur nebenwirkung wird wohl sein
was bei Tysabri gänzlich fehlt
jedoch der Teufel Fliegen zählt
und in der Not auch diese frisst
wenn er schon kein Tysabri kriegt
Msg: 109745 of 109754 5/21/2007 11:21:37 AM
By: liposghost
WHAT'S NEXT FOR AAB-001
the best scenario is as follows
We get PIII started by labor day.
The one year data on the last cohort of PII supports a BLA at that time.
We file in oct/nov.
The PIII six month look will be accepted as proof of symptomatic relief.
Normal 10 month review gets approval sept of 08. We have label and make it to market for Christmas.
Happy Hanukah.
By: liposghost
WHAT'S NEXT FOR AAB-001
the best scenario is as follows
We get PIII started by labor day.
The one year data on the last cohort of PII supports a BLA at that time.
We file in oct/nov.
The PIII six month look will be accepted as proof of symptomatic relief.
Normal 10 month review gets approval sept of 08. We have label and make it to market for Christmas.
Happy Hanukah.
Antwort auf Beitrag Nr.: 29.406.268 von Nostarowie am 21.05.07 17:26:53Holgus und der Nosta dichten
das wird den Kurs dann sicher richten.......:kiss19,10)
das wird den Kurs dann sicher richten.......:kiss19,10)
Es ist Wahnsinn, wie die immer wieder versuchen, mit aller Gewalt den Kurs zu drücken.
Das sind echte Terroristen ... man sollte die US-Armee auf sie hetzen
Das sind echte Terroristen ... man sollte die US-Armee auf sie hetzen
Antwort auf Beitrag Nr.: 29.406.370 von Holgus am 21.05.07 17:32:23Wieso?
wird das Rohr etwa wieder kleiner
wird das Rohr etwa wieder kleiner
Antwort auf Beitrag Nr.: 29.406.370 von Holgus am 21.05.07 17:32:23 - 30000 bei 19,42 USD IM ASK
Birgitbaby unverholen
tut sich selbst den Po versohlen
Klopft drau rumm
macht mächtig bumm
Das pralle Ding es färbt sich rot
danach sind auch die Fliegen tot
tut sich selbst den Po versohlen
Klopft drau rumm
macht mächtig bumm
Das pralle Ding es färbt sich rot
danach sind auch die Fliegen tot
Antwort auf Beitrag Nr.: 29.406.515 von Holgus am 21.05.07 17:39:52Rache ist süss........schon mal was von Karma gehört....--sieht dann gar nicht so gut aus für Dich.....
Msg: 109767 of 109767 5/21/2007 11:39:17 AM
By: FaceReality
The real fun has not even started IMO. Hold those shares! Buy if you can.
Longs,
This is the beginning of the period in Elan's history that has kept me in the game thought all the crap that has hit us. I find it amazing that people are actually selling their shares just when the real funning is getting started. So many want immediate gratification and they must have bought without understand what the might own. Holding a long-term winner takes real courage -- few have what it takes to ride a stock up and up. Wall street knows this and they will soon control the company with over 80% institutional ownership. The bug buying will occur in the weeks ahead. We have a medical miracle in the making here in one of the largest markets remaining in the world of medicine. The data must be very strong to make this bold news announcement now with FDA support. I feel the key is they must get moving on Phase 3 and manufacturing CAPACITY now or the demand for drug across the world will crush both companies soon.
Elan will advance now on every bit of additional data. At some point Wyeth will make a friendly offer for the company at very attractive price. Tysabri will soon be small change to Elan and after Wyeth makes the move, Boob will but Elan's 50% at a very high price.
Congrats to all that had the courage to stay the course. We are back on track now with the real potential for significant growth still ahead. With Wyeth and the FDA on our side, the probability of getting AAB-001 to market is very high. As we move closer to that in the months ahead, the price will flying much, much higher.
Thank God for Elan's SCIENCE and SCIENTISTS!
Msg: 109767 of 109767 5/21/2007 11:39:17 AM
By: FaceReality
The real fun has not even started IMO. Hold those shares! Buy if you can.
Longs,
This is the beginning of the period in Elan's history that has kept me in the game thought all the crap that has hit us. I find it amazing that people are actually selling their shares just when the real funning is getting started. So many want immediate gratification and they must have bought without understand what the might own. Holding a long-term winner takes real courage -- few have what it takes to ride a stock up and up. Wall street knows this and they will soon control the company with over 80% institutional ownership. The bug buying will occur in the weeks ahead. We have a medical miracle in the making here in one of the largest markets remaining in the world of medicine. The data must be very strong to make this bold news announcement now with FDA support. I feel the key is they must get moving on Phase 3 and manufacturing CAPACITY now or the demand for drug across the world will crush both companies soon.
Elan will advance now on every bit of additional data. At some point Wyeth will make a friendly offer for the company at very attractive price. Tysabri will soon be small change to Elan and after Wyeth makes the move, Boob will but Elan's 50% at a very high price.
Congrats to all that had the courage to stay the course. We are back on track now with the real potential for significant growth still ahead. With Wyeth and the FDA on our side, the probability of getting AAB-001 to market is very high. As we move closer to that in the months ahead, the price will flying much, much higher.
Thank God for Elan's SCIENCE and SCIENTISTS!
Antwort auf Beitrag Nr.: 29.406.515 von Holgus am 21.05.07 17:39:52Durch Fliegentot herangezogen
kam Greenpeace auf gar lauten Sohlen
den Po alsbald ganz stillzulegen
damit durch solch ein Mordseregen
nicht nochmehr Tiere schadennehmen
kam Greenpeace auf gar lauten Sohlen
den Po alsbald ganz stillzulegen
damit durch solch ein Mordseregen
nicht nochmehr Tiere schadennehmen
Menno, schon knapp 50 Mio. Stück über den Tisch gegangen und wir kommen von der 19zen nicht weg.
WIR WAREN ALLEIN MIT TYSABRI BEI KNAPP 30ig !!!
Nun haut mal `n Schlag rein ... ihr ANALysten !!!
WIR WAREN ALLEIN MIT TYSABRI BEI KNAPP 30ig !!!
Nun haut mal `n Schlag rein ... ihr ANALysten !!!
Antwort auf Beitrag Nr.: 29.406.598 von Birgit.Tersteegen am 21.05.07 17:45:28
Karma ... die Schwester vom Daleih Lama ?
Schick her die Frau !
Karma ... die Schwester vom Daleih Lama ?
Schick her die Frau !
Antwort auf Beitrag Nr.: 29.406.600 von Nostarowie am 21.05.07 17:45:33
Fliegenkot auf Birgits Hintern
da tun die Tierchen überwintern
Im Sommer dann oh wat´n Grauß
flattern bald die Brummer aus
Braucht Biggi nicht mehr draufzukloppen
Und ihr Mann kann wieder ... ääh ... nu is gut
Fliegenkot auf Birgits Hintern
da tun die Tierchen überwintern
Im Sommer dann oh wat´n Grauß
flattern bald die Brummer aus
Braucht Biggi nicht mehr draufzukloppen
Und ihr Mann kann wieder ... ääh ... nu is gut
Antwort auf Beitrag Nr.: 29.406.725 von Holgus am 21.05.07 17:53:31Immer noch einen drauf wie immer
ist unser Holgus ein ganz schlimmer
doch wenn er dann bei Frau Mathilde
was seine Holde ist, die Wilde
sich geben will wie anderswo
so kriegt er Schläge auch auf den Po
und schluchzt ganz still und heimlich sehr
ach wenn die Alte doch mein Forum währ...
ist unser Holgus ein ganz schlimmer
doch wenn er dann bei Frau Mathilde
was seine Holde ist, die Wilde
sich geben will wie anderswo
so kriegt er Schläge auch auf den Po
und schluchzt ganz still und heimlich sehr
ach wenn die Alte doch mein Forum währ...
Antwort auf Beitrag Nr.: 29.406.804 von Nostarowie am 21.05.07 17:59:12
Mathilde Mausi abgefackt
hat frech in Nostas Bett gekackt
Dann hat er auch noch reingepackt
und schreit ganz laut "Ich glaub es hackt"
Die Mine beginnt alsbald zu sinken
als er riecht wie die Finger stinken
Und dann merkt er trotz aller Wut
wie gut doch so´n Stück Seife tut
Nu is aber gut ...
Mathilde Mausi abgefackt
hat frech in Nostas Bett gekackt
Dann hat er auch noch reingepackt
und schreit ganz laut "Ich glaub es hackt"
Die Mine beginnt alsbald zu sinken
als er riecht wie die Finger stinken
Und dann merkt er trotz aller Wut
wie gut doch so´n Stück Seife tut
Nu is aber gut ...
Antwort auf Beitrag Nr.: 29.407.056 von Holgus am 21.05.07 18:17:47
Ein Paket das mach ich nun an Dir
von deiner Holden, Glanzpapier!
was will dei Alte in mein Bett
schreib ich auf Zettel gar nicht nett
und sudel es mit Dingen voll
die ich im Bett fand, einfach Toll!
schickst deine Terroristin aus
auf das sie ruiniert mein Haus
ganz groß zu schweigem vom Gemüt
was nun bei mir in Scherben liegt
Ich werd sie wieder zurückschießen
samt Westpaket beschwehrt mit Fliesen
als Ziel ist dann Dein Bett genannt
was sowieso gehört abgebrannt...
Ein Paket das mach ich nun an Dir
von deiner Holden, Glanzpapier!
was will dei Alte in mein Bett
schreib ich auf Zettel gar nicht nett
und sudel es mit Dingen voll
die ich im Bett fand, einfach Toll!
schickst deine Terroristin aus
auf das sie ruiniert mein Haus
ganz groß zu schweigem vom Gemüt
was nun bei mir in Scherben liegt
Ich werd sie wieder zurückschießen
samt Westpaket beschwehrt mit Fliesen
als Ziel ist dann Dein Bett genannt
was sowieso gehört abgebrannt...
Antwort auf Beitrag Nr.: 29.407.269 von Nostarowie am 21.05.07 18:31:58
Msg: 109916 of 109926 5/21/2007 1:34:09 PM
By: FaceReality
The math on AAB-001 --- It is Huge!!!!!!!!!!! Just do the math yourself.
I think this is a conservative revenue picture for AAB-001 starting in 2010 for Elan
Assume just 10,000,000 patients and 15% penetration ( ow) at $15,000 per years ( very low for this drug).
10,000,000 X .15 = 1.5 million patients only @ $15,000 each per year = $22.5 Billion Annual Gross Revenue
Assume a low net profit margin, of only 70% (net of cost of manufacturing @ 20% and sales/marketing costs (way too high) at 10%)
$22.5 billion X .70 = $15.75 Billion net profit on AAB-001, now slit it 50% to get Elan's half, or
$7.875 Billion Annual Profit for Elan, divided by 468 million shares outstanding = EPS of $16.83
EPS of $16.83 at a low multiple of say only 15 = Price Per Share of Elan $252.45 per share
Discount this any way you want, change the assumptions, move the timing out, and your probability of success factor. The point is, IF you believe in this science, why in the world would you give your shares away for $19. Please do your own math and don't listen to Wall Street. And this is ABB-001 only; not Tysabri, not ACC-001 or any of the other products in the pipeline for ALZ or PD. Debt ---- forget the debt -- it will be repaid to further drive EPS up from today. Think before you sell. At least do some simple math using your own assumptions and assume the rest of the company is just at break even.
Post your math here. Correct my math. Let's start talking about real numbers.
FaceReality
Hat das Ty-Filmchen schon einer gepostet???
http://kutv.com/healthyliving/local_story_120193850.html
http://kutv.com/healthyliving/local_story_120193850.html
Moin!
Like no other
Alzheimer's Drug Moving Ahead Positively, Boosting Elan's Stock
By Aaron Lorenzo
Washington Editor
Partners Elan Corp. plc and Wyeth said they plan to begin Phase III testing of their lead immunotherapeutic candidate bapineuzumab (AAB-001) for mild to moderate Alzheimer's disease in the second half of this year, boosting excitement around the disease-modifying agent.
Company officials declined to comment beyond a joint press release that said the decision to advance the program reflects findings from a scheduled interim look at an ongoing Phase II study, which remains blinded, as well as the totality of what they've learned from their immunotherapy programs and the severity of the disease. Reading between the lines, there's clearly an assumption of good enough Phase II data, though the partners stressed that no conclusion about the study can be drawn until it's complete and final data are analyzed and released next year.
But all signals certainly appear positive.
"This looks like a real program," said Ian Sanderson, an analyst with Cowen and Co. "There have been lots of rumors that Wyeth would terminate the program, so this relieves a lot of the rumor overhang."
Elan's shares (NYSE:ELN) traded up $2.09 on Monday, or 12.6 percent, to $18.69.
Sanderson told BioWorld Today that the announcement isn't necessarily indicative of moving the product's potential approval ahead of schedule, noting that he's forecasted the partners to file with the FDA in the second half of 2009 and receive a decision in 2010. The companies have not disclosed such schedules, but given bapineuzumab's fast-track status, it might also qualify for a six-month review when Elan and Wyeth submit their application.
The humanized monoclonal antibody "provides a mechanism for which beta-amyloid is cleared from the brain," Sanderson said, by halting the formation of new plaques and possibly removing existing plaques. That would make it a disease-modifying agent like no other in development, assuming the belief that the buildup of beta-amyloid plaques does indeed drive Alzheimer's.
In contrast, Sanderson said two other late-stage drugs in development for the disease, Flurizan (tarenflurbil, from Myriad Genetics Inc.) and Alzhemed (tramiprosate, from Neurochem Inc.), "are much less potent and much less direct in their mechanism."
The randomized, double-blinded, placebo-controlled, multiple-ascending dose study into which the partners peered is to include nearly 240 patients with mild to moderate Alzheimer's, divided into four cohorts. Its primary objective is to measure bapineuzumab's safety, while secondary assessments of cognitive and functional status include evaluations of the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), the Neuropsychological Test Battery (NTB) and the Disability Assessment for Dementia (DAD) scale to measures quality of life. Each patient's participation lasts about 18 months.
It would serve as one of two studies for registration, along with the coming Phase III trial. That study's design has yet to be finalized with regulatory agencies, so the partners declined to share any details on their plans for the protocol. Sanderson speculated that it would evaluate a narrower dose range than Phase II and also include patients with the ApoE4 allele, which seems to provide a genetic predisposition to bapineuzumab response.
In addition, he said the companies would do well to convince the FDA that less rigorous patient monitoring is needed than Phase II, in which they had MRI scans after each infusion, every 12 weeks. "It's very burdensome on the patients and caregivers," he said.
A second Phase II trial is currently being conducted in Europe to evaluate patients' beta-amyloid levels through imaging. The companies do not expect that any data from the two trials to be publicly available until both are complete next year.
Elan, of Dublin, Ireland, and Wyeth, of Madison, N.J., are working in a 50:50 collaboration to research, develop and commercialize bapineuzumab and other immunotherapeutic approaches to treat mild to moderate Alzheimer's, and possibly to prevent the onset of the disease. In addition to bapineuzumab, other programs in their collaborative effort include a subcutaneous formulation of AAB-001, ACC-001 and AAB-002. The partners equally share all costs in the arrangement, and would split any revenues that arise down the road.
Drugs currently indicated for Alzheimer's include Aricept (donepezil, from Pfizer Inc.), Exelon (rivastigmine, from Novartis AG), Cognex (tacrine, from First Horizon Pharmaceutical Corp.), Reminyl (galantamine, from Shire Pharmaceuticals Group plc) and Namenda (memantine, from Forest Laboratories Inc.). All treat disease symptoms, such as slowing patients' declining cognition, but generally they "just buy a little time," Sanderson said.
Published May 22, 2007
Like no other
Alzheimer's Drug Moving Ahead Positively, Boosting Elan's Stock
By Aaron Lorenzo
Washington Editor
Partners Elan Corp. plc and Wyeth said they plan to begin Phase III testing of their lead immunotherapeutic candidate bapineuzumab (AAB-001) for mild to moderate Alzheimer's disease in the second half of this year, boosting excitement around the disease-modifying agent.
Company officials declined to comment beyond a joint press release that said the decision to advance the program reflects findings from a scheduled interim look at an ongoing Phase II study, which remains blinded, as well as the totality of what they've learned from their immunotherapy programs and the severity of the disease. Reading between the lines, there's clearly an assumption of good enough Phase II data, though the partners stressed that no conclusion about the study can be drawn until it's complete and final data are analyzed and released next year.
But all signals certainly appear positive.
"This looks like a real program," said Ian Sanderson, an analyst with Cowen and Co. "There have been lots of rumors that Wyeth would terminate the program, so this relieves a lot of the rumor overhang."
Elan's shares (NYSE:ELN) traded up $2.09 on Monday, or 12.6 percent, to $18.69.
Sanderson told BioWorld Today that the announcement isn't necessarily indicative of moving the product's potential approval ahead of schedule, noting that he's forecasted the partners to file with the FDA in the second half of 2009 and receive a decision in 2010. The companies have not disclosed such schedules, but given bapineuzumab's fast-track status, it might also qualify for a six-month review when Elan and Wyeth submit their application.
The humanized monoclonal antibody "provides a mechanism for which beta-amyloid is cleared from the brain," Sanderson said, by halting the formation of new plaques and possibly removing existing plaques. That would make it a disease-modifying agent like no other in development, assuming the belief that the buildup of beta-amyloid plaques does indeed drive Alzheimer's.
In contrast, Sanderson said two other late-stage drugs in development for the disease, Flurizan (tarenflurbil, from Myriad Genetics Inc.) and Alzhemed (tramiprosate, from Neurochem Inc.), "are much less potent and much less direct in their mechanism."
The randomized, double-blinded, placebo-controlled, multiple-ascending dose study into which the partners peered is to include nearly 240 patients with mild to moderate Alzheimer's, divided into four cohorts. Its primary objective is to measure bapineuzumab's safety, while secondary assessments of cognitive and functional status include evaluations of the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), the Neuropsychological Test Battery (NTB) and the Disability Assessment for Dementia (DAD) scale to measures quality of life. Each patient's participation lasts about 18 months.
It would serve as one of two studies for registration, along with the coming Phase III trial. That study's design has yet to be finalized with regulatory agencies, so the partners declined to share any details on their plans for the protocol. Sanderson speculated that it would evaluate a narrower dose range than Phase II and also include patients with the ApoE4 allele, which seems to provide a genetic predisposition to bapineuzumab response.
In addition, he said the companies would do well to convince the FDA that less rigorous patient monitoring is needed than Phase II, in which they had MRI scans after each infusion, every 12 weeks. "It's very burdensome on the patients and caregivers," he said.
A second Phase II trial is currently being conducted in Europe to evaluate patients' beta-amyloid levels through imaging. The companies do not expect that any data from the two trials to be publicly available until both are complete next year.
Elan, of Dublin, Ireland, and Wyeth, of Madison, N.J., are working in a 50:50 collaboration to research, develop and commercialize bapineuzumab and other immunotherapeutic approaches to treat mild to moderate Alzheimer's, and possibly to prevent the onset of the disease. In addition to bapineuzumab, other programs in their collaborative effort include a subcutaneous formulation of AAB-001, ACC-001 and AAB-002. The partners equally share all costs in the arrangement, and would split any revenues that arise down the road.
Drugs currently indicated for Alzheimer's include Aricept (donepezil, from Pfizer Inc.), Exelon (rivastigmine, from Novartis AG), Cognex (tacrine, from First Horizon Pharmaceutical Corp.), Reminyl (galantamine, from Shire Pharmaceuticals Group plc) and Namenda (memantine, from Forest Laboratories Inc.). All treat disease symptoms, such as slowing patients' declining cognition, but generally they "just buy a little time," Sanderson said.
Published May 22, 2007
Bei aller Freude über den Anstieg und den positiven Verlauf meiner Optionen,
aber der große Wurf war das irgendwie nicht.
61 Millionen Volume ... und nur so ein "bescheidener" Zuwachs ... dazu hier oben im Board Elan tief im "rot" ... irgendwie beschleicht mich schon wieder so ein komisches Gefühl.
aber der große Wurf war das irgendwie nicht.
61 Millionen Volume ... und nur so ein "bescheidener" Zuwachs ... dazu hier oben im Board Elan tief im "rot" ... irgendwie beschleicht mich schon wieder so ein komisches Gefühl.
Wo kommen im Board hier oben diese tiefroten 12,06 her ? So ein Blödsinn, die europäischen Börsen sind doch noch gar nich auf.
Können die den Kurs hier nicht mal komplett rausnehmen, das verwirrt doch nur.
Können die den Kurs hier nicht mal komplett rausnehmen, das verwirrt doch nur.
Making sense of the biotech rumor mill
Last Friday, Elan (ELN, news, msgs) shares gained more than 7% on the rumor that Biogen (BIIB, news, msgs), Elan's half partner for its multiple sclerosis drug Tysabri, is interested in acquiring the company. Yesterday, Elan was up an additional 12.6% on news that the company's Alzheimer's drug (AAB-001) -- which is partnered with Wyeth (WYE, news, msgs) -- is being advanced to Phase 3 trials.
When a stock makes a big move in a short period, there is a tremendous temptation to sell and "lock in profits." However, when the price move is accompanied with good news, the initial bump may be the beginning of a major move up. If you are too quick on the trigger, you may miss the bigger, longer-term move which, in my view, is the main reason to make an investment in the first place. So, before we decide what to do, let's take a look at the news.
The Biogen rumor
There are lots of rumors on Wall Street, and most of them turn out to have nothing to them. If the rumor is true, chances are there are some on Wall Street who know, and they are driving the price up. I never have this kind of information advantage, so I don't trade just because of a rumor. The rumor has to make sense.
The majority of Biogen's sales comes from Avonex, a multiple sclerosis drug that competes with Tysabri. Last year, Biogen's impressive overall sales growth was lead by higher sales of Avonex. However, as I read the numbers, it seems to me that Avonex sales increased less than the price increase that Biogen put through last year. This implies that the number of MS patients using Avonex probably went down last year. Since Biogen probably can't keep raising the price of Avonex at last year's pace, it is going to have a hard time maintaining its sales growth this year -- especially if Avonex is losing patients.
Biogen gets 50% of Tysabri sales but Tysabri's price is just about double that of Avonex. Therefore, as things stand today, whether an MS patient uses Avonex or Tysabri, Biogen gets the same revenue. For Biogen, sales growth from the MS market depends on Tysabri taking market share away from other competitors.
If Biogen were to acquire Elan, however, a patient who switches from Avonex to Tysabri would generate twice as much revenue for Biogen. And, patients who switch to Tysabri from any other drug would have double the impact on Biogen's sales than they do now. In short, this acquisition can make a lot of sense for Biogen, especially if it's done before Tysabri sales ramp up.
The main problem I see is that it would be a big acquisition for Biogen, whose market cap is $16 billion -- roughly double Elan's. But, interest rates are low, and capital seems to be available to do deals of this size. If a deal is done, however, I suspect that it will involve Wyeth because of its involvement with Elan's Alzheimer's drug. That's why yesterday's news on AAB-001 is so interesting.
Alzheimer's drug (AAB-001)
Yesterday's announcement that Elan and Wyeth are going to start a Phase 3 trial for AAB-001 even before the Phase 2 trial is finished speaks volumes. No Phase 2 results have yet been announced, but I infer that both companies must believe that the results are going to be positive or they would not be willing to spend millions of dollars to run the Phase 3 trial.
A successful Alzheimer's drug would be a home run for Elan. About 18 million people worldwide currently have Alzheimer's, compared with 2 million who have multiple sclerosis. Judging just from the number of patients, AAB-001's market potential could be almost 10 times bigger than Tysabri's.
That's why I think that if a deal to acquire Elan is in the works, it probably involves Wyeth and Biogen.
A deal in which Wyeth ends up with 100% of AAB-001 and Biogen ends up with 100% of Tysabri makes a lot more sense than Biogen acquiring all of Elan on its own.
Bottom line
I cannot be sure, but there may be some truth behind the rumors. In the next few days, I suspect that many people will decide to sell to lock in the gains of the past two trading days. I would not be surprised if the stock gave back half of its recent gains. If it does, I'll be buying.
The Marketocracy member who has made the most money on Elan is Chris Rees (view track record) and Elan is currently his biggest position.
The things I've discussed above are based on facts that are readily available to anyone. However, interpreting the facts to come up with the right investment decision requires judgment that is not common. I trust Chris' judgment because of his Marketocracy track record, which is now more than five years long. Chris is the mFOLIO Master I use to manage separate accounts for clients who have a large position in Elan. For information about this program, click here.
http://articles.moneycentral.msn.com/Investing/StrategyLab/R…
..mmmhh...auch nicht schlecht...
..WYETH und BIOGEN übernehmen ELAN...aber erst nach der 3.ten erfolgreiche Phase von AAB....
Antwort auf Beitrag Nr.: 29.412.457 von Holgus am 22.05.07 08:23:07Bei aller Freude über den Anstieg und den positiven Verlauf meiner Optionen,
aber der große Wurf war das irgendwie nicht.
...HOLGER...es wird wohl auch wieder runter gehen...
...hey, Nordlicht , sei doch jetzt mal zufrieden, dass du zur Zeit aktuell nur dick im Plus stehst...
aber der große Wurf war das irgendwie nicht.
...HOLGER...es wird wohl auch wieder runter gehen...
...hey, Nordlicht , sei doch jetzt mal zufrieden, dass du zur Zeit aktuell nur dick im Plus stehst...
Antwort auf Beitrag Nr.: 29.412.541 von Holgus am 22.05.07 08:32:11ab 8.00 Uhr kommen aus München die ersten Zahlen. Hier steht aber meist kein Umsatz hinter, sondern nur eine Wert, der durch einen Händler angegeben wird.
Also keine Angst.
Also keine Angst.
Antwort auf Beitrag Nr.: 29.412.660 von bernie55 am 22.05.07 08:42:16
Bernie, mit dem dicken "Plus" war `ne Nullnummer.
Prompt mit dem Anstieg am Freitag hat mein Broker (Penson)
meinen Einkauf im Trader auf 0,00 gesetzt, sodaß ich jetzt
zwar 50% meines Papierverlustes wieder wett gemacht habe,
aber immer noch ziemlich fett im Minus stehe.
Fiel mir leider erst heute früh auf ... so´n Shit.
Das riecht verdammt nach Manipulation seitens Penson, die wollten
wohl eine Euphorie erzeugen, in der ich dann die Dinger verkaufe.
Ich glaub das alles nicht ... bin leicht angesäuert deswegen.
Wenn das ein Zufall sein sollte, dann fress ich `nen Besen.
Dreckschweine, diese Geldhaie.
Bernie, mit dem dicken "Plus" war `ne Nullnummer.
Prompt mit dem Anstieg am Freitag hat mein Broker (Penson)
meinen Einkauf im Trader auf 0,00 gesetzt, sodaß ich jetzt
zwar 50% meines Papierverlustes wieder wett gemacht habe,
aber immer noch ziemlich fett im Minus stehe.
Fiel mir leider erst heute früh auf ... so´n Shit.
Das riecht verdammt nach Manipulation seitens Penson, die wollten
wohl eine Euphorie erzeugen, in der ich dann die Dinger verkaufe.
Ich glaub das alles nicht ... bin leicht angesäuert deswegen.
Wenn das ein Zufall sein sollte, dann fress ich `nen Besen.
Dreckschweine, diese Geldhaie.
Antwort auf Beitrag Nr.: 29.413.522 von Holgus am 22.05.07 09:44:10Hi Holger,
...das tut mir echt leid....ich kenne mich mit Optionsscheinen überhaupt nicht aus, aber so wie du die Sache beschreibst, scheint da ja eine ganz große " SCH..... " abzulaufen...
...vielleicht gibt es in diesem Jahr ja eine Übernahme durch Biogen und Wyeth ..... sagen wir z.B. 35 USD...
Würden deine Optionsscheine eigentlich diesen Kurssprung dann auch mitmachen ????
Grüße bernie55
...das tut mir echt leid....ich kenne mich mit Optionsscheinen überhaupt nicht aus, aber so wie du die Sache beschreibst, scheint da ja eine ganz große " SCH..... " abzulaufen...
...vielleicht gibt es in diesem Jahr ja eine Übernahme durch Biogen und Wyeth ..... sagen wir z.B. 35 USD...
Würden deine Optionsscheine eigentlich diesen Kurssprung dann auch mitmachen ????
Grüße bernie55
Antwort auf Beitrag Nr.: 29.414.159 von bernie55 am 22.05.07 10:18:03
Würden deine Optionsscheine eigentlich diesen Kurssprung dann auch mitmachen ????
Eigentlich ja, die Dinger orientieren sich ja am Aktienkurs und steigen dementsprechend auch an.
Aber lass uns bloß nicht dieses Übernahme herbeiwünschen ... wenn mit Elan dann bei 35ig Schluß wäre ... und das schöne Potential der nächsten Jahre wäre flöten.
Biogen oder Wyeth kaufen ? Nö ... wär nix für mich.
Würden deine Optionsscheine eigentlich diesen Kurssprung dann auch mitmachen ????
Eigentlich ja, die Dinger orientieren sich ja am Aktienkurs und steigen dementsprechend auch an.
Aber lass uns bloß nicht dieses Übernahme herbeiwünschen ... wenn mit Elan dann bei 35ig Schluß wäre ... und das schöne Potential der nächsten Jahre wäre flöten.
Biogen oder Wyeth kaufen ? Nö ... wär nix für mich.
Antwort auf Beitrag Nr.: 29.414.314 von Holgus am 22.05.07 10:27:26und wenn Du gestern die Optionen verkauft hättest, dann hättest Du den Gewinn eingestrichen?
Habe leider auch keine Ahnung von Optionen, nur dass man damit viiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiel Geld machen kann.
Habe leider auch keine Ahnung von Optionen, nur dass man damit viiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiel Geld machen kann.
Antwort auf Beitrag Nr.: 29.414.314 von Holgus am 22.05.07 10:27:26Aber lass uns bloß nicht dieses Übernahme herbeiwünschen
..nö...will ich zum aktuellen Zeitpunkt ja auch nicht, da ich bei ELAN erheblicheres Potential sehe ......deshalb eben auch schon seit April 2003 investiert bin.....
..wie ich schon unten schrieb :
" ..mmmhh...auch nicht schlecht...
..WYETH und BIOGEN übernehmen ELAN...aber erst nach der 3.ten erfolgreiche Phase von AAB....
..nö...will ich zum aktuellen Zeitpunkt ja auch nicht, da ich bei ELAN erheblicheres Potential sehe ......deshalb eben auch schon seit April 2003 investiert bin.....
..wie ich schon unten schrieb :
" ..mmmhh...auch nicht schlecht...
..WYETH und BIOGEN übernehmen ELAN...aber erst nach der 3.ten erfolgreiche Phase von AAB....
Goodbody: Downgrade to Add from Buy, Target $20.30, midpoint of current valuation range
Pipeline progress priced in.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
In a note issued today, we briefly review the Alzheimer’s Disease drug market, its potential over the next 10 years and the possible position of AAB-001 in that market. Although no data are forthcoming at this time, we must assume that the decision to move AAB-001 into a Phase III study has been taken on a significant response from patients in the Phase II trial. Running this
assumption into our model, relative to the progress of other drug candidates, we have raised our peak sales expectations for AAB-001 to $2.5bn from $2.2bn in 2015, by which time we expect the total market to exceed $10bn. That said, it must be stressed that it is very early to quantify the drug’s potential performance without sight of efficacy data and any idea of the pricing of the drug at the end of the trial process. Again, this could well be dependent on the progress of other drug candidates such as Neurochem’s Alzhemed and Myriad Genetics’ Flurizan, their pricing relative to efficacy and AAB-001’s efficacy relative to those two drugs. Running the improved revenue projections and increased weighting on AAB-001 entering the market (up from 30% to 70%), drives our valuation range for Elan up to the $17.67 to $22.93 per share range (mid-point $20.30) from the $16.82 to $21.88 per share range (mid-point $19.35) enumerated in March.
Elan, however, remains a high risk stock, despite yesterday’s announcement, as AAB-001 still has to complete trials and successfully negotiate the approval process. Given: (i) the successful transition of AAB-001 into Phase III trials while still in Phase II; (ii) the implications that has on the efficacy of the drug in what is forecast to be a rapidly growing market; and (iii) the potential for further upside from Tysabri as efficacy starts to outweigh safety concerns; but (iv) balanced by the related share price appreciation over the past two trading days, we believe that momentum in the stock will now be more muted until the next significant progress point. After the recent surge in share price (up 22% in two trading days), we would temper our enthusiasm in what remains a relatively high risk stock. We are, therefore, revising our recommendation to Add from Buy, while at the same time increasing our price target to $20.30, the mid-point in our current valuation range
Pipeline progress priced in.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
In a note issued today, we briefly review the Alzheimer’s Disease drug market, its potential over the next 10 years and the possible position of AAB-001 in that market. Although no data are forthcoming at this time, we must assume that the decision to move AAB-001 into a Phase III study has been taken on a significant response from patients in the Phase II trial. Running this
assumption into our model, relative to the progress of other drug candidates, we have raised our peak sales expectations for AAB-001 to $2.5bn from $2.2bn in 2015, by which time we expect the total market to exceed $10bn. That said, it must be stressed that it is very early to quantify the drug’s potential performance without sight of efficacy data and any idea of the pricing of the drug at the end of the trial process. Again, this could well be dependent on the progress of other drug candidates such as Neurochem’s Alzhemed and Myriad Genetics’ Flurizan, their pricing relative to efficacy and AAB-001’s efficacy relative to those two drugs. Running the improved revenue projections and increased weighting on AAB-001 entering the market (up from 30% to 70%), drives our valuation range for Elan up to the $17.67 to $22.93 per share range (mid-point $20.30) from the $16.82 to $21.88 per share range (mid-point $19.35) enumerated in March.
Elan, however, remains a high risk stock, despite yesterday’s announcement, as AAB-001 still has to complete trials and successfully negotiate the approval process. Given: (i) the successful transition of AAB-001 into Phase III trials while still in Phase II; (ii) the implications that has on the efficacy of the drug in what is forecast to be a rapidly growing market; and (iii) the potential for further upside from Tysabri as efficacy starts to outweigh safety concerns; but (iv) balanced by the related share price appreciation over the past two trading days, we believe that momentum in the stock will now be more muted until the next significant progress point. After the recent surge in share price (up 22% in two trading days), we would temper our enthusiasm in what remains a relatively high risk stock. We are, therefore, revising our recommendation to Add from Buy, while at the same time increasing our price target to $20.30, the mid-point in our current valuation range
Alzheimer's drug test boosts Elan by over 18pc
Elan boss Kelly Martin
By Jim Aughney
Tuesday May 22 2007
ELAN Corp, the pharma company which has been boom or bust for investors, turned in its biggest one-day share price gain in a year yesterday after its experimental treatment for Alzheimer's Disease (AD) moved into the final stage of testing required for approval.
Shares in Elan rose almost 20pc to €14 at one stage, which was their largest single-day increase since May 2006. The shares closed officially in Dublin at €13.87 which marked a gain of 18.5pc on the day. The jump in the share price jump in Dublin yesterday followed a 5pc gain on Friday ahead of the announcement and brought the gain for the first five months of 2007 to over 25pc.
A Phase III trial of its Bapineuzumab drug (code-named AAB-001) will begin in the second half of this year after an examination of data from current studies, Elan and its partner Wyeth said.
Davy Stockbrokers analyst Jack Gorman said the development is a key positive for Elan shares.
"It underpins the validity of the AAB-001 approach and strengthens the case for the amyloid hypothesis in AD," Mr Gorman said.
"Elan is one of the best AD plays in the sector, with seven separate approaches underway. Our sum of the parts valuation attempts to capture the value of this overall franchise," he said.
The compound AAB-001 is a humanised monoclonal antibody that received fast-track status from the Food and Drug Administration (FDA) in the US - this is given to treatments thataddress an unmet need for serious or life-threatening conditions.
"This is a very positive development for both Elan and Wyeth, given that the acceleration of the drug into a Phase III study was only going to be considered if the interim data showed a significant improvement in patient progress," Goodbody analyst Ian Hunter said.
Bapineuzumab is being tested in patients with mild to moderate Alzheimer's disease in two Phase II studies, Elan said.
The results of the studies are not expected until 2008, the company added.
More than 25 million people worldwide, including four million Americans, suffer from Alzheimer's, a wasting disease which destroys the memory and impairs the ability to communicate and carry out many basic everyday functions.
Elan warned that it is important to remember that Alzheimer's disease is a complex and formidable challenge, and its immunotherapeutic programmes still contain inherent risks.
"Despite the fact that significant risks and challenges clearly remain (as cautioned by Elan), this is very positive news and it increases the likelihood that AAB-001 will eventually get to market", Merrion Securities said.
- Jim Aughney
http://www.investorvillage.com/smbd.asp?mb=160&mn=110355&pt=…
Elan boss Kelly Martin
By Jim Aughney
Tuesday May 22 2007
ELAN Corp, the pharma company which has been boom or bust for investors, turned in its biggest one-day share price gain in a year yesterday after its experimental treatment for Alzheimer's Disease (AD) moved into the final stage of testing required for approval.
Shares in Elan rose almost 20pc to €14 at one stage, which was their largest single-day increase since May 2006. The shares closed officially in Dublin at €13.87 which marked a gain of 18.5pc on the day. The jump in the share price jump in Dublin yesterday followed a 5pc gain on Friday ahead of the announcement and brought the gain for the first five months of 2007 to over 25pc.
A Phase III trial of its Bapineuzumab drug (code-named AAB-001) will begin in the second half of this year after an examination of data from current studies, Elan and its partner Wyeth said.
Davy Stockbrokers analyst Jack Gorman said the development is a key positive for Elan shares.
"It underpins the validity of the AAB-001 approach and strengthens the case for the amyloid hypothesis in AD," Mr Gorman said.
"Elan is one of the best AD plays in the sector, with seven separate approaches underway. Our sum of the parts valuation attempts to capture the value of this overall franchise," he said.
The compound AAB-001 is a humanised monoclonal antibody that received fast-track status from the Food and Drug Administration (FDA) in the US - this is given to treatments thataddress an unmet need for serious or life-threatening conditions.
"This is a very positive development for both Elan and Wyeth, given that the acceleration of the drug into a Phase III study was only going to be considered if the interim data showed a significant improvement in patient progress," Goodbody analyst Ian Hunter said.
Bapineuzumab is being tested in patients with mild to moderate Alzheimer's disease in two Phase II studies, Elan said.
The results of the studies are not expected until 2008, the company added.
More than 25 million people worldwide, including four million Americans, suffer from Alzheimer's, a wasting disease which destroys the memory and impairs the ability to communicate and carry out many basic everyday functions.
Elan warned that it is important to remember that Alzheimer's disease is a complex and formidable challenge, and its immunotherapeutic programmes still contain inherent risks.
"Despite the fact that significant risks and challenges clearly remain (as cautioned by Elan), this is very positive news and it increases the likelihood that AAB-001 will eventually get to market", Merrion Securities said.
- Jim Aughney
http://www.investorvillage.com/smbd.asp?mb=160&mn=110355&pt=…
Antwort auf Beitrag Nr.: 29.414.509 von bernie55 am 22.05.07 10:39:06......deshalb eben auch schon seit April 2003 investiert bin.....
..sorry...April 2005....
..sorry...April 2005....
Welcher Dussel heute seine Aktien zu 13,06 verschenkt hat----oder war es der shorte ZENMAN???
Antwort auf Beitrag Nr.: 29.416.096 von Birgit.Tersteegen am 22.05.07 12:12:43kann mir den Kursrückgang auch nur mit einer SHORT-Attacke erklären.
Antwort auf Beitrag Nr.: 29.416.127 von Poppholz am 22.05.07 12:14:47und mit Gewinnmitnahmen der Ungeduldigen oder derjenigen ,die auf ein Gapclose spekulieren.....
Deshalb sei hier nochmalö an unsere Chancen erinnert....
Msg: 110381 of 110385 5/22/2007 5:41:34 AM
By: okz45
The storyline for openers
We are not a one-trick pony
We have the number one new therapy for MS
We are awaiting approval for the number one new therapy for CD
We are in the process of validating what we expect to be the number one
therapy for A L Z H E I M E R.
We have a very full pipeline that we are looking to enlarge
We lead the industry in approved drugs in the Nano World and expect to continue doing that
We have a young dynamic senior mngt. looking to grow Elan both horizontally and vertically.
We are healthy with no large debt due until the year 2011 with nearly a Billion in the bank with an excellent ratio of current assets to current debt
All systems go
my opinion
Deshalb sei hier nochmalö an unsere Chancen erinnert....
Msg: 110381 of 110385 5/22/2007 5:41:34 AM
By: okz45
The storyline for openers
We are not a one-trick pony
We have the number one new therapy for MS
We are awaiting approval for the number one new therapy for CD
We are in the process of validating what we expect to be the number one
therapy for A L Z H E I M E R.
We have a very full pipeline that we are looking to enlarge
We lead the industry in approved drugs in the Nano World and expect to continue doing that
We have a young dynamic senior mngt. looking to grow Elan both horizontally and vertically.
We are healthy with no large debt due until the year 2011 with nearly a Billion in the bank with an excellent ratio of current assets to current debt
All systems go
my opinion
Ich glaube das langweiligste und unwahrscheinlichste was es geben könnte ist ein Chart, der von links unten nach rechts oben in gerader Linie verläuft.
Antwort auf Beitrag Nr.: 29.416.927 von Nostarowie am 22.05.07 13:07:17Charts, die von links nach rechts oben laufen finde ich überhaupt nicht langweilig.
aktuell in USA
$18,11 zu $18,93
$18,11 zu $18,93
Antwort auf Beitrag Nr.: 29.417.078 von Poppholz am 22.05.07 13:17:47Die betonung liegt ja auf GERADE.
Antwort auf Beitrag Nr.: 29.416.096 von Birgit.Tersteegen am 22.05.07 12:12:43ich shorte keine german elans
aktuell stehen wir bei $18,35 zu $18,36
das wären €13,55.
Somit gibt es in FFM wieder einmal gute Kaufkurse.
das wären €13,55.
Somit gibt es in FFM wieder einmal gute Kaufkurse.
Antwort auf Beitrag Nr.: 29.417.235 von zenman am 22.05.07 13:29:08NA GUT----aber ich hab auch amerikanische :O----Du wirst doch auch älter und musst auch Deine Nerven schonen...also geh`schon mit uns long
Antwort auf Beitrag Nr.: 29.416.927 von Nostarowie am 22.05.07 13:07:17nosta----das sind aber meine LIEBLINGS.....(wenn ich drin bin....)
Poppi,wir haben hier die jungen Wilden an Bord....
Poppi,wir haben hier die jungen Wilden an Bord....
Msg: 110471 of 110474 5/22/2007 9:02:03 AM
By: Franca_ole
Tysabri in Switzerland since May 1st
just to inform you Ty is approved for MS in Switzerland since May 1st
http://www.swissmedic.ch/search.asp?query=tysabri&sitetype=i…
see page 32/34
There is a MS prevalence of approx. 10.000 swiss people:
http://www.ms-diagnose.ch/pages/index.cfm?dom=3&rub=5157
By: Franca_ole
Tysabri in Switzerland since May 1st
just to inform you Ty is approved for MS in Switzerland since May 1st
http://www.swissmedic.ch/search.asp?query=tysabri&sitetype=i…
see page 32/34
There is a MS prevalence of approx. 10.000 swiss people:
http://www.ms-diagnose.ch/pages/index.cfm?dom=3&rub=5157
Msg: 110464 of 110477 5/22/2007 8:53:55 AM
By: pinvestment2
today and thursday should be very interesting
especially given the WYE presentation coming today and the ELN AGM presentation coming on thursday
so the market gave ELN a marginal increase in market cap compared to WYE - over time that will be corrected as aab-001 progresses towards a filing with the FDA
but with a few properly chosen words today and thursday ELN/WYE can make the aab-001 story much clearer for the market to understand the potential value implications
I think that if WYE or ELN verify that the phase III will have a 6 month timepoint to allow filing then wall street will need to move the approval timepoint forward - and with a ton of patient interest the trial will fill quickly and the countdown to intense speculation will begin - wall street will then understand what starting the phase III meant - if WYE says "we only decided to start this phase III because of the efficacy seen in phase II" then wall street will realize that this is just not a phase III for phase III sake - it is a marker for efficacy in a huge drug market that has nothing that really works at all
should be fun to watch as people figure it out
By: pinvestment2
today and thursday should be very interesting
especially given the WYE presentation coming today and the ELN AGM presentation coming on thursday
so the market gave ELN a marginal increase in market cap compared to WYE - over time that will be corrected as aab-001 progresses towards a filing with the FDA
but with a few properly chosen words today and thursday ELN/WYE can make the aab-001 story much clearer for the market to understand the potential value implications
I think that if WYE or ELN verify that the phase III will have a 6 month timepoint to allow filing then wall street will need to move the approval timepoint forward - and with a ton of patient interest the trial will fill quickly and the countdown to intense speculation will begin - wall street will then understand what starting the phase III meant - if WYE says "we only decided to start this phase III because of the efficacy seen in phase II" then wall street will realize that this is just not a phase III for phase III sake - it is a marker for efficacy in a huge drug market that has nothing that really works at all
should be fun to watch as people figure it out
Msg: 110480 of 110481 5/22/2007 9:14:12 AM Recs: 5 Sentiment: Buy
By: donewithpunting
NEW JUNE CALL OPTIONS
New strikes 25-40 BUCKS!!!
WHY?
Who has the need to speculate?
they expire in 3+ weeks,someone think
ELN will appreciate 50-100+% IN 3 WEEKS??
Street Sense baby!!!
PLUS+++++
Great pre market reversal
looks like pre market ATTEMPTED takedown
WONT be sucessfull or limited at best
sorry IF ELN doesn't reach $20 today.....
UP ELN
Smell the bacon!!!
By: donewithpunting
NEW JUNE CALL OPTIONS
New strikes 25-40 BUCKS!!!
WHY?
Who has the need to speculate?
they expire in 3+ weeks,someone think
ELN will appreciate 50-100+% IN 3 WEEKS??
Street Sense baby!!!
PLUS+++++
Great pre market reversal
looks like pre market ATTEMPTED takedown
WONT be sucessfull or limited at best
sorry IF ELN doesn't reach $20 today.....
UP ELN
Smell the bacon!!!
-------g r ü n !
gezielte cent für cent-Preisdrückerei....immer die Kurzen...
Pssssssssssssssssst:
wir sind bei $ 19,00 angekommen.
wir sind bei $ 19,00 angekommen.
Antwort auf Beitrag Nr.: 29.421.135 von Poppholz am 22.05.07 16:54:15na also--geht doch!
19,24$
JETZT WERDEN DIE SHORTIES WILD UND STELLEN 100000 ST.INS ASK bei 19,25$....ES MUSS DOCH AUFZUHALTEN SEIN.....--es scheint kurzfristig zu klappen...
Antwort auf Beitrag Nr.: 29.422.304 von Birgit.Tersteegen am 22.05.07 18:07:25wird auf jeden Fall immer schwieriger.
Besonders unter dem Gesichtspunkt, dass wir das jeden Tag ein wenig höher schließen, sollte die SHORTIES nervös machen.
Besonders unter dem Gesichtspunkt, dass wir das jeden Tag ein wenig höher schließen, sollte die SHORTIES nervös machen.
Schlusskurs über $19,00 wäre klasse. Mal schauen, was zum Ende noch kommt.
Antwort auf Beitrag Nr.: 29.423.585 von Poppholz am 22.05.07 19:20:05gleich beginnt Wyeth`s Conference Call--mal sehen ob das Unterstützung gibt!(Ich hoffe,der Finanzchef darf diesmal nicht sprechen---erinnert Ihr Euch an das letzte Mal als er es tat...:laugh
By: grapesrme54
Posted as a reply to msg 110701 by ipar4s2
Re: 1 hour till Wyeth speaks at Citi conference. Wonder what they might talk about?lol eom.
A follow-up line of questioning would hopefully seek confirmation that P2 was still a Pivotal trial and about implications that can be drawn about an early filing.
If Phase 3 is disease modifying then it makes intuitive sense for an early symtomatic relief BLA based on Phase 2, in line with what other's have suggested here, perhaps as early as this fall.
Staggering possibilities !
JMHO. Long and Strong , Best of luck to all
By: grapesrme54
Posted as a reply to msg 110701 by ipar4s2
Re: 1 hour till Wyeth speaks at Citi conference. Wonder what they might talk about?lol eom.
A follow-up line of questioning would hopefully seek confirmation that P2 was still a Pivotal trial and about implications that can be drawn about an early filing.
If Phase 3 is disease modifying then it makes intuitive sense for an early symtomatic relief BLA based on Phase 2, in line with what other's have suggested here, perhaps as early as this fall.
Staggering possibilities !
JMHO. Long and Strong , Best of luck to all
Msg: 110733 of 110735 5/22/2007 1:52:59 PM
By: pinvestment2
Posted as a reply to msg 110727 by youkei
simple question
as more people understand what the significance of the move to phase III actually was (i.e. per WYE's words - "that they see something spectacular") - how could anyone not want to own what could be one of the most exciting medical and marketplace decision of the coming decades
if WYE/ELN start a trial that has an early look in for filing purposes - and if the trial fills up very rapidly it is a countdown to the greatest potential PR in history - can you imagine what the ELN options with be priced like around the time for the PR on the phase III results - DNDN had 5-7$ of premium in the short term options - I think it will be even more of a circus for ELN and that ELN and WYE will deliver
can you ask what the share price could do on the day WYE/ELN potentially announce highly positive phase III results for aab-001?
alternatively can you imagine what would happen if WYE and ELN file later this year on the phase II data?
at some point ELN will attract just about anybody who likes to speculate - and as every day passes just more and more people will start to understand the timeline
doesn't seem like something you are going to want to be out of for the next year
Link zum CC http://www.veracast.com/webcasts/citigroup/healthcare07/5710…
Allerdings sagten sie gerade sie wollen nichts weiter sagen zu den ALZ-Trials weil sie "blind" seien und er den Erfolg nicht gefährden wolle...
Allerdings sagten sie gerade sie wollen nichts weiter sagen zu den ALZ-Trials weil sie "blind" seien und er den Erfolg nicht gefährden wolle...
Antwort auf Beitrag Nr.: 29.424.391 von Birgit.Tersteegen am 22.05.07 20:04:52falls Bap tatsächlich überwältigende Zwischenergebnisse gezeigt hat - und dies war die ausgesprochene Voraussetzung für ein frühzeitiges Konvertieren in Phase 3 - dann dürften mit zunehmenden Erfolgsaussichten die Begehrlichkeiten des Pharmaschwergewichts zunehmen. Falls eine Übernahme von Elan als Option diskutiert wird, dann dürfte es eher im Interesse der Gesellschaft sein, den möglichen Erfolg klein zu reden. Bin mal gespannt, ob bei Elan am Do andere Töne angeschlagen werden.
Antwort auf Beitrag Nr.: 29.424.720 von Cyberhexe am 22.05.07 20:23:28...das wäre verständlich...und zusätzlich ist folgendes plausibel:
By: ipar4s2
Our Aab-001 PIII will be a USA and EU effort.
Dr. Ruffolo was right on cue.
No PIIb peek discussion as per agreement with the FDA. If we were not talking a "rolling BLA submission from PII data, with PIII peeks being added during the application period, we could talk. Our decision not to discuss data was "in agreement with the Agency".
This is bioworld where anything is possible, but this looks quite good to me.
Anyone remember the discussions regarding PII peek earlier? Seems the data is in fact so compelling, the Agency want everyone to close their lips so they can do their job and get this miracle drug in the hands of those in need as fast as our Congress allows them.
Stay within the lines and you'll never get ticketed for swerving.
By: ipar4s2
Our Aab-001 PIII will be a USA and EU effort.
Dr. Ruffolo was right on cue.
No PIIb peek discussion as per agreement with the FDA. If we were not talking a "rolling BLA submission from PII data, with PIII peeks being added during the application period, we could talk. Our decision not to discuss data was "in agreement with the Agency".
This is bioworld where anything is possible, but this looks quite good to me.
Anyone remember the discussions regarding PII peek earlier? Seems the data is in fact so compelling, the Agency want everyone to close their lips so they can do their job and get this miracle drug in the hands of those in need as fast as our Congress allows them.
Stay within the lines and you'll never get ticketed for swerving.
Msg: 110765 of 110795 5/22/2007 2:35:50 PM
By: dar200
No-brainer inference
Party line is decision to move to P3 was based on the totality of all we know, including the animal studies, AN 1792 data, autopsies, etc.
One questioner said, "Well, you've had all that old information for a long time. What caused the decision to be made now"?
Answer: I will not talk about the P2 study.
While the companies may refuse to talk about the P2 trials, there is no question in my mind that the interim look is what caused the move to P3 now.
By: dar200
No-brainer inference
Party line is decision to move to P3 was based on the totality of all we know, including the animal studies, AN 1792 data, autopsies, etc.
One questioner said, "Well, you've had all that old information for a long time. What caused the decision to be made now"?
Answer: I will not talk about the P2 study.
While the companies may refuse to talk about the P2 trials, there is no question in my mind that the interim look is what caused the move to P3 now.
Antwort auf Beitrag Nr.: 29.423.585 von Poppholz am 22.05.07 19:20:05Schlusskurs über $19,00 wäre klasse. Mal schauen, was zum Ende noch kommt.
YEPP....erreicht....hätte ich nach dem gestrigen Anstieg nicht gedacht..
...ELAN ist für eine Überraschung immer gut....
YEPP....erreicht....hätte ich nach dem gestrigen Anstieg nicht gedacht..
...ELAN ist für eine Überraschung immer gut....
Antwort auf Beitrag Nr.: 29.428.705 von bernie55 am 23.05.07 08:25:18wir kennen doch unsere SHORTIES und KURSMANIPULIERER.
Es wird aber von Tag zu Tag schwieriger den Kurs unten zu halten und irgendwann platzt die BOMBE.
Es wird aber von Tag zu Tag schwieriger den Kurs unten zu halten und irgendwann platzt die BOMBE.
Antwort auf Beitrag Nr.: 29.428.807 von Poppholz am 23.05.07 08:36:23... und irgendwann platzt die BOMBE
Na Poppi, aber hoffentlich nicht morgens auf Klo ... brrrr
Na Poppi, aber hoffentlich nicht morgens auf Klo ... brrrr
Antwort auf Beitrag Nr.: 29.428.852 von Holgus am 23.05.07 08:39:41bei den SHORTIES (und allen anderen Kursmanipulierern) werden bald ganz dunkle Wolken aufziehen.
ein Schlusskurs in den USA von über $19,00 und in ganz Europa schaffen wir nicht einmal die €14,00 Hürde.
Dann warten wir halt wieder bis heute Nachmittag.
Dann warten wir halt wieder bis heute Nachmittag.
dann geht es uuuuuuuuuuuuuuuuuuuuuuuuuuuuuupppppppppppppppppppppppppp
Antwort auf Beitrag Nr.: 29.431.618 von Poppholz am 23.05.07 11:25:00ist natürlich nur meine Meinung uns soll keine Kauf- oder Verkaufsempfehlung sein.
Antwort auf Beitrag Nr.: 29.431.635 von Poppholz am 23.05.07 11:25:48soll keine Kauf- oder Verkaufsempfehlung sein.
Schade Poppi, ich wollt schon grad loslaufen zur Bank ...
Schade Poppi, ich wollt schon grad loslaufen zur Bank ...
Antwort auf Beitrag Nr.: 29.432.043 von Holgus am 23.05.07 11:48:06ich mache mich vielleicht auch noch einmal auf den Weg dorthin.
Antwort auf Beitrag Nr.: 29.432.782 von Poppholz am 23.05.07 12:27:50Hi Ihr Lieben....
Einfach mal einen netten Gruss in die Runde! Birgit
Einfach mal einen netten Gruss in die Runde! Birgit
Antwort auf Beitrag Nr.: 29.434.307 von Birgit.Tersteegen am 23.05.07 13:58:31.....einfach mal einen netten Gruß zurück....
...muss jetzt noch ein bisschen arbeiten....
...muss jetzt noch ein bisschen arbeiten....
auch einen netten Gruß zurück.
Bald haben wir unsere:
Bald haben wir unsere:
Antwort auf Beitrag Nr.: 29.434.909 von Poppholz am 23.05.07 14:31:30Poppi spinnst Du ? Bei 20ig steh ich immer noch über 40ig% im Minus.
Da fühl ich mich dann zwar schon ein klein bißchen wohler, aber `ne
Party ? Na, ich weiß nich ...
Da fühl ich mich dann zwar schon ein klein bißchen wohler, aber `ne
Party ? Na, ich weiß nich ...
Antwort auf Beitrag Nr.: 29.435.119 von Holgus am 23.05.07 14:44:57Wieso das denn?Ich denke Du bist DICK im Plus--wer soll denn sonst das Bier bezahlen??
Antwort auf Beitrag Nr.: 29.435.557 von Birgit.Tersteegen am 23.05.07 15:11:48Das dachte ich bis gestern früh auch, bis ich merkte, daß mein Broker mich anscheinend leimen will.
Der hat eiskalt am Freitag zum 1. dicken Anstieg in meinem Trader
den Einkaufspreis der Optionen auf 0,00 gesetzt, somit war der ganze Anstieg als Netto-Profit ausgewiesen.
War mir gar nicht aufgefallen und so durfte ich ein bißchen träumen, bis mir gestern früh die Augen aufgingen. Ich wollts erst gar nicht glauben.
Diese Schweine haben garantiert damit spekuliert, daß einen der "riesige" Anstieg verwirrt und man das Zeug dann weghaut.
Anders ist das nicht zu erklären, jedenfalls rein zufällig ist der Zeitpunkt auf keinen Fall.
Nun kann man noch nicht mal mehr seinem Broker trauen (CortalConsers > US-Trading/Penson).
Jedenfalls bin ich erstmal bedient und das mit dem Bier müssen wir halt noch etwas aufschieben.
Haltet mit heut die Kurse hoch, ich muß jetzt weg bis heut Abend.
Der hat eiskalt am Freitag zum 1. dicken Anstieg in meinem Trader
den Einkaufspreis der Optionen auf 0,00 gesetzt, somit war der ganze Anstieg als Netto-Profit ausgewiesen.
War mir gar nicht aufgefallen und so durfte ich ein bißchen träumen, bis mir gestern früh die Augen aufgingen. Ich wollts erst gar nicht glauben.
Diese Schweine haben garantiert damit spekuliert, daß einen der "riesige" Anstieg verwirrt und man das Zeug dann weghaut.
Anders ist das nicht zu erklären, jedenfalls rein zufällig ist der Zeitpunkt auf keinen Fall.
Nun kann man noch nicht mal mehr seinem Broker trauen (CortalConsers > US-Trading/Penson).
Jedenfalls bin ich erstmal bedient und das mit dem Bier müssen wir halt noch etwas aufschieben.
Haltet mit heut die Kurse hoch, ich muß jetzt weg bis heut Abend.
Antwort auf Beitrag Nr.: 29.435.821 von Holgus am 23.05.07 15:24:59dass die Geschichte mit den Optionen nicht so leicht zu verstehen ist, wußte ich ja schon, aber das der Broker den Einkaufspreis auf 0,00 setzen kann, grenzt ja nun wirklich schon an "Hütchenspielermentalität".
Antwort auf Beitrag Nr.: 29.435.821 von Holgus am 23.05.07 15:24:59Ist eine Sauerei---aber betrachte es als Wink des Schicksals Dir schon mal zu zeigen, wo die Reise hingeht....
19,34$
Antwort auf Beitrag Nr.: 29.437.005 von Birgit.Tersteegen am 23.05.07 16:15:1214,33 €
Antwort auf Beitrag Nr.: 29.437.031 von bernie55 am 23.05.07 16:16:14
Antwort auf Beitrag Nr.: 29.437.048 von bernie55 am 23.05.07 16:16:52---genau,nicht dass Du Deinen Umrechnungsjob vergisst...so--muss nun wieder "Menschen helfen"....und hätte,vom Gefühl her,gerade ein schönes Tagungshaus zu verschenken....Kunden können sooo blöd sein....:O
Antwort auf Beitrag Nr.: 29.437.831 von Birgit.Tersteegen am 23.05.07 16:51:03und hätte,vom Gefühl her,gerade ein schönes Tagungshaus zu verschenken.... Kunden können sooo blöd sein....
..liebe Birgit, bedenke, dass bald ELANITES und ELANIACS auf deiner Terasse sitzen und dein Tagungshaus bevölkern werden......
......bei solchen Aussichten musst du einfach wieder
..liebe Birgit, bedenke, dass bald ELANITES und ELANIACS auf deiner Terasse sitzen und dein Tagungshaus bevölkern werden......
......bei solchen Aussichten musst du einfach wieder
Antwort auf Beitrag Nr.: 29.438.798 von bernie55 am 23.05.07 17:36:06ok!:kissie meisten Menschen hier sind ja auch SEHR nett....
Hi birgit hatte deine einladung in den party thread rechtzeitig wargenommen.
wolln wir mal schaun wie das hier weitergeht.
wolln wir mal schaun wie das hier weitergeht.
Antwort auf Beitrag Nr.: 29.443.300 von GuHu1 am 23.05.07 22:08:25freut mich GUHU---dann haste ja wirklich den rechtzeitigen Einstieg geschafft
Antwort auf Beitrag Nr.: 29.443.457 von Birgit.Tersteegen am 23.05.07 22:17:46ich stehe halt auf partys und damit kann man mich ködern
Antwort auf Beitrag Nr.: 29.443.514 von GuHu1 am 23.05.07 22:22:44Prima!Dann müssen wir ja mal langsam ins "Dating"gehen.....
Schlusskurs übrigens 19,10$
Schlusskurs übrigens 19,10$
Antwort auf Beitrag Nr.: 29.443.544 von Birgit.Tersteegen am 23.05.07 22:25:39mühsam ernährt sich das Eichhörnchen.
wenn wir in den nächsten Monaten immer im grünen Bereich schließen, dann sind mir kleine Steigerungen auch ganz recht.
wenn wir in den nächsten Monaten immer im grünen Bereich schließen, dann sind mir kleine Steigerungen auch ganz recht.
Antwort auf Beitrag Nr.: 29.443.968 von Poppholz am 23.05.07 23:02:47Moin Poppi-Moin@all!
Folgenden Beitrag find ich richtig gut!!Ihr auch??
Prohost on Elan
ELAN (ELN)
Negative investors perpetrate the notion that, no matter what this firm brings to the market, or has in its pipeline, it is overvalued. If you ask why, the answer will be, because it is risky. Why is it risky? Because its promising products are investigational, which might, or might not be approved. That’s what one of the firm’s critic said. If Elan,which has a unique M.S. product on the market in addition to three other approved and marketed products is risky, then all the biotech firms must be considered risky in the eyes of this critic. Informed investors, including us and many of our subscribers have made excellent investments in the biotechnology industry. We made profit on dozens of biotech firms and we still are. Some of these investments returned 1000% on the initial investment. Many have quadrupled, tripled, or doubled their invested capital. The record is still existing in the past N-letters and E-Letters Most of the gains were huge, thanks to short investors who boxed excellent biotech stock prices, enabling us to own excellent shares at bargain prices. The latest were ABGX, REGN, MEDI, ELN, PDLI, MEDX and others.
Contrary to what the critics claim, Tysabri is not a risk. The PML side effect that caused Biogen Idec to withdraw the drug from the market after the side effect affected only two patients out of several hundreds who took the drug.The affected patients were not taking Tysabri alone but together with other products, mainly immunosuppressive drugs. Many writers miss to mention that many marketed drugs have also caused PML in small percentage of patients. None of these drugs have been withdrawn from the market and some, like Rituxan, for example have become best sellers despite the PML possible threat. Rituxan, which was initially indicated for lymphoma, has recently been approved for other inflammatory and autoimmune diseases. Sales have reached billions of dollars. Some attribute the good penetration of Tysabri to Biogen Idec’s experience and marketing capability, while overlooking the outstanding efficacy of the drug, which has been confirmed in several trials. Finally, they say that Tysa-
bri alone will not be able to balance Elan’s budget, overlooking the fact that Elan has many marketed products,many alliances that developed products based on Elan’s state-of-the-art NanoChrystal technology and the value of its lead investigational drug for Alzheimer disease.
Wyeth, Elan’s partner stated that the most promising Alzheimer’s disease drug among the many it has in its pipeline is AAB-001, co-developed with Elan. As a matter of fact, ELAN stock has become more visible and began to outperform. The firm and its partner Wyeth decided to begin Phase 3 clinical trials on AAB-001.
Acorda’s (ACOR) stock rallied from less than $2.5 in September 2006 to over $24 now. You know the reason? Because it announced positive results from Phase 3 clinical trial of its drug, Fampridine-SR, on walking in people with multiple sclerosis (MS). The stock soared around 1000% despite the fact that the drug has yet to be approved, that the firm has no marketed drugs, that Fampridine-SR is not a treatment for M.S., but for its walking complication, that it has yet to be approved and it had failed previous trials on its primary indication, spinal nerve injury.
Why not Elan for God’s sake?
Folgenden Beitrag find ich richtig gut!!Ihr auch??
Prohost on Elan
ELAN (ELN)
Negative investors perpetrate the notion that, no matter what this firm brings to the market, or has in its pipeline, it is overvalued. If you ask why, the answer will be, because it is risky. Why is it risky? Because its promising products are investigational, which might, or might not be approved. That’s what one of the firm’s critic said. If Elan,which has a unique M.S. product on the market in addition to three other approved and marketed products is risky, then all the biotech firms must be considered risky in the eyes of this critic. Informed investors, including us and many of our subscribers have made excellent investments in the biotechnology industry. We made profit on dozens of biotech firms and we still are. Some of these investments returned 1000% on the initial investment. Many have quadrupled, tripled, or doubled their invested capital. The record is still existing in the past N-letters and E-Letters Most of the gains were huge, thanks to short investors who boxed excellent biotech stock prices, enabling us to own excellent shares at bargain prices. The latest were ABGX, REGN, MEDI, ELN, PDLI, MEDX and others.
Contrary to what the critics claim, Tysabri is not a risk. The PML side effect that caused Biogen Idec to withdraw the drug from the market after the side effect affected only two patients out of several hundreds who took the drug.The affected patients were not taking Tysabri alone but together with other products, mainly immunosuppressive drugs. Many writers miss to mention that many marketed drugs have also caused PML in small percentage of patients. None of these drugs have been withdrawn from the market and some, like Rituxan, for example have become best sellers despite the PML possible threat. Rituxan, which was initially indicated for lymphoma, has recently been approved for other inflammatory and autoimmune diseases. Sales have reached billions of dollars. Some attribute the good penetration of Tysabri to Biogen Idec’s experience and marketing capability, while overlooking the outstanding efficacy of the drug, which has been confirmed in several trials. Finally, they say that Tysa-
bri alone will not be able to balance Elan’s budget, overlooking the fact that Elan has many marketed products,many alliances that developed products based on Elan’s state-of-the-art NanoChrystal technology and the value of its lead investigational drug for Alzheimer disease.
Wyeth, Elan’s partner stated that the most promising Alzheimer’s disease drug among the many it has in its pipeline is AAB-001, co-developed with Elan. As a matter of fact, ELAN stock has become more visible and began to outperform. The firm and its partner Wyeth decided to begin Phase 3 clinical trials on AAB-001.
Acorda’s (ACOR) stock rallied from less than $2.5 in September 2006 to over $24 now. You know the reason? Because it announced positive results from Phase 3 clinical trial of its drug, Fampridine-SR, on walking in people with multiple sclerosis (MS). The stock soared around 1000% despite the fact that the drug has yet to be approved, that the firm has no marketed drugs, that Fampridine-SR is not a treatment for M.S., but for its walking complication, that it has yet to be approved and it had failed previous trials on its primary indication, spinal nerve injury.
Why not Elan for God’s sake?
Antwort auf Beitrag Nr.: 29.444.862 von Birgit.Tersteegen am 24.05.07 07:18:47
International Conference on Prevention of Dementia
09.06.07 -12.06.07
Tuesday, June 12, 2007I
INTERVENTION AND TREATMENTS
..u.a.
- Immunotherapy
Dale Schenk , Élan Pharmaceuticals, South San Francisco, Calif., United States
http://www.alz.org/preventionconference/pc2007/session_detai…
International Conference on Prevention of Dementia
09.06.07 -12.06.07
Tuesday, June 12, 2007I
INTERVENTION AND TREATMENTS
..u.a.
- Immunotherapy
Dale Schenk , Élan Pharmaceuticals, South San Francisco, Calif., United States
http://www.alz.org/preventionconference/pc2007/session_detai…
Antwort auf Beitrag Nr.: 29.445.328 von bernie55 am 24.05.07 08:34:53Edward Owens Buys OSI Pharmaceuticals Inc., Elan Corp. Plc, Amylin Pharmaceuticals Inc., Sells Biomet Inc., Bausch & Lomb Inc., CVS Corp.
Ticker Date* Price* buy/sell Picked By
SIAL 2007-03-31 $39.8 Add David Dreman
BOL 2007-03-31 $52.3 Add David Dreman
AMLN 2007-03-31 $38.8 Buy Edward Owens
BAY 2007-03-31 $56.7 Reduce Edward Owens
BOL 2007-03-31 $52.3 Sell Edward Owens
*The price and date might not be the actual time and price at which the transactions were made. In the case of institutional owners, the date is stated as the last day of their fiscal quarter. The prices are estimates if no accurate information available.
Want to buy healthcare stocks, see what Edward Owens is buying. He is the manager of Vanguard Healthcare Fund since 1984, averaging more than 19% a year. These are his buys and sells during the first quarter. Edward Owens owns 81 stocks with a total value of $24.5 billion.
Edward Owens buys Osi Pharmaceuticals Inc., Elan Corp. Plc, Amylin Pharmaceuticals Inc., sells Biomet Inc., Bausch & Lomb Inc., Cvs Corp. during the 3-months ended 03/31/2007, according to the most recent filings of his investment company, Vanguard Health Care Fund. Edward Owens owns 81 stocks with a total value of $24.5 billion. These are the details of the buys and sells.
New Purchases: AMLN, ELN, OSIP,
Added Positions: SIAL, WAG,
Reduced Positions: BAY, GILD, HGSI, VMSI,
Sold Out: BMET, BOL, CVS,
.......
....
New Purchase: Elan Corp. Plc (ELN)
Edward Owens initiated holdings in Pharmaceuticals company Elan Corp. Plc. His purchase prices were between $12.35 and $14.81, with an estimated average price of $13.3. The impact to his portfolio due to this purchase was 0.1%. His holdings were 1,820,000 shares as of 03/31/2007. Shares of Elan Corp. Plc were traded at around $19.04.
http://www.gurufocus.com/news.php?id=6015
..well done, Edward..
Ticker Date* Price* buy/sell Picked By
SIAL 2007-03-31 $39.8 Add David Dreman
BOL 2007-03-31 $52.3 Add David Dreman
AMLN 2007-03-31 $38.8 Buy Edward Owens
BAY 2007-03-31 $56.7 Reduce Edward Owens
BOL 2007-03-31 $52.3 Sell Edward Owens
*The price and date might not be the actual time and price at which the transactions were made. In the case of institutional owners, the date is stated as the last day of their fiscal quarter. The prices are estimates if no accurate information available.
Want to buy healthcare stocks, see what Edward Owens is buying. He is the manager of Vanguard Healthcare Fund since 1984, averaging more than 19% a year. These are his buys and sells during the first quarter. Edward Owens owns 81 stocks with a total value of $24.5 billion.
Edward Owens buys Osi Pharmaceuticals Inc., Elan Corp. Plc, Amylin Pharmaceuticals Inc., sells Biomet Inc., Bausch & Lomb Inc., Cvs Corp. during the 3-months ended 03/31/2007, according to the most recent filings of his investment company, Vanguard Health Care Fund. Edward Owens owns 81 stocks with a total value of $24.5 billion. These are the details of the buys and sells.
New Purchases: AMLN, ELN, OSIP,
Added Positions: SIAL, WAG,
Reduced Positions: BAY, GILD, HGSI, VMSI,
Sold Out: BMET, BOL, CVS,
.......
....
New Purchase: Elan Corp. Plc (ELN)
Edward Owens initiated holdings in Pharmaceuticals company Elan Corp. Plc. His purchase prices were between $12.35 and $14.81, with an estimated average price of $13.3. The impact to his portfolio due to this purchase was 0.1%. His holdings were 1,820,000 shares as of 03/31/2007. Shares of Elan Corp. Plc were traded at around $19.04.
http://www.gurufocus.com/news.php?id=6015
..well done, Edward..
Antwort auf Beitrag Nr.: 29.444.862 von Birgit.Tersteegen am 24.05.07 07:18:47hört sich sehr gut an.
über welche Bank kann ich Optionsscheine zu Elan kaufen?
Meine Banken (ing-diba und DAB) bieten diese anscheinend nicht an.
Meine Banken (ing-diba und DAB) bieten diese anscheinend nicht an.
Antwort auf Beitrag Nr.: 29.448.393 von Poppholz am 24.05.07 11:44:13über welche Bank kann ich Optionsscheine zu Elan kaufen?
Poppi, Optionen sollte man nur in den USA kaufen,
über einen amerikanischen Broker (das geht in Deutschland am Besten über CortalConsers US-Trading oder auch andere Anbieter).
Man dealt dann allerdings direkt an der Nasdaq.
Ob Elan-Optionen überhaupt in DE angeboten werden, weiß ich nicht.
Würd sie allerdings eh nur da drüben kaufen, da Du sie dort auch
täglich wieder verkaufen kannst (wie Aktien eben), wobei nach deutschem Recht hiesige Optionen erst zum Auslaufdatum
verkauft werden können.
Hier ist also das Risiko viel höher, da Du sie selbst bei schlechtem Verlauf (und dann ev. Totalverlust) bis zum Schluß halten mußt.
Du würdest also tatenlos zusehn müssen.
Poppi, Optionen sollte man nur in den USA kaufen,
über einen amerikanischen Broker (das geht in Deutschland am Besten über CortalConsers US-Trading oder auch andere Anbieter).
Man dealt dann allerdings direkt an der Nasdaq.
Ob Elan-Optionen überhaupt in DE angeboten werden, weiß ich nicht.
Würd sie allerdings eh nur da drüben kaufen, da Du sie dort auch
täglich wieder verkaufen kannst (wie Aktien eben), wobei nach deutschem Recht hiesige Optionen erst zum Auslaufdatum
verkauft werden können.
Hier ist also das Risiko viel höher, da Du sie selbst bei schlechtem Verlauf (und dann ev. Totalverlust) bis zum Schluß halten mußt.
Du würdest also tatenlos zusehn müssen.
DJ Elan:Co Alzheimer's Treatment Will Change Disease's Pathology
By Quentin Fottrell
Of DOW JONES NEWSWIRES
DUBLIN (Dow Jones)--Elan Corp. PLC's (ELN) head of research and
development, Lars Ekman, said Thursday he thinks the company's
Alzheimer's disease treatment, AAB-001, will change the underlying
pathology of the disease. Speaking to Dow Jones Newswires ahead of the company's annual general meeting, Ekman also said that Elan hasn't ruled out initially releasing AAB-001 on a symptomatic label, but that the company's objective is to ultimately release a label for the treatment which
tackles the whole spectrum of the disease.
Crucially, Ekman said he couldn't comment on the ongoing Phase II
AAB-001 trial as that would destroy the trial. But he said Elan's
joint-venture partner Wyeth (WYE) has the capacity to supply AAB-001 for a couple of years.
--------------------------------------------------
DJ Elan: Alzheimer's Treatment Will Change Disease's Pathology-2
"As the market grows, Elan has the right to produce AAB-001," Ekman told Dow Jones Newswires. "Elan doesn't have, at this point, a biological manufacturing plan, but that is a strategic consideration that Elan has to make."
Earlier this week, Elan's share surged after the Irish drug company and its U.S. partner Wyeth said they are to start Phase III clinical trials of AAB-001, their treatment for mild to moderate Alzheimer's disease, earlier than planned.
With Phase III trials starting in mid-2007, rather than mid-2008 as expected, Elan said AAB-001 could potentially receive approval from the U.S. Food & Drug Administration and reach the market in 2009 or 2010.
(MORE TO FOLLOW) Dow Jones Newswires
05-24-07 0611ET
Copyright (c) 2007 Dow Jones & Company, Inc.
- - 06 11 AM EDT 05-24-07
--------------------------------------------------
DJ Elan: Alzheimer's Treatment Will Change Disease's Pathology-3
"Almost all the big pharmas have bought programs that mimic ours, but they are a number of years behind," Ekman said. "That's the best compliment you can get. We have a very strong intellectual property position."
Ekman stopped short of saying the treatment will "cure" Alzheimer's, but said this was only because he didn't want to give patients false hope.
Referring to Pfizer Inc.'s (PFE) Aricept, the leading drug of its kind, Ekman said: "It changes the symptoms, but doesn't change the course of the disease. That is what makes AAB-001 dramatically different."
"AAB-001 changes the underlying pathology of the disease, which gives the possibility to influence the disease at the heart of the
problem," he said. "It takes away the toxic substances that drive the disease."
(MORE TO FOLLOW) Dow Jones Newswires
05-24-07 0616ET
Copyright (c) 2007 Dow Jones & Company, Inc.
- - 06 16 AM EDT 05-24-07
--------------------------------------------------
DJ Elan: Alzheimer's Treatment Will Change Disease's Pathology-4
Ekman said there are about 10 million Alzheimer's patients
collectively in the U.S. and Europe, and about 14 million in the rest of the world, supporting the new drug's potential as a blockbuster. Ian Hunter, analyst with Dublin-based Goodbody Stockbrokers, estimates that "conservative" peak annual sales for AAB-001 could be $2.2 billion by 2014 should the treatment get final approval from the regulatory authorities.
Company Web site: http://www.elan.com
-By Quentin Fottrell, Dow Jones Newswires; +353-1-6762189;
quentin.fottrell@dowjones.com
(END) Dow Jones Newswires
05-24-07 0620ET
Copyright (c) 2007 Dow Jones & Company, Inc.
- - 06 20 AM EDT 05-24-07
...nicht nur schön zu lesen, sondern meiner Meinung nach ein sehr positives Statement über das mögliche Potential von AAB-001
By Quentin Fottrell
Of DOW JONES NEWSWIRES
DUBLIN (Dow Jones)--Elan Corp. PLC's (ELN) head of research and
development, Lars Ekman, said Thursday he thinks the company's
Alzheimer's disease treatment, AAB-001, will change the underlying
pathology of the disease. Speaking to Dow Jones Newswires ahead of the company's annual general meeting, Ekman also said that Elan hasn't ruled out initially releasing AAB-001 on a symptomatic label, but that the company's objective is to ultimately release a label for the treatment which
tackles the whole spectrum of the disease.
Crucially, Ekman said he couldn't comment on the ongoing Phase II
AAB-001 trial as that would destroy the trial. But he said Elan's
joint-venture partner Wyeth (WYE) has the capacity to supply AAB-001 for a couple of years.
--------------------------------------------------
DJ Elan: Alzheimer's Treatment Will Change Disease's Pathology-2
"As the market grows, Elan has the right to produce AAB-001," Ekman told Dow Jones Newswires. "Elan doesn't have, at this point, a biological manufacturing plan, but that is a strategic consideration that Elan has to make."
Earlier this week, Elan's share surged after the Irish drug company and its U.S. partner Wyeth said they are to start Phase III clinical trials of AAB-001, their treatment for mild to moderate Alzheimer's disease, earlier than planned.
With Phase III trials starting in mid-2007, rather than mid-2008 as expected, Elan said AAB-001 could potentially receive approval from the U.S. Food & Drug Administration and reach the market in 2009 or 2010.
(MORE TO FOLLOW) Dow Jones Newswires
05-24-07 0611ET
Copyright (c) 2007 Dow Jones & Company, Inc.
- - 06 11 AM EDT 05-24-07
--------------------------------------------------
DJ Elan: Alzheimer's Treatment Will Change Disease's Pathology-3
"Almost all the big pharmas have bought programs that mimic ours, but they are a number of years behind," Ekman said. "That's the best compliment you can get. We have a very strong intellectual property position."
Ekman stopped short of saying the treatment will "cure" Alzheimer's, but said this was only because he didn't want to give patients false hope.
Referring to Pfizer Inc.'s (PFE) Aricept, the leading drug of its kind, Ekman said: "It changes the symptoms, but doesn't change the course of the disease. That is what makes AAB-001 dramatically different."
"AAB-001 changes the underlying pathology of the disease, which gives the possibility to influence the disease at the heart of the
problem," he said. "It takes away the toxic substances that drive the disease."
(MORE TO FOLLOW) Dow Jones Newswires
05-24-07 0616ET
Copyright (c) 2007 Dow Jones & Company, Inc.
- - 06 16 AM EDT 05-24-07
--------------------------------------------------
DJ Elan: Alzheimer's Treatment Will Change Disease's Pathology-4
Ekman said there are about 10 million Alzheimer's patients
collectively in the U.S. and Europe, and about 14 million in the rest of the world, supporting the new drug's potential as a blockbuster. Ian Hunter, analyst with Dublin-based Goodbody Stockbrokers, estimates that "conservative" peak annual sales for AAB-001 could be $2.2 billion by 2014 should the treatment get final approval from the regulatory authorities.
Company Web site: http://www.elan.com
-By Quentin Fottrell, Dow Jones Newswires; +353-1-6762189;
quentin.fottrell@dowjones.com
(END) Dow Jones Newswires
05-24-07 0620ET
Copyright (c) 2007 Dow Jones & Company, Inc.
- - 06 20 AM EDT 05-24-07
...nicht nur schön zu lesen, sondern meiner Meinung nach ein sehr positives Statement über das mögliche Potential von AAB-001
Antwort auf Beitrag Nr.: 29.449.445 von bernie55 am 24.05.07 12:50:13http://www.investorvillage.com/smbd.asp?mb=160&mn=111828&pt=…
Ich glaube,wir haben wieder eine "not if,but when"Situation...
....letztere Situationseinschätzung nach Absprache mit Bernie55...
Moin!
nach einem super Rebound gestern bin ich gespannt auf heute....
Elan working to fast-track Alzheimer's drug 'potential'
By Jim Aughney
Friday May 25 2007
ELAN, the Irish pharma company, is working to advance its Alzheimer's treatment which has "fantastic potential," chairman Kyran McLaughlin told the agm in Dublin yesterday.
The Dublin-based company also plans to test its multiple sclerosis (MS) drug Tysabri in treating various cancers, the meeting heard. Chief executive Kelly Martin told the agm that results of initial studies into Tysabri's use in cancer will be available in the first half of 2008.
Elan said earlier this week that it will start late-stage trials with its partner Wyeth on its experimental Alzheimer's compound after an interim look at Phase II data. The Bapineuzumab drug, is a humanized monoclonal antibody that received "fast-track" status from the FDA for serious or life-threatening conditions.
Peak revenue from Bapineuzumab could reach $5bn, based on a price of $25,000 per patient a year, according to analyst Catherine Arnold of Credit Suisse.
Analysts estimate the current $3.1bn value of the Alzheimer's disease market will grow to $10.3bn by 2015 and $14.1bn by 2025.
Lars Ekman, Elan's head of research and development, said there is evidence that Bapineuzumab (which is code-numbered AAB-001) "is indeed disease modifying".
Elan and Wyeth plan to start late-stage trials, involving up to 2,000 patients, in the second half 2007, Ekman said.
Progression
If the drug is successful in preventing the progression of the disease, Bapineuzumab could replace rival medicines quickly.
There are four other drugs on the market for Alzheimer's disease. Pfizer has Aricept, Shire has Razadyne, Novartis has Exelon and Forest Laboratories has Namenda. None of the four drugs slow down the disease's progression.
The next stage of trials will attempt to discover if brain scans show a reduction in the amyloid plaque that is believed to cause the disease. Elan won't disclose exact results of the tests or how effective the treatment was in reducing plaque until the FDA has agreed to the Phase III trial.
"The implication is that the AAB-001 data might be strong enough to trigger a request for approval on Phase II data," Goodbody's analyst Ian Hunter said. "If this were the case, the drug could be on the market in late 2008, early 2009."
- Jim Aughney
" target="_blank" rel="nofollow ugc noopener">http://www.independent.ie/business/irish/elan-working-to-fasttrack-alzheimers-drug-potential-684082.html
nach einem super Rebound gestern bin ich gespannt auf heute....
Elan working to fast-track Alzheimer's drug 'potential'
By Jim Aughney
Friday May 25 2007
ELAN, the Irish pharma company, is working to advance its Alzheimer's treatment which has "fantastic potential," chairman Kyran McLaughlin told the agm in Dublin yesterday.
The Dublin-based company also plans to test its multiple sclerosis (MS) drug Tysabri in treating various cancers, the meeting heard. Chief executive Kelly Martin told the agm that results of initial studies into Tysabri's use in cancer will be available in the first half of 2008.
Elan said earlier this week that it will start late-stage trials with its partner Wyeth on its experimental Alzheimer's compound after an interim look at Phase II data. The Bapineuzumab drug, is a humanized monoclonal antibody that received "fast-track" status from the FDA for serious or life-threatening conditions.
Peak revenue from Bapineuzumab could reach $5bn, based on a price of $25,000 per patient a year, according to analyst Catherine Arnold of Credit Suisse.
Analysts estimate the current $3.1bn value of the Alzheimer's disease market will grow to $10.3bn by 2015 and $14.1bn by 2025.
Lars Ekman, Elan's head of research and development, said there is evidence that Bapineuzumab (which is code-numbered AAB-001) "is indeed disease modifying".
Elan and Wyeth plan to start late-stage trials, involving up to 2,000 patients, in the second half 2007, Ekman said.
Progression
If the drug is successful in preventing the progression of the disease, Bapineuzumab could replace rival medicines quickly.
There are four other drugs on the market for Alzheimer's disease. Pfizer has Aricept, Shire has Razadyne, Novartis has Exelon and Forest Laboratories has Namenda. None of the four drugs slow down the disease's progression.
The next stage of trials will attempt to discover if brain scans show a reduction in the amyloid plaque that is believed to cause the disease. Elan won't disclose exact results of the tests or how effective the treatment was in reducing plaque until the FDA has agreed to the Phase III trial.
"The implication is that the AAB-001 data might be strong enough to trigger a request for approval on Phase II data," Goodbody's analyst Ian Hunter said. "If this were the case, the drug could be on the market in late 2008, early 2009."
- Jim Aughney
" target="_blank" rel="nofollow ugc noopener">http://www.independent.ie/business/irish/elan-working-to-fasttrack-alzheimers-drug-potential-684082.html
Re: Because of Tysabri, Wow.....
Damage to the brain continues even when symptoms are not present, she added.
May 24
Renewing the Fight Against MS
From Newsday
RENEWING THE FIGHT AGAINST MS, REAPPROVED DRUG LEADS THE WAY FOR NEW TREATMENTS by Jamie Talen
Elizabeth West, 44, lived nine years with multiple sclerosis, and eventually the medicines she was taking lost their power to preserveher muscle strength.
Finally, in January 2005 the Westbury resident received an infusion of the blockbuster drug Tysabri, which was pulled from the market during the month after her first treatment.
Because of Tysabri, however, West said, "I literally was able to walk out of my doctor's office without my cane."
The day before her second monthly dose, Biogen and Elan Pharmaceuticals voluntarily removed Tysabri from the market after three of the 3,000 patients who had received the novel medicine developed a potentially fatal infection of the brain: progressive multifocal leukoencephalopathy.
"To me, it was a miracle drug," said West, who joined thousands of other patients in fighting for the drug's return.
After a two-year hiatus, Tysabri is back. Seeking to avoid the serious side effect, the company has added a mandatory monitoring and surveillence program. And that's fine with West, who last month picked up where she left off - except that her muscles are much weaker than two years ago.
Tysabri is seen as today's best hope for new research and treatment for multiple sclerosis, an autoimmune disease that damages the protective insulation, called myelin, surrounding fibers of the central nervous system known as axons. When the myelin covering is lost, patients can experience any number of troubling and worsening symptoms - from muscle weakness to cognitive problems and gait disturbances.
Made from an antibody
What is unique and impressive about Tysabri is that it's a monoclonal antibody, a treatment made from the specific antibody involved in the disease process. Scientists can now make targeted antibodies to treat a wide range of diseases.
Tysabri is engineered to target a molecule found on the surface of lymphocytes, immune system cells in the bloodstream. The drug prevents lymphocytes from passing through blood vessels into the brain, which happens abnormally in patients with multiple sclerosis, explained Dr. Patricia K. Coyle, director of the MS care center and acting chair of neurology at Stony Brook University Hospital.
The studies that led to Tysabri's initial federal approval in November 2004 found that patients on the drug had a 68 percent reduction in new attacks, and much less disability than those on a placebo. The U.S. Food and Drug Administration fast-tracked Tysabri for patients with relapsing and remitting multiple sclerosis, a form characterized by symptoms and remission alternating.
What's more, the drug prevented up to 90 percent of new lesions that would have formed in the brains of patients. These lesions, scientists say, are markers for cell damage. In trying to figure out how multiple sclerosis works, scientists need to understand why the lesions are present in all forms of the disease.
Lesions seen during remission
Scientists used to think the lesions disappeared when patients were in remission, but newer scanning technologies revealed only 4 percent of the lesions go away, said Dr. Lauren Krupp, professor of neurolgy and director of the pediatric MS center at Stony Brook. The next question, then, is what are they doing there?
To answer that question, Stony Brook scientists head to the magnetic resonance imaging machine, which provides a picture of the lesions - in both the brain's white matter, containing nerve fibers, and in the gray matter, the cortex. What Coyle and Krupp are showing is that 80 percent of the lesions seen on the MRI are not associated with an MS attack but are contributing to the underlying disease process.
Damage without symptoms
They now believe that the relapsing and remitting of the disease "gives patients a false impression," Coyle said. Damage to the brain continues even when symptoms are not present, she added.
Half a million people in the United States have multiple sclerosis, and scientists think immune-mediated diseases are on the rise. Krupp said she is finding evidence that environmental exposures such as certain viruses, combined with genetic factors, can increase a person's risk for the disease.
While there are many experimental drugs in the pipeline, the National Multiple Sclerosis Society recently convened its scientists to talk about the role of stem cells in repairing the brain and repopulating it with oligodendrocytes, cells essential to forming the axon's protective myelin sheath. In mice, placing the stem cells in the brain seems to repair damage, scientists say.
Breakthrough with MRI
The Stony Brook scientists have in their hands what they think could be one of the greatest discoveries of the day. Dr. Mirjana Savatic, who works at Stony Brook and Cold Spring Harbor Laboratory, has developed a method of observing stem cells in the living human brain using an MRI machine.
In the past decade it's become clear that the adult brain has discrete populations of stem cells. Krupp is collaborating with Savatic to study the MS brain, and they can actually see recruitment of the stem cells after a new lesion - suggesting that the brain is trying to somehow repair itself.
"It's pretty amazing," said Krupp.
They will follow patients over time to understand what the stem cells are doing. They can also use the technology to test the effectiveness of treatments.
MRI spectroscopy is a noninvasive scan of the brain that provides information about its chemistry. Savatic used it to identify a substance present only in stem cells and not in mature cells, including neurons, glial cells or inflammatory cells.
When Krupp asked her to run a few patients through the MRI scan, searching for stem cells, she said she didn't expect to see much. But to her surprise, Krupp said, "where there's a lesion, we saw a peak in these stem cells."
Hope on several fronts
"It's extremely exciting to see so many new things coming," said Dr. Mark Gudesblatt, a neurologist with offices in Bay Shore and Patchogue who specializes in multiple sclerosis. In addition to Tysabri, which is given by monthly intravenous infusions, Gudesblatt suspects that the first oral MS medicine will be available in a few years.
"It gives patients tremendous hope," he added.
So far, about 100 of his 2,500 MS patients have opted for Tysabri. Other medicines are injectables that have to be taken daily or weekly. "And Tysabri is incredibly effective and well tolerated," Gudesblatt said.
West said that the gap in her treatment definitely set her back. She's hoping that within a few months her nightly dreams of running will become a reality. "I'm staying positive," she said. "I look forward to the day that I may say, 'Hey, guess what? It worked.'"
Damage to the brain continues even when symptoms are not present, she added.
May 24
Renewing the Fight Against MS
From Newsday
RENEWING THE FIGHT AGAINST MS, REAPPROVED DRUG LEADS THE WAY FOR NEW TREATMENTS by Jamie Talen
Elizabeth West, 44, lived nine years with multiple sclerosis, and eventually the medicines she was taking lost their power to preserveher muscle strength.
Finally, in January 2005 the Westbury resident received an infusion of the blockbuster drug Tysabri, which was pulled from the market during the month after her first treatment.
Because of Tysabri, however, West said, "I literally was able to walk out of my doctor's office without my cane."
The day before her second monthly dose, Biogen and Elan Pharmaceuticals voluntarily removed Tysabri from the market after three of the 3,000 patients who had received the novel medicine developed a potentially fatal infection of the brain: progressive multifocal leukoencephalopathy.
"To me, it was a miracle drug," said West, who joined thousands of other patients in fighting for the drug's return.
After a two-year hiatus, Tysabri is back. Seeking to avoid the serious side effect, the company has added a mandatory monitoring and surveillence program. And that's fine with West, who last month picked up where she left off - except that her muscles are much weaker than two years ago.
Tysabri is seen as today's best hope for new research and treatment for multiple sclerosis, an autoimmune disease that damages the protective insulation, called myelin, surrounding fibers of the central nervous system known as axons. When the myelin covering is lost, patients can experience any number of troubling and worsening symptoms - from muscle weakness to cognitive problems and gait disturbances.
Made from an antibody
What is unique and impressive about Tysabri is that it's a monoclonal antibody, a treatment made from the specific antibody involved in the disease process. Scientists can now make targeted antibodies to treat a wide range of diseases.
Tysabri is engineered to target a molecule found on the surface of lymphocytes, immune system cells in the bloodstream. The drug prevents lymphocytes from passing through blood vessels into the brain, which happens abnormally in patients with multiple sclerosis, explained Dr. Patricia K. Coyle, director of the MS care center and acting chair of neurology at Stony Brook University Hospital.
The studies that led to Tysabri's initial federal approval in November 2004 found that patients on the drug had a 68 percent reduction in new attacks, and much less disability than those on a placebo. The U.S. Food and Drug Administration fast-tracked Tysabri for patients with relapsing and remitting multiple sclerosis, a form characterized by symptoms and remission alternating.
What's more, the drug prevented up to 90 percent of new lesions that would have formed in the brains of patients. These lesions, scientists say, are markers for cell damage. In trying to figure out how multiple sclerosis works, scientists need to understand why the lesions are present in all forms of the disease.
Lesions seen during remission
Scientists used to think the lesions disappeared when patients were in remission, but newer scanning technologies revealed only 4 percent of the lesions go away, said Dr. Lauren Krupp, professor of neurolgy and director of the pediatric MS center at Stony Brook. The next question, then, is what are they doing there?
To answer that question, Stony Brook scientists head to the magnetic resonance imaging machine, which provides a picture of the lesions - in both the brain's white matter, containing nerve fibers, and in the gray matter, the cortex. What Coyle and Krupp are showing is that 80 percent of the lesions seen on the MRI are not associated with an MS attack but are contributing to the underlying disease process.
Damage without symptoms
They now believe that the relapsing and remitting of the disease "gives patients a false impression," Coyle said. Damage to the brain continues even when symptoms are not present, she added.
Half a million people in the United States have multiple sclerosis, and scientists think immune-mediated diseases are on the rise. Krupp said she is finding evidence that environmental exposures such as certain viruses, combined with genetic factors, can increase a person's risk for the disease.
While there are many experimental drugs in the pipeline, the National Multiple Sclerosis Society recently convened its scientists to talk about the role of stem cells in repairing the brain and repopulating it with oligodendrocytes, cells essential to forming the axon's protective myelin sheath. In mice, placing the stem cells in the brain seems to repair damage, scientists say.
Breakthrough with MRI
The Stony Brook scientists have in their hands what they think could be one of the greatest discoveries of the day. Dr. Mirjana Savatic, who works at Stony Brook and Cold Spring Harbor Laboratory, has developed a method of observing stem cells in the living human brain using an MRI machine.
In the past decade it's become clear that the adult brain has discrete populations of stem cells. Krupp is collaborating with Savatic to study the MS brain, and they can actually see recruitment of the stem cells after a new lesion - suggesting that the brain is trying to somehow repair itself.
"It's pretty amazing," said Krupp.
They will follow patients over time to understand what the stem cells are doing. They can also use the technology to test the effectiveness of treatments.
MRI spectroscopy is a noninvasive scan of the brain that provides information about its chemistry. Savatic used it to identify a substance present only in stem cells and not in mature cells, including neurons, glial cells or inflammatory cells.
When Krupp asked her to run a few patients through the MRI scan, searching for stem cells, she said she didn't expect to see much. But to her surprise, Krupp said, "where there's a lesion, we saw a peak in these stem cells."
Hope on several fronts
"It's extremely exciting to see so many new things coming," said Dr. Mark Gudesblatt, a neurologist with offices in Bay Shore and Patchogue who specializes in multiple sclerosis. In addition to Tysabri, which is given by monthly intravenous infusions, Gudesblatt suspects that the first oral MS medicine will be available in a few years.
"It gives patients tremendous hope," he added.
So far, about 100 of his 2,500 MS patients have opted for Tysabri. Other medicines are injectables that have to be taken daily or weekly. "And Tysabri is incredibly effective and well tolerated," Gudesblatt said.
West said that the gap in her treatment definitely set her back. She's hoping that within a few months her nightly dreams of running will become a reality. "I'm staying positive," she said. "I look forward to the day that I may say, 'Hey, guess what? It worked.'"
Guten Morgen
- There are four other drugs on the market for Alzheimer's disease. Pfizer has Aricept, Shire has Razadyne, Novartis has Exelon and Forest Laboratories has Namenda. None of the four drugs slow down the disease's progression.
- "The implication is that the AAB-001 data might be strong enough to trigger a request for approval on Phase II data," Goodbody's analyst Ian Hunter said. "If this were the case, the drug could be on the market in late 2008, early 2009."
- AAB-001, will change the underlying pathology of the disease.
- Referring to Pfizer Inc.'s (PFE) Aricept, the leading drug of its kind.........."It changes the symptoms, but doesn't change the course of the disease. That is what makes AAB-001 dramatically different."
....viele..... sehr gute Kernsätze, die das Potential von AAB-001 unterstreichen...
- There are four other drugs on the market for Alzheimer's disease. Pfizer has Aricept, Shire has Razadyne, Novartis has Exelon and Forest Laboratories has Namenda. None of the four drugs slow down the disease's progression.
- "The implication is that the AAB-001 data might be strong enough to trigger a request for approval on Phase II data," Goodbody's analyst Ian Hunter said. "If this were the case, the drug could be on the market in late 2008, early 2009."
- AAB-001, will change the underlying pathology of the disease.
- Referring to Pfizer Inc.'s (PFE) Aricept, the leading drug of its kind.........."It changes the symptoms, but doesn't change the course of the disease. That is what makes AAB-001 dramatically different."
....viele..... sehr gute Kernsätze, die das Potential von AAB-001 unterstreichen...
May 24, 2007, 1:00 pm
Elan CEO: Collaboration Prevents Predation
Posted by Jacob Goldstein
With a market cap of about $9 billion and a few products already on the market, Irish biotech shop Elan could be a ripe target for a takeover by any of several Big Pharma players eager to expand their biotech footprint. (For evidence of that eagerness, see AstraZeneca’s recent $15 billion buyout of MedImmune.)
But no one has bid on Elan, CEO Kelly Martin said today. Part of the reason: The company’s sprawling array of complicated joint ventures with other pharmaceutical and biotech companies would make it hard for a potential acquirer to get its money’s worth. “These assets are partnered and have various chains of control triggers, so it’s not terribly straightforward,” Martin told Dow Jones in an interview after the company’s annual meeting.
The company has a 50-50 partnership with Biogen Idec on its multiple sclerosis drug Tysabri. And it’s partnered with Wyeth on an experimental Alzheimer’s drug that the companies said this week is going into late-stage trials.
“Elan is not a corporate asset that can be freely traded around,” Martin said. “Elan shareholders would need to get full value for all assets. The best defense is a good offense and that is to grow the company.”
http://blogs.wsj.com/health/2007/05/24/elan-ceo-collaboratio…
...die ganze Kooperations und Vertragsvereinbarungen werden eine Übernahme für einen BIG PHARMA PLAYER nicht leicht machen...
Elan CEO: Collaboration Prevents Predation
Posted by Jacob Goldstein
With a market cap of about $9 billion and a few products already on the market, Irish biotech shop Elan could be a ripe target for a takeover by any of several Big Pharma players eager to expand their biotech footprint. (For evidence of that eagerness, see AstraZeneca’s recent $15 billion buyout of MedImmune.)
But no one has bid on Elan, CEO Kelly Martin said today. Part of the reason: The company’s sprawling array of complicated joint ventures with other pharmaceutical and biotech companies would make it hard for a potential acquirer to get its money’s worth. “These assets are partnered and have various chains of control triggers, so it’s not terribly straightforward,” Martin told Dow Jones in an interview after the company’s annual meeting.
The company has a 50-50 partnership with Biogen Idec on its multiple sclerosis drug Tysabri. And it’s partnered with Wyeth on an experimental Alzheimer’s drug that the companies said this week is going into late-stage trials.
“Elan is not a corporate asset that can be freely traded around,” Martin said. “Elan shareholders would need to get full value for all assets. The best defense is a good offense and that is to grow the company.”
http://blogs.wsj.com/health/2007/05/24/elan-ceo-collaboratio…
...die ganze Kooperations und Vertragsvereinbarungen werden eine Übernahme für einen BIG PHARMA PLAYER nicht leicht machen...
Elan to Present at the Goldman Sachs 28th Annual Global Healthcare Conference
- -
Elan Corporation, plc announces that it will present at the Goldman Sachs 28th Annual Global Healthcare Conference in Laguna Niguel, California on Wednesday, June 13th, 2007 at 10.40 a.m. Pacific Time, 1.40 p.m. Eastern Time and 6.40 p.m. British Summer Time.
Interested parties may access a live audio webcast of the presentation by visiting Elan’s website at www.elan.com and clicking on the Investor Relations section, then on the event icon.
- -
Elan Corporation, plc announces that it will present at the Goldman Sachs 28th Annual Global Healthcare Conference in Laguna Niguel, California on Wednesday, June 13th, 2007 at 10.40 a.m. Pacific Time, 1.40 p.m. Eastern Time and 6.40 p.m. British Summer Time.
Interested parties may access a live audio webcast of the presentation by visiting Elan’s website at www.elan.com and clicking on the Investor Relations section, then on the event icon.
damit sich alle schon einmal einen Vorgeschmack auf die Kursentwicklung machen können:
Antwort auf Beitrag Nr.: 29.462.535 von Poppholz am 25.05.07 10:22:12...Poppie, du "alter" ELANITER....du kannst es einfach nicht lassen...
.....dem Kursverlauf nach zu urteilen, müsstest du deinen ganzen Aktienbestand verkaufen....
...also dann doch BB Company....
.....dem Kursverlauf nach zu urteilen, müsstest du deinen ganzen Aktienbestand verkaufen....
...also dann doch BB Company....
Antwort auf Beitrag Nr.: 29.462.850 von bernie55 am 25.05.07 10:40:05 meine Aktien würden doch nicht schon bei $38,00 weg gehen.
Wenn dann würde ich eher noch zukaufen, damit der Kurs nach oben geht.
Der Chart ist auch noch nicht an den Kursverlauf unserer Aktie angepasst.
Wenn dann würde ich eher noch zukaufen, damit der Kurs nach oben geht.
Der Chart ist auch noch nicht an den Kursverlauf unserer Aktie angepasst.
Antwort auf Beitrag Nr.: 29.463.284 von Poppholz am 25.05.07 11:03:37G O L D M A N S A C H S
Elan Corporation (ADR) (ELN) Buy:
Tysabri, tax losses and Bapineuzumab; initiating as
a Buy
Company Name: Elan Corporation (ADR)
Ticker: ELNPrice: 19.1 52-Week Price Range (US$): 19-12
Year Net EPS . . Gross
Source of opportunity
We initiate coverage of Elan as Buy with a 12-month price target of US$25/ADR. In our view, the value of Tysabri, the leveraging potential of the Alzheimer?s Disease franchise and the value of the group?s c.US$3 bn of utilizable tax losses are inadequately reflected in the shares. Despite near-term risks for Tysabri (new PML cases), in our view, the group?s improved risk profile is under-appreciated by investors. As an alternative to buying the stock, our Credit Research team recommends buying long-dated (2013) bonds which are more sensitive to Tysabri than the R&D pipeline, for yield. Our Options team also discusses derivatives strategies.
Catalyst
Continuing growth of Tysabri sales (in MS) should provide solid support for the shares, and if growth stays at current levels, could push the stock higher. US and/or EU approvals
for Tysabri in Crohn?s Disease are potential catalysts before year-end. Phase II Bapineuzumab data (30-patient PET scan study) could be a significant catalyst if positive, as could a sub part E filing for Bapineuzumab in the US.
Valuation
Using our risk-adjusted DCF valuation methodology, we calculate a 12-month price target of US$25/ADR; this implies a technology value of US$27.40/ADR. Should Tysabri be approved in Crohn?s Disease, it could add up to US$4/ADR to our price target.
Key risks
The main near-term risk to our price target and view is an increase in cases of PML reported with Tysabri. In this scenario, we would view the risk of another product withdrawal as low, unless there were a significant number of new cases. However, we would expect acute share price weakness if any cases are reported. Elan also has product development risks, in common with other biotech companies.
The Goldman Sachs Group Inc. does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report.
Investors should consider this report as only a single factor in making their investment decision.
http://www.investorvillage.com/smbd.asp?mb=160&mn=112536&pt=…
Elan Corporation (ADR) (ELN) Buy:
Tysabri, tax losses and Bapineuzumab; initiating as
a Buy
Company Name: Elan Corporation (ADR)
Ticker: ELNPrice: 19.1 52-Week Price Range (US$): 19-12
Year Net EPS . . Gross
Source of opportunity
We initiate coverage of Elan as Buy with a 12-month price target of US$25/ADR. In our view, the value of Tysabri, the leveraging potential of the Alzheimer?s Disease franchise and the value of the group?s c.US$3 bn of utilizable tax losses are inadequately reflected in the shares. Despite near-term risks for Tysabri (new PML cases), in our view, the group?s improved risk profile is under-appreciated by investors. As an alternative to buying the stock, our Credit Research team recommends buying long-dated (2013) bonds which are more sensitive to Tysabri than the R&D pipeline, for yield. Our Options team also discusses derivatives strategies.
Catalyst
Continuing growth of Tysabri sales (in MS) should provide solid support for the shares, and if growth stays at current levels, could push the stock higher. US and/or EU approvals
for Tysabri in Crohn?s Disease are potential catalysts before year-end. Phase II Bapineuzumab data (30-patient PET scan study) could be a significant catalyst if positive, as could a sub part E filing for Bapineuzumab in the US.
Valuation
Using our risk-adjusted DCF valuation methodology, we calculate a 12-month price target of US$25/ADR; this implies a technology value of US$27.40/ADR. Should Tysabri be approved in Crohn?s Disease, it could add up to US$4/ADR to our price target.
Key risks
The main near-term risk to our price target and view is an increase in cases of PML reported with Tysabri. In this scenario, we would view the risk of another product withdrawal as low, unless there were a significant number of new cases. However, we would expect acute share price weakness if any cases are reported. Elan also has product development risks, in common with other biotech companies.
The Goldman Sachs Group Inc. does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report.
Investors should consider this report as only a single factor in making their investment decision.
http://www.investorvillage.com/smbd.asp?mb=160&mn=112536&pt=…
Antwort auf Beitrag Nr.: 29.464.897 von bernie55 am 25.05.07 12:31:05Goldman Sachs gibt also einen 12 Monate " target - price " von 25 USD , bei einem Approval in CD immerhin schon 29 USD...
..in meinen Augen ein Anfang der Upgrades, die noch kommen werden...
....so oder so...an ELAN kommt jetzt keiner mehr vorbei, da durch das Starten der 3. Phase bei AD die Aktie immer mehr in den Fokus der Anleger und Analysten gerückt ist.....
...weiter so...
..in meinen Augen ein Anfang der Upgrades, die noch kommen werden...
....so oder so...an ELAN kommt jetzt keiner mehr vorbei, da durch das Starten der 3. Phase bei AD die Aktie immer mehr in den Fokus der Anleger und Analysten gerückt ist.....
...weiter so...
...zum Thema Alzheimer noch ein Artikel aus AMA News vom April 9,
http://www.ama-assn.org/amednews/2007/04/09/hlsb0409.htm
........New drugs are in the pipeline and could arrive at the Food and Drug Administration by fall for possible approval next year, Sam Gandy, MD, PhD, director of Thomas Jefferson University's Farber Institute for Neurosciences, in Philadelphia, told the Senate panel. Dr. Gandy's laboratory is participating in clinical trials for two of the new drugs.
So far, the FDA has approved several drugs that temporarily slow symptoms in some people, but the medicines being tested are intended to attack the disease directly. Among them are two that target the amyloid plaques that are a molecular hallmark of Alzheimer's, Dr. Gandy said. Reports on the new entities are very encouraging, he added. "These drugs are safe. Patients tolerate them well. And they appear to show significant positive impact, slowing progression of the disease."
The drugs could transform Alzheimer's from a death sentence to a manageable chronic illness, he told the Senate panel.
http://www.ama-assn.org/amednews/2007/04/09/hlsb0409.htm
........New drugs are in the pipeline and could arrive at the Food and Drug Administration by fall for possible approval next year, Sam Gandy, MD, PhD, director of Thomas Jefferson University's Farber Institute for Neurosciences, in Philadelphia, told the Senate panel. Dr. Gandy's laboratory is participating in clinical trials for two of the new drugs.
So far, the FDA has approved several drugs that temporarily slow symptoms in some people, but the medicines being tested are intended to attack the disease directly. Among them are two that target the amyloid plaques that are a molecular hallmark of Alzheimer's, Dr. Gandy said. Reports on the new entities are very encouraging, he added. "These drugs are safe. Patients tolerate them well. And they appear to show significant positive impact, slowing progression of the disease."
The drugs could transform Alzheimer's from a death sentence to a manageable chronic illness, he told the Senate panel.
Warum is´n das GS-Update noch nicht bei Yahoo veröffentlicht ?
Wenn das nur ein internes Papier von denen ist, wie sollen
die Anleger denn die schmackhafte Empfehlung aufschnappen ?
Wenn das nur ein internes Papier von denen ist, wie sollen
die Anleger denn die schmackhafte Empfehlung aufschnappen ?
Antwort auf Beitrag Nr.: 29.465.616 von Holgus am 25.05.07 13:14:05Hi Holger,
...ich habe auf Goggle gesucht und dieses Upgrade auch noch nicht gefunden....
...deshalb auch mein link- Verweis auf die IV seite...
...ich habe auf Goggle gesucht und dieses Upgrade auch noch nicht gefunden....
...deshalb auch mein link- Verweis auf die IV seite...
Antwort auf Beitrag Nr.: 29.465.667 von bernie55 am 25.05.07 13:17:25Is it me, or does it seem as if there is almost an effort to suppress the GS news?
Any other company that received an upgrade that raised their price target by these percentages would have the news being screamed from the roof tops.
If it were not for the incredible investigative shareholders on this board, I still would not know about this upgrade.
Why is it that this has still not hit the Yahoo news postings?
http://www.investorvillage.com/smbd.asp?mb=160&mn=112549&pt=…
...mmmhhhhh.............war das nur Verar---ung mit dem Upgrade ???.
Any other company that received an upgrade that raised their price target by these percentages would have the news being screamed from the roof tops.
If it were not for the incredible investigative shareholders on this board, I still would not know about this upgrade.
Why is it that this has still not hit the Yahoo news postings?
http://www.investorvillage.com/smbd.asp?mb=160&mn=112549&pt=…
...mmmhhhhh.............war das nur Verar---ung mit dem Upgrade ???.
Goldman Sachs starts coverage of Elan at buy
By Sarah Turner
Last Update: 7:50 AM ET May 25, 2007
LONDON (MarketWatch) -- Goldman Sachs initiated coverage on Irish pharmaceutical Elan (UK:ELA : elan corp ord eur0.05
12:40pm 05/25/2007
UK:ELA13.98, +0.47, +3.5%) (ELN : Elan Corporation, plc
Last: 19.01-0.09-0.47%
6:50am 05/25/2007
ELN19.01, -0.09, -0.5%) with a buy rating on Friday. "In our view, the value of Tysabri, the leveraging potential of the Alzheimer's disease franchise and the value of the group's $3 billion of utilizable tax losses are inadequately reflected in the shares," said the broker. Elan shares rose 3.9% in London.
http://www.marketwatch.com/News/Story/Story.aspx?guid=%7bDF6…
By Sarah Turner
Last Update: 7:50 AM ET May 25, 2007
LONDON (MarketWatch) -- Goldman Sachs initiated coverage on Irish pharmaceutical Elan (UK:ELA : elan corp ord eur0.05
12:40pm 05/25/2007
UK:ELA13.98, +0.47, +3.5%) (ELN : Elan Corporation, plc
Last: 19.01-0.09-0.47%
6:50am 05/25/2007
ELN19.01, -0.09, -0.5%) with a buy rating on Friday. "In our view, the value of Tysabri, the leveraging potential of the Alzheimer's disease franchise and the value of the group's $3 billion of utilizable tax losses are inadequately reflected in the shares," said the broker. Elan shares rose 3.9% in London.
http://www.marketwatch.com/News/Story/Story.aspx?guid=%7bDF6…
....Mannomann.....da wird man ja ganz pille palle von...
Antwort auf Beitrag Nr.: 29.466.412 von bernie55 am 25.05.07 14:04:50...upgrade....buy...ja....nein.....ja. doch.....nein.....oder wie.... ???
Antwort auf Beitrag Nr.: 29.466.434 von bernie55 am 25.05.07 14:06:07der Kurs geht vorbörslich auf jeden Fall hoch.
RT $19,25 zu $19,34
RT $19,25 zu $19,34
Antwort auf Beitrag Nr.: 29.466.434 von bernie55 am 25.05.07 14:06:07UPGRADE - BUY von GS
YEPP !!!!!
YEPP !!!!!
weiß einer von Euch, wie viele Aktien bei ELAN momentan SHORT sind?
RT $§19,28 zu $19,40
Nun stehts auch bei Yahoo drin ...
19,50 zur Zeit ... hoffentlich ist das der Trend.
19,50 zur Zeit ... hoffentlich ist das der Trend.
der Kurs wird mit großen Blöcken gedrückt.
aktuell stehen 11.000 bei 19,26 im Ask. Diese werden immer wieder aufgefüllt.
Mal sehen, wie lange dass noch so weiter gehen soll.
aktuell stehen 11.000 bei 19,26 im Ask. Diese werden immer wieder aufgefüllt.
Mal sehen, wie lange dass noch so weiter gehen soll.
Antwort auf Beitrag Nr.: 29.468.617 von Poppholz am 25.05.07 16:15:54das war es.
Kurs steht über $19,40
Kurs steht über $19,40
Antwort auf Beitrag Nr.: 29.468.897 von Poppholz am 25.05.07 16:30:2920,52
Antwort auf Beitrag Nr.: 29.469.473 von surga am 25.05.07 17:05:54$20,66 Wow...........
Leute, wo seid Ihr?
Leute, wo seid Ihr?
Antwort auf Beitrag Nr.: 29.466.856 von Poppholz am 25.05.07 14:37:37jetzt sagt mir nicht das elan auch stark geshortet wird.
.
freue mich aber auch über das satte grün, tut meiner geschundenen seele gut.
.
freue mich aber auch über das satte grün, tut meiner geschundenen seele gut.
Hi
Himmel---das ist ja wohl SPITZE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Über 20 $ und über 15€---WAS SOLLEN WIR DENN JETZT MIT DER !§ € PARTY MACHEN???????????????????????????????????????????????
ICH FREU MICH--und WIR wissen,das ist nur der ANFANG!!!!!!
Himmel---das ist ja wohl SPITZE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Über 20 $ und über 15€---WAS SOLLEN WIR DENN JETZT MIT DER !§ € PARTY MACHEN???????????????????????????????????????????????
ICH FREU MICH--und WIR wissen,das ist nur der ANFANG!!!!!!
Antwort auf Beitrag Nr.: 29.470.164 von Birgit.Tersteegen am 25.05.07 17:40:26...ich meinte 13€-Party....bin schon ganz konfus....
Antwort auf Beitrag Nr.: 29.470.220 von Birgit.Tersteegen am 25.05.07 17:42:38die Party kann kommen.
Wenn ich gewußt hätte, dass mein Verkauf einiger Aktien den Kurs so nach oben schieben würde, dann hätte ich bereits vor einem Jahr verkauft.
Wenn ich gewußt hätte, dass mein Verkauf einiger Aktien den Kurs so nach oben schieben würde, dann hätte ich bereits vor einem Jahr verkauft.
Antwort auf Beitrag Nr.: 29.470.164 von Birgit.Tersteegen am 25.05.07 17:40:26nah ich hoff doch das das erst der anfang ist
bin schließlich noch nicht allzulange dabei.
bin schließlich noch nicht allzulange dabei.
Antwort auf Beitrag Nr.: 29.470.286 von Poppholz am 25.05.07 17:45:39...aber echt Poppi----und meine ersten Elanies habe ich unter 3 € gekauft.....
gruß Noogmann
Antwort auf Beitrag Nr.: 29.470.325 von GuHu1 am 25.05.07 17:47:28viele gute Nachrichten kommen---hier ist schon eine
By: NIGHTRADER44
just out on briefing.com
BIIB Biogen Idec will ask U.S panel to weigh expanded use of Tysabri, advisory panel will consider Tysabri for severe Crohn's- Bloomberg (49.02 +1.11)
FDA Advisory panel scheduled to meet on July 31st
By: NIGHTRADER44
just out on briefing.com
BIIB Biogen Idec will ask U.S panel to weigh expanded use of Tysabri, advisory panel will consider Tysabri for severe Crohn's- Bloomberg (49.02 +1.11)
FDA Advisory panel scheduled to meet on July 31st
Antwort auf Beitrag Nr.: 29.470.342 von Birgit.Tersteegen am 25.05.07 17:48:21hallo Birgit,
so mutig bin ich nicht gewesen.
Habe meine erste Postion zu €5,18 bekommen und dann nach und nach aufgestockt, aber das ist ja in diesem Thread kommentiert worden.
so mutig bin ich nicht gewesen.
Habe meine erste Postion zu €5,18 bekommen und dann nach und nach aufgestockt, aber das ist ja in diesem Thread kommentiert worden.
Antwort auf Beitrag Nr.: 29.470.342 von Birgit.Tersteegen am 25.05.07 17:48:21----und meine ersten Elanies habe ich unter 3 € gekauft.....
...du bist mir ja eine...unter 3....aber hallo.
..nur ganz kurz...gehe mit meiner family in den Biergarten....werde heute abend nochmals reinschauen....
..haltet die Stellung.......und ELAN ....weiter so...
Grüße bernie55
...du bist mir ja eine...unter 3....aber hallo.
..nur ganz kurz...gehe mit meiner family in den Biergarten....werde heute abend nochmals reinschauen....
..haltet die Stellung.......und ELAN ....weiter so...
Grüße bernie55
Hätte mich auch gewundert wenn die Drücker heute nicht aktiv wären.......aber sie haben es nach den guten Nachrichten und jetzt auch der ersten Empfehlung von Goldman Sachs immer schwerer billig zu sammeln...
Salve, mein Longdepot strahlt beruhigend auf mich ein.
Die korrektur jetzt hängt meiner M. mit dem Markt zusammen-guckt ma Dow und so. Schade das ich meine Tradeposi gewürfelt habe dachte das verflixte gap wird noch geschlossen
So fahr jetzt erst ma 3h nach Hause und dann is Beinebaumeln angesagt bis Dienstag...
Die korrektur jetzt hängt meiner M. mit dem Markt zusammen-guckt ma Dow und so. Schade das ich meine Tradeposi gewürfelt habe dachte das verflixte gap wird noch geschlossen
So fahr jetzt erst ma 3h nach Hause und dann is Beinebaumeln angesagt bis Dienstag...
hi freaks,
und wißt ihr, wer auch noch an board ist??????
Der Mr Ti nämlich -der jetzt endlich wieder in NRW wohnt und weiß, daß was geht bei Ty usw. Jeden Tag bekomme ich es mit. Aber darf leider hier nichts quatschen.
ein longinvestierter grüßt die Bekannten.
Grüße Mr Ti
und wißt ihr, wer auch noch an board ist??????
Der Mr Ti nämlich -der jetzt endlich wieder in NRW wohnt und weiß, daß was geht bei Ty usw. Jeden Tag bekomme ich es mit. Aber darf leider hier nichts quatschen.
ein longinvestierter grüßt die Bekannten.
Grüße Mr Ti
Antwort auf Beitrag Nr.: 29.471.364 von Mr Ti am 25.05.07 18:53:13Hi Herr Mister!
FEIN, dass Du noch dabei bist!!Aber wieso musst Du schweigen??
Nrw ist auch praktisch...
FEIN, dass Du noch dabei bist!!Aber wieso musst Du schweigen??
Nrw ist auch praktisch...
TY for CD AC meeting
JOINT MEETING OF THE GASTROINTESTINAL DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
DATE AND TIME: July 31, 8:00 a.m.
LOCATION: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD.
CONTACT: Victoria Ferretti-Aceto, Center for Drug Evaluation and Research, 301-827-7001. The committee will discuss TYSABRI biologic license application 125104/33, Biogen Idec, Inc., for the proposed indication of inducing and maintaining sustained response and remission, and eliminating corticosteroid use in patients with moderately to severely active Crohn’s disease with inflammation, as evidenced by elevated C-reative protein level or another objective marker. More Information
JOINT MEETING OF THE GASTROINTESTINAL DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
DATE AND TIME: July 31, 8:00 a.m.
LOCATION: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD.
CONTACT: Victoria Ferretti-Aceto, Center for Drug Evaluation and Research, 301-827-7001. The committee will discuss TYSABRI biologic license application 125104/33, Biogen Idec, Inc., for the proposed indication of inducing and maintaining sustained response and remission, and eliminating corticosteroid use in patients with moderately to severely active Crohn’s disease with inflammation, as evidenced by elevated C-reative protein level or another objective marker. More Information
Antwort auf Beitrag Nr.: 29.471.476 von Birgit.Tersteegen am 25.05.07 18:59:53bin noch in der probezeit im neuen job, aber nur so viel:
es geht ne menge an werbemat über mein tisch, was div firmen so produziert haben wollen.
ich bin ganz nah am geschehen plötzlich und unerwartet und das bekräftigt mich sehr, nicht mehr zu verkaufen, wie ich es mal gedacht hatte bei 14 eur
es geht ne menge an werbemat über mein tisch, was div firmen so produziert haben wollen.
ich bin ganz nah am geschehen plötzlich und unerwartet und das bekräftigt mich sehr, nicht mehr zu verkaufen, wie ich es mal gedacht hatte bei 14 eur
Antwort auf Beitrag Nr.: 29.471.692 von Mr Ti am 25.05.07 19:15:27Das klingt spannend....und ...ich bin immer so neugierig....---Aber dass Du auch zum überzeugten Super-Longie geworden bist ist doch schon mal klasse!!
PS.Dann benimm Dich bloss gut in der Probezeit....
PS.Dann benimm Dich bloss gut in der Probezeit....
Antwort auf Beitrag Nr.: 29.471.774 von Birgit.Tersteegen am 25.05.07 19:21:39superlong bin ich seit der thread hier eröffnet worden ist, glaube ich. und wer bei 4-5 eu diese karte spielte, einmal glatt stellte bei 14 und dann bei 10 wieder an board ist, weil er überzeugt ist und sich für keine andere aktie mehr interessiert,
den kann man longinvestiert, aber auch faul nennen.
aber bin einfach das hin und her in aktien überdrüssig und hier weiß man irgendwie, was man hat.
elan ist ein jahrhundertjahrgangswein
den kann man longinvestiert, aber auch faul nennen.
aber bin einfach das hin und her in aktien überdrüssig und hier weiß man irgendwie, was man hat.
elan ist ein jahrhundertjahrgangswein
Antwort auf Beitrag Nr.: 29.472.050 von Mr Ti am 25.05.07 19:43:53...da hast Du Recht!
INTRADAY ELAN:
Abschlusskurs 19,33 USD
..allen ein schönes Wochenende...
Abschlusskurs 19,33 USD
..allen ein schönes Wochenende...
Antwort auf Beitrag Nr.: 29.474.263 von bernie55 am 25.05.07 23:29:27wünsche ebenfalls allen Investierten (und denen, die es noch werden wollen) ein paar schöne Pfingsttage.
Entspannt Euch, es werden demnächst noch spannende Tage auf uns zukommen.
Entspannt Euch, es werden demnächst noch spannende Tage auf uns zukommen.
Antwort auf Beitrag Nr.: 29.474.299 von Poppholz am 25.05.07 23:36:44wünsche ebenfalls allen Investierten (und denen, die es noch werden wollen) ein paar schöne Pfingsttage.
..ich konnte " Klein-Alf " von einem Investment in ELAN überzeugen...und nicht nur das......
..... er hat sogar sein Interesse an der PBB Company bekundet...
..ich konnte " Klein-Alf " von einem Investment in ELAN überzeugen...und nicht nur das......
..... er hat sogar sein Interesse an der PBB Company bekundet...
...so..nun ein kleiner Test für alle ....ELANITES...ELANIACS...ELANNIES.....
http://www.chaospisser.de/flash/hoer-seh-test.swf" target="_blank" rel="nofollow ugc noopener">http://www.chaospisser.de/flash/hoer-seh-test.swf
http://www.chaospisser.de/flash/hoer-seh-test.swf" target="_blank" rel="nofollow ugc noopener">http://www.chaospisser.de/flash/hoer-seh-test.swf
Antwort auf Beitrag Nr.: 29.494.654 von bernie55 am 27.05.07 20:38:41http://www.chaospisser.de/flash/hoer-seh-test.swf
...wenn es über den link nicht geht, dann einfach o.g.kopieren...
..viel Spaß...
...wenn es über den link nicht geht, dann einfach o.g.kopieren...
..viel Spaß...
Antwort auf Beitrag Nr.: 29.484.233 von bernie55 am 27.05.07 12:54:32Grüsse!
Msg: 113543 of 113553 5/28/2007
By: winonefortheteam
Why Kelly is talking price NOW
Kelly Martin talking about pricing on AAB-001? For a drug that has not yet completed its Phase II testing which does not even have an approved protocol for Phase III?
If it is going to take 6 months to start up the Phase III and another 18-24 months to perform the Phase III, and another 9 months (at best) to gather the data and for the FDA to provide approval, we are talking 2010 under a best-case scenario. Today is May 28, 2007. Why would KM be talking about pricing in such a case? And why is the the Financial Times – which usually doesn’t cover Elan that closely -- actually devoting a full article to KM’s musings without pointing out that this is crazy talk if the drug is not coming on the market for years?
The answer is obvious to everyone who follows the company closely not named Dick Silver. Elan/Wyeth are actively pushing for a shortened time-frame with the FDA and if successful, AAB-001 is going to be on the market late next year. Robert Essner has been talking for years how we need to approach Alzheimer’s like we did AIDS, getting drugs into the marketplace soon after successful Phase II is complete. Ghost and Orla Hartford have explained how this can be done – do a shortened Phase III for symptomatic relief while we file on the basis of the Phase II data.
It is all well and good for Wyeth and Elan to make promises in private to the FDA about not making them look ridiculous if they approve a shortened route to market. But if the companies actually make a public promise to keep the drug universally affordable – which just happened with this article – then the rationale for the FDA signing off on the accelerated course to market makes a heck of a lot of sense.
I also have to say that there is a practical point to Elan/Wyeth pricing this drug low. If it was priced at $25k per year, and you had 4 million people take the drug, the companies would be bringing in $100 billion a year in revenue, and making $60-75 billion in profit. Sorry, but that ain’t going to happen. Almost all of this $100 billion would be paid by governments (think Medicaid), who aren’t really good about calculating future savings against costs incurred today. Pricing at $25k per patient, the companies would see the patent on AAB-001 taken away from them as governments around the world declared an “emergency”. (OK, let’s have some fun, even though it can’t happen. Applying a 4x sales revenue number to the firm’s half of the $100 billion in sales, gives us a value for one share of Elan at $428.27 for AAB-001 alone.)
So instead of charging $25k, we will charge $5k. The good news is that we START at 4 million patients globally and then move up from there dramatically. Either way is OK with me.
The FDA has not yet met with Elan/Wyeth to talk officially about Phase III. KM coming out at this time with an announcement about drug pricing is very exciting. It tells us what we think is going to happen – accelerated approval – is really in the cards and under active negotiation. The pricing concession was going to happen anyway, so don’t knock KM. I am sure that Wyeth is on-board with this approach, but it is easier from a public relations point of view for the partner that is not making money at the present time to be making the pitch. The pricing concession is being made because:
1) The drug works
2) It is going to be used by millions of people right off the bat
3) The companies want this on the market by 2008 rather than 2010 / 2011
The Alzheimer market is huge and getting bigger. Throw in Mild Cognitive Impairment, and you double the numbers. If AAB-001 does what we think it does, we are going to be incredibly rich.
By: winonefortheteam
Why Kelly is talking price NOW
Kelly Martin talking about pricing on AAB-001? For a drug that has not yet completed its Phase II testing which does not even have an approved protocol for Phase III?
If it is going to take 6 months to start up the Phase III and another 18-24 months to perform the Phase III, and another 9 months (at best) to gather the data and for the FDA to provide approval, we are talking 2010 under a best-case scenario. Today is May 28, 2007. Why would KM be talking about pricing in such a case? And why is the the Financial Times – which usually doesn’t cover Elan that closely -- actually devoting a full article to KM’s musings without pointing out that this is crazy talk if the drug is not coming on the market for years?
The answer is obvious to everyone who follows the company closely not named Dick Silver. Elan/Wyeth are actively pushing for a shortened time-frame with the FDA and if successful, AAB-001 is going to be on the market late next year. Robert Essner has been talking for years how we need to approach Alzheimer’s like we did AIDS, getting drugs into the marketplace soon after successful Phase II is complete. Ghost and Orla Hartford have explained how this can be done – do a shortened Phase III for symptomatic relief while we file on the basis of the Phase II data.
It is all well and good for Wyeth and Elan to make promises in private to the FDA about not making them look ridiculous if they approve a shortened route to market. But if the companies actually make a public promise to keep the drug universally affordable – which just happened with this article – then the rationale for the FDA signing off on the accelerated course to market makes a heck of a lot of sense.
I also have to say that there is a practical point to Elan/Wyeth pricing this drug low. If it was priced at $25k per year, and you had 4 million people take the drug, the companies would be bringing in $100 billion a year in revenue, and making $60-75 billion in profit. Sorry, but that ain’t going to happen. Almost all of this $100 billion would be paid by governments (think Medicaid), who aren’t really good about calculating future savings against costs incurred today. Pricing at $25k per patient, the companies would see the patent on AAB-001 taken away from them as governments around the world declared an “emergency”. (OK, let’s have some fun, even though it can’t happen. Applying a 4x sales revenue number to the firm’s half of the $100 billion in sales, gives us a value for one share of Elan at $428.27 for AAB-001 alone.)
So instead of charging $25k, we will charge $5k. The good news is that we START at 4 million patients globally and then move up from there dramatically. Either way is OK with me.
The FDA has not yet met with Elan/Wyeth to talk officially about Phase III. KM coming out at this time with an announcement about drug pricing is very exciting. It tells us what we think is going to happen – accelerated approval – is really in the cards and under active negotiation. The pricing concession was going to happen anyway, so don’t knock KM. I am sure that Wyeth is on-board with this approach, but it is easier from a public relations point of view for the partner that is not making money at the present time to be making the pitch. The pricing concession is being made because:
1) The drug works
2) It is going to be used by millions of people right off the bat
3) The companies want this on the market by 2008 rather than 2010 / 2011
The Alzheimer market is huge and getting bigger. Throw in Mild Cognitive Impairment, and you double the numbers. If AAB-001 does what we think it does, we are going to be incredibly rich.
Antwort auf Beitrag Nr.: 29.512.023 von Birgit.Tersteegen am 28.05.07 18:10:161) The drug works
2) It is going to be used by millions of people right off the bat
3) The companies want this on the market by 2008 rather than 2010 / 2011
bei aller liebe und zuversicht ich bin mittlerweile echt vorsichtig geworden.
bin zwar recht neu im thema elan, habe aber mitbekommen das auch hier wieder stark geshortet wird.
bitte nicht falsch verstehen, das ist keine contra aussage zu elan.
stehe halt noch unter dndn einfluß und habe das auch noch nicht komplett verloren gegeben, das wurmt mich total, bin da jetzt mittlerweile aus prinzip aktiv!
2) It is going to be used by millions of people right off the bat
3) The companies want this on the market by 2008 rather than 2010 / 2011
bei aller liebe und zuversicht ich bin mittlerweile echt vorsichtig geworden.
bin zwar recht neu im thema elan, habe aber mitbekommen das auch hier wieder stark geshortet wird.
bitte nicht falsch verstehen, das ist keine contra aussage zu elan.
stehe halt noch unter dndn einfluß und habe das auch noch nicht komplett verloren gegeben, das wurmt mich total, bin da jetzt mittlerweile aus prinzip aktiv!
Antwort auf Beitrag Nr.: 29.517.467 von GuHu1 am 28.05.07 22:42:35das Problem bei den SHORTIES ist, dass man nicht weiß, wann die Blase platzt und der Kurs gegebenenfalls nach oben gehen wird.
Bei Firmen wie Dendreon besteht die Gefahr, dass die Firma durch SHORTIES kaputt gemacht wird. Dies wird dadurch erreicht, dass der Kurs so niedrig ist, dass die Firma auch kein neues Geld durch die Ausgabe neuer Aktien rein bekommt.
Bei ELAN mache ich mir diesbezüglich keine Sorgen, da hier genügend in der Pipeline ist und die Produkte bereits Geld einbringen.
Bei Firmen wie Dendreon besteht die Gefahr, dass die Firma durch SHORTIES kaputt gemacht wird. Dies wird dadurch erreicht, dass der Kurs so niedrig ist, dass die Firma auch kein neues Geld durch die Ausgabe neuer Aktien rein bekommt.
Bei ELAN mache ich mir diesbezüglich keine Sorgen, da hier genügend in der Pipeline ist und die Produkte bereits Geld einbringen.
sollte einen grünen Start in den USA geben.
RT: $19,65 zu $19,72
RT: $19,65 zu $19,72
Möcht nicht den Informationsthread mit unqualifizierten Fragen zumüllen. Aber Cyberhexe schrieb dort von der Möglichkeit einer direkten Zulassung nach PII. Kommt so etwas gelegentlich vor?
Aus dem persönlichen Bereich hörte ich vor ein paar Jahren, daß man die Symptome von Alzheimer mit verfügbaren Mitteln ca 2 Jahre hinauszögern kann. Wie kann der Erfolg von AAB-001 bei einer bisher noch nicht so lang dauernden Studie gemessen werden?
Welche Konkurrenzprodukte mit dem Ansatz, gegen das Alzheimer-Target Beta Amyloid Plaque richten, gibt es zur Zeit in klinischen Phasen?
Danke.
Aus dem persönlichen Bereich hörte ich vor ein paar Jahren, daß man die Symptome von Alzheimer mit verfügbaren Mitteln ca 2 Jahre hinauszögern kann. Wie kann der Erfolg von AAB-001 bei einer bisher noch nicht so lang dauernden Studie gemessen werden?
Welche Konkurrenzprodukte mit dem Ansatz, gegen das Alzheimer-Target Beta Amyloid Plaque richten, gibt es zur Zeit in klinischen Phasen?
Danke.
Antwort auf Beitrag Nr.: 29.532.991 von Henrig am 29.05.07 23:22:49@Cyberhexe
Die Fragen sind aus rein informativen und nicht aus provokativen Gründen gestellt. Hab ein paar hundert Elan ( mehr als GPC ) und frag mich, ob ich nochmals nachkaufen soll.
Die Fragen sind aus rein informativen und nicht aus provokativen Gründen gestellt. Hab ein paar hundert Elan ( mehr als GPC ) und frag mich, ob ich nochmals nachkaufen soll.
Antwort auf Beitrag Nr.: 29.534.119 von Henrig am 30.05.07 08:17:05Hi Henrig,
die Studien zu AAB01 laufen schon einiges länger als 2 Jahre,
da war schonmal in 2002 ein Testabbruch wegen zu starker
Nebenwirkungen ... ist also schon ewig im Gange.
Und anscheinend wirkt das Medikament wohl einiges besser,
als eben nur die Symthome für 2 Jahre aufzuschieben.
EIne Zulassung nach der PII ist durchaus möglich, wenn eine
großer Bedarf da ist und die Ergebnisse überzeugen.
PIII läuft dann nur noch, um zusätzliche Erkenntnisse zu
gewinnen bzw. die Sicherheit zu erhöhen.
Und da drin liegt ja auch die große Hoffnung.
Einige sehen die Möglichkeit einer Marktzulassung bis Ende 08
durchaus als machbar an.
Das wäre dann wirklich gigantisch, zumal auch die Konkurrenz
kaum ein so wirkungsvolles Medikament im Portfolio hat.
So, falls da jetzt was falsch war, dann bitte ich die Anderen
hier es zu korrigieren.
die Studien zu AAB01 laufen schon einiges länger als 2 Jahre,
da war schonmal in 2002 ein Testabbruch wegen zu starker
Nebenwirkungen ... ist also schon ewig im Gange.
Und anscheinend wirkt das Medikament wohl einiges besser,
als eben nur die Symthome für 2 Jahre aufzuschieben.
EIne Zulassung nach der PII ist durchaus möglich, wenn eine
großer Bedarf da ist und die Ergebnisse überzeugen.
PIII läuft dann nur noch, um zusätzliche Erkenntnisse zu
gewinnen bzw. die Sicherheit zu erhöhen.
Und da drin liegt ja auch die große Hoffnung.
Einige sehen die Möglichkeit einer Marktzulassung bis Ende 08
durchaus als machbar an.
Das wäre dann wirklich gigantisch, zumal auch die Konkurrenz
kaum ein so wirkungsvolles Medikament im Portfolio hat.
So, falls da jetzt was falsch war, dann bitte ich die Anderen
hier es zu korrigieren.
Antwort auf Beitrag Nr.: 29.536.340 von Holgus am 30.05.07 10:54:53Nur ganz kurz in der Mittagspause: Danke.
Indirekt hat der gleiche Antikörper wohl schon damals (als der Körper selbst zu seiner Erzeugung angeregt wurde) gewirkt und jetzt können die negativen Nebenwirkungen vermieden werden. Aber ob man AN-1792 einfach als Studie zu AAB-001 sehen kann?
Wär schön, wenn noch weitere Meinungen kommen. Danke
Indirekt hat der gleiche Antikörper wohl schon damals (als der Körper selbst zu seiner Erzeugung angeregt wurde) gewirkt und jetzt können die negativen Nebenwirkungen vermieden werden. Aber ob man AN-1792 einfach als Studie zu AAB-001 sehen kann?
Wär schön, wenn noch weitere Meinungen kommen. Danke
Antwort auf Beitrag Nr.: 29.536.340 von Holgus am 30.05.07 10:54:53
http://www.clinicaltrials.gov/ct/show/NCT00112073
Total Enrollment: 240
Study start: April 2005; Study completion: April 2008
...du scheinst etwas zu verwechseln, AN-1792 ist das Vorgängervakzin zu ACC-001, AAB-001 oder Bapineuzumab ist der entsprechende Antikörper; aber wie du bereits festgestellt hast, konnte bereits mit AN-1792 der "proof of concept" nachgewiesen werden!
http://www.clinicaltrials.gov/ct/show/NCT00112073
Total Enrollment: 240
Study start: April 2005; Study completion: April 2008
...du scheinst etwas zu verwechseln, AN-1792 ist das Vorgängervakzin zu ACC-001, AAB-001 oder Bapineuzumab ist der entsprechende Antikörper; aber wie du bereits festgestellt hast, konnte bereits mit AN-1792 der "proof of concept" nachgewiesen werden!
Biogen Idec (NASDAQ: BIIB - Nachrichten) kündigt einen Rückkauf von Aktien von 3 Milliarden Dollar an.
Die werden schon wissen, warum dies sinnvoll ist.
Die werden schon wissen, warum dies sinnvoll ist.
Antwort auf Beitrag Nr.: 29.540.138 von Cyberhexe am 30.05.07 14:35:19Ich glaub, Schering hat Ende 2006 auch ein Vakzin mit ähnlichem Ansatz in eine P1-Studie gebracht. Ist Dir über die Entwicklung dort und über weitere Konkurrenten etwas bekannt? Hälst du es für möglich, in weniger als zwei Jahren ausreichende Erkenntnisse zu sammeln? Ist ne unvoreingenommene Frage. Hab übrigens vor kurzem vor allem wegen Denen guten Infos zu Elan meine Position etwas aufgestockt. Danke.
Antwort auf Beitrag Nr.: 29.546.099 von Henrig am 30.05.07 20:21:18Ende 2006
Sollte heißen Ende 2005.... in P1-Sudie
Sollte heißen Ende 2005.... in P1-Sudie
Hi Ihr Lieben!/Willkommen im Club Henrig
Morningstar Upgrade - New Report FYI
Thesis 05-30-2007
Elan has had its troubles in the past, but it is taking solid steps to right the ship. But even then, the company faces an uphill path to become cash-flow positive.
Elan nearly collapsed in 2002 as a result of heavy debt, failed clinical trials, and numerous complex development partnerships that carried significant debt to let Elan book revenue far in advance of ever having a product. The firm has since shed most of its businesses, closed all off-balance-sheet partnerships, and refocused its clinical pipeline. It has made a remarkable recovery now that Tysabri is back on the U.S. and European markets after a safety scare caused it to be pulled from the shelves, but the firm's heavy net debt position makes us of wary of its ability to weather any further large setbacks.
We believe Tysabri has strong market potential, despite the safety concerns. The market for multiple sclerosis drugs is currently around $4 billion, but we expect Tysabri's introduction will expand the total market with better efficacy over existing therapies and a more desirable monthly dosing schedule. Unlike immunomodulators (such as Biogen Idec's BIIB Avonex and Merck Serono's Rebif), which attempt to help the body's immune system fight the disease, Tysabri is a monoclonal antibody that attempts to stop the harmful cells from moving between the blood stream and the brain and spinal cord. Although Tysabri has not been tested directly against other forms of treatment, clinical studies versus placebo showed a 68% reduction in clinical relapses, whereas the typical immunomodulator showed a one third reduction in clinical relapses relative to placebo.
More patients than we originally expected are switching from existing treatments, indicating that physician acceptance might come more quickly than we thought, despite the rigorous safety protocol in place. We expect that the drug's sales (including an approval in Crohn's disease) could top $2 billion by 2012, and we expect Elan to turn an operating profit around a year or two earlier, when sales surpass $1.5 billion.
Beyond Tysabri, Elan's pipeline could be stronger. Later this year, it plans to initiate late-stage clinical trials on the monoclonal antibody bapineuzumab, which is used to treat Alzheimer's Disease. Although the decision implies Elan's hopes for the trial on the bases of Phase II studies, no study results have been released yet, so we remain conservative on the drug's sales potential. Otherwise, Elan has only two antibiotics and a pain-management drug on the market and three other early-stage Alzheimer's treatments in trials. One antibiotic came off patent this year, another loses patent protection by 2008, and sales of Prialt, its new pain-management drug, have been disappointing. With such a heavy debt burden already, Elan isn't in the best position to fill its pipeline through acquisition, and smoother sailing will only come with additional commercial successes.
Valuation
We are increasing our fair value estimate for Elan to $15 per share from $12 now that the firm has indicated plans to initiate late-stage trials for bapineuzumab. With Tysabri showing some strength and the company paying down some of its heavy debt burden, we lowered our cost of equity to 13% from 14.5%--more in line with unprofitable biotechs that have had some commercial success. We assume 38% average annual sales growth through 2011, driven mostly by Tysabri sales, which we expect to reach $1 billion by 2009. We expect bapineuzumab to reach the market in 2010, and that, assuming the firm can keep research and development expenses in check, it can turn a profit that year. Now that Elan has Tysabri on the market and a late-stage drug in clinical trials, we are reducing our risk rating to above average from speculative but continue to believe that with negative free cash flow for the next several years, Elan remains a risky investment.
------------------------------------------------------------
Schon die 2. Analysten Hochstufung....auch das ist erst der Anfang!!
Morningstar Upgrade - New Report FYI
Thesis 05-30-2007
Elan has had its troubles in the past, but it is taking solid steps to right the ship. But even then, the company faces an uphill path to become cash-flow positive.
Elan nearly collapsed in 2002 as a result of heavy debt, failed clinical trials, and numerous complex development partnerships that carried significant debt to let Elan book revenue far in advance of ever having a product. The firm has since shed most of its businesses, closed all off-balance-sheet partnerships, and refocused its clinical pipeline. It has made a remarkable recovery now that Tysabri is back on the U.S. and European markets after a safety scare caused it to be pulled from the shelves, but the firm's heavy net debt position makes us of wary of its ability to weather any further large setbacks.
We believe Tysabri has strong market potential, despite the safety concerns. The market for multiple sclerosis drugs is currently around $4 billion, but we expect Tysabri's introduction will expand the total market with better efficacy over existing therapies and a more desirable monthly dosing schedule. Unlike immunomodulators (such as Biogen Idec's BIIB Avonex and Merck Serono's Rebif), which attempt to help the body's immune system fight the disease, Tysabri is a monoclonal antibody that attempts to stop the harmful cells from moving between the blood stream and the brain and spinal cord. Although Tysabri has not been tested directly against other forms of treatment, clinical studies versus placebo showed a 68% reduction in clinical relapses, whereas the typical immunomodulator showed a one third reduction in clinical relapses relative to placebo.
More patients than we originally expected are switching from existing treatments, indicating that physician acceptance might come more quickly than we thought, despite the rigorous safety protocol in place. We expect that the drug's sales (including an approval in Crohn's disease) could top $2 billion by 2012, and we expect Elan to turn an operating profit around a year or two earlier, when sales surpass $1.5 billion.
Beyond Tysabri, Elan's pipeline could be stronger. Later this year, it plans to initiate late-stage clinical trials on the monoclonal antibody bapineuzumab, which is used to treat Alzheimer's Disease. Although the decision implies Elan's hopes for the trial on the bases of Phase II studies, no study results have been released yet, so we remain conservative on the drug's sales potential. Otherwise, Elan has only two antibiotics and a pain-management drug on the market and three other early-stage Alzheimer's treatments in trials. One antibiotic came off patent this year, another loses patent protection by 2008, and sales of Prialt, its new pain-management drug, have been disappointing. With such a heavy debt burden already, Elan isn't in the best position to fill its pipeline through acquisition, and smoother sailing will only come with additional commercial successes.
Valuation
We are increasing our fair value estimate for Elan to $15 per share from $12 now that the firm has indicated plans to initiate late-stage trials for bapineuzumab. With Tysabri showing some strength and the company paying down some of its heavy debt burden, we lowered our cost of equity to 13% from 14.5%--more in line with unprofitable biotechs that have had some commercial success. We assume 38% average annual sales growth through 2011, driven mostly by Tysabri sales, which we expect to reach $1 billion by 2009. We expect bapineuzumab to reach the market in 2010, and that, assuming the firm can keep research and development expenses in check, it can turn a profit that year. Now that Elan has Tysabri on the market and a late-stage drug in clinical trials, we are reducing our risk rating to above average from speculative but continue to believe that with negative free cash flow for the next several years, Elan remains a risky investment.
------------------------------------------------------------
Schon die 2. Analysten Hochstufung....auch das ist erst der Anfang!!
Antwort auf Beitrag Nr.: 29.549.301 von Birgit.Tersteegen am 31.05.07 00:40:47eine Hochstufung ist es zwar gewesen, aber von $12,- auf $15,- ist doch wohl ein Witz.
Es wird zwar auf die "turbulente" Vergangenheit eingegangen und auch darauf hingewiesen, dass aus diesem Grunde ELAN ein "riskantes Invest" ist, aber auf der anderen Seite werden Milliarden an Dollar als Einnahmen dargestellt.
Also wieder einmal "schön in der Grauzone".
Holgus würde sagen: die haben doch keinen A. in der Hose.
Es wird zwar auf die "turbulente" Vergangenheit eingegangen und auch darauf hingewiesen, dass aus diesem Grunde ELAN ein "riskantes Invest" ist, aber auf der anderen Seite werden Milliarden an Dollar als Einnahmen dargestellt.
Also wieder einmal "schön in der Grauzone".
Holgus würde sagen: die haben doch keinen A. in der Hose.
Antwort auf Beitrag Nr.: 29.532.991 von Henrig am 29.05.07 23:22:49Hallo Henrig,
nachfolgend ein Nature Artikel der viele deine Fragen zu Konkurrenzprodukten beantworten dürfte und in Hinblick auf die ALZ-News noch interessanter zu lesen ist. Hier wird nochmal die Strategie hervorgehoben, daß eine verkürzte Phase III möglich ist, wenn unter dem Mantel der "Symptom-Behandlung" eingereicht wird. Anschließend kann die "Ursachen-Modifizierende" Wirkung in Nachfolgestudien gezeigt werden.
Hintergrund ist der, daß Symptom-Behandlung schneller und einfacher gezeigt werden kann als "Ursachen-Modifizierung".
Nature Reviews Drug Discovery 6, 341-342 (May 2007) | doi:10.1038/nrd2314
From the analyst's couch: Therapies for Alzheimer's disease
Irena Melnikova1
Alzheimer's disease (AD) is a devastating neurological disorder that affects more than 37 million people worldwide1. The economic burden of AD is massive; in the United States alone, the estimated direct and indirect annual cost of patient care is at least US$100 billion.
However, the number of therapeutic options for AD remains severely limited. Currently marketed drugs for AD do not prevent or reverse this disease and are approved only for the management of symptoms. Driven by the clear unmet medical need and a better understanding of the biology and pathophysiology of AD, the number of drugs in development for this indication has increased dramatically in recent years.
Current therapies
The five drugs currently on the market - the cholinesterase inhibitors donepezil (Aricept; Eisai/Pfizer), rivastigmine (Exelon; Novartis), galantamine (Razadyne; Johnson & Johnson) and tacrine (Cognex; First Horizon Pharmaceuticals), and the N-methyl-D-aspartate (NMDA)-receptor modulator memantine (Namenda; Forest/Lundbeck) - are approved for the treatment of symptoms of AD. Despite being unable to prevent or reverse the disease progression, and being only modestly efficacious, these drugs have performed exceptionally well commercially, having collectively generated $3 billion in sales in 2006 (Fig. 1). Currently marketed drugs for the management of symptoms of AD are going to continue to be the mainstay of therapy for the next 4-5 years.
Figure 1 | US sales of marketed AD drugs.
Source: IMS Health.
Disease-modifying strategies
Neurotoxic -amyloid (A) peptide and the senile plaques composed of aggregated A, as well as the neurofibrillary tangles composed of tau protein, are thought to be central to the pathogenesis of AD2. Although both molecules present multiple opportunities to create disease-modifying therapies for AD, most of the industry's efforts have been focused on the 'amyloid hypothesis' and associated targets (Table 1). Therapeutic strategies aimed at preventing A formation, blocking its aggregation into plaques, lowering its levels in the brain, and disassembling the existing amyloid plaques might potentially slow down or stop the progression of AD3.
The most advanced disease-modifying drug (DMD) candidate in development is Neurochem's tramiprosate. Tramiprosate is a glycosaminoglycan mimetic designed to bind to A peptides, thereby stopping the formation of amyloid plaques. Owing to the short duration (3 months) of the tramiprosate Phase II trial, no dramatic effects on cognition were observed. However, in an open-label extension study, tramiprosate showed clinically significant benefits on cognitive and global performance measures, with a stabilization of the disease in a proportion of patients with mild AD after 3 years of treatment. Tramiprosate is being investigated in two pivotal 18-month Phase III clinical trials with data expected in 2007 and 2008. Positive outcomes of these trials would be the first proof-of-concept validation of the amyloid hypothesis in humans. If proved to be safe and effective, tramiprosate could reach the market in 2009 and could become the first DMD approved for AD.
Myriad Genetics' tarenflurbil - a modulator of -secretase activity - is the most advanced agent in clinical development for preventing A formation. In a Phase II trial in patients with mild-to-moderate AD, tarenflurbil was safe and well tolerated, and demonstrated a reduced rate of cognitive decline compared with a placebo. Tarenflurbil is currently in an 18-month pivotal Phase III study. Final data from the US sites are anticipated in the second half of 2008. Provided the trial is successful, tarenflurbil could be launched as soon as 2009/2010.
Extensive animal data suggest that antibodies against A, produced by the body after a vaccination (active immunization) or administered peripherally (passive immunization), can reduce amyloid deposition and produce functional improvements, thereby ameliorating cognitive deficits. Both approaches are now being tested in the clinic.
The first-generation amyloid vaccine, AN-1792 (Elan/Wyeth), demonstrated a positive efficacy trend: patients with AD who developed an antibody response significantly improved over a 1-year period in a number of memory tests. However, owing to the development of aseptic meningoencephalitis in 6% of the patients, the AN-1792 programme was discontinued. A second-generation vaccine, ACC-001 (Elan/Wyeth), which was engineered to have an improved safety profile, is now in a Phase I trial.
Compared to active immunization, passive immunization would be a more expensive and cumbersome approach, requiring frequent anti-A monoclonal antibody (mAb) administration, but on the other hand, it might offer more control over both safety and efficacy. Three mAbs against various domains of A are currently in development: bapineuzumab (Elan/Wyeth) and LY2062430 (Eli Lilly) in Phase II trials, and RN1219 (Pfizer) in Phase I. Elan/Wyeth could initially bring bapineuzumab to the market as a symptom-management drug and then secure disease-modifying claims in post-approval studies. In an 8-week Phase I study, bapineuzumab showed statistically significant improvement in cognitive function. If interim data from the ongoing Phase II trial, expected in mid 2007, confirm this result, Elan/Wyeth could initiate a short Phase III trial (3-6 months as opposed to an 18-month study required for a DMD) and file for a cognitive improvement/symptom-management label.
Improving symptom management
Clinical development of symptom-management drugs is considered to be easier, faster and cheaper than that of DMDs (Table 2). Given the modest efficacy of approved symptom-management therapies, new agents in this area are also needed. Experts suggest that the best strategy for the development of such drugs is to focus on novel targets. Neuronal nicotinic acetylcholine receptors (nAChRs), specifically the 42 and 7 receptors, have attracted a lot of attention in this regard. Several nAChR agonists are currently in Phase II trials: AZD3480 (AstraZeneca/Targacept), MEM 3454 (Roche/Memory Pharmaceuticals), and GTS-21 (CoMentis).
Outlook
Disease-modifying therapies that target the underlying pathogenic mechanisms represent one of the most exciting approaches to novel drug development for AD. Some of these therapies could reach the market as soon as 2009/2010. Owing to the currently limited options for treating AD, the first wave of DMDs is likely to be rapidly adopted.
In the next 5-10 years, the AD market is expected to undergo a major expansion driven by the ageing population, improvements in diagnostic testing and by the approval of novel therapeutics (Table 1). However, given the upcoming patent expirations (rivastigmine going off-patent in 2007, galantamine in 2008, donepezil and memantine in 2010) and the likely entry of generics, the total value of the AD market might decline around 2010-2011. But with the launch of the first wave of novel drugs occurring potentially as soon as 2009, the AD market could resume growth by 2011-2012 when new agents could achieve widespread market penetration.
Competing interests statement
The author declares no competing financial interests.
nachfolgend ein Nature Artikel der viele deine Fragen zu Konkurrenzprodukten beantworten dürfte und in Hinblick auf die ALZ-News noch interessanter zu lesen ist. Hier wird nochmal die Strategie hervorgehoben, daß eine verkürzte Phase III möglich ist, wenn unter dem Mantel der "Symptom-Behandlung" eingereicht wird. Anschließend kann die "Ursachen-Modifizierende" Wirkung in Nachfolgestudien gezeigt werden.
Hintergrund ist der, daß Symptom-Behandlung schneller und einfacher gezeigt werden kann als "Ursachen-Modifizierung".
Nature Reviews Drug Discovery 6, 341-342 (May 2007) | doi:10.1038/nrd2314
From the analyst's couch: Therapies for Alzheimer's disease
Irena Melnikova1
Alzheimer's disease (AD) is a devastating neurological disorder that affects more than 37 million people worldwide1. The economic burden of AD is massive; in the United States alone, the estimated direct and indirect annual cost of patient care is at least US$100 billion.
However, the number of therapeutic options for AD remains severely limited. Currently marketed drugs for AD do not prevent or reverse this disease and are approved only for the management of symptoms. Driven by the clear unmet medical need and a better understanding of the biology and pathophysiology of AD, the number of drugs in development for this indication has increased dramatically in recent years.
Current therapies
The five drugs currently on the market - the cholinesterase inhibitors donepezil (Aricept; Eisai/Pfizer), rivastigmine (Exelon; Novartis), galantamine (Razadyne; Johnson & Johnson) and tacrine (Cognex; First Horizon Pharmaceuticals), and the N-methyl-D-aspartate (NMDA)-receptor modulator memantine (Namenda; Forest/Lundbeck) - are approved for the treatment of symptoms of AD. Despite being unable to prevent or reverse the disease progression, and being only modestly efficacious, these drugs have performed exceptionally well commercially, having collectively generated $3 billion in sales in 2006 (Fig. 1). Currently marketed drugs for the management of symptoms of AD are going to continue to be the mainstay of therapy for the next 4-5 years.
Figure 1 | US sales of marketed AD drugs.
Source: IMS Health.
Disease-modifying strategies
Neurotoxic -amyloid (A) peptide and the senile plaques composed of aggregated A, as well as the neurofibrillary tangles composed of tau protein, are thought to be central to the pathogenesis of AD2. Although both molecules present multiple opportunities to create disease-modifying therapies for AD, most of the industry's efforts have been focused on the 'amyloid hypothesis' and associated targets (Table 1). Therapeutic strategies aimed at preventing A formation, blocking its aggregation into plaques, lowering its levels in the brain, and disassembling the existing amyloid plaques might potentially slow down or stop the progression of AD3.
The most advanced disease-modifying drug (DMD) candidate in development is Neurochem's tramiprosate. Tramiprosate is a glycosaminoglycan mimetic designed to bind to A peptides, thereby stopping the formation of amyloid plaques. Owing to the short duration (3 months) of the tramiprosate Phase II trial, no dramatic effects on cognition were observed. However, in an open-label extension study, tramiprosate showed clinically significant benefits on cognitive and global performance measures, with a stabilization of the disease in a proportion of patients with mild AD after 3 years of treatment. Tramiprosate is being investigated in two pivotal 18-month Phase III clinical trials with data expected in 2007 and 2008. Positive outcomes of these trials would be the first proof-of-concept validation of the amyloid hypothesis in humans. If proved to be safe and effective, tramiprosate could reach the market in 2009 and could become the first DMD approved for AD.
Myriad Genetics' tarenflurbil - a modulator of -secretase activity - is the most advanced agent in clinical development for preventing A formation. In a Phase II trial in patients with mild-to-moderate AD, tarenflurbil was safe and well tolerated, and demonstrated a reduced rate of cognitive decline compared with a placebo. Tarenflurbil is currently in an 18-month pivotal Phase III study. Final data from the US sites are anticipated in the second half of 2008. Provided the trial is successful, tarenflurbil could be launched as soon as 2009/2010.
Extensive animal data suggest that antibodies against A, produced by the body after a vaccination (active immunization) or administered peripherally (passive immunization), can reduce amyloid deposition and produce functional improvements, thereby ameliorating cognitive deficits. Both approaches are now being tested in the clinic.
The first-generation amyloid vaccine, AN-1792 (Elan/Wyeth), demonstrated a positive efficacy trend: patients with AD who developed an antibody response significantly improved over a 1-year period in a number of memory tests. However, owing to the development of aseptic meningoencephalitis in 6% of the patients, the AN-1792 programme was discontinued. A second-generation vaccine, ACC-001 (Elan/Wyeth), which was engineered to have an improved safety profile, is now in a Phase I trial.
Compared to active immunization, passive immunization would be a more expensive and cumbersome approach, requiring frequent anti-A monoclonal antibody (mAb) administration, but on the other hand, it might offer more control over both safety and efficacy. Three mAbs against various domains of A are currently in development: bapineuzumab (Elan/Wyeth) and LY2062430 (Eli Lilly) in Phase II trials, and RN1219 (Pfizer) in Phase I. Elan/Wyeth could initially bring bapineuzumab to the market as a symptom-management drug and then secure disease-modifying claims in post-approval studies. In an 8-week Phase I study, bapineuzumab showed statistically significant improvement in cognitive function. If interim data from the ongoing Phase II trial, expected in mid 2007, confirm this result, Elan/Wyeth could initiate a short Phase III trial (3-6 months as opposed to an 18-month study required for a DMD) and file for a cognitive improvement/symptom-management label.
Improving symptom management
Clinical development of symptom-management drugs is considered to be easier, faster and cheaper than that of DMDs (Table 2). Given the modest efficacy of approved symptom-management therapies, new agents in this area are also needed. Experts suggest that the best strategy for the development of such drugs is to focus on novel targets. Neuronal nicotinic acetylcholine receptors (nAChRs), specifically the 42 and 7 receptors, have attracted a lot of attention in this regard. Several nAChR agonists are currently in Phase II trials: AZD3480 (AstraZeneca/Targacept), MEM 3454 (Roche/Memory Pharmaceuticals), and GTS-21 (CoMentis).
Outlook
Disease-modifying therapies that target the underlying pathogenic mechanisms represent one of the most exciting approaches to novel drug development for AD. Some of these therapies could reach the market as soon as 2009/2010. Owing to the currently limited options for treating AD, the first wave of DMDs is likely to be rapidly adopted.
In the next 5-10 years, the AD market is expected to undergo a major expansion driven by the ageing population, improvements in diagnostic testing and by the approval of novel therapeutics (Table 1). However, given the upcoming patent expirations (rivastigmine going off-patent in 2007, galantamine in 2008, donepezil and memantine in 2010) and the likely entry of generics, the total value of the AD market might decline around 2010-2011. But with the launch of the first wave of novel drugs occurring potentially as soon as 2009, the AD market could resume growth by 2011-2012 when new agents could achieve widespread market penetration.
Competing interests statement
The author declares no competing financial interests.
HI
Msg: 114940 of 114985 6/1/2007
By: fred4german
NCB...EU/RoW Continues to Drive Tysabri Uptake
from NCB
Biogen Idec held its AGM yesterday and provided an update on Tysabri utilisation. As of
late May 2007, 10,800 patients have been treated with Tysabri in the commercial setting
(an additional c.1,200 patients have been treated with Tysabri in the clinical setting) with
7,600 patients treated in the US and 3,200 patients treated in Europe. As of mid-April, the
number of patients infused with Tysabri commercially was 9,100. On this basis, c.1,700
new patients have been treated with Tysabri over the last c. 6 weeks (1000 new patients in
the US and 700 new patients in EU/RoW), which equates to 283 new patients per week.
This uptake is broadly flat on Q1 2007 where c.280 patients were treated with Tysabri per
• EU/RoW continues to drive the uptick in new patient numbers with the average number of
new patients treated per week in EU/RoW at 116 (in Q1 the average number of new
patients treated per week in Eu/RoW was 100). The number of new patients treated per
week in the US with Tysabri is at 170 (in Q1 the average number of new patients treated
per week in the US was 180). This quarter Tysabri is expected to be launched in France
and Switzerland with launches expected in Spain, Slovenia, Belgium and the Czech
Republic in H2 2007, which will continue to underpin our patient numbers/revenues. We
continue to expect Tysabri for multiple sclerosis to generate $2bn at peak.
• With AAB-001 progressing to Phase III studies in H2 2007, we have revised our sum-ofthe-
parts valuation to $22.30-$24.44 with AAB-001 accounting for $11.50 of our valuation.
Msg: 114940 of 114985 6/1/2007
By: fred4german
NCB...EU/RoW Continues to Drive Tysabri Uptake
from NCB
Biogen Idec held its AGM yesterday and provided an update on Tysabri utilisation. As of
late May 2007, 10,800 patients have been treated with Tysabri in the commercial setting
(an additional c.1,200 patients have been treated with Tysabri in the clinical setting) with
7,600 patients treated in the US and 3,200 patients treated in Europe. As of mid-April, the
number of patients infused with Tysabri commercially was 9,100. On this basis, c.1,700
new patients have been treated with Tysabri over the last c. 6 weeks (1000 new patients in
the US and 700 new patients in EU/RoW), which equates to 283 new patients per week.
This uptake is broadly flat on Q1 2007 where c.280 patients were treated with Tysabri per
• EU/RoW continues to drive the uptick in new patient numbers with the average number of
new patients treated per week in EU/RoW at 116 (in Q1 the average number of new
patients treated per week in Eu/RoW was 100). The number of new patients treated per
week in the US with Tysabri is at 170 (in Q1 the average number of new patients treated
per week in the US was 180). This quarter Tysabri is expected to be launched in France
and Switzerland with launches expected in Spain, Slovenia, Belgium and the Czech
Republic in H2 2007, which will continue to underpin our patient numbers/revenues. We
continue to expect Tysabri for multiple sclerosis to generate $2bn at peak.
• With AAB-001 progressing to Phase III studies in H2 2007, we have revised our sum-ofthe-
parts valuation to $22.30-$24.44 with AAB-001 accounting for $11.50 of our valuation.
Antwort auf Beitrag Nr.: 29.573.059 von Birgit.Tersteegen am 01.06.07 14:03:30jetzt hat die heutige Kursdrückerei in Europa auch endlich ein Ende.
Bisher sind in Irland schon über 1.2 mio. Aktien gehandelt worden.
und dass noch bevor die USA eröffnet haben.
Mal sehen wo die Reise heute hingeht.
Bisher sind in Irland schon über 1.2 mio. Aktien gehandelt worden.
und dass noch bevor die USA eröffnet haben.
Mal sehen wo die Reise heute hingeht.
Antwort auf Beitrag Nr.: 29.573.257 von Poppholz am 01.06.07 14:17:13nur kurz zur Info:
RT in den USA ist über $20,00.
RT in den USA ist über $20,00.
wann kaufen eigentlich die "SELL IN MAY"-Freunde wieder Aktien ein?
Am 1. Juni?
Am 1. Juni?
USA RT
20,35 zu 20,41
Dies sind umgerechnet über €15,00
So kann der Sommer ruhig weiter gehen.
20,35 zu 20,41
Dies sind umgerechnet über €15,00
So kann der Sommer ruhig weiter gehen.
Na also---geht doch!!
Msg: 115155 of 115281 6/1/2007 10:27:04 AM
By: biib_must_go S
This board ROCKS>>>>>>> this is the LS summary..... thanks to Powershares.... .. we owe him a few pints..
I still cant believe $40...... hot dog.....
Elan Corporation
Unforgettable pipeline - Initiating coverage at
Outperform
• We are initiating research coverage of ELN shares with an
Outperform rating and believe a 12-month fair value is
approximately $40. We are also adding the stock to the Leerink
Swann Focus List.
• We believe Tysabri remains well positioned to become a mainstay
therapeutic for treating relapsing forms of MS by virtue of a superior
efficacy profile relative to existing therapies.
• If PML does not resurface as a significant safety concern or if JC virus
infection can effectively be addressed, we believe Tysabri could eventually
displace other injectable agents whose efficacy profiles are far less robust.
• A new commercial opportunity for Tysabri could emerge with approval as a
treatment for Crohn's disease. A decision from the CHMP is expected in the
mid-2007 time frame and by the FDA in October of this year. We note that
an FDA advisory committee will discuss Tysabri for Crohn's on July 31.
• Advancement of the MAb AAB-001 into Phase III testing may represent a
significant milestone in treating Alzheimer's disease (AD). It is anticipated
that data from a Phase II clinical study would be released in 2008 following
completion around the end of 2007. We project AAB-001 launched in the
2012 time frame.
• If the data are sufficiently robust, it is possible they could support a BLA
filing under the FDA's Subpart E procedure. If so, AAB-001 may reach the
market in the 2010 time frame.
• ELN has a deep pipeline of experimental agents that also modulate beta
amyloid, potentially expanding the commercial opportunity beyond that
evidently validated by AAB-001.
• We believe ELN shares will be driven by sales of Tysabri and regulatory
actions for Crohn's disease. Most important to share performance would
likely be the nature of the Phase II data for AAB-001 released in early 2008.
• Given the substantial ownership (50%) of what may prove to be a
revolutionary drug (AAB-001) in a growing and exceedingly under-served
market (AD), we believe ELN shares are among the most attractive in the
biopharmaceutical industry.
Msg: 115155 of 115281 6/1/2007 10:27:04 AM
By: biib_must_go S
This board ROCKS>>>>>>> this is the LS summary..... thanks to Powershares.... .. we owe him a few pints..
I still cant believe $40...... hot dog.....
Elan Corporation
Unforgettable pipeline - Initiating coverage at
Outperform
• We are initiating research coverage of ELN shares with an
Outperform rating and believe a 12-month fair value is
approximately $40. We are also adding the stock to the Leerink
Swann Focus List.
• We believe Tysabri remains well positioned to become a mainstay
therapeutic for treating relapsing forms of MS by virtue of a superior
efficacy profile relative to existing therapies.
• If PML does not resurface as a significant safety concern or if JC virus
infection can effectively be addressed, we believe Tysabri could eventually
displace other injectable agents whose efficacy profiles are far less robust.
• A new commercial opportunity for Tysabri could emerge with approval as a
treatment for Crohn's disease. A decision from the CHMP is expected in the
mid-2007 time frame and by the FDA in October of this year. We note that
an FDA advisory committee will discuss Tysabri for Crohn's on July 31.
• Advancement of the MAb AAB-001 into Phase III testing may represent a
significant milestone in treating Alzheimer's disease (AD). It is anticipated
that data from a Phase II clinical study would be released in 2008 following
completion around the end of 2007. We project AAB-001 launched in the
2012 time frame.
• If the data are sufficiently robust, it is possible they could support a BLA
filing under the FDA's Subpart E procedure. If so, AAB-001 may reach the
market in the 2010 time frame.
• ELN has a deep pipeline of experimental agents that also modulate beta
amyloid, potentially expanding the commercial opportunity beyond that
evidently validated by AAB-001.
• We believe ELN shares will be driven by sales of Tysabri and regulatory
actions for Crohn's disease. Most important to share performance would
likely be the nature of the Phase II data for AAB-001 released in early 2008.
• Given the substantial ownership (50%) of what may prove to be a
revolutionary drug (AAB-001) in a growing and exceedingly under-served
market (AD), we believe ELN shares are among the most attractive in the
biopharmaceutical industry.
Antwort auf Beitrag Nr.: 29.573.409 von Poppholz am 01.06.07 14:24:55wann kaufen eigentlich die "SELL IN MAY"-Freunde wieder Aktien ein?
Am 1. Juni?
Ich schätze, die wollten in Erinnerung an die letztjährige Zwischenbaisse dieses Jahr raus, sobald es runtergeht, sind dann alle Ende Februar raus, haben durch die schnelle Erholung den Wiedereinstieg verpaßt und trauten sich nicht mehr rein, weil ja bald der Mai komme und warten immer noch auf den Rücksetzer, bei dem sie einsteigen können. Die ersten werden jetzt in ausgesuchte Werte - gerne Elan - einsteigen.
@Birgit
Danke. Ich gehöre aber nicht zum Club. Hier sind so gute Leute drin, daß ich da nicht viel beitrgen kann. Ich les aber Eure Infos gerne.
Gruß HenRiG
Am 1. Juni?
Ich schätze, die wollten in Erinnerung an die letztjährige Zwischenbaisse dieses Jahr raus, sobald es runtergeht, sind dann alle Ende Februar raus, haben durch die schnelle Erholung den Wiedereinstieg verpaßt und trauten sich nicht mehr rein, weil ja bald der Mai komme und warten immer noch auf den Rücksetzer, bei dem sie einsteigen können. Die ersten werden jetzt in ausgesuchte Werte - gerne Elan - einsteigen.
@Birgit
Danke. Ich gehöre aber nicht zum Club. Hier sind so gute Leute drin, daß ich da nicht viel beitrgen kann. Ich les aber Eure Infos gerne.
Gruß HenRiG
Moin!
Msg: 115414 of 115467 6/1/2007
By: andy_1939
AARP Bulletin on Alzheimers Disease
I just received the June, 2007 issue of the AARP Bulletin which, as you all know, has a huge circulation. The feature article this month is on Alzheimer’s Disease, focusing on new drugs on the horizon. They report primarily on Alzhemed, Flurizan, and our “Elan drugs.” Here are some of their words:
“In an earlier, tantalizing study with 375 Alzheimer’s patients, researchers at Elan Pharmaceuticals tested a vaccine designed to trigger an immune response that prompts the body to produce antibodies against amyloid. The vaccine had worked extremely well in mice, but the human trial was halted in 2002 when about 6 percent of the subjects developed brain inflammation.
International researchers located 159 people from the aborted study and tracked their health over four and a half years. They found that the patients who had produced antibodies were doing significantly better than those who didn’t.
“The follow-up data are very encouraging,” says Dale Shenck, chief scientific officer for Elan in South San Francisco. Moreover, Swiss researchers found four patients they had tracked showed no mental decline at all. One even ran a marathon recently.
Scientists say the follow-up findings have given them a better understanding of the level of antibodies needed to produce the best results.
Now Elan, in collaboration with drug manufacturer Wyeth, is back in Phase II trials with a vaccine researchers believe is as effective as the first, but safer.
The chances of hitting upon a successful therapy soon are high, experts say, because the drugs in the pipeline attack amyloid at different stages. Flurizan, for example works to inhibit the production of amyloid while Alzhemed is believed to discourage it from forming plaque. The antibodies in the vaccine are thought to bind to amyloid and help the body to eliminate it."
Not bad for a bit of publicity!
Msg: 115414 of 115467 6/1/2007
By: andy_1939
AARP Bulletin on Alzheimers Disease
I just received the June, 2007 issue of the AARP Bulletin which, as you all know, has a huge circulation. The feature article this month is on Alzheimer’s Disease, focusing on new drugs on the horizon. They report primarily on Alzhemed, Flurizan, and our “Elan drugs.” Here are some of their words:
“In an earlier, tantalizing study with 375 Alzheimer’s patients, researchers at Elan Pharmaceuticals tested a vaccine designed to trigger an immune response that prompts the body to produce antibodies against amyloid. The vaccine had worked extremely well in mice, but the human trial was halted in 2002 when about 6 percent of the subjects developed brain inflammation.
International researchers located 159 people from the aborted study and tracked their health over four and a half years. They found that the patients who had produced antibodies were doing significantly better than those who didn’t.
“The follow-up data are very encouraging,” says Dale Shenck, chief scientific officer for Elan in South San Francisco. Moreover, Swiss researchers found four patients they had tracked showed no mental decline at all. One even ran a marathon recently.
Scientists say the follow-up findings have given them a better understanding of the level of antibodies needed to produce the best results.
Now Elan, in collaboration with drug manufacturer Wyeth, is back in Phase II trials with a vaccine researchers believe is as effective as the first, but safer.
The chances of hitting upon a successful therapy soon are high, experts say, because the drugs in the pipeline attack amyloid at different stages. Flurizan, for example works to inhibit the production of amyloid while Alzhemed is believed to discourage it from forming plaque. The antibodies in the vaccine are thought to bind to amyloid and help the body to eliminate it."
Not bad for a bit of publicity!
Hi!--Korrektur beginnt + unser Schätzchen hält sich gut...
Kein Wunder bei dieser Perspektive!!
Msg: 116202 of 116233 6/5/2007 10:41:44 AM
By: splaylaywahtheepi
Re: lts get real / phition42
I have no idea what PPS will do or when it will do it, but Elan has an excellent chance of PPS appreciating past $100/sh. The reason is that they have absolutely blanketed the AD waterfront:
1. They hold about 50% of the IP and anyone targeting beta amyloid with mAbs or secretase inhibitors will need licenses.
2. They have at least 50% of those seemingly effective compounds that are farthest along:
a. AAB-001 (50% with Wyeth)
b. ACC-001 (50% with Wyeth)
c. Gamma #1 (50% with LLY)
d. AZD-103 (70% with TTH)
These are worth many, many billions per year in revenues. Above $30b. With $15b in revs to Elan and with other revenues from T and nano also presenting nicely, $100/sh would be a very stingy valuation.
3. They have additional AD and PD and other pipeline products at early stage.
I can see Elan at $100+ but imagine that they will be acquired prior to achieving that goal.
Kein Wunder bei dieser Perspektive!!
Msg: 116202 of 116233 6/5/2007 10:41:44 AM
By: splaylaywahtheepi
Re: lts get real / phition42
I have no idea what PPS will do or when it will do it, but Elan has an excellent chance of PPS appreciating past $100/sh. The reason is that they have absolutely blanketed the AD waterfront:
1. They hold about 50% of the IP and anyone targeting beta amyloid with mAbs or secretase inhibitors will need licenses.
2. They have at least 50% of those seemingly effective compounds that are farthest along:
a. AAB-001 (50% with Wyeth)
b. ACC-001 (50% with Wyeth)
c. Gamma #1 (50% with LLY)
d. AZD-103 (70% with TTH)
These are worth many, many billions per year in revenues. Above $30b. With $15b in revs to Elan and with other revenues from T and nano also presenting nicely, $100/sh would be a very stingy valuation.
3. They have additional AD and PD and other pipeline products at early stage.
I can see Elan at $100+ but imagine that they will be acquired prior to achieving that goal.
Antwort auf Beitrag Nr.: 29.650.561 von Birgit.Tersteegen am 05.06.07 17:58:38Die Perspektiven für unser Baby ist uns "Longies" ja schon lange bewußt, dennoch verblüfft es mich immer wieder, wie der Kurs (nach einer guten News) über Tage hinweg nach unten geht, anstatt kontinuierlich zu steigen.
Sind halt auch in ELAN einige Shorties drin. Da der Kursverlauf auch schon vorhersehbar ist, verkaufen wohl auch immer öfter Trader Ihre Aktien von ELAN nach einer guten Meldung (Sell on good news).
Aber wartet mal ab, bald gibt es nur noch eine Richtung für unser Baby.
Sind halt auch in ELAN einige Shorties drin. Da der Kursverlauf auch schon vorhersehbar ist, verkaufen wohl auch immer öfter Trader Ihre Aktien von ELAN nach einer guten Meldung (Sell on good news).
Aber wartet mal ab, bald gibt es nur noch eine Richtung für unser Baby.
Antwort auf Beitrag Nr.: 29.695.159 von Poppholz am 07.06.07 22:44:46MOIN!
In der Panik verkaufen die Leute erstmal Alles....um es dann teurer wieder zu kaufen---Elan hält sich hier gut!!
Gruss in die Runde!
In der Panik verkaufen die Leute erstmal Alles....um es dann teurer wieder zu kaufen---Elan hält sich hier gut!!
Gruss in die Runde!
Hi!
Msg: 117516 of 117521 6/8/2007 11:58:54 AM
By: kcchris
fun 2 days
I remember when they did this same thing back in 04. Took it from 23 to 16 or 18. Whatever happened it was a fall that lasted several days and then it snapped back in one day. I see this as the same.
ELN has so many great things happening. Being in the teens is a joke.
Ty is growing and is about to get another indication.
Nano is finally looking to get a new drug. A big one too. when approved in 08 it will bring in siginificant revenues with a profit margin of nearly 100%.
AAB - We know it works. Moving to phase 3. last time AD looked good ELN moved to the $60s. This time we have more shares o/s but it could lead to the $40s once the market truly understands. This could take up to 9 months but it will happen.
Hopefully the visibility into the future will push us higher soon. This is either one inst selling or an effort to push us lower to pick up more shares.
I am looking forward to seeing inst interest at the end of July. I am betting we are well over 60%. I would at least hope that is the case.
Msg: 117516 of 117521 6/8/2007 11:58:54 AM
By: kcchris
fun 2 days
I remember when they did this same thing back in 04. Took it from 23 to 16 or 18. Whatever happened it was a fall that lasted several days and then it snapped back in one day. I see this as the same.
ELN has so many great things happening. Being in the teens is a joke.
Ty is growing and is about to get another indication.
Nano is finally looking to get a new drug. A big one too. when approved in 08 it will bring in siginificant revenues with a profit margin of nearly 100%.
AAB - We know it works. Moving to phase 3. last time AD looked good ELN moved to the $60s. This time we have more shares o/s but it could lead to the $40s once the market truly understands. This could take up to 9 months but it will happen.
Hopefully the visibility into the future will push us higher soon. This is either one inst selling or an effort to push us lower to pick up more shares.
I am looking forward to seeing inst interest at the end of July. I am betting we are well over 60%. I would at least hope that is the case.
Moin! Tolles Feed-Back auf TY
Msg: 117990 of 118076 6/10/2007 5:38:19 PM
By: schaakjan
" The last time I was able to do this kind of activity was 7 years ago ! "
Today from an MS board
" Hello, I just received my 2nd infusion!
No side-effects this time. My 1st infusion was not as easy as the 2nd..........I had nausea, fatigue and headache. I was thinking that I'm not seeing real results yet, but then I realized that within 24 hrs of my infusion last week, I cleaned the house (twice), did 7 loads of laundry and have now entertained most of the weekend. Wow, I just realized I haven't used my cane since ( I normally use it daily after 2pm).
The last time I was able to do this kind of activity was 7 years ago !!!!
If anyone is reading this who is thinking of starting Tysabri, rest assured this is a wonderful medication. Tysabri has starting giving me my life back...........I can't wait to see a sustained level of function. I know in reading some of your posts that it may take sometimes 6 months to see the full benefit of Tysabri. I can't wait ! "
Msg: 117990 of 118076 6/10/2007 5:38:19 PM
By: schaakjan
" The last time I was able to do this kind of activity was 7 years ago ! "
Today from an MS board
" Hello, I just received my 2nd infusion!
No side-effects this time. My 1st infusion was not as easy as the 2nd..........I had nausea, fatigue and headache. I was thinking that I'm not seeing real results yet, but then I realized that within 24 hrs of my infusion last week, I cleaned the house (twice), did 7 loads of laundry and have now entertained most of the weekend. Wow, I just realized I haven't used my cane since ( I normally use it daily after 2pm).
The last time I was able to do this kind of activity was 7 years ago !!!!
If anyone is reading this who is thinking of starting Tysabri, rest assured this is a wonderful medication. Tysabri has starting giving me my life back...........I can't wait to see a sustained level of function. I know in reading some of your posts that it may take sometimes 6 months to see the full benefit of Tysabri. I can't wait ! "
Scientists find cure for mice with Alzheimer's
Pharmaceutical company declaring war on defiant disease
05:13 PM CDT on Sunday, June 10, 2007
The New York Times
In the book Mrs. Frisby and the Rats of NIMH, a group of lab rats acquire human intelligence through a genetic experiment. Children recognize the charming tale as pure fantasy, yet something similar is occurring at a major pharmaceuticals company, Wyeth, where rodents tested in its labs have, indeed, taken on some features of the human brain.
Unlike the fictional rats that learned to read, write and operate machinery, Wyeth's animals are slow-witted, confused and forgetful because they suffer from the crippling dementia of Alzheimer's disease, which they acquired from a transplanted human gene.
Something else extraordinary is going on at Wyeth. The company's scientists not only can give rodents Alzheimer's – they have also figured out how to take it away. Curing mice is a lot simpler than curing people, but the results are a tantalizing development that offers hope to humans suffering from the disease. The work also advances what Wyeth executives describe as their war on Alzheimer's.
Wyeth's team faces a formidable foe. In an industry often criticized as making pricey "me too" drugs that involve minor tweaks to competitors' products, as well as promoting medicines of marginal value, Wyeth has decided to go full bore against Alzheimer's, a disease that has defied effective treatment since it was first identified a century ago. The company has dedicated more than 350 scientists exclusively to Alzheimer's research, and they are working on 23 separate projects for medicines to possibly treat the disease.
"I think this is going to be the disease, and maybe one of the biggest health care political issues of my generation," says Robert Essner, 59, Wyeth's chief executive.
Mr. Essner confides that a relative has been caught in the disease's maw. In fact, Mr. Essner is just one of several senior managers involved in the Alzheimer's drug discovery program at Wyeth whose families have been affected by the disease.
Among the others is Dr. Menelas Pangalos, the company's vice president for neuroscience research and a biochemist. He remembers visiting his grandmother in Greece while she was in the throes of the disease.
At Wyeth's research lab near Princeton, N.J., scientists have tested a drug called bapineuzumab and other compounds on genetically altered mice, using a special swimming pool equipped with an invisible platform.
When a mouse is placed in the pool, it instinctively begins swimming around to find a resting place. Once a normal mouse finds the platform the first time, it can find its way back on follow-up swims. But the genetically altered mice become lost.
"The Alzheimer's mouse cannot remember the location of the platform," says Reka Hosszu, a research scientist at Wyeth who works with the rodents. She says that an Alzheimer's mouse will paddle aimlessly in the pool.
After treatment, the Alzheimer's mice can find the platform more easily. And their brains look better. In before-and-after images, it is clear that globs of toxic plaque have cleared. "You can get rid of pretty much all of the amyloid," says Dr. Pangalos as he displays a three-dimensional image of a mouse brain on his computer. "And you can reverse their memory to normal, like a young mouse."
If all goes according to Wyeth's plan, it should work in humans, too. "We're going after this," Dr. Pangalos says, "and we're not stopping until we've nailed it."
http://www.dallasnews.com/sharedcontent/dws/news/nation/stor…
Pharmaceutical company declaring war on defiant disease
05:13 PM CDT on Sunday, June 10, 2007
The New York Times
In the book Mrs. Frisby and the Rats of NIMH, a group of lab rats acquire human intelligence through a genetic experiment. Children recognize the charming tale as pure fantasy, yet something similar is occurring at a major pharmaceuticals company, Wyeth, where rodents tested in its labs have, indeed, taken on some features of the human brain.
Unlike the fictional rats that learned to read, write and operate machinery, Wyeth's animals are slow-witted, confused and forgetful because they suffer from the crippling dementia of Alzheimer's disease, which they acquired from a transplanted human gene.
Something else extraordinary is going on at Wyeth. The company's scientists not only can give rodents Alzheimer's – they have also figured out how to take it away. Curing mice is a lot simpler than curing people, but the results are a tantalizing development that offers hope to humans suffering from the disease. The work also advances what Wyeth executives describe as their war on Alzheimer's.
Wyeth's team faces a formidable foe. In an industry often criticized as making pricey "me too" drugs that involve minor tweaks to competitors' products, as well as promoting medicines of marginal value, Wyeth has decided to go full bore against Alzheimer's, a disease that has defied effective treatment since it was first identified a century ago. The company has dedicated more than 350 scientists exclusively to Alzheimer's research, and they are working on 23 separate projects for medicines to possibly treat the disease.
"I think this is going to be the disease, and maybe one of the biggest health care political issues of my generation," says Robert Essner, 59, Wyeth's chief executive.
Mr. Essner confides that a relative has been caught in the disease's maw. In fact, Mr. Essner is just one of several senior managers involved in the Alzheimer's drug discovery program at Wyeth whose families have been affected by the disease.
Among the others is Dr. Menelas Pangalos, the company's vice president for neuroscience research and a biochemist. He remembers visiting his grandmother in Greece while she was in the throes of the disease.
At Wyeth's research lab near Princeton, N.J., scientists have tested a drug called bapineuzumab and other compounds on genetically altered mice, using a special swimming pool equipped with an invisible platform.
When a mouse is placed in the pool, it instinctively begins swimming around to find a resting place. Once a normal mouse finds the platform the first time, it can find its way back on follow-up swims. But the genetically altered mice become lost.
"The Alzheimer's mouse cannot remember the location of the platform," says Reka Hosszu, a research scientist at Wyeth who works with the rodents. She says that an Alzheimer's mouse will paddle aimlessly in the pool.
After treatment, the Alzheimer's mice can find the platform more easily. And their brains look better. In before-and-after images, it is clear that globs of toxic plaque have cleared. "You can get rid of pretty much all of the amyloid," says Dr. Pangalos as he displays a three-dimensional image of a mouse brain on his computer. "And you can reverse their memory to normal, like a young mouse."
If all goes according to Wyeth's plan, it should work in humans, too. "We're going after this," Dr. Pangalos says, "and we're not stopping until we've nailed it."
http://www.dallasnews.com/sharedcontent/dws/news/nation/stor…
Elan to Present at the Goldman Sachs 28th Annual Global Healthcare Conference
DUBLIN, Ireland--(BUSINESS WIRE)--May 24, 2007--Elan Corporation, plc announces that it will present at the Goldman Sachs 28th Annual Global Healthcare Conference in Laguna Niguel, California on Wednesday, June 13th, 2007 at 10.40 a.m. Pacific Time, 1.40 p.m. Eastern Time and 6.40 p.m. British Summer Time.
Interested parties may access a live audio webcast of the presentation by visiting Elan's website at www.elan.com and clicking on the Investor Relations section, then on the event icon.
DUBLIN, Ireland--(BUSINESS WIRE)--May 24, 2007--Elan Corporation, plc announces that it will present at the Goldman Sachs 28th Annual Global Healthcare Conference in Laguna Niguel, California on Wednesday, June 13th, 2007 at 10.40 a.m. Pacific Time, 1.40 p.m. Eastern Time and 6.40 p.m. British Summer Time.
Interested parties may access a live audio webcast of the presentation by visiting Elan's website at www.elan.com and clicking on the Investor Relations section, then on the event icon.
Hi Freaks Folgendes hört sich doch prima an...
Msg: 118729 of 118732 6/12/2007 3:09:09 PM
By: teknowizz
"Elan/Wyeth's bapineuzumab, the first biologic agent expected to win approval ..."
This is more like it .
[http://www.upi.com/Health_Business/Analysis/2007/06/11/analy…
Analysis: Shake-up for Alzheimer's market
Published: June 11, 2007 at 6:03 PM
By STEVE MITCHELL
UPI Senior Medical Correspondent
WASHINGTON, June 11 (UPI) -- Elan/Wyeth's bapineuzumab, the first biologic agent expected to win approval for the treatment of Alzheimer's disease, will triple the market for medications for the brain illness to $8.8 billion by 2016, according to an analyst's report issued Monday.
Elan/Wyeth's monoclonal antibody, which is expected to launch by 2011 in both the United States and Europe, is projected to be responsible for most of the increase in the market by generating more than $5 billion in sales in 2016, according to the report from the analyst firm Decision Resources.
Bapineuzumab's uptake could be limited due to safety concerns, but the biologic is expected to have considerable success. This is despite an anticipated price tag nearly eight times higher than currently approved Alzheimer's drugs.
Nitasha Manchanda, an analyst with Decision Resources and author of the report, told United Press International there's been a significant shift in the pipeline of Alzheimer's medications, with experts in this field thinking the immunotherapies hold the greatest promise for treating the disorder.
Tops among these so far is Elan/Wyeth's biologic, which is anticipated to have demonstrated better efficacy than other current therapies at the time of its launch, Manchanda said.
In some studies, bapineuzumab has showed a remarkable clearance of amyloid plaques -- thought to contribute to the mental decline associated with Alzheimer's -- but concerns about the possibility of serious side effects remain. This is primarily because Elan's once hailed but now discontinued immunotherapeutic AN-1792 was found to cause inflammation in the brain.
"The phase 3 trials will have to definitively establish its safety because that's unclear at this point," Manchanda said.
Elan and Wyeth said last month they were initiating a phase 3 trial of bapineuzumab in patients with mild to moderate Alzheimer's disease. The study is slated to begin later this year.
The decision to proceed with a phase 3 study was partially based on an interim look at data from an ongoing phase 2 trial that remains blinded, the companies said. The final analysis of the phase 2 data is not expected to be completed until 2008.
Only 20 percent to 25 percent of patients are expected to receive bapineuzumab once it hits the market, but this will still be enough to expand the market due its anticipated higher price.
"It's because of the high price point that sales will be so large," Manchanda said.
Another factor driving the market expansion is that patients might be on several drugs at once in the coming years.
"Several disease-modifying drugs might be used in combination because they target different mechanisms," Manchanda said. "So that's one of the reasons the market will expand so much."
Acetylcholinesterase inhibitors will still be used, and there probably won't be a significant decline in prescriptions of those drugs. However, they will start going off patent beginning in 2008, so the revenue generated from them will decline, sending their share of the market tumbling from 70 percent of sales in 2006 to 13 percent by 2016.
Another biologic coming down the pipeline that could make a splash is Eli Lilly's LY-2062430, which could launch as early as 2016.
But the monoclonal antibody is still in phase 2, so it's difficult to predict whether it will demonstrate efficacy.
"We don't have as much information on that drug yet, so it's hard to tell at this point," Manchanda said.
The report projects Myriad Genetics' Flurizan and Neurochem's Alzhemed, which are anticipated to launch in 2010, also will contribute to the market expansion, accounting for 8 percent and 13 percent, respectively, of Alzheimer's treatment sales by 2016.
The drugs have good safety profiles, so if they have even slight efficacy, physicians will probably use them on top of other therapies, Manchanda said.
"There's such a high unmet need, these drugs will be used even if they don't show remarkable efficacy," she said.
However, some analysts suspect Neurochem's delay in releasing results of a phase 3 trial of Alzhemed indicates the drug failed to meet its endpoints in the study.
Neurochem, which said in April it was making an adjustment to the initial statistical model of the phase 3 results, said Monday its efforts were still ongoing and "no predictions or conclusions can yet be made regarding the outcome."
Paul Aisen, a professor of neurology and medicine at Georgetown University Medical Center and principal investigator of the phase 3 trial, was scheduled Monday to present an update at the Alzheimer's Association International Conference on the Prevention of Dementia in Washington.
The company said it expects to announce the results of the trial during the second quarter of this year.
Msg: 118729 of 118732 6/12/2007 3:09:09 PM
By: teknowizz
"Elan/Wyeth's bapineuzumab, the first biologic agent expected to win approval ..."
This is more like it .
[http://www.upi.com/Health_Business/Analysis/2007/06/11/analy…
Analysis: Shake-up for Alzheimer's market
Published: June 11, 2007 at 6:03 PM
By STEVE MITCHELL
UPI Senior Medical Correspondent
WASHINGTON, June 11 (UPI) -- Elan/Wyeth's bapineuzumab, the first biologic agent expected to win approval for the treatment of Alzheimer's disease, will triple the market for medications for the brain illness to $8.8 billion by 2016, according to an analyst's report issued Monday.
Elan/Wyeth's monoclonal antibody, which is expected to launch by 2011 in both the United States and Europe, is projected to be responsible for most of the increase in the market by generating more than $5 billion in sales in 2016, according to the report from the analyst firm Decision Resources.
Bapineuzumab's uptake could be limited due to safety concerns, but the biologic is expected to have considerable success. This is despite an anticipated price tag nearly eight times higher than currently approved Alzheimer's drugs.
Nitasha Manchanda, an analyst with Decision Resources and author of the report, told United Press International there's been a significant shift in the pipeline of Alzheimer's medications, with experts in this field thinking the immunotherapies hold the greatest promise for treating the disorder.
Tops among these so far is Elan/Wyeth's biologic, which is anticipated to have demonstrated better efficacy than other current therapies at the time of its launch, Manchanda said.
In some studies, bapineuzumab has showed a remarkable clearance of amyloid plaques -- thought to contribute to the mental decline associated with Alzheimer's -- but concerns about the possibility of serious side effects remain. This is primarily because Elan's once hailed but now discontinued immunotherapeutic AN-1792 was found to cause inflammation in the brain.
"The phase 3 trials will have to definitively establish its safety because that's unclear at this point," Manchanda said.
Elan and Wyeth said last month they were initiating a phase 3 trial of bapineuzumab in patients with mild to moderate Alzheimer's disease. The study is slated to begin later this year.
The decision to proceed with a phase 3 study was partially based on an interim look at data from an ongoing phase 2 trial that remains blinded, the companies said. The final analysis of the phase 2 data is not expected to be completed until 2008.
Only 20 percent to 25 percent of patients are expected to receive bapineuzumab once it hits the market, but this will still be enough to expand the market due its anticipated higher price.
"It's because of the high price point that sales will be so large," Manchanda said.
Another factor driving the market expansion is that patients might be on several drugs at once in the coming years.
"Several disease-modifying drugs might be used in combination because they target different mechanisms," Manchanda said. "So that's one of the reasons the market will expand so much."
Acetylcholinesterase inhibitors will still be used, and there probably won't be a significant decline in prescriptions of those drugs. However, they will start going off patent beginning in 2008, so the revenue generated from them will decline, sending their share of the market tumbling from 70 percent of sales in 2006 to 13 percent by 2016.
Another biologic coming down the pipeline that could make a splash is Eli Lilly's LY-2062430, which could launch as early as 2016.
But the monoclonal antibody is still in phase 2, so it's difficult to predict whether it will demonstrate efficacy.
"We don't have as much information on that drug yet, so it's hard to tell at this point," Manchanda said.
The report projects Myriad Genetics' Flurizan and Neurochem's Alzhemed, which are anticipated to launch in 2010, also will contribute to the market expansion, accounting for 8 percent and 13 percent, respectively, of Alzheimer's treatment sales by 2016.
The drugs have good safety profiles, so if they have even slight efficacy, physicians will probably use them on top of other therapies, Manchanda said.
"There's such a high unmet need, these drugs will be used even if they don't show remarkable efficacy," she said.
However, some analysts suspect Neurochem's delay in releasing results of a phase 3 trial of Alzhemed indicates the drug failed to meet its endpoints in the study.
Neurochem, which said in April it was making an adjustment to the initial statistical model of the phase 3 results, said Monday its efforts were still ongoing and "no predictions or conclusions can yet be made regarding the outcome."
Paul Aisen, a professor of neurology and medicine at Georgetown University Medical Center and principal investigator of the phase 3 trial, was scheduled Monday to present an update at the Alzheimer's Association International Conference on the Prevention of Dementia in Washington.
The company said it expects to announce the results of the trial during the second quarter of this year.
Hi WO seit Ihr eigentlich ALLE??
Heute Nachmittag können wir über die Website Elans Beitrag auf der ALZ Konferenz miterleben!
Elan at 1:40pm eastern today - fyi
Not that I expect anything jaw dropping, just something to know.
Elan to Present at the Goldman Sachs 28th Annual Global Healthcare Conference
Global Healthcare Conference
Elan to Present at the Goldman Sachs 28th Annual Global Healthcare Conference
DUBLIN, Ireland--(BUSINESS WIRE)--May 24, 2007--
Elan Corporation, plc announces that it will present at the Goldman Sachs
28th Annual Global Healthcare Conference in Laguna Niguel, California on
Wednesday, June 13th, 2007 at 10.40 a.m. Pacific Time, 1.40 p.m. Eastern Time
and 6.40 p.m. British Summer Time. Interested parties may access a live audio
webcast of the presentation by visiting Elan's website at www.elan.com and
clicking on the Investor Relations section, then on the event icon.
About Elan
Elan Corporation, plc (NYSE: ELN) is a neuroscience-based biotechnology
company committed to making a difference in the lives of patients and their
families by dedicating itself to bringing innovations in science to fill
significant unmet medical needs that continue to exist around the world. Elan
shares trade on the New York, London and Dublin Stock Exchanges. For additional
information about the company, please visit http://www.elan.com.
CONTACT: Elan Corporation
Investor Relations:
Chris Burns, 353-1-709-4444
800-252-3526
or
Media Relations:
Matt Dallas, 212-850-5664
or
Elizabeth Headon, 353-1-498-0300
SOURCE: Elan Corporation, plc
Copyright Business Wire 2007
Heute Nachmittag können wir über die Website Elans Beitrag auf der ALZ Konferenz miterleben!
Elan at 1:40pm eastern today - fyi
Not that I expect anything jaw dropping, just something to know.
Elan to Present at the Goldman Sachs 28th Annual Global Healthcare Conference
Global Healthcare Conference
Elan to Present at the Goldman Sachs 28th Annual Global Healthcare Conference
DUBLIN, Ireland--(BUSINESS WIRE)--May 24, 2007--
Elan Corporation, plc announces that it will present at the Goldman Sachs
28th Annual Global Healthcare Conference in Laguna Niguel, California on
Wednesday, June 13th, 2007 at 10.40 a.m. Pacific Time, 1.40 p.m. Eastern Time
and 6.40 p.m. British Summer Time. Interested parties may access a live audio
webcast of the presentation by visiting Elan's website at www.elan.com and
clicking on the Investor Relations section, then on the event icon.
About Elan
Elan Corporation, plc (NYSE: ELN) is a neuroscience-based biotechnology
company committed to making a difference in the lives of patients and their
families by dedicating itself to bringing innovations in science to fill
significant unmet medical needs that continue to exist around the world. Elan
shares trade on the New York, London and Dublin Stock Exchanges. For additional
information about the company, please visit http://www.elan.com.
CONTACT: Elan Corporation
Investor Relations:
Chris Burns, 353-1-709-4444
800-252-3526
or
Media Relations:
Matt Dallas, 212-850-5664
or
Elizabeth Headon, 353-1-498-0300
SOURCE: Elan Corporation, plc
Copyright Business Wire 2007
Antwort auf Beitrag Nr.: 29.876.494 von Birgit.Tersteegen am 13.06.07 17:11:11
Elan Corporation, plc at Goldman Sachs 28th Annual Global Healthcare Conference 13-Jun-07 1:40 PM
..etws nach unten scrollen, dann habt den ELAN Audio-Link von der GS Conference...
http://www.fulldisclosure.com/company.asp?client=cb&ticker=E…
Elan Corporation, plc at Goldman Sachs 28th Annual Global Healthcare Conference 13-Jun-07 1:40 PM
..etws nach unten scrollen, dann habt den ELAN Audio-Link von der GS Conference...
http://www.fulldisclosure.com/company.asp?client=cb&ticker=E…
Antwort auf Beitrag Nr.: 29.885.619 von bernie55 am 14.06.07 09:37:47....werde später mal reinhören....muss jetzt ein bisschen arbeiten...
Msg: 119166 of 119258 6/13/2007 6:19:50 PM
By: Blackwatch
My notes on cc - its available now.
KM
Critical point in company history.
Objective as a company: World’s leading neuro science based company in the next five years.
Thought about it deeply.
Leading = depth and breath of our science; innovation; IP; diversifying risk financially – nano; leading in profit
Pipeline: chart shows end of 2007. T for MS; Crohns; AZ, two phase III, BAP, and 2nd is Lilly;
Lilly has the right to opt into to ours.
By end of year, Three P II; Aab 002; ACC001; ELD 005 [I might have these wrong, but there are three]
Another AZ and MS in P 1 by the end of the year, as well as more next year.
IP: AZ estate 200 patents issued, 1000 pending. They focus on this.
Drug Deliverey: significant cash flow with less risk. Some have filed, some are p III, some are P II. Expect to build this portfolio.
Can leverage science into other immunotherapy, oncology, cardiology
Tax structure will help, especially vs. competitors.
Repeat leading company objective. Based on our pipeline.
Q&A
Any problems with regulators re Crohns? Lars focus on where is the unmet need, because of other drugs. Where others fail. Second topic, how does T work in combination? We try to avoid this. So we are showing we work as monotherapy. Topics to be considered with FDA at end of July.
How will MS develop in next several years? KM market unchanged for 10 years. We will change. Other new entrants will come. T with outstanding efficacy, will over time (because of PML) change market dramatically. T will come out good vs competitors (meaning the new ones they expect to the extent of their knowledge).
What Data re P II in AZ was available for P III decision?. Lars. We haven’t disclosed about cohorts. We are two years out of three. Start with low dose. So figure it out yourself. Low dose cohorts have progressed further.
What shortest PIII? ; Lars = traditionally 18 mos for disease modifying; will discuss earlier time points with FDA; also could be a conditional approval. Need to start P III asap. Will need 1000 patients or more. That is why we and wye are eager to start.
Question about manufacturing of BAP. We could do it, but we will rely on Wye for now. Mentions that there are multiple programs.
What are the specifics with Wye. KM simple everything is 50/50 globally.
Who can market – up to the CEOs to figure that out.
Will figure it out in the next 6-9 months.
Lilly: KM, now we will contact them regarding what commercial context makes sense. Prior to now it was too early because only in P II.
QA from audience: ELND product what is it? ACC 003 This is TTP. 70/30 deal. TTP can opt in for higher levels. Excellent opportunity. Lots of different apps. Wide array of diseases. Lars refs Nature Mag. article from 2006. Confirmed in recent Neurology. Move to P II later this year.
KM we are getting more knowledge all the time in this disease. Human data across wide selection of patients.
QA: Crohns touch? KM we assume yes. Touch slows the front end but gives you a wealth of information.
QA: Size of C market? Much less clear than MS. Think initial opp is not large. Get in and work with it.
QA: How will capital structure change over next few years? Shane: T will work before debt due, with one to three AZ products. No change in next few years. Talk about tax issues; all located in Ireland so good situation.
QA: Small molecule products, what’s going on. LARs: general talk about small molecule benefits; better ability to design; oral compound is obvious benefit.
QA: What’s Elan’s R and D capability. Came from athena. 200 scientists work on AZ. Then more neurologists; Team for discovery to clinic. All of Lars comments related to AZ.
QA: What about competitors? KM very hard to exclude people; so you look for royalty. [What he means is that under US patent law it is very hard to impossible to get a patent based injunction against an infringer who is using the technology to address human health issues, expecially serious ones] That is why so important to get BAP into the market. Scientists think is likely others use Elan IP.
QA: Regarding the pricing. KM “I got a lot of love notes on that subject.” High pricing would bankrupt payors. In AZ. Have to think of systems globally. Have to think realistically. Flawed to price high for few patients. This discussion is not directly related to BAP.
By: Blackwatch
My notes on cc - its available now.
KM
Critical point in company history.
Objective as a company: World’s leading neuro science based company in the next five years.
Thought about it deeply.
Leading = depth and breath of our science; innovation; IP; diversifying risk financially – nano; leading in profit
Pipeline: chart shows end of 2007. T for MS; Crohns; AZ, two phase III, BAP, and 2nd is Lilly;
Lilly has the right to opt into to ours.
By end of year, Three P II; Aab 002; ACC001; ELD 005 [I might have these wrong, but there are three]
Another AZ and MS in P 1 by the end of the year, as well as more next year.
IP: AZ estate 200 patents issued, 1000 pending. They focus on this.
Drug Deliverey: significant cash flow with less risk. Some have filed, some are p III, some are P II. Expect to build this portfolio.
Can leverage science into other immunotherapy, oncology, cardiology
Tax structure will help, especially vs. competitors.
Repeat leading company objective. Based on our pipeline.
Q&A
Any problems with regulators re Crohns? Lars focus on where is the unmet need, because of other drugs. Where others fail. Second topic, how does T work in combination? We try to avoid this. So we are showing we work as monotherapy. Topics to be considered with FDA at end of July.
How will MS develop in next several years? KM market unchanged for 10 years. We will change. Other new entrants will come. T with outstanding efficacy, will over time (because of PML) change market dramatically. T will come out good vs competitors (meaning the new ones they expect to the extent of their knowledge).
What Data re P II in AZ was available for P III decision?. Lars. We haven’t disclosed about cohorts. We are two years out of three. Start with low dose. So figure it out yourself. Low dose cohorts have progressed further.
What shortest PIII? ; Lars = traditionally 18 mos for disease modifying; will discuss earlier time points with FDA; also could be a conditional approval. Need to start P III asap. Will need 1000 patients or more. That is why we and wye are eager to start.
Question about manufacturing of BAP. We could do it, but we will rely on Wye for now. Mentions that there are multiple programs.
What are the specifics with Wye. KM simple everything is 50/50 globally.
Who can market – up to the CEOs to figure that out.
Will figure it out in the next 6-9 months.
Lilly: KM, now we will contact them regarding what commercial context makes sense. Prior to now it was too early because only in P II.
QA from audience: ELND product what is it? ACC 003 This is TTP. 70/30 deal. TTP can opt in for higher levels. Excellent opportunity. Lots of different apps. Wide array of diseases. Lars refs Nature Mag. article from 2006. Confirmed in recent Neurology. Move to P II later this year.
KM we are getting more knowledge all the time in this disease. Human data across wide selection of patients.
QA: Crohns touch? KM we assume yes. Touch slows the front end but gives you a wealth of information.
QA: Size of C market? Much less clear than MS. Think initial opp is not large. Get in and work with it.
QA: How will capital structure change over next few years? Shane: T will work before debt due, with one to three AZ products. No change in next few years. Talk about tax issues; all located in Ireland so good situation.
QA: Small molecule products, what’s going on. LARs: general talk about small molecule benefits; better ability to design; oral compound is obvious benefit.
QA: What’s Elan’s R and D capability. Came from athena. 200 scientists work on AZ. Then more neurologists; Team for discovery to clinic. All of Lars comments related to AZ.
QA: What about competitors? KM very hard to exclude people; so you look for royalty. [What he means is that under US patent law it is very hard to impossible to get a patent based injunction against an infringer who is using the technology to address human health issues, expecially serious ones] That is why so important to get BAP into the market. Scientists think is likely others use Elan IP.
QA: Regarding the pricing. KM “I got a lot of love notes on that subject.” High pricing would bankrupt payors. In AZ. Have to think of systems globally. Have to think realistically. Flawed to price high for few patients. This discussion is not directly related to BAP.
Bin BEGEISTERT!
Die Amis sind eben etwas langsam--sie haben erst heute verstanden was sie gestrn gehört haben....
Die Amis sind eben etwas langsam--sie haben erst heute verstanden was sie gestrn gehört haben....
Msg: 119450 of 119456 6/14/2007 11:15:55 AM
By: pharmd_97
Merion on ELN
Elan ($19.49) : Elan gives upbeat presentation at healthcare conference
Thu, 14 Jun 2007
Elan gave an upbeat presentation at Goldman Sachs healthcare conference yesterday evening at 18.40 GMT. Kelly Martin, CEO announced the company’s objective to become the “leading neuroscience based biotech company” in the world over the next five years and discussed the various strands of development (numerous Alzheimer’s, the potential for Tysabri, and the small molecule programmes). He was keen to point out that the breadth of this development combined with the Nano Technology business offers an investor diversified risk.
In the Q&A of interest were comments on the potential for Crohn’s disease. Management indicated that the initial opportunity for Tysabri in Crohn’s would ‘not be huge’ but it is envisaged that Tysabri could be a strong alternative for the 40% of patients with Crohns disease that fail the anti-TNF drugs and that this population will grow over time. Given the strong efficacy of existing drugs and PML related concerns surrounding Tysabri we do not expect Tysabri in Crohn’s to be a significant driver of value for Elan in the near term.
On Bapineuzumab (AAB-001), the company confirmed that the Phase III trial will most likely have a duration of 18 months, but that Elan and Wyeth will meet with the FDA and will discuss the potential of conditional approval of the drug prior to the full completion of this trial.
We have a HOLD recommendation on Elan.
Robert Brisbourne/Sam Farthing
By: pharmd_97
Merion on ELN
Elan ($19.49) : Elan gives upbeat presentation at healthcare conference
Thu, 14 Jun 2007
Elan gave an upbeat presentation at Goldman Sachs healthcare conference yesterday evening at 18.40 GMT. Kelly Martin, CEO announced the company’s objective to become the “leading neuroscience based biotech company” in the world over the next five years and discussed the various strands of development (numerous Alzheimer’s, the potential for Tysabri, and the small molecule programmes). He was keen to point out that the breadth of this development combined with the Nano Technology business offers an investor diversified risk.
In the Q&A of interest were comments on the potential for Crohn’s disease. Management indicated that the initial opportunity for Tysabri in Crohn’s would ‘not be huge’ but it is envisaged that Tysabri could be a strong alternative for the 40% of patients with Crohns disease that fail the anti-TNF drugs and that this population will grow over time. Given the strong efficacy of existing drugs and PML related concerns surrounding Tysabri we do not expect Tysabri in Crohn’s to be a significant driver of value for Elan in the near term.
On Bapineuzumab (AAB-001), the company confirmed that the Phase III trial will most likely have a duration of 18 months, but that Elan and Wyeth will meet with the FDA and will discuss the potential of conditional approval of the drug prior to the full completion of this trial.
We have a HOLD recommendation on Elan.
Robert Brisbourne/Sam Farthing
20,39 - 20,40
...nicht schlecht, Herr Specht...
@ Holger
...jetzt sieht die Welt doch wieder besser aus....
@birgit
...jetzt sieht die Welt doch wieder besser aus....
@Poppie
...jetzt sieht die Welt doch wieder besser aus....
@Cyberhexe
...jetzt sieht die Welt doch wieder besser aus....
@alle
...jetzt sieht die Welt doch wieder besser aus....
..so , jetzt mal eine Runde joggen und saunieren.....
...nicht schlecht, Herr Specht...
@ Holger
...jetzt sieht die Welt doch wieder besser aus....
@birgit
...jetzt sieht die Welt doch wieder besser aus....
@Poppie
...jetzt sieht die Welt doch wieder besser aus....
@Cyberhexe
...jetzt sieht die Welt doch wieder besser aus....
@alle
...jetzt sieht die Welt doch wieder besser aus....
..so , jetzt mal eine Runde joggen und saunieren.....
Antwort auf Beitrag Nr.: 29.895.249 von bernie55 am 14.06.07 17:46:26ja!
Antwort auf Beitrag Nr.: 29.895.249 von bernie55 am 14.06.07 17:46:26Hi
...nicht schlecht, Herr Specht...
@ Holger
...jetzt sieht die Welt doch wieder besser aus....
@birgit
...jetzt sieht die Welt doch wieder besser aus....
@Poppie
...jetzt sieht die Welt doch wieder besser aus....
@Cyberhexe
...jetzt sieht die Welt doch wieder besser aus....
@alle
...jetzt sieht die Welt doch wieder besser aus.... nur weiter so
gruß Noogmann
...nicht schlecht, Herr Specht...
@ Holger
...jetzt sieht die Welt doch wieder besser aus....
@birgit
...jetzt sieht die Welt doch wieder besser aus....
@Poppie
...jetzt sieht die Welt doch wieder besser aus....
@Cyberhexe
...jetzt sieht die Welt doch wieder besser aus....
@alle
...jetzt sieht die Welt doch wieder besser aus.... nur weiter so
gruß Noogmann
Antwort auf Beitrag Nr.: 29.895.797 von noogmann am 14.06.07 18:06:20Hi Noogmann--der zerstreute Bernie hat Dich doch glatt vergessen.:O..und Surga und Mr ti und,und,und.....Dabei ist gemeinsame Freude doch grösste Freude...
Antwort auf Beitrag Nr.: 29.895.249 von bernie55 am 14.06.07 17:46:26...und dies sollte wirklich erst der Anfang sein!
Tysabri-Zulassung für MC sowie zunehmende Applikation bei MS,
Entwicklung der Alzheimer-Pipeline sowie neue Abkommen mit nanoformulierten Aktivsubstanzen sollten die kurstreibenden Schlagzeilen der Zukunft sein.
good luck
ch
Tysabri-Zulassung für MC sowie zunehmende Applikation bei MS,
Entwicklung der Alzheimer-Pipeline sowie neue Abkommen mit nanoformulierten Aktivsubstanzen sollten die kurstreibenden Schlagzeilen der Zukunft sein.
good luck
ch
Antwort auf Beitrag Nr.: 29.895.980 von Birgit.Tersteegen am 14.06.07 18:12:32Hi
Ich stelle mich gerne hinten an ( bin doch erst 1,5 Jahre dabei )
Und kann ja nicht viel beitragen ( stiller Leser )
Fühle mich hier gut aufgehoben bei euch allen.
Noogmann
Ich stelle mich gerne hinten an ( bin doch erst 1,5 Jahre dabei )
Und kann ja nicht viel beitragen ( stiller Leser )
Fühle mich hier gut aufgehoben bei euch allen.
Noogmann
Antwort auf Beitrag Nr.: 29.895.980 von Birgit.Tersteegen am 14.06.07 18:12:32Genau Biggi, danke!
Die gemeinsame Freude ist die grösste Freude
Die gemeinsame Freude ist die grösste Freude
In diesem Bericht vom 10.Juni07 werden die überaus viel versprechenden Forschungsergebnisse von Elan deutlich, die die Wyeth-Wissenschaftler veranlassten, auf eine Partnertschaft mit Elan hinzuwirken. Elan ist bereits fast 20 Jahre auf der Suche nach einer Therapiemöglichkeit und hat bereits 2002 mit dem Vakzin AN-1792 spektakuläre Erfolge erzielt. Allerdings sind bei 6% der Studienteilnehmer (AN1792) unerwünschte Nebenwirkungen in Form von Hirnhautentzündungen aufgetreten, weshalb diese Studie sofort abgebrochen wurde.
Die Erkenntnisse daraus waren jedoch Bahn brechend:
AAB-001 oder Bapineuzumab ist der korrespondierende Antikörper und ist bereits seit 2 Jahren in einer klinischen Phase-2-Studie. Noch vor Ablauf dieser 3-jährigen Studie soll mit einer breiten Phase-3-Studie begonnen werden, da die vorläufigen Ergebnisse aus dieser Phase-2-Studie (bisher nicht veröffentlicht) spektakulär sein sollen - so zumindest wurde dies früher angekündigt, dass nur dann vorzeitig eine Phase-3-Studie begonnen würde, wenn spektakuläre Zwischenergebnisse vorliegen.
Da es sich bei Bapineuzumab nicht um eine aktive Immunantwort handelt sind keine schwerwiegenden NW wie bei AN1792 zu erwarten. Dies scheint sich nun zu bestätigen!
Die Spannung steigt und der Kursverlauf spiegelt dies langsam wider - aktuell $20.73!
http://www.wilmingtonstar.com/apps/pbcs.dll/article?AID=/200…
Die Erkenntnisse daraus waren jedoch Bahn brechend:
AAB-001 oder Bapineuzumab ist der korrespondierende Antikörper und ist bereits seit 2 Jahren in einer klinischen Phase-2-Studie. Noch vor Ablauf dieser 3-jährigen Studie soll mit einer breiten Phase-3-Studie begonnen werden, da die vorläufigen Ergebnisse aus dieser Phase-2-Studie (bisher nicht veröffentlicht) spektakulär sein sollen - so zumindest wurde dies früher angekündigt, dass nur dann vorzeitig eine Phase-3-Studie begonnen würde, wenn spektakuläre Zwischenergebnisse vorliegen.
Da es sich bei Bapineuzumab nicht um eine aktive Immunantwort handelt sind keine schwerwiegenden NW wie bei AN1792 zu erwarten. Dies scheint sich nun zu bestätigen!
Die Spannung steigt und der Kursverlauf spiegelt dies langsam wider - aktuell $20.73!
http://www.wilmingtonstar.com/apps/pbcs.dll/article?AID=/200…
Was für eine geile Kurve heute an der Nasdaq ... suuuper
Antwort auf Beitrag Nr.: 29.897.694 von Cyberhexe am 14.06.07 19:08:45Cyber, klasse wär ja wirklich, wenn die PII-Ergebnisse noch dieses
Jahr kämem und dann das Filing durchgezogen würde.
Das wär dann wohl endgültig der Startschuß für den RunUP.
Jahr kämem und dann das Filing durchgezogen würde.
Das wär dann wohl endgültig der Startschuß für den RunUP.
Antwort auf Beitrag Nr.: 29.894.360 von Birgit.Tersteegen am 14.06.07 17:14:51"sie haben erst heute verstanden was sie gestrn gehört haben"
Die Information ist gestern in ihr linkes Ohr vorgedrungen
und hat bis heute Nachmittag verzweifelt nach einem Gehirn
gesucht
Ich schmeiß mich weg.
Die Information ist gestern in ihr linkes Ohr vorgedrungen
und hat bis heute Nachmittag verzweifelt nach einem Gehirn
gesucht
Ich schmeiß mich weg.
Antwort auf Beitrag Nr.: 29.896.378 von Cyberhexe am 14.06.07 18:26:31"Entwicklung der Alzheimer-Pipeline sowie neue Abkommen mit nanoformulierten Aktivsubstanzen sollten die kurstreibenden Schlagzeilen der Zukunft sein."
Man Cyber, wie lange hast Du für den Satz geübt ? lach
Man Cyber, wie lange hast Du für den Satz geübt ? lach
Bin froh,daß die Hexe wieder zur alten Liebe zurückgekehrt ist.
Dem Kurs scheint es nicht zu schaden.
posimist
Dem Kurs scheint es nicht zu schaden.
posimist
SUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUPER!!
Antwort auf Beitrag Nr.: 29.895.980 von Birgit.Tersteegen am 14.06.07 18:12:32der zerstreute Bernie hat Dich doch glatt vergessen. ..und Surga und Mr ti und,und,und
...ja...ja....der zerstreute bernie.....
...liebe Birgit, um mich vor solchen Aussagen zu schützen, hatte ich ja sicherheitshalber noch @alle geschrieben.....genützt hat es ja, wie man bei dir lesen kann, leider nicht.....
..der Vollständigkeit halber:
...jetzt sieht die Welt doch wieder besser aus....was heißt besser - noch besser als besser....
@Yogibroker ( ein ELANITE, der in NRW lebt und BAYERN FAN ist....kaum zu glauben........ich habe ihn von ELAN überzeugt...warum nun auch nicht von einem anderen Bundesligaverein...
@Nostarowie
@ surga
@posimist
@Mr Ti
@noogmann
@hechtbarsch
@mikel_ann
@en57
....@.....@.....@.......@..........@.....@...
Grüße
bernie55
...ja...ja....der zerstreute bernie.....
...liebe Birgit, um mich vor solchen Aussagen zu schützen, hatte ich ja sicherheitshalber noch @alle geschrieben.....genützt hat es ja, wie man bei dir lesen kann, leider nicht.....
..der Vollständigkeit halber:
...jetzt sieht die Welt doch wieder besser aus....was heißt besser - noch besser als besser....
@Yogibroker ( ein ELANITE, der in NRW lebt und BAYERN FAN ist....kaum zu glauben........ich habe ihn von ELAN überzeugt...warum nun auch nicht von einem anderen Bundesligaverein...
@Nostarowie
@ surga
@posimist
@Mr Ti
@noogmann
@hechtbarsch
@mikel_ann
@en57
....@.....@.....@.......@..........@.....@...
Grüße
bernie55
...mal was für die Linsen....
After Hours
Last: $ 21.45
After Hours
High: $ 21.50
After Hours
Volume: 3,021,400
After Hours
Low: $ 20.042
Last: $ 21.45
After Hours
High: $ 21.50
After Hours
Volume: 3,021,400
After Hours
Low: $ 20.042
Sieht verdammt gut aus Charttechnisch.
20 gehalten! Guckt man anfang 2004 war dasselbe Scenario, mit gewaltiger Rally darauf. Die Kurse haben ein Gedächtniss bedingt durchs ähnliche handeln der Aktionäre meine ich...meistens zumindest.
Stopp würde ich bei einer kürzlich eingegangenen Posi bei $18,60 rum platzieren.
Guckt ma Lenovo da scheint die Masse auch aufzuwachen. Haier ist noch sehr interessant vorallendingen bei Wvollkommen vernachlässigt von den Lemmingen. Je mehr vom Chinacrash faseln desto höher wird der Asiensenf getrieben.
lets rock
20 gehalten! Guckt man anfang 2004 war dasselbe Scenario, mit gewaltiger Rally darauf. Die Kurse haben ein Gedächtniss bedingt durchs ähnliche handeln der Aktionäre meine ich...meistens zumindest.
Stopp würde ich bei einer kürzlich eingegangenen Posi bei $18,60 rum platzieren.
Guckt ma Lenovo da scheint die Masse auch aufzuwachen. Haier ist noch sehr interessant vorallendingen bei Wvollkommen vernachlässigt von den Lemmingen. Je mehr vom Chinacrash faseln desto höher wird der Asiensenf getrieben.
lets rock
Moin!
Über die Kurse hier kann man sich ja nur wundern....16,03 wäre der korrekte Preis....Klasse,dass wir alles was Wallstreet JETZT sieht schon "jahrelang" gesehen haben...
Über die Kurse hier kann man sich ja nur wundern....16,03 wäre der korrekte Preis....Klasse,dass wir alles was Wallstreet JETZT sieht schon "jahrelang" gesehen haben...
Antwort auf Beitrag Nr.: 29.935.654 von Birgit.Tersteegen am 15.06.07 10:42:22Na Biggi, auch mal am Rechner
GoldmanSachs hat einen neuen Kommentar zu Elan herausgegeben. Hierbei wird die Zulassungsentscheidung von Tysabri zur Behandlung von Morbus Crohn mit zusätzlichem Kurspotential in Höhe von 4$/Aktie gewichtet.
Interessanterweise rechnet GS mit einer Zulassungsentscheidung der EMEA auf Mitte 07. Man darf wirklich gespannt sein, ob die EMEA tatsächlich eine Entscheidung vor dem Advisory Committee der FDA bekanntgeben wird - dies würde mich sehr überraschen, zumnal man bisher nur selten den Eindruck haben konnte, dass es sich bei der EMEA um eine von der FDA unabhängige Institution handeln würde.
Elan's management team presented at the Goldman Sachs Global Healthcare conference on Wednesday. The group highlighted its goal of becoming the leading neuroscience-based biotech company, with a portfolio of products driven by Tysabri and Bapineuzumab initially. In our view, the group remains conservative on the outlook and potential approval path and approval timing for Bapineuzumab.
Implications
We re-iterate our Buy rating and12-month target price of $25/ADR. In our view, should the group announce a preliminary US filing for approval for Bapineuzuamb within the next 12 months and begin a phase III programme, the stock could rally significantly.
Within the next 6-12 months, Elan and partner Wyeth will finalise the logistics and responsibilities for the commercialization of Bapineuzumab. We also expect further progress in the group?s R&D pipeline over the coming 12 months which could increase the profile of the group?s position within the neuroscience field.
Valuation
Our 12-month risk-adjusted DCF target price is $25/ADR. Should Tysabri be approved in Crohn?s Disease (EU decision due mid-year, US FDAC 31 July), this could add another $4/ADR to our target price.
Zulassungsantrag Ty für MC --> FDA (2006)
http://www.elan.com/News/full.asp?ID=942628
Zulassungsantrag Ty für MC --> EMEA (2004)
http://www.elan.com/News/2004/20040929.asp
Interessanterweise rechnet GS mit einer Zulassungsentscheidung der EMEA auf Mitte 07. Man darf wirklich gespannt sein, ob die EMEA tatsächlich eine Entscheidung vor dem Advisory Committee der FDA bekanntgeben wird - dies würde mich sehr überraschen, zumnal man bisher nur selten den Eindruck haben konnte, dass es sich bei der EMEA um eine von der FDA unabhängige Institution handeln würde.
Elan's management team presented at the Goldman Sachs Global Healthcare conference on Wednesday. The group highlighted its goal of becoming the leading neuroscience-based biotech company, with a portfolio of products driven by Tysabri and Bapineuzumab initially. In our view, the group remains conservative on the outlook and potential approval path and approval timing for Bapineuzumab.
Implications
We re-iterate our Buy rating and12-month target price of $25/ADR. In our view, should the group announce a preliminary US filing for approval for Bapineuzuamb within the next 12 months and begin a phase III programme, the stock could rally significantly.
Within the next 6-12 months, Elan and partner Wyeth will finalise the logistics and responsibilities for the commercialization of Bapineuzumab. We also expect further progress in the group?s R&D pipeline over the coming 12 months which could increase the profile of the group?s position within the neuroscience field.
Valuation
Our 12-month risk-adjusted DCF target price is $25/ADR. Should Tysabri be approved in Crohn?s Disease (EU decision due mid-year, US FDAC 31 July), this could add another $4/ADR to our target price.
Zulassungsantrag Ty für MC --> FDA (2006)
http://www.elan.com/News/full.asp?ID=942628
Zulassungsantrag Ty für MC --> EMEA (2004)
http://www.elan.com/News/2004/20040929.asp
Antwort auf Beitrag Nr.: 29.935.750 von Nostarowie am 15.06.07 10:47:18
Antwort auf Beitrag Nr.: 29.944.718 von Birgit.Tersteegen am 15.06.07 17:56:03Biggi, warum ist der ASK Kurs in FFM bei 16 Euro geblieben?
Antwort auf Beitrag Nr.: 29.945.648 von surga am 15.06.07 18:37:04Who knows Surga;wird sich eh bald ändern
----und wir wollen doch die 100,oder??
----und wir wollen doch die 100,oder??
Antwort auf Beitrag Nr.: 29.956.464 von Birgit.Tersteegen am 16.06.07 18:44:44die 100? eins nach dem anderen würd ich sagen.
aber abgeneigt wäre ich letztlich auch nicht
noch mal danke für deinen tip.
aber abgeneigt wäre ich letztlich auch nicht
noch mal danke für deinen tip.
Antwort auf Beitrag Nr.: 29.956.464 von Birgit.Tersteegen am 16.06.07 18:44:44ich hangel mich bei meinen Kurszielen immer in 10er Schritten nach oben.
Ist doch schöner, wenn das Kursziel noch acht Mal (ein Mal haben wir ja schon erreicht) erreicht wird, wenn wir die 100 sehen werden.
Ist doch schöner, wenn das Kursziel noch acht Mal (ein Mal haben wir ja schon erreicht) erreicht wird, wenn wir die 100 sehen werden.
nur mal so nebenbei......aktuell geht ELAN mal wieder in die Höhe...
21,96 USD = 16,38 €
21,96 USD = 16,38 €
Antwort auf Beitrag Nr.: 30.001.399 von bernie55 am 18.06.07 17:16:16
June 18, 2007, 10:22 am
Tysabri Update: No New Infections for MS DrugPosted by Jacob Goldstein
Tysabri, the multiple sclerosis drug that was withdrawn temporarily from the market after reports of serious brain infections, hasn’t been connected with any such infections since shipments resumed last July, the latest data show.
Biogen Idec, which co-markets the drug with Elan, made the update in a securities filing today. Since the companies resumed selling the drug, there have been “no confirmed cases of PML or other serious opportunistic infections,” according to a single PowerPoint slide Biogen Idec filed with the SEC. The filing occurred in advance of a presentation today at a neurology meeting in Greece.
Tysabri was approved in late 2004 then withdrawn in early 2005, after it emerged that three people in clinical trials of the drug developed PML, or progressive multifocal leukoencephalopathy, a very rare, very serious infection of the brain. As of May 23rd of this year, about 12,000 patients worldwide were on the drug, including about 7,600 in this country.
The agreement the company worked out with the FDA — described here — suggests the agency will continue to scrutinize the drug. The agreement requires the company monitor all patients on the drug, and to report to the FDA every quarter for the first year, every six months for the next two years, and annually after that. If any cases of PML or other serious opportunistic infections emerge, they must be reported within 15 days.
http://blogs.wsj.com/health/2007/06/18/tysabri-update-no-new…
Tysabri Update: No New Infections for MS DrugPosted by Jacob Goldstein
Tysabri, the multiple sclerosis drug that was withdrawn temporarily from the market after reports of serious brain infections, hasn’t been connected with any such infections since shipments resumed last July, the latest data show.
Biogen Idec, which co-markets the drug with Elan, made the update in a securities filing today. Since the companies resumed selling the drug, there have been “no confirmed cases of PML or other serious opportunistic infections,” according to a single PowerPoint slide Biogen Idec filed with the SEC. The filing occurred in advance of a presentation today at a neurology meeting in Greece.
Tysabri was approved in late 2004 then withdrawn in early 2005, after it emerged that three people in clinical trials of the drug developed PML, or progressive multifocal leukoencephalopathy, a very rare, very serious infection of the brain. As of May 23rd of this year, about 12,000 patients worldwide were on the drug, including about 7,600 in this country.
The agreement the company worked out with the FDA — described here — suggests the agency will continue to scrutinize the drug. The agreement requires the company monitor all patients on the drug, and to report to the FDA every quarter for the first year, every six months for the next two years, and annually after that. If any cases of PML or other serious opportunistic infections emerge, they must be reported within 15 days.
http://blogs.wsj.com/health/2007/06/18/tysabri-update-no-new…
Antwort auf Beitrag Nr.: 30.001.684 von bernie55 am 18.06.07 17:29:07
Antwort auf Beitrag Nr.: 30.001.546 von bernie55 am 18.06.07 17:23:29Schön ist das schon, aber....
ich habe mir mal zum Vergleich eine Apple angeschaut.
Über 5 Jahre liegt unsere ELN bei 200% eine AAPL bei 1400%
Ich denke das ist bei Bio's einfach immer etwas Roulette.
ich habe mir mal zum Vergleich eine Apple angeschaut.
Über 5 Jahre liegt unsere ELN bei 200% eine AAPL bei 1400%
Ich denke das ist bei Bio's einfach immer etwas Roulette.
22,17 - 22,18
...WWWWOOOOHHHHHH.......
...WWWWOOOOHHHHHH.......
Antwort auf Beitrag Nr.: 30.001.750 von mikel_ann am 18.06.07 17:32:30Schön ist das schon, aber....
ich habe mir mal zum Vergleich eine Apple angeschaut.
Über 5 Jahre liegt unsere ELN bei 200% eine AAPL bei 1400%
...Yepp...so ist es.....so mag es sein....
..wenn wir vorher schon wüßten, wie Aktien steigen, hätten wir bestimmt einen Applestapler gekauft....
..und unsere ELAN solange in die Vorratskammer...
ich habe mir mal zum Vergleich eine Apple angeschaut.
Über 5 Jahre liegt unsere ELN bei 200% eine AAPL bei 1400%
...Yepp...so ist es.....so mag es sein....
..wenn wir vorher schon wüßten, wie Aktien steigen, hätten wir bestimmt einen Applestapler gekauft....
..und unsere ELAN solange in die Vorratskammer...
Hi Ihr Lieben!
Was soll man/frau sagen????????????????????????????????????????????
Einfach SUPER!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Was soll man/frau sagen????????????????????????????????????????????
Einfach SUPER!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Antwort auf Beitrag Nr.: 30.001.950 von Birgit.Tersteegen am 18.06.07 17:43:49...mehr als das, Biggie...
huhu @ll!!
zu 15418: bernie, mein kleiner lieblings-schalker!! für den Elan-tip werde ich dir ewig dankbar sein.. aber ich bleib Bayern-Fan!!!!
auch für genta und hana....hihi!!!
ich werd den grill in holland dann anwerfen....bei dir im garten....;-))))....bier wirst du ja wohl haben....freu mich schon auf endlose börsengespräche!!!
gruß jörg
zu 15418: bernie, mein kleiner lieblings-schalker!! für den Elan-tip werde ich dir ewig dankbar sein.. aber ich bleib Bayern-Fan!!!!
auch für genta und hana....hihi!!!
ich werd den grill in holland dann anwerfen....bei dir im garten....;-))))....bier wirst du ja wohl haben....freu mich schon auf endlose börsengespräche!!!
gruß jörg
Der bekannte Analyst Cramer,der ähnlich wie Frick es tat,eine beliebte Show im Ami-Fernsehen mit Aktientipps unterhält und immer ein dickes "SELL" für Elan übrig hatte empfiehlt es jetzt...
Msg: 121193 of 121282 6/18/2007 7:35:07 PM
By: jivetalkin03
well i guess hell has now frozen over
kramer has apologizied tonight for being be wrong about elan. he even stuck a forked tongue in his mouth, how appropriate.
Msg: 121193 of 121282 6/18/2007 7:35:07 PM
By: jivetalkin03
well i guess hell has now frozen over
kramer has apologizied tonight for being be wrong about elan. he even stuck a forked tongue in his mouth, how appropriate.
Msg: 121196 of 121282 6/18/2007 7:56:58 PM
By: menachem10
Are you irrational
Ken Kam was the ONLY professional investment adviser to own and recommend ELN. He reduced his holding of ELN from 27% to 20% to comply with his main objective - being an investment adviser.
What do people here do - paint him as an enemy.
The second one is going to be harder. Cramer has told people to sell ELN all the way from $3 to $21. Now at $21 he converted to a 'BUY' recommendation. Now, if he holds his 'BUY' all the way to $150, he'd be able to rightfully claim that he made great money for his listeners!
By: menachem10
Are you irrational
Ken Kam was the ONLY professional investment adviser to own and recommend ELN. He reduced his holding of ELN from 27% to 20% to comply with his main objective - being an investment adviser.
What do people here do - paint him as an enemy.
The second one is going to be harder. Cramer has told people to sell ELN all the way from $3 to $21. Now at $21 he converted to a 'BUY' recommendation. Now, if he holds his 'BUY' all the way to $150, he'd be able to rightfully claim that he made great money for his listeners!
Antwort auf Beitrag Nr.: 30.012.304 von Birgit.Tersteegen am 19.06.07 08:23:16
Birgit, Kramer ist ein riesen Arschloch, das wird schon klar,
wenn man sich den Typen einfach nur ansieht
Birgit, Kramer ist ein riesen Arschloch, das wird schon klar,
wenn man sich den Typen einfach nur ansieht
Antwort auf Beitrag Nr.: 30.014.077 von Holgus am 19.06.07 10:20:05Holgus schrieb:
Birgit, Kramer ist ein riesen Arschloch, das wird schon klar,
wenn man sich den Typen einfach nur ansieht
??????????
Birgit, Kramer ist ein riesen Arschloch, das wird schon klar,
wenn man sich den Typen einfach nur ansieht
??????????
Antwort auf Beitrag Nr.: 30.014.611 von Cyberhexe am 19.06.07 10:48:36
Doch Hexe, was der für einen Müll erzählt hat über Elan,
und plötzlich kippt er um ... ne ne.
Als Typ ist er mir auch schon total unsympathisch.
Doch Hexe, was der für einen Müll erzählt hat über Elan,
und plötzlich kippt er um ... ne ne.
Als Typ ist er mir auch schon total unsympathisch.
Antwort auf Beitrag Nr.: 30.015.893 von Holgus am 19.06.07 11:50:39Doch Hexe, was der für einen Müll erzählt hat über Elan,
und plötzlich kippt er um ... ne ne.
...ok Cramer hat die damalige Chance, als viele von uns angefangen haben, bei ELAN um die 3 € einzusteigen ,
nicht genutzt bzw. nicht erkannt....
Er sah nach dem " Black Monday " und den Zahlen auch damals keinen Anlass einzusteigen....
....jetzt sieht er seine Chance...
...er will bei unserem " moneyship " ELAN dabei sein.....
..dann soll er es halt tun.....
..wenn ich mir vorstellte, er würde noch einmal so richtig über ELAN lästern, dann würde ich " volle Pulle " nachkaufen.......
..aber ich denke, die Zeiten sind vorbei...
Grüße bernie55
und plötzlich kippt er um ... ne ne.
...ok Cramer hat die damalige Chance, als viele von uns angefangen haben, bei ELAN um die 3 € einzusteigen ,
nicht genutzt bzw. nicht erkannt....
Er sah nach dem " Black Monday " und den Zahlen auch damals keinen Anlass einzusteigen....
....jetzt sieht er seine Chance...
...er will bei unserem " moneyship " ELAN dabei sein.....
..dann soll er es halt tun.....
..wenn ich mir vorstellte, er würde noch einmal so richtig über ELAN lästern, dann würde ich " volle Pulle " nachkaufen.......
..aber ich denke, die Zeiten sind vorbei...
Grüße bernie55
Antwort auf Beitrag Nr.: 30.015.893 von Holgus am 19.06.07 11:50:39Als Typ ist er mir auch schon total unsympathisch
Yepp....mir auch, aber ich würde ihm trotzdem keine Therapie bzw. Schönheitsoperation bezahlen....
Yepp....mir auch, aber ich würde ihm trotzdem keine Therapie bzw. Schönheitsoperation bezahlen....
Warum habe ich damals nicht auf die WO Leute gehört ?????
....ich , Blödel....
Antwort auf Beitrag Nr.: 30.016.511 von bernie55 am 19.06.07 12:21:00Bernie Du bist `ne Knalltüte ... könnt piepen
Dank Dir für Deine überzeugende Unterstützung.
Dank Dir für Deine überzeugende Unterstützung.
Wie Biermann schon vor Jahren bemerkte:Ab 30 ist man für sein Gesicht selber verantwortlich-----den Selbstdarsteller und Choleriker kann man(?)und frau(!)bei Cramer deutlich erkennen....aber er könnte uns trotzdem unsere Elanies für vielleicht 150$ abkaufen;ODER??
Longies, paßt mir auf Elan auf, bin für 3 Wochen im Roussion!
posimist
posimist
hallo leute
könnte mich mal einer kurz informieren wie es bei euerer elan derzeit aussachut und welche news und welche perspektiven ihr seht
DANKE
könnte mich mal einer kurz informieren wie es bei euerer elan derzeit aussachut und welche news und welche perspektiven ihr seht
DANKE
Ty in 6/21 issue of NEW ENGL J of MEDICINE
Eight page article that reviews the use of Ty in treating MS. Article begins with a clinical vignette about a 30 yr old women who was referred to an MS center for treatment with Ty. Thorough discussion of clinical trials showing Ty's effectiveness, indications in MS, TOUCH program, and the development of PML in 3 patients (2 w/MS) who were also being treating with interferon beta. Wonderful venue for Ty.
I imagine that neurologists will be more comfortable with Ty after having read this article.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…
Eight page article that reviews the use of Ty in treating MS. Article begins with a clinical vignette about a 30 yr old women who was referred to an MS center for treatment with Ty. Thorough discussion of clinical trials showing Ty's effectiveness, indications in MS, TOUCH program, and the development of PML in 3 patients (2 w/MS) who were also being treating with interferon beta. Wonderful venue for Ty.
I imagine that neurologists will be more comfortable with Ty after having read this article.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…
Antwort auf Beitrag Nr.: 30.069.145 von 24littlehours am 20.06.07 10:22:25könnte mich mal einer kurz informieren wie es bei euerer elan derzeit aussachut und welche news und welche perspektiven ihr seht
31 Juli - Experten der AC beraten über Tysabri für Behandlung von Morbus Crohn.
Empfehlung auf Zulassung von Tysabri zur Behandlung von MC wird hoffentlich ausgesprochen...
AAB 001 - Medikament zur Behandlung von Alsheimer- geplante ZULA 2010
Jedoch geht das Gerücht rum, dass die Daten aus Phase II sehr spektakulär sein sollen.
Mögliche Zula mit Phase II Daten 2008/2009 ?????
..das wäre der Oberhammer...
Grüße , auf die schnelle...
bernie55
31 Juli - Experten der AC beraten über Tysabri für Behandlung von Morbus Crohn.
Empfehlung auf Zulassung von Tysabri zur Behandlung von MC wird hoffentlich ausgesprochen...
AAB 001 - Medikament zur Behandlung von Alsheimer- geplante ZULA 2010
Jedoch geht das Gerücht rum, dass die Daten aus Phase II sehr spektakulär sein sollen.
Mögliche Zula mit Phase II Daten 2008/2009 ?????
..das wäre der Oberhammer...
Grüße , auf die schnelle...
bernie55
Antwort auf Beitrag Nr.: 30.073.428 von bernie55 am 20.06.07 14:12:13Beginn der 3. Klinischen Phase bezüglich Alsheimer ist in der zweiten Hälfte des Jahres 2007 geplant..
Antwort auf Beitrag Nr.: 30.073.428 von bernie55 am 20.06.07 14:12:13herzlichen dank lieber bernie grazie ich denke ich steige hier mal wieder zu die nächsten tage
Antwort auf Beitrag Nr.: 30.073.576 von 24littlehours am 20.06.07 14:19:54....just do it...
Antwort auf Beitrag Nr.: 30.073.521 von bernie55 am 20.06.07 14:17:12Also doch keine frühere Zulassung?
Antwort auf Beitrag Nr.: 30.074.345 von moneyseeker am 20.06.07 14:57:55die zweite Hälfte 2007 beginnt bereits in 10 Tagen.
Mal ein kurzes "HALLO"-muss im Moment auch mal arbeiten...
Guten Morgen alle miteinander,
gestern Abend ist der Kurs ja dann doch noch einmal runter gegangen. Interessant dabei, dass dieses bei ELAN und bei DENDREON geschehen ist.
gestern Abend ist der Kurs ja dann doch noch einmal runter gegangen. Interessant dabei, dass dieses bei ELAN und bei DENDREON geschehen ist.
hat Cyberhexe Ihre Depots gelöscht?
Antwort auf Beitrag Nr.: 30.086.377 von Poppholz am 21.06.07 08:39:15NO !!!
Antwort auf Beitrag Nr.: 30.074.345 von moneyseeker am 20.06.07 14:57:55Also doch keine frühere Zulassung?
@moneyseeker
...es scheint, dass die Daten aus den aktuell laufenden Phase II Studien durchaus vielversprechende Ergebnisse aufzeigen.Deshalb auch der Start der Phase III im zweiten Halbjahr 2007.
Sollten möglicherweise die Phase II Daten " spektakulär " sein , ist eine Zulassung auf Basis dieser Phase-II-Studien durchaus denkbar!!
Also..... die Möglichkeit einer früheren Zulassung von AAB-001 wird durch den Beginn der Phase III Studie nicht ausgeschlossen.
Grüße
bernie55
@moneyseeker
...es scheint, dass die Daten aus den aktuell laufenden Phase II Studien durchaus vielversprechende Ergebnisse aufzeigen.Deshalb auch der Start der Phase III im zweiten Halbjahr 2007.
Sollten möglicherweise die Phase II Daten " spektakulär " sein , ist eine Zulassung auf Basis dieser Phase-II-Studien durchaus denkbar!!
Also..... die Möglichkeit einer früheren Zulassung von AAB-001 wird durch den Beginn der Phase III Studie nicht ausgeschlossen.
Grüße
bernie55
Antwort auf Beitrag Nr.: 30.088.764 von bernie55 am 21.06.07 10:53:11danke
Antwort auf Beitrag Nr.: 30.091.338 von moneyseeker am 21.06.07 13:02:41....never mind....
...die letzte Ankündigung , von keinen weiteren PML Fälle in Zuammenhang mit Ty als Monotherapie, könnte sich auch auf das prozentuale PML Risiko Verhältnis auswirken.
Tysabri PML risk.
"But a third study reviewing records of more than 3,100 patients who received Tysabri in clinical trials found no new cases of PML beyond the three that had already been reported. The estimated risk for PML was about one in 1,000 patients treated with Tysabri for a mean of 17.9 months, wrote Eugene O. Major Ph.D., of the National Institute of Neurological Disorders and Stroke in Bethesda, Md., and colleagues in the United States and Europe."
That's where the AC got the 1:1000 number. Those calculations were based upon available data at the time. I had a friend who is dynamic with numbers, update the calculation. BIIB will most certainly try this on July 31st. That's the reason they have Biostatisticians on the payroll.
In our opinion, the current risk of a PML event with Tysabri stands at something like 1:5500 @ 17.9 months mean.
We will hear more about this very soon....
http://www.investorvillage.com/smbd.asp?mb=160&mn=121936&pt=…
Tysabri PML risk.
"But a third study reviewing records of more than 3,100 patients who received Tysabri in clinical trials found no new cases of PML beyond the three that had already been reported. The estimated risk for PML was about one in 1,000 patients treated with Tysabri for a mean of 17.9 months, wrote Eugene O. Major Ph.D., of the National Institute of Neurological Disorders and Stroke in Bethesda, Md., and colleagues in the United States and Europe."
That's where the AC got the 1:1000 number. Those calculations were based upon available data at the time. I had a friend who is dynamic with numbers, update the calculation. BIIB will most certainly try this on July 31st. That's the reason they have Biostatisticians on the payroll.
In our opinion, the current risk of a PML event with Tysabri stands at something like 1:5500 @ 17.9 months mean.
We will hear more about this very soon....
http://www.investorvillage.com/smbd.asp?mb=160&mn=121936&pt=…
Pre-Market
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Antwort auf Beitrag Nr.: 30.094.001 von bernie55 am 21.06.07 15:21:0513:30:54 15,06 1200
13:30:44 15,05 1000
...0,50 € unter pari verkauft.....das soll einer verstehen....
13:30:44 15,05 1000
...0,50 € unter pari verkauft.....das soll einer verstehen....
Antwort auf Beitrag Nr.: 30.094.284 von bernie55 am 21.06.07 15:32:26gut dass es Doofe gibt--denen können wir die Schätzchen abkaufen...Wir sind GRÜN in Amiland....
Ich habe gerade 10kg Paprika in FEINE Streifen geschnitten....GRRRHHH...
Ich habe gerade 10kg Paprika in FEINE Streifen geschnitten....GRRRHHH...
Antwort auf Beitrag Nr.: 30.095.768 von Birgit.Tersteegen am 21.06.07 16:31:32Ich habe gerade 10kg Paprika in FEINE Streifen geschnitten....GRRRHHH
...back to the roots, Birgit.....
...back to the roots, Birgit.....
...so jetzt gehts auf die Piste.....haltet die Stellung....bis denn....
Antwort auf Beitrag Nr.: 30.095.768 von Birgit.Tersteegen am 21.06.07 16:31:32was gibts denn?
Antwort auf Beitrag Nr.: 30.096.316 von moneyseeker am 21.06.07 16:57:06Ein Buffet für 80 peoples....
ELN is Ken Kam's #1 Pick for the Remainder of 2007! Great article
http://www.bloggingstocks.com/2007/06/21/top-20-advisors-ken…
Top 20 advisors: Ken Kam boosts Elan
Posted Jun 21st 2007 1:50PM by Steven Halpern
Filed under: Newsletters, Top Picks 2007
Last December, over 100 stocks were featured in our Top Picks for 2007 report. Now, at mid-year, we turn to the 20 advisors whose picks showed the strongest gains to get an update on their previous picks, as well as a new favorite stock for the second half of the year.
Ken Kam, editor of Marketscope, chose two stocks in the Top Picks for 2007 report and both picks qualified him for our Top 20 Advisors. His selection of Valero Energy Corp. (NYSE: VLO) rose 48%. Here is his original recommendation for Valero and his current opinion on the stock.
In addition, Ken also picked Elan Corp. (NYSE: ELN) in our Top Picks 2007 report and its gain of 35% also qualifies among our Top 20 Advisors. Now, he is now re-recommending the shares as his current favorite for the balance of 2007.
The advisor explains, "Elan has been strong on rumors that Biogen (NASDAQ: BIIB) -- Elan's 50% partner for its multiple sclerosis drug Tysabri -- is interested in acquiring the company. Elan has also show recent strength on news that the company's Alzheimer's drug (AAB-001), which is partnered with Wyeth (NYSE: WYE), is being advanced to Phase 3 trials.
"When a stock makes a big move in a short period, there is a tremendous temptation to sell and 'lock in profits.' However, when the price move is accompanied with good news, the initial bump may be the start of a major move up. If you are too quick on the trigger, you may miss the bigger, longer term.
"As to the Biogen story, I never trade just because of a rumor. However, I'd note that the majority of Biogen's sales comes from Avonex, a multiple sclerosis drug that competes with Tysabri. Biogen gets 50% of Tysabri sales, but Tysabri's price is just about double that of Avonex.
"Therefore, as things stand today, whether an MS patient uses Avonex or Tysabri, Biogen gets the same revenue. If Biogen were to acquire Elan, however, a patient that switches from Avonex to Tysabri would generate twice as much revenue for Biogen.
"And, patients who switch to Tysabri from any other drug would have double the impact on Biogen's sales than they do now. In short, this acquisition can make a lot of sense for Biogen especially if its done before Tysabri sales ramp up.
"The main problem I see is that it would be a big acquisition for Biogen whose market cap is $16 billion -- roughly double Elan's. But, interest rates are low, and capital seems to be available to do deals of this size. If a deal is done, however, I suspect that it will involve Wyeth because of its involvement with Elan's Alzheimer's drug. That's why today's news on AAB-001 is so interesting.
"No Phase 2 results have yet been announced, but I infer that both companies must believe that the results are going to be positive or they would not be willing to spend the millions of dollars its going to cost to run the Phase 3 trial.
"A successful Alzheimer's drug would be a home run for Elan. About 18 million people worldwide currently have Alzheimer's, compared to 2 million who have multiple sclerosis. Judging just from the number of patient's, AAB-001's potential may be almost 10 times bigger than Tysabri's.
"That's why I think that if a deal to acquire Elan is in the works, it probably involves Wyeth as well as Biogen. A deal in which Wyeth ends up with 100% of AAB-001, and Biogen ends up with 100% of Tysabri makes a lot more sense than Biogen acquiring all of Elan on its own.
"Bottom line, I cannot be sure, but there may be some truth behind the rumors. In the meantime, I suspect that many people will decide to sell to lock in the strong recent gains. I would not be surprised if the stock gave back half of its recent rise. If it does, I'll be buying more."
http://www.bloggingstocks.com/2007/06/21/top-20-advisors-ken…
Top 20 advisors: Ken Kam boosts Elan
Posted Jun 21st 2007 1:50PM by Steven Halpern
Filed under: Newsletters, Top Picks 2007
Last December, over 100 stocks were featured in our Top Picks for 2007 report. Now, at mid-year, we turn to the 20 advisors whose picks showed the strongest gains to get an update on their previous picks, as well as a new favorite stock for the second half of the year.
Ken Kam, editor of Marketscope, chose two stocks in the Top Picks for 2007 report and both picks qualified him for our Top 20 Advisors. His selection of Valero Energy Corp. (NYSE: VLO) rose 48%. Here is his original recommendation for Valero and his current opinion on the stock.
In addition, Ken also picked Elan Corp. (NYSE: ELN) in our Top Picks 2007 report and its gain of 35% also qualifies among our Top 20 Advisors. Now, he is now re-recommending the shares as his current favorite for the balance of 2007.
The advisor explains, "Elan has been strong on rumors that Biogen (NASDAQ: BIIB) -- Elan's 50% partner for its multiple sclerosis drug Tysabri -- is interested in acquiring the company. Elan has also show recent strength on news that the company's Alzheimer's drug (AAB-001), which is partnered with Wyeth (NYSE: WYE), is being advanced to Phase 3 trials.
"When a stock makes a big move in a short period, there is a tremendous temptation to sell and 'lock in profits.' However, when the price move is accompanied with good news, the initial bump may be the start of a major move up. If you are too quick on the trigger, you may miss the bigger, longer term.
"As to the Biogen story, I never trade just because of a rumor. However, I'd note that the majority of Biogen's sales comes from Avonex, a multiple sclerosis drug that competes with Tysabri. Biogen gets 50% of Tysabri sales, but Tysabri's price is just about double that of Avonex.
"Therefore, as things stand today, whether an MS patient uses Avonex or Tysabri, Biogen gets the same revenue. If Biogen were to acquire Elan, however, a patient that switches from Avonex to Tysabri would generate twice as much revenue for Biogen.
"And, patients who switch to Tysabri from any other drug would have double the impact on Biogen's sales than they do now. In short, this acquisition can make a lot of sense for Biogen especially if its done before Tysabri sales ramp up.
"The main problem I see is that it would be a big acquisition for Biogen whose market cap is $16 billion -- roughly double Elan's. But, interest rates are low, and capital seems to be available to do deals of this size. If a deal is done, however, I suspect that it will involve Wyeth because of its involvement with Elan's Alzheimer's drug. That's why today's news on AAB-001 is so interesting.
"No Phase 2 results have yet been announced, but I infer that both companies must believe that the results are going to be positive or they would not be willing to spend the millions of dollars its going to cost to run the Phase 3 trial.
"A successful Alzheimer's drug would be a home run for Elan. About 18 million people worldwide currently have Alzheimer's, compared to 2 million who have multiple sclerosis. Judging just from the number of patient's, AAB-001's potential may be almost 10 times bigger than Tysabri's.
"That's why I think that if a deal to acquire Elan is in the works, it probably involves Wyeth as well as Biogen. A deal in which Wyeth ends up with 100% of AAB-001, and Biogen ends up with 100% of Tysabri makes a lot more sense than Biogen acquiring all of Elan on its own.
"Bottom line, I cannot be sure, but there may be some truth behind the rumors. In the meantime, I suspect that many people will decide to sell to lock in the strong recent gains. I would not be surprised if the stock gave back half of its recent rise. If it does, I'll be buying more."
Antwort auf Beitrag Nr.: 30.102.895 von Birgit.Tersteegen am 21.06.07 22:14:56Doofe Frage:
Ist eine (frühe) Übernahme von Elan nicht eher ungünstig, da dann die erwartette Kursteigerung nicht mehr stattfindet?
Ist eine (frühe) Übernahme von Elan nicht eher ungünstig, da dann die erwartette Kursteigerung nicht mehr stattfindet?
Antwort auf Beitrag Nr.: 30.141.454 von moneyseeker am 22.06.07 09:19:25...also, wenn Übernahme, dann müssten meiner Meinung nach die imaginären " homerun " Prozente für AAB-001 in irgendeiner Form berücksichtigt werden.....
....sprich für die Übernahme müsste wesentlich tiefer in die Tasche gegriffen werden.....
...aber zu welchem Preis ?????
.....zum aktuellen Zeitpunkt sind meine ELAN Aktien unverkäuflich.......
..aber ich lass natürlich gerne mit mir reden....
....sprich für die Übernahme müsste wesentlich tiefer in die Tasche gegriffen werden.....
...aber zu welchem Preis ?????
.....zum aktuellen Zeitpunkt sind meine ELAN Aktien unverkäuflich.......
..aber ich lass natürlich gerne mit mir reden....
Antwort auf Beitrag Nr.: 30.102.895 von Birgit.Tersteegen am 21.06.07 22:14:56"No Phase 2 results have yet been announced, but I infer that both companies must believe that the results are going to be positive or they would not be willing to spend the millions of dollars its going to cost to run the Phase 3 trial.
...also diese Aussage bestätigt auch mein Posting #15467 ......
KURZUM:
...denn sie wissen , was sie tun...
...also diese Aussage bestätigt auch mein Posting #15467 ......
KURZUM:
...denn sie wissen , was sie tun...
Antwort auf Beitrag Nr.: 30.142.151 von bernie55 am 22.06.07 09:47:28.....zum aktuellen Zeitpunkt sind meine ELAN Aktien unverkäuflich.......
..aber ich lass natürlich gerne mit mir reden....
...natürlich nur in Absprache mit dem PBB Vorstand....
..aber ich lass natürlich gerne mit mir reden....
...natürlich nur in Absprache mit dem PBB Vorstand....
ALLGEMEINE INFOS zur Zulassung neuer Arzneien
22.06.2007 - 09:28 Uhr
FTD: Das kann ja heiter werden
Die Zulassung neuer Arzneien ist für die Pharmabranche längst keine Kleinigkeit mehr. Regelmäßig lassen die Behörden Hoffnungsträger durchfallen und Börsenträume platzen. Künftig kommt es noch dicker.
Sanofi-Aventis ist fassungslos über die Ablehnung seiner Diätpille Acomplia bei der US-Behörde FDA. Begründung: psychische Nebenwirkungen.
GlaxoSmithKline fürchtet das Aus für das umsatzstarke Diabetesmittel Avandia. Risiko: Herzinfarkt.
Das neue Krebsmittel Vectibix vom weltgrößten Biotechkonzern Amgen findet nicht den Zuspruch der Kontrolleure bei der EU-Behörde Emea. Erklärung: Wirksamkeit zweifelhaft.
Drei Beispiele aus der jüngsten Vergangenheit - eine gemeinsame Wirkung: Aufruhr an der Börse. Die Aktienkurse der betreffenden Konzerne sackten nacheinander auf ein Zweijahrestief. Allen Beteiligten, den Managern, Analysten und Kontrolleuren steckt noch der Skandal um das Schmerzmittel Vioxx in den Knochen. Die Folge für den Hersteller Merck & Co. sowie die Branche waren Tausende Schadensersatzklagen, Imagekrisen und Milliardenverluste. Das mahnte zur Vorsicht. Im Jahr drei nach Vioxx zieht die Politik auf beiden Seiten des Atlantiks die Zügel nun noch fester an.
So feilten am Donnerstag in Washington US-Senatoren an letzten Details für ein Gesetz, das der FDA mehr Einfluss und Geld für zusätzliche Sicherheitskontrollen von Medikamenten gibt. Dazu zahlt die Industrie an die FDA Gebühren von rund 400 Mio. $ jährlich, weitere 225 Mio. $ bringt sie in den kommenden fünf Jahren für die FDA-Observierung von Neueinführungen auf. "Die Nation hat aus den Sicherheitsproblemen mit dem Diabetesmedikament Avandia gelernt", sagte der Vorsitzende des Kongressausschusses, John Dingell, vor wenigen Tagen. Zudem können Verstöße gegen Marketing- und Sicherheitsauflagen mit bis zu 100 Mio. $
Strafe geahndet werden.
Und auch die Emea kann nun härter durchgreifen. Die EU-Kommission hat am 15. Juni eine Verordnung in Kraft gesetzt die Verstöße gegen Emea-Regeln mit hohen Geldbußen ahndet - etwa, wenn Firmen Vorgaben ihrer Arzneimittelzulassungen nicht einhalten, Informationen zur Risikobewertung ihrer Produkte zurückhalten oder deren Nebenwirkungen gar nicht oder erst sehr spät melden.
"Sehr harte Sanktionen"
Die Höchstgrenze der Geldbußen liegt bei fünf Prozent des Jahresumsatzes des betroffenen Zulassungsinhabers. Zulassungsinhaber kann auch eine Konzerntochter sein. "Das dürfte zu ungerechten Bestrafungen führen", sagte Unternehmensanwalt Uwe Fröhlich vom Pharmakonzern Baxter. "Zufälligerweise oder sogar absichtlich kann ein besonders umsatzstarker oder umsatzschwacher Teil eines Konzerns Inhaber der Zulassung sein. Ein Schlupfloch könnten auch Vermarktungspartnerschaften unabhängiger Unternehmen bieten, von denen nur eines die Zulassung hält." Gerechter sei es, die Buße am EU-weiten Umsatz der Arznei festzumachen. "Das sind alles in allem sehr harte Sanktionen", sagt Anwalt Jörg Schickert von der Kanzlei Lovells in München. Er findet manches an der Verordnung unausgereift. "Es gibt noch Schwachstellen, darunter die Frage, wie die Abgrenzung zwischen einzelstaatlichen Strafmaßnahmen und EU-weiten Sanktionen geregelt werden soll."
Das für Zulassungen zuständige Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) habe in der jüngeren Vergangenheit einige Straf- und Bußgeldverfahren eingeleitet, mit unterschiedlichem Ausgang entsprechend der Beweislage, heißt es auf Anfrage. "Ob es in Zukunft wichtiger sein wird, derartige Instrumentarien zur Verfügung zu haben, lässt sich nur schwer einschätzen", so das BfArM. Die im Arzneimittelgesetz für Ordnungswidrigkeiten vorgesehenen Bußgelder von maximal 25.000 Euro seien vergleichsweise gering.
Die Verordnung (EG) 658/2007 zur Auferlegung von Geldbußen durch die Kommission ist ein neuartiges Sanktionsmittel, das es für von der Emea zugelassene Arzneimittel bislang noch nicht gab. "Die Industrie sollte schnellstmöglich alle Schwachstellen abklopfen und Verfahren aufsetzen, die zukünftig Verstöße vermeiden. Dies sollte auch dokumentiert werden", sagte der Anwalt Schickert.
Emea-Chef Thomas Lönngren zumindest will nie mehr einen Tag wie den 30. September 2004 erleben: Weder der Vioxx-Hersteller Merck & Co. noch die FDA-Kollegen hatten ihn frühzeitig über den geplanten Rückruf der Schmerzpille informiert. Die Börse wusste früher Bescheid als er. "Wir wollen von Konzernen so schnell wie möglich informiert werden", sagte er.
Autor/Autoren: Peter Kuchenbuch
http://www.finanztreff.de/ftreff/news.htm?sektion=topthemen&…
22.06.2007 - 09:28 Uhr
FTD: Das kann ja heiter werden
Die Zulassung neuer Arzneien ist für die Pharmabranche längst keine Kleinigkeit mehr. Regelmäßig lassen die Behörden Hoffnungsträger durchfallen und Börsenträume platzen. Künftig kommt es noch dicker.
Sanofi-Aventis ist fassungslos über die Ablehnung seiner Diätpille Acomplia bei der US-Behörde FDA. Begründung: psychische Nebenwirkungen.
GlaxoSmithKline fürchtet das Aus für das umsatzstarke Diabetesmittel Avandia. Risiko: Herzinfarkt.
Das neue Krebsmittel Vectibix vom weltgrößten Biotechkonzern Amgen findet nicht den Zuspruch der Kontrolleure bei der EU-Behörde Emea. Erklärung: Wirksamkeit zweifelhaft.
Drei Beispiele aus der jüngsten Vergangenheit - eine gemeinsame Wirkung: Aufruhr an der Börse. Die Aktienkurse der betreffenden Konzerne sackten nacheinander auf ein Zweijahrestief. Allen Beteiligten, den Managern, Analysten und Kontrolleuren steckt noch der Skandal um das Schmerzmittel Vioxx in den Knochen. Die Folge für den Hersteller Merck & Co. sowie die Branche waren Tausende Schadensersatzklagen, Imagekrisen und Milliardenverluste. Das mahnte zur Vorsicht. Im Jahr drei nach Vioxx zieht die Politik auf beiden Seiten des Atlantiks die Zügel nun noch fester an.
So feilten am Donnerstag in Washington US-Senatoren an letzten Details für ein Gesetz, das der FDA mehr Einfluss und Geld für zusätzliche Sicherheitskontrollen von Medikamenten gibt. Dazu zahlt die Industrie an die FDA Gebühren von rund 400 Mio. $ jährlich, weitere 225 Mio. $ bringt sie in den kommenden fünf Jahren für die FDA-Observierung von Neueinführungen auf. "Die Nation hat aus den Sicherheitsproblemen mit dem Diabetesmedikament Avandia gelernt", sagte der Vorsitzende des Kongressausschusses, John Dingell, vor wenigen Tagen. Zudem können Verstöße gegen Marketing- und Sicherheitsauflagen mit bis zu 100 Mio. $
Strafe geahndet werden.
Und auch die Emea kann nun härter durchgreifen. Die EU-Kommission hat am 15. Juni eine Verordnung in Kraft gesetzt die Verstöße gegen Emea-Regeln mit hohen Geldbußen ahndet - etwa, wenn Firmen Vorgaben ihrer Arzneimittelzulassungen nicht einhalten, Informationen zur Risikobewertung ihrer Produkte zurückhalten oder deren Nebenwirkungen gar nicht oder erst sehr spät melden.
"Sehr harte Sanktionen"
Die Höchstgrenze der Geldbußen liegt bei fünf Prozent des Jahresumsatzes des betroffenen Zulassungsinhabers. Zulassungsinhaber kann auch eine Konzerntochter sein. "Das dürfte zu ungerechten Bestrafungen führen", sagte Unternehmensanwalt Uwe Fröhlich vom Pharmakonzern Baxter. "Zufälligerweise oder sogar absichtlich kann ein besonders umsatzstarker oder umsatzschwacher Teil eines Konzerns Inhaber der Zulassung sein. Ein Schlupfloch könnten auch Vermarktungspartnerschaften unabhängiger Unternehmen bieten, von denen nur eines die Zulassung hält." Gerechter sei es, die Buße am EU-weiten Umsatz der Arznei festzumachen. "Das sind alles in allem sehr harte Sanktionen", sagt Anwalt Jörg Schickert von der Kanzlei Lovells in München. Er findet manches an der Verordnung unausgereift. "Es gibt noch Schwachstellen, darunter die Frage, wie die Abgrenzung zwischen einzelstaatlichen Strafmaßnahmen und EU-weiten Sanktionen geregelt werden soll."
Das für Zulassungen zuständige Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) habe in der jüngeren Vergangenheit einige Straf- und Bußgeldverfahren eingeleitet, mit unterschiedlichem Ausgang entsprechend der Beweislage, heißt es auf Anfrage. "Ob es in Zukunft wichtiger sein wird, derartige Instrumentarien zur Verfügung zu haben, lässt sich nur schwer einschätzen", so das BfArM. Die im Arzneimittelgesetz für Ordnungswidrigkeiten vorgesehenen Bußgelder von maximal 25.000 Euro seien vergleichsweise gering.
Die Verordnung (EG) 658/2007 zur Auferlegung von Geldbußen durch die Kommission ist ein neuartiges Sanktionsmittel, das es für von der Emea zugelassene Arzneimittel bislang noch nicht gab. "Die Industrie sollte schnellstmöglich alle Schwachstellen abklopfen und Verfahren aufsetzen, die zukünftig Verstöße vermeiden. Dies sollte auch dokumentiert werden", sagte der Anwalt Schickert.
Emea-Chef Thomas Lönngren zumindest will nie mehr einen Tag wie den 30. September 2004 erleben: Weder der Vioxx-Hersteller Merck & Co. noch die FDA-Kollegen hatten ihn frühzeitig über den geplanten Rückruf der Schmerzpille informiert. Die Börse wusste früher Bescheid als er. "Wir wollen von Konzernen so schnell wie möglich informiert werden", sagte er.
Autor/Autoren: Peter Kuchenbuch
http://www.finanztreff.de/ftreff/news.htm?sektion=topthemen&…
um 18:30 mit ca. 275.000 Stücken den Kurs gedrückt?
Hi Ihr Lieben!
Ich hoffe,Ihr hattet ein schönes WE--Ich hatte es: Kino,Entspannen am Fluss,Krimi lesen,kollektives Singen etc...
Im IV-Board ein guter Artikel über die Geschichte von Elan...
Msg: 122722 of 122730 6/24/2007 2:03:56 PM
By: huntsmann_ie
Repost of B&F article which new Elan investors should like.
Title: Elan reborn – the drug company as Lazarus
Subheading: CEO Kelly Martin is happy to have Elan back on its feet but his work is far from done, he tells Fearghal O’Connor. Could 2007 be the year that the drug company finally delivers on its potential?
More than anything, Multiple Sclerosis (MS) sufferers fear their next relapse. In some cases each relapse leaves a person weaker than before, taking away something forever – the sight in their left eye, the feeling in their right arm or maybe the ability to stand up.
It could be said that in recent years Elan has suffered from a case of corporate MS. In 2001 it appeared to be in its prime, a young, healthy company with a bright future ahead. But over the next number of years, it suffered crisis after crisis. Each attack left it weaker and even when it appeared to be getting back on its feet, a relapse seemed never far away. Its share price peaked and troughed like a heart monitor.
But just as MS sufferers have clung to the hope of Tysabri, so too did Elan. Unlike any other currently available MS drug, Elan’s Tysabri can halt future relapses for a large percentage of sufferers of the disease. While there are still issues to overcome, the drug finally reached the end of its tortuous run to market last July and may now be capable of bringing some measure of relief to many MS sufferers as well as to the company’s long-suffering shareholders.
Added to the fact that the company’s much-heralded work on Alzheimer’s disease looks likely to move a step closer to reality, the successful roll-out of Tysabri means 2007 could finally be the year that Elan is cured of its troubled past. If that proves to be the case, Kelly Martin deserves much of the praise.
Following a successful career at Merrill Lynch where he was president of the Private Client Group, he took the job as Elan’s chief executive at a time when the company was in freefall and many others would not have touched the job.
“As a non-medical or scientific person, if I can help bring the science to the patients in the areas in which we work – for example, MS, Alzheimer’s, Crohn’s or Parkinson’s – it is a unique opportunity to really feel like I have done something significant in my life,” he says.
Arguably, what Kelly Martin has achieved in his four years as chief executive goes well beyond significant. He has resuscitated a company that looked destined to be broken up and sold off in bits and pieces.
“I couldn’t say that I have done an amazing job because we are not finished. You can’t put a grade on the performance until we are further along,” he says.
No doubt his cautious approach to praise is partly informed by previous experience that nothing is certain when you are trying to bring a significant new drug to market.
At the end of 2004, Elan looked as if its rehabilitation was complete. Its MS drug Tysabri had finally been launched and the company’s share price was once again heading skyward after plummeting to unfathomable depths.
Within 10 weeks of its launch, there were 5,000 patients on Tysabri and another 25,000 in the queue. In revenue terms, Elan was looking at a billion-dollar blockbuster.
“The drug had blown away any expectations there had been as far as efficacy and market potential,” says Martin. “We couldn’t believe the data on Tysabri. It was so strong, it was incredible.”
But then disaster struck once again. Three patients on Elan’s Tysabri trial were confirmed to have a rare disease of the central nervous system called PML. Two of the patients died and, although demand for the drug was shooting up, it had to be taken off the market. Once again, Elan’s share price dived.
“We had done thousands of studies about what adverse effects there could be, and PML had never even been on thelist. It was a real left hook. You couldn’t draw conclusions on why it happened. There were tens of thousands of patients queuing up to take the drug but we couldn’t play God and do Russian roulette and say ‘take it and we will figure it out later’. We knew it would kill the stock price but we wanted to protect the patients and protect the drug because the drug can save the lives of these patients. We had to take the drug off the market.”
It was not until August 2006 that Tysabri finally returned to the market – this time with a strict set of new guidelines from the US and European regulators. While there have been no further cases of PML – it is believed to be a risk only for a very small subsection of patients – there is still some apprehension around the drug among both neurologists who have not used the drug before and investors considering putting their money into Elan. But it is likely to be the MS patients themselves who will drive demand.
“The longer we go without any PML issues or other adverse events, the more the patients will choose Tysabri over other therapies because the difference between Tysabri’s efficacy and current therapies’ efficacy is gigantic,” says Martin.
“After PML, people believed that the only people who would now take Tysabri were patients on their last gasp who had quit all other therapy because it had not worked. But 75% of the patients moving to Tysabri are coming from other therapies. This is very consistent with the fact that 70% to 75% of patients find that the other available therapies fail and that they continue to decline. To me, that is the most important number with regard to Tysabri and it could mean that the market opportunity for this drug is up to 500,000 patients.”
This figure pales into insignificance when set beside the market potential of Elan’s other area of expertise – Alzheimer’s disease. It is estimated that there are currently 18 million Alzheimer’s sufferers, and with the baby boomer generation moving into its 60s, analysts believe there could be nearly 50 million sufferers worldwide by 2020, just 13 years away. Success in this area could utterly transform Elan.
“We, along with our partners in this area, Wyeth, are the only company in the world that has three different approaches to Alzheimer’s that are all disease-modifying. It is very complicated, very exciting and – on the human scale – somebody needs to crack this code because it is truly an epidemic.”
Currently most interest is focused on the drug known as AAB001, which is undergoing Phase 2 trials. The limited data available on it suggests it has huge potential, and analysts are hopeful that the company will announce that it is moving to the final Phase 3 trials during the first quarter of this year. Indeed, the company’s share price is likely to suffer if news on this is not forthcoming, as AAB001 is viewed as something of a test case for Elan’s entire approach to Alzheimer’s. Nevertheless, Kelly Martin is determined not to be rushed by such expectations.
“The decision to move from Phase 2 to Phase 3 is a large one because we have responsibilities to the patients. If you publicly announce that you are at the last stage of a disease-modifying therapy for Alzheimer’s, first you better be really sure that you are. And second, you better be ready to handle hundreds of thousands of calls and enquiries from people wanting to get their loved ones into the trial and onto the drug. That is a big social responsibility. We have had 15 to 20 years of work on this. The data will tell us whether we can move from Phase 2 to Phase 3 in February, July or next November. It might feel like a big deal in the short term but we have come very far and the responsibility is awful big. For the sake of a few weeks or months, let’s not screw it up.”
Unfortunately, in the wake of Elan’s meltdown in 2002, most observers lost confidence in the company and many skeptics still exist. However, Martin is adamant that the one place that their standing wasn’t damaged was where it really matters – with the US Food and Drug Administration (FDA) and its regulatory equivalent in Europe, the European Agency for the Evaluation of Medicinal Products (EMEA). With few other companies so far advanced in tackling devastating auto-immune diseases such as Alzheimer’s, MS and Parkinson’s, Martin believes that the regulators were more interested in the science than the business story.
“They are human, they read the newspapers,” he says. “But through all of the challenges, we always funded the scientific pipeline. The science is the most unique thing we have in Elan. I’m sure the FDA as individuals read the paper and I’m sure at times when they were meeting us they were aware that we were having issues but the meetings were always about the science. I don’t think those other issues had any impact on their assessment of our programmes at all. Nor should it.”
But Martin is also well-aware – and no doubt it informs his current caution- that Elan’s troubles were linked to problems with the science. As well as the corporate governance issues that dogged the company in 2001, it was the failure in January 2002 to complete clinical trials of its original Alzheimer’s compound, AN1792, that finally caused the share price to implode, eventually falling from over $60 to just over $1.
“A lot of things didn’t pan out,” he says. “That is part of the business- science is unpredictable. That is why this business is so interesting. It isn’t like building condominiums. The science is particularly complicated because, at the end of the day, your market place are human beings so you can’t afford to have faulty products and do recalls. Expectations were very high that Elan was going to cure Alzheimer’s. If you cure Alzheimer’s, you are going to create a lot of shareholder value but you are also going to have a huge impact on society. So there was an expectation, internal and external, that this was really working. But part of that expectation was that the science was just going to keep going forever with no issues and no challenges. That was unrealistic.”
Unfortunately for the company, the first dent in these expectations came just as Enron and Worldcom were focusing attention like never before on accounting issues. Elan’s aggressive use of its Irish tax status and its use of financial engineering to grow the company left it wide open for a fall. While this predates Martin’s time with the company, he believes there was a strategic logic to what the then Elan management was trying to achieve with its heavily criticized strategy of forming joint ventures with a large number of smaller companies.
“If you owned a small start-up oncology company with 20 scientists, Elan would help fund part of your research and, in return, it got certain options on your science. That was completely logical. That was the end and the means to get there was the financial structure. But I think as Elan kept growing there was a loss in recognition as to what was the means and what was the end. Was the end to be involved with you and your company from an oncology “extension of our science’ point of view? If it was, great. But if the end was just to do a financial transaction to grow the company, that wasn’t the right direction. I think the philosophy was completely logical and had strategic merit initially, but it went too far. At the end of the day, Elan became the main funder for 55 companies and it was too many things to manage. It was sort of like being a venture capital company to 55 companies. To do that, you need a staff of a few hundred people and the company was just not equipped to handle all of that. I think it was a very good logical extension to our science but it just went too far and then became impossible to really manage.”
He points out that a lot of big pharmaceutical companies still use similar methods today. However, these days the funding company will always insist on having a bigger input and oversight in the research, something Elan did not always do at the time.
“Elan’s management team was very smart and completely dedicated to growing Elan to be a global pharmaceutical company. But I think that the operational and governance ramifications of the expanse of the ambition got away from them. That often happens to visionary people with big ideas. You’ve got to make sure the plumbing works,” he says.
Looking on from the outside, Martin believed he could fix the business problems. He was heartened by the fact that most of Elan’s scientists stuck with the company despite the mounting problems.
“If I had actually put pencil to paper before I came to Elan and did the pros and cons, it wasn’t really a balanced scorecard. But opportunities don’t come up that often and you either take them or you don’t. I thought there was enough to Elan that we could make it work. Most people thought I was nuts. My colleagues at Merrill Lynch thought I was crazy. That was confirmatory evidence to me that this was exactly the right thing to be doing,” he laughs.
His first priority after taking the job was to plug the leaks. He implemented a recovery plan that involved selling off chunks of the business but stopped short of those pieces that now, four years later, look set to bear fruit.
“It was two-and-a-half years which felt like 25 years,” says Martin. “Our decisions were all geared towards Elan surviving as an entity, allowing what we believed to be very significant science to have an opportunity to live again.”
He is particularly proud of living up to his promise to a skeptical market in March 2005 that the company would be cashflow positive operationally (excluding the Tysabri roll-out) by the end of that year. Nevertheless, critics still question the amount of debt with which Elan is burdened – currently standing at about $1.2bn – and its ability to keep funding the development of an expensive pipeline. For his part, Martin believes that Elan now uses debt in a very productive manner that is new to the biotech industry.
“We just raised $615m at eight and seven-eights interest. The margin on our business is about 60%. If Tysabri and Prialt (a drug for the management of severe chronic pain) revenues start to go up, our margin is probably going to drift up beyond 80%. If I can borrow money at 8% and invest it at 60%, I am not sure that is that complicated. But people seem to be stunned by this because biotech traditionally doesn’t use debt. Rather than doing an equity issue at this time, we are balancing our cashflows with debt and keeping the pipeline moving along. We just refinanced our debt so we don’t have any principle payments until 2011. We have interest costs but we match them against the operating costs and against the cashflow we generate and we have $1b of cash on our balance sheet.”
Martin rejects the notion that, given its past history, there may be a certain nervousness in some quarters if Elan appears to be overly inventive with its balance sheet. “The toughest, most-sophisticated creditors around are willing to lend us up to $700m at lesss than 9%. They must have some confidence that we know what we are doing. I think it is actually pretty simple – we have cash, we have cashflow, we have operating liabilities and we have debt liabilities. To understand Elan that is all you really need to see. I don’t think it is that complicated. If people ask you the question as to why you are using debt, what they really want to know is what do you think of your equity. Because if we are issuing equity like there is no tomorrow, then we don’t think it has an upside and that is a big signal. But we do think there is a lot of upside in our equity so we don’t want to issue equity, at least at the moment. We don’t think that would be good for shareholders.”
He points out Elan’s shareholder register is also no longer dominated by hedgefunds. Large institutions now hold about 50% of the company, with the likes of Fidelity, Wellington and Standard Life all owning substantial chunks.
“The most important feedback I get on Elan’s performance is what our creditors and what our equity-holders think of us,” says Martin. “I think they are comfortable with what we are doing and how we are running it. The equity people expect equity value increases and the credit people expect operational discipline and focus from a cashflow point of view. If we can do both of those things, we will make everybody happy.”
If Elan also successfully delivers on its promise in the areas of MS, Alzheimer’s and Parkinson’s in particular, it will be more than just shareholders who will have something to smile about. 2007 should see a lot of questions answered one way or another in that regard. Kelly Martin has brought the company back to a point where it at least is able to give the science a fighting chance. Is he happy to settle in as a pharma CEO for the long term or will he move on and look for another company in distress to rescue?
“The only thing I think about is being in Elan and executing the plans that we have laid out,” he says. “I don’t think about what is beyond that. There are so many things in Elan to be accountable for and to be focused on that I don’t think about doing anything else. Does that mean I will do this for 25 more years? I don’t think so. But I think it is hard to put timelines on the goals and objectives that we have. If we do the things that we talk about today, that will be fantastic. It will be great to be part of that.” (END)
Ich hoffe,Ihr hattet ein schönes WE--Ich hatte es: Kino,Entspannen am Fluss,Krimi lesen,kollektives Singen etc...
Im IV-Board ein guter Artikel über die Geschichte von Elan...
Msg: 122722 of 122730 6/24/2007 2:03:56 PM
By: huntsmann_ie
Repost of B&F article which new Elan investors should like.
Title: Elan reborn – the drug company as Lazarus
Subheading: CEO Kelly Martin is happy to have Elan back on its feet but his work is far from done, he tells Fearghal O’Connor. Could 2007 be the year that the drug company finally delivers on its potential?
More than anything, Multiple Sclerosis (MS) sufferers fear their next relapse. In some cases each relapse leaves a person weaker than before, taking away something forever – the sight in their left eye, the feeling in their right arm or maybe the ability to stand up.
It could be said that in recent years Elan has suffered from a case of corporate MS. In 2001 it appeared to be in its prime, a young, healthy company with a bright future ahead. But over the next number of years, it suffered crisis after crisis. Each attack left it weaker and even when it appeared to be getting back on its feet, a relapse seemed never far away. Its share price peaked and troughed like a heart monitor.
But just as MS sufferers have clung to the hope of Tysabri, so too did Elan. Unlike any other currently available MS drug, Elan’s Tysabri can halt future relapses for a large percentage of sufferers of the disease. While there are still issues to overcome, the drug finally reached the end of its tortuous run to market last July and may now be capable of bringing some measure of relief to many MS sufferers as well as to the company’s long-suffering shareholders.
Added to the fact that the company’s much-heralded work on Alzheimer’s disease looks likely to move a step closer to reality, the successful roll-out of Tysabri means 2007 could finally be the year that Elan is cured of its troubled past. If that proves to be the case, Kelly Martin deserves much of the praise.
Following a successful career at Merrill Lynch where he was president of the Private Client Group, he took the job as Elan’s chief executive at a time when the company was in freefall and many others would not have touched the job.
“As a non-medical or scientific person, if I can help bring the science to the patients in the areas in which we work – for example, MS, Alzheimer’s, Crohn’s or Parkinson’s – it is a unique opportunity to really feel like I have done something significant in my life,” he says.
Arguably, what Kelly Martin has achieved in his four years as chief executive goes well beyond significant. He has resuscitated a company that looked destined to be broken up and sold off in bits and pieces.
“I couldn’t say that I have done an amazing job because we are not finished. You can’t put a grade on the performance until we are further along,” he says.
No doubt his cautious approach to praise is partly informed by previous experience that nothing is certain when you are trying to bring a significant new drug to market.
At the end of 2004, Elan looked as if its rehabilitation was complete. Its MS drug Tysabri had finally been launched and the company’s share price was once again heading skyward after plummeting to unfathomable depths.
Within 10 weeks of its launch, there were 5,000 patients on Tysabri and another 25,000 in the queue. In revenue terms, Elan was looking at a billion-dollar blockbuster.
“The drug had blown away any expectations there had been as far as efficacy and market potential,” says Martin. “We couldn’t believe the data on Tysabri. It was so strong, it was incredible.”
But then disaster struck once again. Three patients on Elan’s Tysabri trial were confirmed to have a rare disease of the central nervous system called PML. Two of the patients died and, although demand for the drug was shooting up, it had to be taken off the market. Once again, Elan’s share price dived.
“We had done thousands of studies about what adverse effects there could be, and PML had never even been on thelist. It was a real left hook. You couldn’t draw conclusions on why it happened. There were tens of thousands of patients queuing up to take the drug but we couldn’t play God and do Russian roulette and say ‘take it and we will figure it out later’. We knew it would kill the stock price but we wanted to protect the patients and protect the drug because the drug can save the lives of these patients. We had to take the drug off the market.”
It was not until August 2006 that Tysabri finally returned to the market – this time with a strict set of new guidelines from the US and European regulators. While there have been no further cases of PML – it is believed to be a risk only for a very small subsection of patients – there is still some apprehension around the drug among both neurologists who have not used the drug before and investors considering putting their money into Elan. But it is likely to be the MS patients themselves who will drive demand.
“The longer we go without any PML issues or other adverse events, the more the patients will choose Tysabri over other therapies because the difference between Tysabri’s efficacy and current therapies’ efficacy is gigantic,” says Martin.
“After PML, people believed that the only people who would now take Tysabri were patients on their last gasp who had quit all other therapy because it had not worked. But 75% of the patients moving to Tysabri are coming from other therapies. This is very consistent with the fact that 70% to 75% of patients find that the other available therapies fail and that they continue to decline. To me, that is the most important number with regard to Tysabri and it could mean that the market opportunity for this drug is up to 500,000 patients.”
This figure pales into insignificance when set beside the market potential of Elan’s other area of expertise – Alzheimer’s disease. It is estimated that there are currently 18 million Alzheimer’s sufferers, and with the baby boomer generation moving into its 60s, analysts believe there could be nearly 50 million sufferers worldwide by 2020, just 13 years away. Success in this area could utterly transform Elan.
“We, along with our partners in this area, Wyeth, are the only company in the world that has three different approaches to Alzheimer’s that are all disease-modifying. It is very complicated, very exciting and – on the human scale – somebody needs to crack this code because it is truly an epidemic.”
Currently most interest is focused on the drug known as AAB001, which is undergoing Phase 2 trials. The limited data available on it suggests it has huge potential, and analysts are hopeful that the company will announce that it is moving to the final Phase 3 trials during the first quarter of this year. Indeed, the company’s share price is likely to suffer if news on this is not forthcoming, as AAB001 is viewed as something of a test case for Elan’s entire approach to Alzheimer’s. Nevertheless, Kelly Martin is determined not to be rushed by such expectations.
“The decision to move from Phase 2 to Phase 3 is a large one because we have responsibilities to the patients. If you publicly announce that you are at the last stage of a disease-modifying therapy for Alzheimer’s, first you better be really sure that you are. And second, you better be ready to handle hundreds of thousands of calls and enquiries from people wanting to get their loved ones into the trial and onto the drug. That is a big social responsibility. We have had 15 to 20 years of work on this. The data will tell us whether we can move from Phase 2 to Phase 3 in February, July or next November. It might feel like a big deal in the short term but we have come very far and the responsibility is awful big. For the sake of a few weeks or months, let’s not screw it up.”
Unfortunately, in the wake of Elan’s meltdown in 2002, most observers lost confidence in the company and many skeptics still exist. However, Martin is adamant that the one place that their standing wasn’t damaged was where it really matters – with the US Food and Drug Administration (FDA) and its regulatory equivalent in Europe, the European Agency for the Evaluation of Medicinal Products (EMEA). With few other companies so far advanced in tackling devastating auto-immune diseases such as Alzheimer’s, MS and Parkinson’s, Martin believes that the regulators were more interested in the science than the business story.
“They are human, they read the newspapers,” he says. “But through all of the challenges, we always funded the scientific pipeline. The science is the most unique thing we have in Elan. I’m sure the FDA as individuals read the paper and I’m sure at times when they were meeting us they were aware that we were having issues but the meetings were always about the science. I don’t think those other issues had any impact on their assessment of our programmes at all. Nor should it.”
But Martin is also well-aware – and no doubt it informs his current caution- that Elan’s troubles were linked to problems with the science. As well as the corporate governance issues that dogged the company in 2001, it was the failure in January 2002 to complete clinical trials of its original Alzheimer’s compound, AN1792, that finally caused the share price to implode, eventually falling from over $60 to just over $1.
“A lot of things didn’t pan out,” he says. “That is part of the business- science is unpredictable. That is why this business is so interesting. It isn’t like building condominiums. The science is particularly complicated because, at the end of the day, your market place are human beings so you can’t afford to have faulty products and do recalls. Expectations were very high that Elan was going to cure Alzheimer’s. If you cure Alzheimer’s, you are going to create a lot of shareholder value but you are also going to have a huge impact on society. So there was an expectation, internal and external, that this was really working. But part of that expectation was that the science was just going to keep going forever with no issues and no challenges. That was unrealistic.”
Unfortunately for the company, the first dent in these expectations came just as Enron and Worldcom were focusing attention like never before on accounting issues. Elan’s aggressive use of its Irish tax status and its use of financial engineering to grow the company left it wide open for a fall. While this predates Martin’s time with the company, he believes there was a strategic logic to what the then Elan management was trying to achieve with its heavily criticized strategy of forming joint ventures with a large number of smaller companies.
“If you owned a small start-up oncology company with 20 scientists, Elan would help fund part of your research and, in return, it got certain options on your science. That was completely logical. That was the end and the means to get there was the financial structure. But I think as Elan kept growing there was a loss in recognition as to what was the means and what was the end. Was the end to be involved with you and your company from an oncology “extension of our science’ point of view? If it was, great. But if the end was just to do a financial transaction to grow the company, that wasn’t the right direction. I think the philosophy was completely logical and had strategic merit initially, but it went too far. At the end of the day, Elan became the main funder for 55 companies and it was too many things to manage. It was sort of like being a venture capital company to 55 companies. To do that, you need a staff of a few hundred people and the company was just not equipped to handle all of that. I think it was a very good logical extension to our science but it just went too far and then became impossible to really manage.”
He points out that a lot of big pharmaceutical companies still use similar methods today. However, these days the funding company will always insist on having a bigger input and oversight in the research, something Elan did not always do at the time.
“Elan’s management team was very smart and completely dedicated to growing Elan to be a global pharmaceutical company. But I think that the operational and governance ramifications of the expanse of the ambition got away from them. That often happens to visionary people with big ideas. You’ve got to make sure the plumbing works,” he says.
Looking on from the outside, Martin believed he could fix the business problems. He was heartened by the fact that most of Elan’s scientists stuck with the company despite the mounting problems.
“If I had actually put pencil to paper before I came to Elan and did the pros and cons, it wasn’t really a balanced scorecard. But opportunities don’t come up that often and you either take them or you don’t. I thought there was enough to Elan that we could make it work. Most people thought I was nuts. My colleagues at Merrill Lynch thought I was crazy. That was confirmatory evidence to me that this was exactly the right thing to be doing,” he laughs.
His first priority after taking the job was to plug the leaks. He implemented a recovery plan that involved selling off chunks of the business but stopped short of those pieces that now, four years later, look set to bear fruit.
“It was two-and-a-half years which felt like 25 years,” says Martin. “Our decisions were all geared towards Elan surviving as an entity, allowing what we believed to be very significant science to have an opportunity to live again.”
He is particularly proud of living up to his promise to a skeptical market in March 2005 that the company would be cashflow positive operationally (excluding the Tysabri roll-out) by the end of that year. Nevertheless, critics still question the amount of debt with which Elan is burdened – currently standing at about $1.2bn – and its ability to keep funding the development of an expensive pipeline. For his part, Martin believes that Elan now uses debt in a very productive manner that is new to the biotech industry.
“We just raised $615m at eight and seven-eights interest. The margin on our business is about 60%. If Tysabri and Prialt (a drug for the management of severe chronic pain) revenues start to go up, our margin is probably going to drift up beyond 80%. If I can borrow money at 8% and invest it at 60%, I am not sure that is that complicated. But people seem to be stunned by this because biotech traditionally doesn’t use debt. Rather than doing an equity issue at this time, we are balancing our cashflows with debt and keeping the pipeline moving along. We just refinanced our debt so we don’t have any principle payments until 2011. We have interest costs but we match them against the operating costs and against the cashflow we generate and we have $1b of cash on our balance sheet.”
Martin rejects the notion that, given its past history, there may be a certain nervousness in some quarters if Elan appears to be overly inventive with its balance sheet. “The toughest, most-sophisticated creditors around are willing to lend us up to $700m at lesss than 9%. They must have some confidence that we know what we are doing. I think it is actually pretty simple – we have cash, we have cashflow, we have operating liabilities and we have debt liabilities. To understand Elan that is all you really need to see. I don’t think it is that complicated. If people ask you the question as to why you are using debt, what they really want to know is what do you think of your equity. Because if we are issuing equity like there is no tomorrow, then we don’t think it has an upside and that is a big signal. But we do think there is a lot of upside in our equity so we don’t want to issue equity, at least at the moment. We don’t think that would be good for shareholders.”
He points out Elan’s shareholder register is also no longer dominated by hedgefunds. Large institutions now hold about 50% of the company, with the likes of Fidelity, Wellington and Standard Life all owning substantial chunks.
“The most important feedback I get on Elan’s performance is what our creditors and what our equity-holders think of us,” says Martin. “I think they are comfortable with what we are doing and how we are running it. The equity people expect equity value increases and the credit people expect operational discipline and focus from a cashflow point of view. If we can do both of those things, we will make everybody happy.”
If Elan also successfully delivers on its promise in the areas of MS, Alzheimer’s and Parkinson’s in particular, it will be more than just shareholders who will have something to smile about. 2007 should see a lot of questions answered one way or another in that regard. Kelly Martin has brought the company back to a point where it at least is able to give the science a fighting chance. Is he happy to settle in as a pharma CEO for the long term or will he move on and look for another company in distress to rescue?
“The only thing I think about is being in Elan and executing the plans that we have laid out,” he says. “I don’t think about what is beyond that. There are so many things in Elan to be accountable for and to be focused on that I don’t think about doing anything else. Does that mean I will do this for 25 more years? I don’t think so. But I think it is hard to put timelines on the goals and objectives that we have. If we do the things that we talk about today, that will be fantastic. It will be great to be part of that.” (END)
Hi Morgen...
Präsentation von Dr. Sperling vor der NYAS:
- bei Punkt 32 geht es um AAB-001....
http://www.nyas.org/ebriefreps/ebrief/000508/presentations/s…
Präsentation von Dr. Sperling vor der NYAS:
- bei Punkt 32 geht es um AAB-001....
http://www.nyas.org/ebriefreps/ebrief/000508/presentations/s…
Total Shares Out Standing (millions): 467
Market Capitalization ($ millions): $9,940
Institutional Ownership: 55.2%
Price (as of 6/21/2007) 21.3
http://holdings.nasdaq.com/asp/Institutional.asp?FormType=In…
Market Capitalization ($ millions): $9,940
Institutional Ownership: 55.2%
Price (as of 6/21/2007) 21.3
http://holdings.nasdaq.com/asp/Institutional.asp?FormType=In…
Antwort auf Beitrag Nr.: 30.309.743 von surga am 25.06.07 17:18:46
Antwort auf Beitrag Nr.: 30.309.743 von surga am 25.06.07 17:18:46na ja, bleibt leider nicht viel grün übrig.
Antwort auf Beitrag Nr.: 30.316.561 von GuHu1 am 25.06.07 23:24:38Wenn der Markt insgesamt fällt--nutzen dies die Grossen mit sogenannten Eisblockordern um den Preis der Aktie zwechs preiswertem Einkauf zu drücken....wird aber auf Dauer immer weniger klappen...
ach ja und :GUTEN MORGEN!
ach ja und :GUTEN MORGEN!
Antwort auf Beitrag Nr.: 30.318.323 von Birgit.Tersteegen am 26.06.07 08:45:29ist halt ein alt bekanntes Spiel.
Ich lasse mich hier auch nicht aus der Ruhe bringen. Allerdings ist der Reiz doch groß, das Spiel mal ein wenig mitzuspielen.
Ich lasse mich hier auch nicht aus der Ruhe bringen. Allerdings ist der Reiz doch groß, das Spiel mal ein wenig mitzuspielen.
Morgn....oh es is schon fast 13Uhr
Antwort auf Beitrag Nr.: 30.323.191 von Nostarowie am 26.06.07 12:48:35Das ist mir schon zu Spät...ich geh wieder schlafen...
WOOOOOOOOOOOOOOOOOOWW!21.54!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Qualität setzt sich eben doch immer durch....
Qualität setzt sich eben doch immer durch....
Was ist los was wir nicht wissen????????????????????? 21,66
WAS ist hier LOS???Im Iv-Board weiss auch niemand etwas...wyeth ging parallel hoch...22,03
Antwort auf Beitrag Nr.: 30.329.439 von Birgit.Tersteegen am 26.06.07 17:35:19
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