Biotech Depot 2006 - 500 Beiträge pro Seite

[ipollit]

hallo zusammen!

hier finden sich ja die einen oder anderen Einzeltitel aus dem Bio-Bereich... die sind mir meistens aber zu speziell. Setze daher mal mein Depot hier rein... nachdem die Performence dieses Jahr eher unterdurchschnittlich war (naja, wenn man z.B. den Dax als Benchmark nimmt... ich bin soweit zufrieden), hoffe ich auf ein gutes neues Jahr 2006. Sollte sich die Sache gut entwickeln, poste ich hin und wieder meine Kommentare... im schlechten Fall schleiche ich mich schnell wieder davon.

das Depot besteht aus 100% reinen Biotechs (sowohl qualitativ als auch quantitativ). wie man sieht, bevorzuge ich ein wenig mehr als die sonst üblichen 3, 4, 5 Werte... hoffe dadurch Fehlschäge (die sich definitiv nie vermeiden lassen) ohne größere Probleme verdauen zu können - so wie z.B. letzte Woche meine PCYCs über 60% gecrasht sind. Zocker-Werte wie OTCs wird man vergeblich suchen... ich orientiere mich im wesentlichen an Fundamental-Daten: z.B. Pipeline, Cash, MK, usw., beachte zwar die Charts, mehr noch das Sentiment/Trends, doch dies ist eher sekundär. Technische Trades werde ich nicht machen.

und so sieht es im Moment aus... bin in der Regel 100% investiert. Sortiert nach Gewichtung(Anteil), mit Kaufkurs(KK):

Anteil Aktie Symbol KK Kurs Gewinn
18,9% Morphosys MOR.de 20,43 EUR 41,85 + 105%
15,7% GPC Biotech GPC.de 7,31 EUR 10,78 + 47%
8,5% Medigene MDG.de 7,34 EUR 8,51 + 16%
7,0% OSI Pharm OSIP 25,53 USD 27,41 + 7%
6,3% Adolor ADLR 8,53 USD 14,91 + 75%
6,1% Arena ARNA 9,77 USD 14,44 + 48%
5,4% Atherogenics AGIX 18,56 USD 21,14 + 14%
4,4% Pain Therapeutics PTIE 7,08 USD 6,97 - 2%
4,4% Imclone IMCL 31,41 USD 34,52 + 10%
4,2% Indevus IDEV 7,11 USD 5,02 - 29%
3,0% Regeneron REGN 9,14 USD 13,76 + 51%
3,0% Cardiome CRME 9,95 USD 9,98 + 0%
2,8% Nektar NKTR 15,96 USD 16,51 + 3%
2,5% Onyx ONXX 25,45 USD 29,52 + 16%
2,3% Telik TELK 15,15 USD 17,24 + 14%
1,5% KOS Pharma KOSP 68,41 USD 52,24 - 24%
1,5% Introgen INGN 8,23 USD 5,72 - 30%
1,3% Millennium MLNM ? USD 10,23

INGN und MLNM werde ich wohl bei Gelegenheit abgeben. Bei KOSP bin ich mir noch nicht sicher (muss mir die Komkurrenz noch genauer ansehen). Sollten sich MDG und MOR in der nächsten Zeit gut entwickeln, wird hier Kapital für weitere Käufe frei (Teilverkäufe). IDEV und PTIE stehen eher auf der Verkaufsseite... werde hier die weitere Entwicklung abwarten.

auf meiner Watchliste stehen neben PCYC und PGNX, die ich vorerst aus dem Depot genommen habe...
SPPI, LGND, ARRY, SNUS, Genmab, YMI, DSCO, DOVP, GTCB, INSM und KERX.
DSCO könnte dabei der nächste Kauf sein.

so... das hilfst erstmal nicht viel. Werde im Laufe der Zeit die einzelnen Werte kommentieren.

allen ein erfolgreiches Jahr 2006!

mfg ipollit

[ipollit]

die dazugehörigen charts...

dolor ADLR - KK 8.53 USD

Arena ARNA - KK 9.77 USD

Atherogenics AGIX - KK 18.56 USD

Cardiome CRME - KK 9.95 USD

GPC Biotech GPC.de - KK 7.31 EUR

Imclone IMCL - KK 31.41 USD

Indevus IDEV - KK 7.11 USD

Introgen INGN - KK 8.23 USD

KOS Pharma KOSP - KK 68.41 USD

Medigene MDG.de - KK 7.34 EUR

Millennium MLNM - KK

Morphosys MOR.de - KK 20.43 EUR

Nektar NKTR - KK 15.96 USD

Onyx ONXX - KK 25.45 USD

OSI Pharma OSIP - KK 25.53 USD

Pain Therapeutics PTIE - KK 7.08 USD

Regeneron REGN - KK 9.14 USD

Telik TELK - KK 15.15 USD


mfg ipollit

[Salem88]

Hast ja auch Adolor? Was für eine Überraschung. Lief die letzten Wochen super. Du weist, im März wird das Ergebnis der letzten Phase III Studie für POI (Post Operative Ileus) veröffentlicht. 2-3 Monate später entscheidet dann die FDA. Wäre nat Klasse wenn Alvimopan (Entereg) durchkommt. Profitiert nicht nur Adolor, sonderen auch GSK und nat. Girindus aus Bensberg davon.

[ipollit]

[posting]19.413.769 von Salem88 am 27.12.05 10:20:19[/posting]@Salem

ja... da habe ich ziemlich Glück gehabt und genau im August-Tief gekauft. Das mit den Daten entspricht auch dem, was ich kenne... März POI-PhaseIII Ergebnisse, ca. Juni Zulassungsantrag... für OBD FDA-Antrag erst 2007.

So weit ich es verstehe, geht es bei dieser Medikamentenklasse darum, das bei Verabreichung von Schmerzmitteln (Opiate) nicht der Darm usw. lahmgelegt wird. Das Marktpotential liegt über 1 Mrd USD, wobei OBD (chronisch) eine großere Indikation ist als POI (nach einer OP).

einige Daten von yahoo...

MK 582 Mio USD
EV 464 Mio USD
Cash 119 Mio USD
Schulden 0

Adolor Corporation, a development stage biopharmaceutical corporation, engages in the discovery, development, and commercialization of prescription pain management products primarily in the United States. Its lead product candidate, Entereg, is a small molecule, peripherally-acting mu opioid receptor antagonist. As of July 6, 2005, the company was under development of Entereg for the management of the gastrointestinal side effects associated with opioid use. Adolor other products under development include a sterile lidocaine patch, is in Phase 2 clinical development, for treating postoperative incisional pain, and analgesics for treating moderate-to-severe pain conditions. The company has collaboration agreement with Glaxo Group Limited for the development and commercialization of Entereg in multiple indications. It also has a license agreement with EpiCept Corporation to develop and commercialize a sterile lidocaine patch in North America. Adolor was formed in 1993 and is headquartered in Exton, Pennsylvania.

http://www.adolor.com



zu beachten ist, dass Entereg durch MNTX von Progenics PGNX Konkurrenz bekommt... MNTX ist ebenfalls in PIII und zielt auf dieselben Indikationen ab wie Entereg. PGNX hat hierfür in der letzten Woche einen 400 Mio USD Deal mit Wyeth geschlossen:

Reuters
Wyeth says strikes development deal with Progenics
Friday December 23, 12:32 pm ET
By Lewis Krauskopf


NEW YORK (Reuters) - Wyeth (NYSE:WYE - News) said on Friday that it agreed to pay as much as $416.5 million and other fees to Progenics Pharmaceuticals Inc. (NasdaqNM:PGNX - News) for rights to an experimental treatment for constipation, bowel dysfunction and other side effects induced by opioid use.
ADVERTISEMENT


Shares of Progenics jumped more than 11 percent in morning trade.

Under the terms of the deal, Wyeth will receive worldwide rights to methylnaltrexone, also called MNTX, while Progenics will retain an option to co-promote the product in the United States.

Punk, Ziegel & Co. analyst Sharon Seiler said while the financial terms look attractive, another key positive is that the scope of the deal indicates Wyeth envisions the drug as a major product.

"A lot of biotech companies end up partnering things for what look like good financial terms and then the product languishes somewhere on a shelf," Seiler said. "So having a partner that`s really dedicated to promoting the product is important."

Wyeth said the deal includes an upfront payment of $60 million to Progenics with as much as an additional $356.5 million payable upon achieving certain milestones.

Under the announced terms, Wyeth will pay Progenics royalties on worldwide sales of MNTX and co-promotion fees within the United States. Wyeth is also responsible for all future development and commercialization costs.

"We believe this provides substantial validation of the market potential and intellectual property for MNTX," CIBC analyst Tariq Kassum wrote in a research note. "In our view, the timing and quality of a partnership was a major overhang on the stock, which is now definitively removed."

Opioids used to relieve pain can cause debilitating side effects, such as constipation, urinary retention and severe itching, according to the companies. They said MNTX is designed to block receptors that can trigger these side effects, while not interfering with pain relief.

Progenics is developing MNTX as a drug that can be injected, given intravenously and taken orally.

A second late-stage study of the injection in patients with advanced illness is finishing, the companies said. Seiler expects the company to file the injected version with regulators in the middle of 2006, with approval coming as soon as the end of next year.

An intravenous version studied in post-operative bowel dysfunction is scheduled to begin Phase 3 trials in 2006, the companies said. Also next year. a mid-stage trial of an oral version is scheduled to start in patients receiving opioids for chronic pain.

Seiler said peak annual sales for the injected MNTX could reach $450 million, while uses of the drug in two other patient populations could surpass $1 billion each in eventual peak sales.

"This is potentially a huge drug," said Seiler, who said she owns Progenics shares.

Progenics shares rose $2.58, or 11.2 percent, to $25.67 on the Nasdaq. Wyeth shares rose 92 cents, or 2 percent, to $47.69 on the New York Stock Exchange.

Bei der wichtigen OBD Indikation scheint MNTX einen Schritt weiter zu sein, während Entereg versucht für POI die Zulassung zu erhalten. Das ist allerdings erstmal unverständlich, da Entereg mit POI mehr Probleme hat, als mit OBD. Bei yahoo gibt es dazu eine interessante Diskussion...

*****

Re: PGNX and WYE in methylnaltrexone deal
by: DVOowner
Long-Term Sentiment: Hold 12/23/05 10:39 am
Msg: 6216 of 6221

pgnx will be 1st approved for OBD/cancer patients with subcue shot --- they will beat aldr/glaxo to OBD NDA....

adlr/glaxo went for oral POI application approval, but entereg doesnt work as well for POI as it does for OBD..... is will be hard to get full approval for POI, but it does work, but not as well was it does for OBD...

adlr/glaxo are now enrolling in their phase 3 OBD trials with oral pill that workes great, but pgnx is already into 2nd phase 3 trials with OBD cancer ...

so i see both getting approval ... keep inmind that pgnx`s OBD chronic pain med is oral... their OBD/cancer is subcue shot or IV, and their POI is IV .....

so pgnx has jump on OBD cancer applicatin, and aldr has jump on POI - but POI is alot harder to see the results for it as opposed to how well it works for OBD ... i see both companies getting approval for different applications of POI & OBD application..... regards

***********

Re: PGNX and WYE in methylnaltrexone deal
by: alizumo 12/23/05 05:07 pm
Msg: 6217 of 6221

It is striking that the number of patients enrolled in Entereg studies is much higher than in MNTX studies and that ADLR/Glaxo took more time to conduct the trials. As you have to ask the right questions to your study and then to get statistically significant answers when asking multiple questions to a study, you need big samples. My bet is that Entereg trials were much more carefully planned and that MNTX trials won`t respond to all FDA potential questions. I believe it will take longer for MNTX to be approved.

**********

PGNX ADLR Differences
by: alizumo 12/23/05 05:41 pm
Msg: 6218 of 6221

Entereg or MTNX are to be taken on a long term basis by OBD patients. In order to make appear infrequent but potentially devastating side effects in a small proportion of patients (increased vascular accidents for instance) you need big populations. Look at what happened to Vioxx. The FDA will be a lot more cautious. By the way this is the explanation given by ADLR as to why they started POI first: you take the drug just for a few days so that you don’t need to look for long term side effects. Nobody seems to understand this point.

And remember that the FDA said that fighting POI was not a big deal in itself: ADLR will have to prove by pooling all studies together and getting something like 3000 patients overall that interesting effects like Time to hospital discharge, reports of nausea, vomiting, nasogastric tube re-insertion and Hospital readmission are statistically significant. Time of first solid food or first bowel movement is interesting only if the above factors are treated….MNTX will have only a few hundreds patients at best to demonstrate their efficacy in these endpoints. You can’t blame PGNX for that. They didn’t have enough cash to enrol as many patients.

I think WYETH knows they will have to conduct more studies with more patients. The 30 Millions dollars upfront payment is not a big deal for WYETH and it should have been much higher if PGNX was on the verge of achieving an easy approval. The upfront payment given to ADLR was higher despite it was supposed to be at that time much further away from approval.

**********

Re: PGNX ADLR Differences
by: jstw2001
Long-Term Sentiment: Strong Buy 12/23/05 05:53 pm
Msg: 6219 of 6221

Glaxo is one of the best companies in terms of getting drugs to market. I have heard the time difference between the two is rapidly shrinking for OBD.

If you recall Lilly`s Cialis was way ahead of Glaxo/Bayers Levitra in terms of approval and look who came out first. I wouldn`t be suprised if Entereg was out before the Wyeth`s drug or it will be right on its heels.

Also, Entereg will be used in OBD off-label by docs right away because they know the indication is coming and there is a need an unmet need for this type of product. Once Entereg gets its POI indication there will be outflow right into OBD patients. This will take a lot of the wind out of Wyeth`s sales. Plus the oral advantage is huge.

Entereg will run away with the OBD markt. POI looks somewhat limited but still will help sales.

**********

Re: PGNX ADLR Differences
by: DVOowner 12/25/05 06:37 pm
Msg: 6221 of 6221

how will the drs use entereg in OBD patients off label if it is approved for POI ....

the dose of the POI patients will be 6-12mg and you cannot take more then 1mg of entereg if you are a OBD patient ....

and if i remeber right, the POI meds will be in gel pills .... i have asked my dr about this.... how can we dilute or score a gel pill that mostly will be at least 3mg, and could be 6mg for the POI patients....

this is a serious question and i would appreciate any input you may have... regards/thanks in advance.


********

ADLR hatte Signifikanzprobleme mit Entereg gg POI in PIII... Anfang und Ende 2004 (was man auch im Chart sieht)... das macht die Zulassung für POI sicherlich nicht zu einem Selbstläufer!

By David Nierengarten
January 20, 2004
In another reminder of the volatility inherent to biotech investing, Adolor`s (Nasdaq: ADLR) shares dropped more than 30% last week on news that its drug to treat post-operative ileus -- a post-surgery paralysis of the intestines -- failed to significantly treat the problem. This complication is very common after abdominal surgery and is a major cause of lengthened hospital stays.


In a classic example of the cure sometimes being worse than the disease, one of the major causes of post-operative ileus is pain-killing opioid drugs like morphine. Opioid drugs are the world`s best pain killers, but they have boatloads of side effects, not the least of which is their paralyzing effects on a patient`s gut.


However, this finding leads itself to an obvious solution -- block the action of opioids in the gut, while maintaining their pain-killing properties in the brain. And that was precisely what Entereg from Adolor was meant to do. Despite promising Phase II tests, the Phase III results just did not achieve statistical significance. Even more troubling was the finding that both the low and high dose produced similar results. It is more difficult to salvage a clinical trial when the researchers don`t even know what dose to use!


While the news is bad for Adolor and its partner, GlaxoSmithKline (NYSE: GSK), trials for Entereg continue for other applications, such as painkiller-induced constipation and chronic constipation/irritable bowel syndrome. Early trial results for these indications look good, but as history shows, that`s no guarantee of Phase III success.


As is often the case, what`s bad news for one company is good news for its competition, and Adolor is no exception. Its competitors include Pain Therapeutics (Nasdaq: PTIE) in the irritable bowel field (which I discussed recently and since then has risen over 45%), and more directly, Progenics (Nasdaq: PGNX).


Progenics picked up a 20 year-old compound called methylnatrexone, which was known to block opioid action everywhere but the brain, and decided it was perfect to prevent ileus and opioid-induced constipation. The company`s approach to the problem was the same as Adolor, but its researchers cut out the development time and money Adolor`s chemists spent on formulating a completely new drug. Investors should appreciate the cost savings.


Progenics trades at about $266 million in enterprise value, while Adolor trades around $340 million in EV. While Adolor still has Entereg in trials for other indications and the company still might rescue it for post-operative ileus, I would rather own Progenics and their pipeline, which also has investigational new drugs for HIV and prostate cancer.

ich denke mal, dass GSK alles mögliche tut, um Entereg auf den Markt zu bringen.

Wenn man sicher gehen will, so könnte es sinnvoll sein, vor den POI-Daten im März ADLR zu verkaufen... zweimal waren die PIII-Daten schon negativ. Das Risiko eines Crashs ist im März also nicht gering!! (muss ich mir noch genauer ansehen)

ich habe meine Girindus verkauft, da mir nach der Quasi-Übernahme die Sache zu unsicher ist.

mfg ipollit

[ipollit]

heute sieht es bei REGN ganz gut aus... upgrade von lehman brothers)... vorbörslich +8%, könnte ein weiteres 52W-Hoch geben. Sind mit über 800 Mio USD MK alles andere als billig, obwohl nichts in der nächsten Zeit auf den Markt kommen kann. In der PI/II befindet sich aber ein potentieller Nachfolger von Avastin. Wem das nichts sagt... für Avastin wurden schon peak sales von 10 Mrd USD genannt.





(auch nicht schlecht heute NEOL... +45%)

mfg ipollit

[thomtrader]

@ipollit:

Es ist zwar keine reine Biotech-Aktie, aber wieso ist die deutsche Biotest nicht auf deinem Radarschirm?

Gruß tt

[ipollit]

[posting]19.417.677 von thomtrader am 27.12.05 15:55:33[/posting]kenne ich zu wenig, um etwas darüber sagen zu können... müsste ich mir ansehen.

*********

heute sieht es gut aus. Wenn mich nicht alles täuscht befinden wir uns beim NBI und BTK in der Buy-Triggerlinie nach oben... könnten ein paar schöne Wochen werden.





Ich denke der BTK zeigt die Outperformence der LageCaps... die MidCaps sollten langsam nachziehen (Ausbruch NBI)...

bei OSIP kann es zu einem short-squeeze kommen... mal sehen:



mfg ipollit

[amorphis]

hola ipollit...

in ein biotech-depot 2006 gehört meiner meinung nach auch eine medx...bei medx stehen demnächst ergebnisse zum wichtigsten antikörper an...ausserdem besteht aufgrund der übernahme von abgx durch amgn weitere fantasie.

dann fehlen mir noch pdli und vphm...

[ipollit]

[posting]19.419.076 von amorphis am 27.12.05 17:42:49[/posting]amorphis,

okay, dass sind sicherlich keine schlechten Werte. Allerdings soll das ja auch nicht DAS Bio-Depot sein, sondern es ist mein aktuelles... und kein Depot ist perfekt

PDLI habe ich vor ein paar Wochen verkauft... nicht, dass dieser Wert schlecht wäre, aber 3,3 Mrd USD MK sind nicht gerade wenig. Das eKGV06 liegt bei etwa 100... wie sieht es da mit 2007 aus... ansonsten sehr solide durch zahlreiche Royalties.

VPHM hat ja ordenlich zugelegt... allerdings gehen die Schätzungen von yahoo von einem stagnierenden EPS aus... da ist selbst ein KGV von 20 u.U. zuviel. Was ist da der Gewinntreiber in der Zukunft?

MEDX... kommen da Ergebnisse zu MDX-010? finde die HP etwas verwirrend, da sich da kaum Infos finden lassen. Wie sollen den peak-sales aussehen, wer sind die Konkurrenten und wann ist eine Zulassung möglich? ABGX hatte ich auch im Depot und nach dem Übernahmeangebot ist wohl nicht mehr viel zu holen. In diesem EGFR-Bereich habe ich noch IMCL (Erbitux)... hier gibt es ja auch Übernahmegerüchte bezügl. BMS... interessant dürften meiner Meinung nach Genmab (und darüber auch MEDX) und YMI sein. Genmab soll eine verbesserte Version von Erbitux in PII haben, YMI ist sehr billig und ebenfalls mit einem EGFR-Kandidaten und einer vollen Pipeline. Wer soll den MEDX übernehmen?

apropo Übernahme... hier sind auf Dauer auch meine letzten Käufe AGIX und CRME interessant. AGIX dürfte nach dem 1 Mrd. Deal irgendwann von Pfizer geschluckt werden, CRME von Astellas:
img220.imageshack.us/img220/5638/com5br.jpg

mfg ipollit

[ipollit]

ich weiß nicht, ob das etwas zu bedeuten hat, aber bei IDEV und PTIE gibt es in der letzten Zeit größere Insiderkäufe... jeweils Fonds mit >10% Anteil. Zudem ist IDEV über die 5 USD Marke ausgebrochen...

IDEV... Käufe durch "EDELMAN JOSEPH PERCEPTIVE LIFE SCIENCES MASTER FUND LTD PERCEPTIVE ADVISORS LLC", zuletzt am 19.12. für 753k USD (4.231 USD p.s.)



PTIE... Käufe durch "BLACK BEAR OFFSHORE MASTER FUND LP", z.B. am 20.12. für 311k USD (6.794 USD p.s.)



mfg ipollit

[amorphis]

[posting]19.420.239 von ipollit am 27.12.05 18:46:53[/posting]werd dir gleich ausführlich antworten...

[ipollit]

noch zu REGN... jetzt +16%

von yahoo...

MK 894 Mio USD
EV 665 Mio USD
Cash 307 Mio USD
Schulden 200 Mio USD
Umsatz ca. 50-70 Mio USD

Pipeline...
VEGF Trap - AMD(Eye) PhaseI (->Lucentis)
VEGF Trap - Krebs PhaseI (->Avastin)
IL-1 Trap PhaseII (z.B. gegen RA)

Regeneron Pharmaceuticals, Inc. engages in the discovery and development of pharmaceutical products for the treatment of human disorders and conditions. Its clinical and preclinical pipeline includes product candidates for the treatment of cancer, diseases of the eye, rheumatoid arthritis, and other inflammatory conditions like allergies, asthma, and other diseases and disorders. The company primarily focuses on the development of the VEGF Trap in oncology and eye diseases, which are in phase I clinical trails; and the IL (Interleukin)-1 Trap in various indications in, which interleukin-1 plays a role, including rheumatoid arthritis and other inflammatory conditions. VEGF TRAP is a protein-based product candidate designed to bind Vascular Endothelial Growth Factor (VEGF) and the related Placental Growth Factor, and prevent their interaction with cell surface receptors. Interleukin-1 Trap, which is in preclinical stage, is a protein-based product candidate designed to bind the interleukin-1 cytokine and prevent its interaction with cell surface receptors used for the treatment of diseases associated with inflammation in blood vessels. IL-1 Trap is in phase 2b study for its use in rheumatoid arthritis in a double blind, placebo-controlled, and multicenter trial. Regeneron’s product candidates in preclinical development stage include Interleukin-4/Interleukin-13 Trap, a protein-based product candidate designed to bind both the interleukin-4 and interleukin-13, which is used for the treatment of diseases, such as asthma, allergic disorders, and other inflammatory diseases. The company also provides contract manufacturing services for the production of an intermediate for a pediatric vaccine. Regeneron has collaboration and licensing agreements with sanofi-aventis Group, Novartis Pharma AG, and The Procter & Gamble Company. The company was founded by Leonard S. Schleifer in 1988. Regeneron is headquartered in Tarrytown, New York.

http://www.regeneron.com

kann mir allerdings nicht vorstellen, dass sie stetig nach oben laufen, dafür ist VEGF Trap noch zu weit von einer möglichen Marktzulassung weg (gerade mal in Phase I)und die MK von 900 Mio USD einfach sehr hoch... sollten wirklich Kurse von um die 19 USD erreicht werden, werde ich wohl Gewinne mitnehmen, um günstiger einsteigen zu können

AP
Regeneron Shares Rise on Analyst Upgrade
Tuesday December 27, 11:35 am ET
Regeneron Shares Up After Lehman Analyst Sees Improving Prospects for Experimental Drug


NEW YORK (AP) -- Shares of Regeneron Pharmaceuticals Inc. jumped Tuesday after the drug maker received an upgrade from an analyst optimistic about the company`s experimental drug, VEGF Trap, which could prove to be a competitor for Genentech Inc.`s cancer drug Avastin.

Lehman Brothers upgraded the company to "Overweight" from "Equal Weight" and raised his target price to $19 from $9 based on "improving prospects" for VEGF Trap -- which works by blocking blood vessel formation.

Analyst Jim Birchenough wrote in a note to clients that the drug could be a "long-term value driver" for the company as an alternative to Avastin. While data from 19 key studies will likely not be announced until the second half of 2006, the analyst added, "commercial prospects are attractive enough to engage investor interest now."

Regeneron shares surged $2.42, or 17.6 percent, to $16.18 in late-morning trading on the Nasdaq, surpassing their previous 52-week high of $13.83.

In addition to cancer, the drug could also work to treat certain forms of age-related macular degeneration, a common cause of blindness among the elderly. While VEGF Trap`s development in both areas is still in the early stages, Birchenough wrote that the opportunity in each market is "large enough to command significant attention in 2006."

Last week, Regeneron and Paris-based drug maker Sanofi-Aventis expanded their partnership to include Japan, a move worth $25 million to Regeneron. Under the terms of the agreement, Sanofi-Aventis will pay all development expenses for VEGF Trap until it hits the market, when Regeneron will repay half those costs.

mfg ipollit

[amorphis]

[posting]19.420.239 von ipollit am 27.12.05 18:46:53[/posting]zu medx:

http://www.forbes.com/markets/2005/05/10/0510automarketscan0…
Medarex Boosted By Bristol-Myers, Pfizer Partnerships
05.10.05, 9:27 AM ET

Standard & Poor`s Equity Research maintained a "buy" rating and 12-month target price of $13 on Medarex (nasdaq: MEDX - news - people ) after the company reported a first-quarter loss narrower than expected. S&P Equity Research said, "Sales from Bristol-Myers Squibb (nyse: BMY - news - people ) and Pfizer (nyse: PFE - news - people ) collaborations were higher than our forecast, while R&D expenses were lower." Medarex has 22 products in clinical trials but "not much additional information on the trials was provided during conference call," the research firm said. "However, we do expect data next week on a Phase II study of MDX-010 alone, in combination with dacarbazine in metastatic melanoma, and data for MDX-010 in renal cancer," S&P Equity Research said.

ich vermute medx ist sowohl für pfe als auch für bmy interessant...

guck allein mal was da an milestones anstehen könnte...

13-Jan-2005

Other Events, Financial Statements and Exhibits


Item 8.01. Other Events.

On January 13, 2005, Medarex, Inc. issued a press release to announce that its global development and commercialization collaboration agreement with Bristol-Myers Squibb Company ("BMS"), previously announced by both companies on November 8, 2004, has become effective. The agreement became effective after all conditions were satisfied, including expiration of the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Under the collaboration agreement, BMS and Medarex plan to jointly develop MDX-010, a fully human antibody investigational product targeting the CTLA-4 receptor, which is currently in Phase III clinical development for the treatment of metastatic melanoma.

As previously announced, Medarex will receive a cash payment of $50 million, of which $25 million will be for a purchase of Medarex`s common stock by BMS. In addition, Medarex could receive as much as $205 million if all regulatory milestones are met, and up to $275 million in sales-related milestones. Medarex has an option to co-promote and share profits with BMS in the United States. BMS will receive an exclusive license outside of the United States and will pay royalties to Medarex on any commercial sales.

und...

http://www.thestreet.com/_yahoo/stocks/robertsteyer/10223433…

In addition to Bristol-Myers Squibb and J&J, Medarex has signed deals with Amgen (AMGN:Nasdaq - commentary - research), Novartis (NVS:NYSE - commentary - research), Medimmune (MEDI:Nasdaq - commentary - research) and Pfizer (PFE:NYSE - commentary - research).

The Pfizer deal, signed in September, was notable because Pfizer paid $80 million upfront, bought $30 million in Medarex stock, promised to pay as much as an extra $400 million assuming all goals of the pact are met, and agreed to pay royalties on products that reach the market. The agreement, which runs for 10 years, calls for Medarex to provide up to 50 antibodies.


was mdx-010 angeht...hab am wochenende noch einen bericht gelesen...das die daten in kürze erscheinen werden/müssen. würd dir die quelle gerne posten...finde die seite nur momentan nicht. war aber definitiv so!

medx ist aktuell ja auch endlich über die 13$ gegangen...würd mir das ganze nochmal ansehen!wenn man den abgx deal zugrunde legt...ist medx deutlich mehr wert!eine übernahme wird meiner meinung nach nicht unter 20$ stattfinden!


was vphm angeht...ich würde hier nicht auf die daten der yahoo-seite vertrauen...das kgv sollte für 2005 unter 20 liegen...mit blick auf 2006 gehe ich von einem eps von mindestens 1,5$ aus...der umsatz und gewinntreiber der letzten monate - vancocin - dürfte auch im kommenden jahr für wachstum sorgen...c-diff breitet sich immer mehr aus...das ganze wird schon als epidemie bezeichnet...vancocin ist der "gold-standard" in diesem bereich...und laut forbes ist vancocin noch immer etwa 65% unterbewertet...d.h. es ist mit weiteren preiserhöhungen zu rechnen...die nächste erwarte ich schon im januar...zusammen mit einer weiterhin anziehenden nachfrage!außerdem sollen 1-2 weitere fertige wirkstoffe hinzu gekauft werden (dafür die letzte kapitalerhöhung!) und in 2006 wird man sich von den letzten langfristigen schulden befreien!alles in allem ist vphm für eine verdopplung in 2006 gerüstet...evtl ist sogar mehr drin!

pdli befindet sich immer noch in einem klaren aufwärtstrend...ich glaube auch das dieser weiterhin anhalten wird...hier glaube ich das die relation pdli/dna für weiteres wachstum sorgen wird!pdli gilt zudem als interessantes übernahme objekt!

http://www.forbes.com/2005/12/23/biotech-acquisition-pharmac…

greez

[amorphis]

weiteres "alarm"-zeichen...die umsätze sind in letzter zeit relativ hoch in medx...selbst heute...an einem allgemeinen flaute-tag!
Volume: 1,765,729
Avg Vol (3m): 976,797

[Fruehrentner]

n`Abend in die Runde.

Neben PDLI und VPHM empfehle ich auch mal einen Blick auf
INTERCELL aus Österreich.

Siehe dazu auch den entsprechenden thread auf WO

[aurisinterna]

Hi alle,

ich hoffe, daß meine alte konservative Amgen weiter steigt und meine spekulativen Titel wie

Medarex
Biogen
Affymetrix
Medimmune

weiter steigt.

Der überwiegende Teil bleibt eiter konservativ ( einer ausgewogenen Länder-und Branchenstreuung.

Viel Erfolg für 2006 wünsche ich allen.
auris

[ipollit]

[posting]19.421.426 von amorphis am 27.12.05 21:03:03[/posting]@amorphis

danke... wollte zwar eher meine Werte hier diskutieren, aber für Anregungen bin ich immer zu haben. Werde später mal genauer auf deine Aussagen eingehen... MEDX hat wirklich eine interessante Pipeline, allerdings sind mir die peak sales noch nicht klar und es handelt sich meistens um Partnerprojekte - d.h. u.U. erhält MEDX nur einen kleinen Teil des Kuchens. Z.B. musste CATG um jedes Prozent von Humira kämpfen... viel haben sie nicht erhalten. Eine Übernahme sehe ich im Moment trotzdem nicht...

ein guter Überblick über die Pipeline...
http://library.corporate-ir.net/library/63/639/63952/items/1…

wenn du MEDX gut findest, was hälst du dann von Genmab? Die sind fast nur ein drittel so hoch bewertet und haben dennoch mehrere MEDX-AKs in der Pipeline (zum Teil mit 100% Lizenz-Rechten)... wenn ich das richtig gesehen habe, gehört MEDX 22% von Genmab.

mfg ipollit

[amorphis]

[posting]19.422.130 von ipollit am 27.12.05 23:30:40[/posting]sorry, du sollst natürlich weiter deine werte diskutieren...dachte nur eine medx passt recht gut zur überschrift...

was meinst du mit partnerprojekten?bin mir relativ sicher das medx von der gesamten pipeline etliche rechte usw noch gänzlich alleine hält...kann mich an worte vom CEO erinnern, dass man keine "eile" hat betimmte partner zu finden...will heißen...entweder drakeman sieht einen angemessen preis (milestones und umsatzbeteiligungen) für seine "ware" oder man kommt mit big-pharma nicht ins geschäft und "boxt" die einzelnen antikörper alleine durch!wenn ich mir so die abkommen ansehe...die medx in den letzten beiden jahren erzielen konnte...dann sehe ich das es sich dort um beträge dreht...die ich selten bei anderen biotechs der größe medx sehe...

zu genemab kann ich recht wenig sagen...habe mich nicht mit der firma beschäftigt!

naja...mein fazit ist auf jeden fall...die aktivitäten rund um medx sind derzeit nicht "normal" und ich gehe jede wette ein...das da "noch was kommt"...

greez

[ipollit]

[posting]19.439.533 von amorphis am 29.12.05 08:59:59[/posting]wenn du dir das pdf mal ansiehts... die meisten Projekte werden ganz oder teilweise vom Partner entwickelt (eine Co-Entwicklung ist allerdings auch schon nicht schlecht).

z.B. in Phase III... MDX-010 (zusammen mit BMS), HuMax-CD4 (Genmab), CNTO 148 (Centocor)
in Phase II gehören von 7 Kandidaten 2 (MDX-060 und MDX-070) alleine Medarex, die anderen 5 werden von Partnern entwicklelt.
in Phase I/II gehört von 3 Kandidaten einer MEDX (MDX-214)

was Genmab betrifft... wenn du ernsthaft längerfristig in MEDX investierst (nicht nur auf eine Übernahme spekulierst), dann solltest du dir dieses Unternehmen mal genauer ansehen. Zum einen gehört MEDX fast ein Viertel von Genmab und zum anderen haben die eine Menge MEDX-AKs in der Pipeline, die sie vermarkten können und an MEDX davon Royalties zahlen. Von den 13 MEDX-AKs in Phase I/II-III sind das alleine 5 (HuMax-CD4, AMG 714, HuMax-CD20, MDX-018 und HuMax-EGFR)... vor allen Dingen HuMax-EGFR in Phase I/II finde ich interessant, weil es eine praktisch identische nur humanisierte Form von Erbitux ist.

Genmab`s Product Pipeline
Title Indications Development status Our rights

HuMax-CD4™ (zanolimumab) Cutaneous T-Cell Lymphoma (CTCL)
Non-Cutaneous T-Cell Lymphoma

Phase III

Phase II
Worldwide in collaboration with Serono
Worldwide in collaboration with Serono

AMG 714* Rheumatoid arthritis (RA) Phase II Worldwide in collaboration with Amgen
HuMax-EGFr Head and neck cancer

Phase I/II Worldwide
HuMax-Inflam Various inflammatory conditions
Phase I/II (completed) 50% of worldwide (except for Asia) in collaboration with Medarex
HuMax-CD20 Non-Hodgkin’s Lymphoma (NHL)
Chronic Lymphocytic Leukemia (CLL)
Rheumatoid Arthritis (RA)


Phase I/II
Phase I/II

Phase II
Worldwide
Worldwide

Worldwide

HuMax-TAC Organ transplant rejection Pre-clinical Worldwide in collaboration with Serono
HuMax-HepC Hepatitis C Pre-clinical Worldwide rights acquired from Connex GmbH and INSERM
HuMax-CD38 Multiple Myeloma Pre-clinical Worldwide

**************

Genmab and Medarex: a Unique Alliance

Genmab has a unique alliance with Medarex that gives us access to the UltiMAb® system for creating the full range of human antibody isotypes. Under this agreement, Genmab has the right to obtain licenses for an unlimited number of antibodies and owns the worldwide development and commercialization rights to these products. Genmab’s principal obligation under this agreement is to make royalty payments in connection with any such product licenses. Genmab received these rights in exchange for stock in the company, and we also received 16 fully paid up product licenses, which require no further payments to Medarex. Medarex currently holds approximately 24% of our stock.



In 2000, Genmab entered into the Genomics Agreement, pursuant to which Medarex granted the company exclusive rights to market its transgenic mouse technologies for multi-target (five or more targets) European genomics partnerships. Genmab’s territory includes companies with European headquarters that have either developed or gained access to genomics or other novel targets. The company may also conduct business with any company it chooses for non multi-target (less than five targets) agreements. The Genomics Agreement has an initial term of five years which ends in 2005.


Product Collaboration with Medarex

In addition, in June 2001, we entered into a collaboration with Medarex to develop a human antibody to treat inflammation, HuMax-Inflam. In December 2004, Genmab and Medarex announced encouraging safety and efficacy data from a phase I/II trial using HuMax-Inflam. The disease and the target mechanism for HuMax-Inflam have not yet been made public.



Genmab and Medarex share all development costs and commercial rights throughout the world with the exception of Asia, which is held by Medarex alone.



ich kann dir allerdings nur gratulieren... bis jetzt hast du alles richtig gemacht. MEDX steigt schön entgegen dem Markt. Allerdings kann ich mir nach wie vor keine Übernahme vorstellen und wenn doch, sollte man sich mal genauer CATG und Morphosys ansehen. Denn dann wären die beiden größten AK-Lieferanten weg vom Markt und die bisherigen Partner wohl wenig begeistert, nicht mehr zusammen mit ABGX und MEDX zu forschen, sondern ihre Targets dann AMGN und BMS (oder wer soll es werden???) Preis zu geben.

Bei Genmab ist bei Erfolg z.B. von HuMax-EGFR eine Übernahme meiner Meinung nach sehr wahrscheinlich... das kann aber noch dauern.

mfg ipollit

[ipollit]

REGN ist in den letzen Tagen sehr gut gelaufen... eine MK von fast 900 Mio USD ist schon eine ganze Menge. Die Pipeline ist zwar meiner Meinung nach sehr aussichtsreich (und dieses Jahr sollen mehrere Sudiendaten kommen) doch noch in einer zu frühen Phase für eine MK im 1 Mrd Bereich. Ich überlege mir, diese je nach der Kursentwicklung in den nächsten Tagen zu verkaufen... ebenfalls kann ich bei meiner MLNM Altlast keine klaren Fortschritte erkennen (okay... dieses Jahr BE, allerdings Umsatz rückläufig und keine Kandidaten in PIII). Mit einem Verkauf von REGN und MLNM wäre Platz für drei neue Kandidaten...

DSCO... MK 384 Mio USD: Surfaxin ist schon so gut wie zugelassen, im April sollte das FDA-OK erfolgen. Surfaxin hört sich nicht schlecht an und es sollten sich größere Märkte erschließen lassen.

DOVP... MK 338 Mio USD: Bis zum PDUFA am 15.2. entscheidet die FDA über die Zulassung von NBIX Indiplon... DOVP erhält 3,5% Royalties von diesem potentiellen 2 Mrd USD Blockbuster. Zusätzlich befinden sich einige Kandidaten in PIII und PII, die allerdings auch ein gewisses Risiko beinhalten.

ENCY... MK 460 Mio USD: ENCY wurde ordentlich verprügelt wegen guter Daten des Konkurrenten MYOG... finde aber, dass Thelin doch konkurrenzfähiger ist, als es im Moment aussieht. Entscheidung über Thelin Zulassung am 24.3.

also REGN und MLNM raus... DSCO, DOVP und ENCY rein... wenn die Börse da mitmacht, mal sehen...









mfg ipollit

[Hopi1]

moin zusammen,

dein depot liest sich nicht schlecht. biotechs sind in der regel sehr risikoreich. moechte aber auch noch einen aussichtereichen wert reinstellen, der nach erfolgter korrektur sicherlich potential hat. vielleicht hat ja jemand eine meinung dazu: Actelion

haben in den letzten wochen zwei grosse ruecksetzer gemacht. 1. weil das hauptprodukt wahrscheinlich nicht in weiteren anwendungsgebieten genutzt werden kann.
2. weil ein konkurrent positive news gebracht hat (das konkurrenzprodukt kommt aber erst fruehestens 2007 auf den markt)

ich bin letzte woche eingestiegen und hoffe auf eine erholung. wie ist eure meinung dazu?

wuensche noch ein gesundes und erfolgreiches jahr, hopi1

[Boersenkrieger]

was haltet ihr von Biolitec ?
die sind doch eigentlich auch EK-mäßig gut bestückt und nicht überbewertet
celgene fehlt auch noch ...allerdings würde ich sie jetzt nicht mehr unbedingt kaufen (wegen anstieg und bewertung)
millennium wird wohl immer ne niete bleiben auch wenn ich da schon jahre auf ein wunder hoffe

[ipollit]

[posting]19.509.950 von Hopi1 am 03.01.06 04:10:11[/posting]hopi, du bist gut

die Konkurrenten sind ENCY (die ich eigentlich kaufen will) und MYOG bzw. Thelin und Ambrisentan. Ich hoffe mal, dass ENCY im März die Zulassung erhält... also nicht erst in 2007. Tracleer ist wie du schon gesagt hast das Hauptprodukt von Actelion... die beiden Konkurrenten sollten diesem deutlich überlegen sein und starken Druck auf Actelion ausüben. Ich habe mich mit dieser Aktie noch nicht näher befasst, aber vor diesem Hintergrund wäre ich vorsichtig. (nicht alles, was fällt, wird billig)... kann mich aber auch irren


Posted by: drbio45
In reply to: None Date:12/17/2005 9:59:25 PM
Post #of 21321

There was something funny about the ambrisenten data

The population of that trial seems to act differently than other drugs and even Myogen`s phase 2 trial

I am not so sure that the next trial will have the results that this recent trial did.

Myogen also eliminated people with connective tissue disease from this trial. Those people don`t do as well as the rest of the population with the endothelin antagonists.

Encysive included those patients in their trials. Does that mean ambrisenten should be excluded for that population if it does get approved?

DENVER, May 23 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG), a
biopharmaceutical company focused on the discovery, development and
commercialization of small molecule therapeutics for the treatment of
cardiovascular disorders, today announced that two abstracts describing the
effects of ambrisentan in patients with pulmonary arterial hypertension (PAH)
were presented at ATS 2005 - San Diego, the annual International Conference of
the American Thoracic Society. These abstracts summarize additional results
from the Phase 2 study of ambrisentan in 64 patients with PAH (AMB-220) and
the subsequent open-label long-term study (AMB-220-E). One-year follow-up
safety and efficacy results, as well as comparable effects of ambrisentan in
WHO functional Class II and Class III PAH patients, were presented.
On Sunday, May 22, 2005, Adaani E. Frost, M.D., presented "Ambrisentan
Improves 6-Minute Walk Distance Comparably for WHO Class II and III PAH
Patients." Dr. Frost is Professor of Medicine at Baylor University and a
principal investigator for AMB-220. This abstract reported on the relative
efficacy observed for ambrisentan following treatment in patients classified
as having WHO Class II symptoms at the start of treatment versus those
classified with WHO Class III symptoms. Of the 64 patients enrolled in the
study, 23 patients had WHO Class II symptoms and 41 patients had WHO Class III
symptoms. The mean baseline six-minute walk distance for these two groups of
patients were substantially different: the patients with Class II symptoms
had a mean six-minute walk distance at baseline of 390 meters and the patients
with Class III symptoms had a mean six-minute walk distance at baseline of
316 meters. The data showed that both patient populations benefited equally
in their improvement in six-minute walk distance at 12 weeks (37.7 meters for
patients with Class II symptoms and 35.2 meters for patients with Class III
symptoms) and at 24 weeks (58.3 meters for patients with Class II symptoms and
51.9 meters for patients with Class III symptoms). There were no
statistically significant differences between the two groups in the change
from baseline at either time point.
Improvements in six-minute walk distance at week 12 and week 24 were
accompanied with sustained or improved levels of dyspnea (or breathlessness)
compared to baseline for both classes. Class III patients had a significant
improvement from baseline in dyspnea following exercise at week 12 and
week 24, while Class II patients maintained a similar level of dyspnea
compared to baseline, even though they were walking substantially further in
the six-minute walk test. The improvements in Borg dyspnea index between the
two groups were significantly greater for the Class III patients at week 24,
but not at week 12.

**************

Posted by: drbio45
In reply to: drbio45 who wrote msg# 20714 Date:12/17/2005 10:10:16 PM
Post #of 21321

elevated liver enzymes

Analysts went ga ga because ambrisentan did have elevated liver enzymes in their trial but Thelin only had 3 percent and that was 18 week data. I believe it may just be that 12 weeks was too soon to cause the elevations.

The lack of interaction with heparin is an advantage but most doctors don`t seem to find that a problem.

I don`t think it makes up for the 1.5 year lead that thelin will have getting to the market first. It is a much better drug than TRacleer is but Ambrisentan is not that much if any better than thelin

Encysive should not have dropped as much as it did in my opinion. It is 6500 times more selective to endothlin a than b. Ambrisentan is only 20 times more selective to a than b and I think that is a big deal

********

Posted by: OakesCS
In reply to: drbio45 who wrote msg# 20715 Date:12/18/2005 11:21:46 PM
Post #of 21321

ENCY/MYOG

drbio45,
I`ve been looking into this a bit & I`m leaning toward your scepticism of the MYOG announcement. Why are the 6MWD numbers for the ARIES1 test so much better than for the phase II study? Secondly, the earlier results did not show a dose response whereas The ARIES1 trial shows a huge dose response. (both of which you alluded to)

MYOG`s December announcement also doesnt indicate what % were class II vs class III patients. Their numbers for placebo-corrected 6 MWD would seem quite impressive if they included a large % of class II patients since the usual case seems to be that healthier patients show a lower relative improvement. So why didnt they present the specfics of their population? In addition, their earlier, smaller patient populations did contain several patients in the treatment arms that showed increases in serum aminotransferases greater than three times the upper limit of normal range. Makes one wonder.

The thelin trial populations tended to contain about 20% with connective tissue (CT) disease & as you pointed out these patients dont tend to respond well to treatment. The CT patients would drag thelin`s absolute 6MWD numbers down but presumably the placebo population would contain a similar population so the relative numbers shouldnt suffer. I dont think that elimination of CT patients from the MYOG trials would enhance ambrisentan`s placebo corrected numbers but they are comparing apples & oranges as far as patient populations are concerned. MYOG also didnt include patients with congenital heart disease whereas the Thelin trials did. Portrayal of superiority in such cases makes me sceptical.

I dont doubt that ambrisentan is an effective drug. I just have my doubts as to the robustness of the information that MYOG has recently released & that it is as effective as the market seems to think. Looks to me like ambrisentan would split market with Thelin for class II & would share market with Tracleer & Thelin for class III while Thelin & Tracleer have class IV.

Any idea how the NYHA and WHO classifications compare?

Also kind of curious as to where you got the 20:1 selectivity number for ambrisentan. Not doubting it`s validity since I`ve seen numbers ranging from 77:1 (Motte 2005 Pharmacology & Therapeutics in press) to 260:1 (Teerlink 2004 Business Briefing:US Cardiology) so there`s obviously some uncertainty. In anycase, intermediate in selectivity between Thelin (6500:1) & Tracleer (which I think is close to 20:1 but I might have that reversed). If ambrisentan does turn out to be more effective than Thelin it might indicate an optimal level for blocking the ETA receptor relative to the ETB receptor.

Charlie
BTW I`m not an MD, biologist, or statistician of any variety so please treat any errors kindly but I do appreciate commentary.


mfg ipollit

[Hopi1]

danke fuer das "lob"

ich hoffe, ich kann dass auch in ein paar monaten von mir sagen... bin kein biotechexperte sondern denke ziemlich einfach strukturiet: actelion macht dieses und naechstes jahr gute gewinne und hat die prognose fuer 05 schon drei mal angehoben. alle schlechten nachrichten sind im kurs, auch die von den kokurrenzfirmen.
die firmen mit "vielleicht"-produkten erfordern zu viel aufmerksamkeit fuer mich. die zeit habe ich nicht.

aber "vielleicht" ist die boerse ja tatsaechlich so einfach, wie ich denke. time will tell...

wuensche viel erfolg mit ency (der zug bei myog ist ja schon abgefahren), Hopi1

[ipollit]

na das Jahr fängt doch gar nicht schlecht an...

der TecDax gibt die Richtung vor


ich denke, dass innerhalb des TecDax GPC, MOR und MDG gar nicht schlecht darstehen... GPC in ein paar Monaten mit ersten PIII Daten, MOR hatte in den letzten Wochen einen guten Newsflow und bald dürfte eine weitere PI anstehen... bei MDG steht noch der Vermarktungspartner aus. Also wird hoffentlich in der nächsten Zeit das nachgeholt, was im letzten Jahr versäumt wurde.







mfg ipollit

[ipollit]

finde im Moment sieht alles recht positiv aus, was die nächsten Wochen betrifft. Allerdings haben die dt. Bios bis jetzt wenig vom Aufwind der letzten Tage profitieren können. Es war zwar ein wenig teuerer als noch vor kurzen... aber besser spät als nie: REGN habe ich (mit einer ambitionierten MK von fast 1 Mrd USD) vorerst aus dem Depot genommen... ebenfalls habe ich einen Teil von ADLR verkauft (das Risiko im März ist nicht gering) - rein dafür wie geplant gleichgewichtet DSCO, DOVP, ENCY, die jeweils heute eine Performance von ca. 5% hingelegt haben. Mal sehen, ob es so weiter geht...

MOR.de 17,9%
GPC.de 15,3%
MDG.de 8,7%
OSIP 7,0%
ARNA 6,9%
AGIX 4,9%
IDEV 4,7%
PTIE 4,7%
IMCL 4,3%
ADLR 3,8%
CRME 3,1%
NKTR 3,0%
ONXX 2,3%
TELK 2,3%
ENCY 2,1%
DSCO 2,1%
DOVP 1,9%
KOSP 1,4%
INGN 1,3%
MLNM 1,3%

ganz gut gelaufen auch CRME, PTIE und OSIP:







ein Auge sollte man mal auf YMI, PANC und werfen...




der NBI setzt munter seinen Weg fort...


mfg ipollit

[ipollit]

zu ENCY, MYOG und Actelion...

DJ ENcysive Pharma CEO: Market Misinterpreted Myogen Data

New York (Dow Jones) – Encysive Pharmaceuticals Inc. Chief Executive Bruce Given said the market mininterpreted recently released data from Myogen Inc.’s (MYOG) pulmonary arterial hypertension drug, ambrisentan, escalating the tit-for-tat struggle between the two large biotech companies.

“In the market place, it’s axiomatic that you always want to be second, you never want to be third … I think we’ve dealt with a market stampede here, we’ve seen these before … what happens eventually is the cattle stop running and people go back to fundamentals, and that’s what will happen here,” he said.

Encysive shares plummeted as Myogen released hopeful data from its Phase III trial of its ambrisentan drug in December of last year. Encysive makes a similar drug called Thelin.

Swiss biotechnology company Actelion Ltd. Is the only company with a drug for pulmonary hybertension on the market, Tracleer. Both Myogen and Encysive must wait for U.S. Food and Drug Administration approval of their drugs.

Shares of Encysive were at 8.89, up 11 cents, or 1.3%.

- By Henry Sanderson, Dow Jones Newswires

mfg ipollit

[ipollit]

das Jahr hat relativ gut begonnen... der Solar-Dax liegt zwar deutlich mehr als eine Nase vorne, doch im Branchenvergleich steht das Depot nicht schlecht dar...

Anteil Aktie Symbol Kurs KK Gewinn
20,2% Morphosys MOR.de 48,52 EUR 20,43 + 137%
15,5% GPC GPC.de 11,58 EUR 7,31 + 58%
8,1% Medigene MDG.de 8,72 EUR 7,34 + 19%
6,6% Arena ARNA 17,33 USD 9,77 + 77%
6,4% OSI Pharm OSIP 28 USD 25,53 + 10%
5,3% Pain Therap PTIE 9,19 USD 7,08 + 30%
4,1% Indevus IDEV 5,41 USD 7,11 - 24%
4,1% Imclone IMCL 36,05 USD 31,41 + 15%
3,9% Atherogenics AGIX 16,86 USD 18,56 - 9%
3,7% Adolor ADLR 15,1 USD 8,53 + 77%
3,2% Nektar NKTR 20,75 USD 15,96 + 30%
3,2% Cardiome CRME 11,81 USD 9,95 + 19%
2,3% Telik TELK 18,99 USD 15,15 + 25%
2,3% Encysive ENCY 9,84 USD 8,80 + 12%
2,1% Onyx ONXX 27,5 USD 25,45 + 8%
2,1% Discovery Labs DSCO 7,84 USD 7,46 + 5%
1,8% DOV Pharma DOVP 15,61 USD 15,75 - 1%
1,3% Introgen INGN 5,45 USD 8,23 - 34%
1,2% Millennium MLNM 10,28 USD
1,2% KOS Pharma KOSP 44,27 USD 68,41 - 35%

********
Performance 2006
Depot (EUR, netto) +8,1%
NBI (EUR) +3,3%
BTK (EUR) +3,0%
TecDax +13,0%

... so kann es weitergehen.

auf meiner Kaufliste stehen in erster Linie Paion, YMI, Genmab, PANC.

auf der Verkaufsseite ADLR (spätestens bis März, im Moment recht stabil), NKTR (hängt von der Entwicklung der nächsten Tage ab... die besten Meldungen sind im Moment raus, allerdings fundamental können die zusätzlichen Royalties bis 2010 auf ca. 300 Mio USD p.a. anwachsen), MLNM und INGN. Wenn MOR in den nächsten Wochen deutlich ansteigen sollte, würde viel Kapital frei für Käufe... mal sehen.

mfg ipollit

[ipollit]

ADLR - neues 52WHigh... weiter auf Verkauf


DOVP - es geht aufwärts ohne Meldung... 3,5% Indiplon Royalties!


PTIE - wohin geht die Reise?


NKTR - hat es hier eine Zulassung gegeben?


*********

meine Watch macht mir Spaß... solange nicht im Depot läuft es rund

Genmab


YMI


PANC


Paion


mfg ipollit

[ONYXLeader]

Hi ipollit !!

Du mal eine Frage !!

Was haltetst du von der ONYX WKN 900778 ?
So allgemein !!
Charttechnisch auch wieder interessant , oder ?

Wo wird es deiner Meinung nach hin gehen ?

Würde mich über deine Antwort freuen.

mfg. OMYX

[ipollit]

[posting]20.045.147 von ONYXLeader am 04.02.06 20:32:16[/posting]hi onyxleader

du meinst ONXX, die ich im Depot habe?

halte sie erstmal... ist mit 2,1% eine kleinere Position.



ja, was sagt der Chart?

fundamental... aktuelle MK 970 Mio USD, EV 818 Mio USD, 173 Mio USD Cash. Ich hoffe mal, dass Nexavar ein Erfolg wird... Bayer peilt ja mehr als 1 Mrd USD an... bei einer 50:50-Coop könnte die MK auf vielleicht 2 Mrd USD steigen, wenn sich der Erfolg in den nächsten Jahren abzeichnet. ich denke mittelfristig (kann auch 1-2 Jahre dauern) sollte das Gap bis 40 geschlossen werden - ich denke, wenn die Umsätze sich dieses Jahr gut entwickeln und es nach weiteren Zulassungen aussieht, sind so 40 bis 45 USD drin. Im Moment sieht es aber nicht nach einem Schub nach oben aus, oder? Vielleicht gibt es mittelfristig auch eine Spekulation auf Übenahme durch Bayer.

Morgan Stanley analyst Steven Harr reiterated an "overweight" rating on Onyx Pharmaceuticals (nasdaq: ONXX - news - people ) after the company announced Tuesday that the U.S. Food and Drug Administration approved Nexavar, the company`s kidney cancer drug with collaborator Bayer (nyse: BAY - news - people ), and announced higher-than-anticipated pricing on the drug.

Onyx announced that Nexavar will be priced at $4,333 a month, above the firm`s estimate of $3,200 and a Street consensus of $3,000, the analyst said in a report issued Wednesday. With approximately 2,100 patients currently on the drug, "2006 sales of approximately $35 million are basically in the bag," he said.

"We believe the drug should have limited exposure to price sensitivity, since Medicare Part D insulates Medicare patients from the cost of highly expensive drugs," said the research analyst. "Private insurers are likely to look favorably on this drug as well, especially when compared to potentially toxic competitors with high treatment-associated costs," he said.

"We expect the first half of 2006 to be a volatile period as investors try to handicap the sales trajectory for the drug and the market share split with Pfizer`s (nyse: PFE - news - people ) Sutent. But with "a strong expected launch" and "and even greater potential first mover advantage in the European Union," Onyx could see a strong first half, said the analyst.

The launch of Nexavar is "a harbinger of things to come," said Harr. Pfizer`s Sutent and Genentech`s (nyse: DNA - news - people ) Avastin will be fast on the heels of Nexavar in renal cell carcinoma (although Avastin has a significant price disadvantage)," he said. "Near-term investor attention is likely to focus on Nexavar`s launch as well as its ability to retain market share after a likely Sutent launch in the second quarter of 2006."

mfg ipollit

[ipollit]

ADLR gab heute unerwartet positive PIII POI Daten bekannt. Was ich bis jetzt immer dazu gelesen hatte, war, dass die Zulassung für POI im Juni sehr schwer sei. Sieht jetzt vielleicht anders aus. Nach dem 40%-Schub heute ist die MK mit ca. 870 Mio USD schon ganz ordentlich... vielleicht sind noch 25 USD drin, mehr traue ich der Aktie aber in der nächsten Zeit nicht zu - habe daher die komplette Position (mit 160% Gewinn ) rausgenommen.



dafür rein eine 3%-Position YMI... ich weiß, dass es nicht ohne ist, vielleicht in eine Fahnenstange zu geraten (aktuell auf 52WH, ATH?)... in diesem Fall würde ich nachkaufen


Morgen vielleicht KOSP raus und eine 5%-Position Paion rein. Leider ist das mit ADLR nicht früher gelaufen, sonst hätte ich Paion einiges billiger bekommen... allerdings mit ca 170 Mio USD bei weitem noch nicht zu teuer (schätze mal 100% sind drin).

mfg ipollit

[ONYXLeader]

Hi ipollit !!!

Ja, genau die meine ich !!

Super von dir, das du mir geantwortet hast.

Das würde mich freuen, wenn mal wieder auf die 40 Dollar steigen würden !

mfg. ONYX

PS: Was ist von dem Momentanen Kursverlauf zu sagen !!

Ist der interessant, weil er ja immer zwischen der 38 und der
200 Linie hin und her geht !

Bricht er aus ?

[ipollit]

mit Paion war ich mir heute noch nicht sicher... habe erst mal nur die halbe Position gekauft... 2.Hälfte bei weiterem Ausbruch oder Korrektur. ADLR hat heute noch mal einen drauf gelegt und die 25 USD erreicht... Kurse drüber halte ich allerdings für übertrieben.

Anteil Aktie Symbol Kurs KK Gewinn
20,1% Morphosys MOR.de 50,02 EUR 20,43 + 145%
15,8% GPC GPC.de 12,16 EUR 7,31 + 66%
7,6% Medigene MDG.de 8,45 EUR 7,34 + 15%
6,9% OSI Pharm OSIP 30,61 USD 25,53 + 20%
5,9% Arena ARNA 15,74 USD 9,77 + 61%
5,1% Pain Therap PTIE 9,09 USD 7,08 + 28%
4,1% Indevus IDEV 5,46 USD 7,11 - 23%
4,0% Imclone IMCL 35,87 USD 31,41 + 14%
3,6% Atherogenics AGIX 16,22 USD 18,56 - 13%
3,4% Cardiome CRME 13,05 USD 9,95 + 31%
3,0% Nektar NKTR 19,82 USD 15,96 + 24%
2,8% YM Bioscience YMI 4,67 USD 4,44 + 5%
2,5% Paion PA8 9,38 EUR 9,14 + 3%
2,2% Telik TELK 18,74 USD 15,15 + 24%
2,1% Encysive ENCY 9,15 USD 8,80 + 4%
2,0% DOV Pharma DOVP 18,02 USD 15,75 + 14%
2,0% Onyx ONXX 26,87 USD 25,45 + 6%
2,0% Discovery Labs DSCO 7,55 USD 7,46 + 1%
1,2% KOS Pharma KOSP 45,52 USD 68,41 - 33%
1,2% Millennium MLNM 10,21 USD
1,1% Introgen INGN 5,1 USD 8,23 - 38%

********

Performance 2006
Depot (EUR, netto) 12,0%
NBI (EUR) 1,3%
BTK (EUR) 0,9%
TecDax 17,7%


Genmab halte ich zwar für gut, aber mit rund 1 Mrd USD MK ist es mir jetzt zu teuer. Auf meiner Kaufliste habe ich jetzt PANC und KERX... u.U. eine highrisk-Position VSGN (hier kommen am 12.3. PIII-Daten mit hohem Risiko). Auf der Verkaufsseite sind KOSP (u.U. Zahlen abwarten, sonst Verlust mitnehmen und beobachten), INGN, MLNM und u.U. NKTR.

mfg ipollit

[ipollit]

[posting]20.121.825 von ONYXLeader am 09.02.06 18:15:17[/posting]naja nach Ausbruch sieht das im Moment für mich nicht aus, dafür muss es schon deutlich über 30 gehen (bin allerdings auch kein Charttechniker) Stehen denn demnächst irgendwelche News an? müsste ich mir mal genauer ansehen. Ist im Moment eine Halteposition, die ich auch verkaufen könnte, wenn andere Werte vielversprechend sind, oder zukaufen, wenn sich der Kurs deutlich nach oben oder unten bewegt. 40 USD sehe ich kurzfristig so nicht...

Nach der Meldung unten dürfte ONXX auch von Sutent beeinflusst werden... wie sieht es denn da aus?

mfg ipollit

[ipollit]

Vasogen VSGN scheint sehr interessant zu sein... wie ich ja bereits sagte, stehen PIII-Ergebnisse zu Celcade am 12.3. an. Es ist kaum anzunehmen, dass diese erfolgreich sein werden, da diese Studie letztes Jahr gestoppt wurde. Die PAD Indikation scheint schwer zu erreichen zu sein... die Probleme sind bekannt und eingepreist, weshalb die Aktie eher niedrig bewertet ist. Die zweite Indikation CHF in PIII sieht dagegen eher nach einem Erfolg aus. Sollte also am 12.3. alles negativ sein, könnte die Aktie nochmals einbrechen... dann wäre ein guter Zeitpunkt zum Nachkauf. Ist etwas positiv, dann erwarte ich einen kleinen Peak nach oben. Wenn später ACCLAIM positiv ausfällt, sollte sich die Aktie locker verdoppeln können.

Re: Mean Target of $9.42 on VSGN?
by: docrocphd
Long-Term Sentiment: Strong Buy 02/11/06 09:26 pm
Msg: 13161 of 13165

The price targets are essentially meaningless at this point. You are correct on the two phase III clinical trials already completed but not as of yet reported due to data clean-up and subsequent lock prior to analysis. SIMPADICO trial is significantly less important and was halted early due to "modest imbalance" in observed cancer rates and lack of "sufficiently strong efficacy signal" in primary endpoints. The cancer issue was closely examined by outside experts and found not to be an issue at all in either the SIMPADICO or ACCLAIM trials. SIMPADICO deals with PAD which is much harder to impact quickly due to the nature of the manifested disease process and the role of placebo variance in the study end points. They key here is in the analysis of process measures, secondary end points and examination of primary endpoints trend. ACCLAIM deals with CHF and is likely one of the most significant phase III trials in many years with clear-cut primary end points including mortality and hospitalization rates. Obviously, placebo variance plays very little role here. If SIMPADICO yields positive results in process/secondary measures then VSGN likely doubles. If ACCLAIM results are good then VSGN takes off with literally the sky as the limit. The medical conditions likely to benefit from Celcade are numerous to the benefit of mankind and to VSGN shareholders. Five years from now $100 stock price is a possibility. It the ACCLAIM results come in negative then VSGN will drop 50-75% and our life spans just shortened significantly with a lot more discomfort. There is a medication on the horizon as well which would have a multiplying effect on VSGN stock price. It is still too early to comment on VP025 efficacy. The company may be coming out with news here.

I have followed this company for six years now and am fairly confident of the results with my money behind it. It is a risk however so due your research.

**************

Re: DOC Dillerdoc
by: da_doc (32/M/AZ)
Long-Term Sentiment: Buy 02/11/06 10:59 pm
Msg: 13162 of 13165

In theory Celcade should work rather well on any type of autoimmune disorder. I believe that Vasogen has a patent for using this technology to treat Rheumatoid Arthritis (RA). I wonder how many in the SIMPADICO or ACCLAIM trials have RA and what data they will have. Furthermore, I wouldn`t be surprised if clinical trials to get Celcade approved for RA were begun sometime before the end of the decade.

However, Celcade will be second or third line therapy because of cost and inconvenience. Pills are much cheaper and easier to use. However side effects from steroids, methotrexate are significant. Celcade would be on par with some of the newer treatments in terms of cost however. We shall see!

I think Celcade`s potential is not being fully appreciated yet. Everyone has CHF/PAD blinders on except for us physicians.

Celcade`s other potential applications include: Inflammatory Bowel Disease, lupus, Rheumatoid arthritis, prevention of organ transplant rejection, Autoimmune hepatitis, Autoimmune thrombocytopenic purpura (ITP), Vasculitidies (multiple types), Sarcoidosis, Autoimmune hemolytic anemias, Myasthenia gravis (remote possibility), Glomerulonephritidies (multiple types)....etc.

Those are just off the top of my head. I am sure there are more. This is why the potential of Vasogen is so underestimated. Celcade has the potential to treat so many disease processes that the market potential is enormous. We are talking multibillion dollars.

AMGEN`s epogen is a great example of this. When initially developed it was for Anemia of Chronic Renal Disease. Today we use it for virtually everyone with chronic anemia of almost ALL types.

Vasogen`s Celcade potentiall has applications in any disease process that is caused or exacerbated by an increase in autoimmune function.

EVERY other biotech develops drugs/treatments usually geared toward a very narrow spectrum of disease processes and hence have limited market potential.

The opportunity to get in on the ground floor of a completely revolutionary treatment is at hand. It`s worth at least a gamble of $5,000.

***********

Posted by: AlohaDan
In reply to: rfj1862 who wrote msg# 23820 Date:2/12/2006 2:52:01 AM
Post #of 23839

MOA of Celcade in crayon diagram is on the company web site at:

http://www.vasogen.com/sec/immune


The Phase II results as you stated were excellent. As we all know these do not necessarily carry over to Phase III. But 2400 pts enrolled and the time length to the trigger point would be favorable indicators of positive results in CHF. Not a bad market. So I`m betting on a favorable outcome as your looking for a 4-5 bagger versus maybe a drop to 1.5-2 on failure.

I`ll be interested in your review of their literature, including the VP025 kicker.

PAD is dead for the moment IMHO. But it`s built into the current price unless you can`t read what`s been released { Guys on the Motley Fool board think any end point subjectively measuring walking is doomed anyway.}
Re press release

Vasogen Announces the Early Close Out of the SIMPADICO Peripheral Arterial Disease Trial

Toronto, Ontario - August 30, 2005

Vasogen Inc. (NASDAQ:VSGN; TSX:VAS), focused on the development of immune modulation therapies for the treatment of cardiovascular disease, today announced the early close out of the 550-patient, double-blind, placebo-controlled phase III SIMPADICO trial of its Celacade™ technology for the treatment of symptomatic peripheral arterial disease (PAD). The decision to close out the trial at this time is based on a recommendation received from the SIMPADICO Steering Committee.

The Steering Committee’s recommendation was based on a recommendation by the trial’s External Safety and Efficacy Monitoring Committee (ESEMC). The ESEMC recommended the early close out of the study based on the absence of a sufficiently strong efficacy signal and their observation of a modest imbalance in the distribution of a small number of malignancy cases. Based on the Steering Committee’s own review, and the findings of an independent expert in medical oncology, the Steering Committee concluded that no safety concern existed. However, given that the ESEMC’s analysis also incorporated efficacy information and all patients have completed the assessments necessary for the analysis of the primary endpoint, the Steering Committee recommended the early close out of the trial.

“While the Steering Committee does not agree that a safety concern existed, our knowledge that the ESEMC’s analysis also considered efficacy led to our decision to recommend stopping the study at this time,” stated Dr. Jeffrey Olin, Professor of Medicine at the Mount Sinai School of Medicine, Director of Vascular Medicine at The Zena and Michael A. Wiener Cardiovascular Institute in New York, Principal Investigator and Chairman of the Steering Committee for the SIMPADICO trial. “We are now proceeding to lock the data base, fully analyze the data, and report the final results of the trial.”

*************

UPDATE 2-Vasogen sees Celacade trials data in 1st-half 2006
Wed Dec 7, 2005 11:59 AM ET
(Recasts, adds analyst comments, details, stock prices, changes dateline from TORONTO)
OTTAWA, Dec 7 (Reuters) - Vasogen Inc. (VAS.TO: Quote, Profile, Research) (VSGN.O: Quote, Profile, Research) said on Wednesday that it expects to complete and release results from two pivotal late-stage trials of its Celacade heart disease therapy in the first half of 2006.

"Vasogen expects data for both of these trials to be released within the next three to four months," Needham & Co. analyst Mark Monane said in a note. "These data will be critical for Vasogen."

Six-month assessments for all patients in the company`s Acclaim trial, using Celacade to treat chronic heart failure, are expected to be complete next month. Results of the study and plans for presentation and publication of the data are seen during the first half of 2006, Vasogen said.

"This data will be critical for Vasogen and is the major value driver for the stock," Monane wrote. "We believe the Acclaim data release will be the most important event in Vasogen`s short term history."

Mid-stage data from the Acclaim trial suggests that therapy holds a higher probability of success than Simpadico, said National Bank Financial in a recent research note.

In August, Vasogen shares plunged more than 40 percent when it said it was halting its Simpadico late-stage trial because it was not effective enough. But its shares got a lift in November when it said its Acclaim trail had met its targeted number of end-point events.

The Acclaim trial will assess the impact of Celacade on reducing the risk of death and cardiovascular hospitalization in patients with advanced chronic heart failure.

Vasogen also said on Wednesday that 12-month assessments for all patients in its Simpadico trial, using Celacade treatment for peripheral heart disease, are complete.

A steering committee will likely meet to analyze study results in late January or early February 2006. Afterward, results and plans to present and publish the data will be made public, said Mississauga, Ontario-based Vasogen.

"We believe that investors have assigned no value to this trial, so any positive news may provide upside to the stock," Monane noted.

Celacade is an immune modulation therapy, in which a small sample of patient blood is treated and then injected back into muscle tissue.

Vasogen shares rose 4 Canadian cents to C$2.60 on the Toronto Stock Exchange and added 4 cents to $2.24 on Nasdaq on Wednesday.

The company, which ended the third quarter with C$65.1 million ($56 million) in cash, will likely raise additional funds through a partnership with a major pharmaceutical or device company to develop and commercialize Celacade, Monane wrote.

($1=$1.16 Canadian)

(Additional reporting by Sue Thomas)

****************

Vasogen Inc (up $0.13 to $3.24, Research). is testing its experimental product Celacade in two phase 3 studies: the SIMPADICO study for the treatment of peripheral arterial disease, which impairs the flow of blood to the lower limbs, and ACCLAIM for chronic heart failure. The Toronto-based biotech plans to raise the curtain on its arterial disease study on March 12, at the American College of Cardiology`s annual conference in Atlanta.

"If SIMPADICO and ACCLAIM are positive, this could be a $500 million to $700 million [product]," said Mark Monane, analyst for Needham & Co. "Not too shabby for a biotech."

These areas are potentially lucrative for treatment because they are common in the aging U.S. population. Peripheral heart disease affects eight to 12 million Americans, according to the American Heart Association. More than 20 percent of the population over 70 years old has the disease, which increases six to seven times the risk of heart attack or stroke. As for chronic heart failure, some five million Americans are living with it, and another 550,000 are diagnosed every year.

"A diagnosis in heart failure is worse than many forms of cancer, with a mortality rate of 50 percent over five years," said Vasogen chief executive officer David Elsley. "The hope for our product is to reduce the risk of death and to reduce cardiovascular hospitalization."

***************

okay... 100 USD sind sehr übertrieben. 1 Mrd USD MK sind aber bei einem erfolgreichen CHF-Medikament nicht zuviel, was ca 300% Gewinn wären.

aktuell 3.08 USD, MK 251 Mio USD, Cash 57 Mio USD, EV 194 Mio USD.





sieht nach einer 3 USD Konsolidierung aus... ich werde wohl den Paion Zukauf verschieben und zuerst eine 3% Position VSGN kaufen. Risiko sind vielleicht 75%, Chance 100-300%.

mfg ipollit

[cyberhai]

Hallo ipollit,

dickes Lob für Deinen Thread, ist jetzt unter meinen Favoriten

Wir haben einen gemeinsamen Wert: IDEV, habe den Wert allerdings mit 10,15% Depotanteil gewichtet.

Bist Du nur in Biotechs investiert oder hast Du noch andere Depotwerte?

Gruß Cyberhai

[ipollit]

[posting]20.170.304 von cyberhai am 12.02.06 19:14:59[/posting]hallo cyberhai!

danke... ich habe praktisch nur Biotechs (so wie ich das Depot hier poste); sonst habe ich nur noch eine kleine Restposition Nokia

IDEV hätte ich am liebsten schon rausgeworfen... bin seit der Sanctura-Zulassung dabei (bzw. kurz vorher), hat sich aber alles andere als ausgezahlt und Sanctura ist gefloppt. Jetzt ist es wieder eine Halteposition geworden. Mal sehen, ob Sanctura XR Sanctura auf die Gewinnerstraße bringt. Pagoclone scheint ja auch wieder ein wenig im Rennen zu sein. Pro 2000 kann ich nicht so recht einschätzen, wird aber stark gefördert. Wenn ich das richtig gelesen habe, ist IP 751 mit der interessanteste Kandidat, wird allerdings von IDEV vernachlässigt. Aber solange die Insider weiter so dabei sind, ist bei einer MK von 258 Mio USD inkl 100 Mio USD Cash noch Platz nach oben.

**********

noch ein paar Ideen, die ich neben PANC (HIV) und KERX (Diabetis) auf der Watchliste habe.

Micromet geht statt eines IPO einen Merger mit CNVX ein (2/3 Micromet, 1/3 CNVX)... habe sie schon am Jahresanfang beobachtet, habe leider den letzten Anstieg verpasst.



ANDS... 500 Mio USD Deal für PI-Knadidat ist nicht schlecht... vielversprechende PI/II Pipeline gegen Hepatitis B&C



LGND... u.a. 5-10% Royalties für potentiellen Blockbuster Eltrombopag (in PII bei GSK) und Nahe am BE... allerdings mit rund 1 Mrd USD MK nicht ganz billig



ARRY


SNUS


INCY


mfg ipollit

[ipollit]

wenn MOR jetzt weiter Richtung 60-65 läuft, hätte ich auch wieder Cash frei... mal sehen, ob es da demnächst mit dem Aufbau einer eigenen Pipeline begonnen wird (würde ich für die Zukunft für sinnvoll halten)... hoffentlich nimmt der Markt das nicht übel.





CAT als MOR Konkurrent könnte auch interessant sein... haben so etwa 300 Mio USD als Entschädigung für Humira-Royalties von Abbott bekommen... Humira Umsatz liegt deutlich über 1 Mrd USd und den Erwartungen, wofür CATG irgendetwas um 2,5% Royalties erhält.MK 635 Mio USD, EV 370 Mio USD, Cash 265 Mio USD. Naja... müsste mir die Pipeline mal genauer ansehen.



mfg ipollit

[cyberhai]

[posting]20.172.181 von ipollit am 12.02.06 23:05:50[/posting]Ich bin nur noch in Biotechs investiert.

Indevus habe ich im Prinzip nur wegen Pro 2000 gekauft.

Die folgenden Werte habe ich auch bereits auf der engeren Kaufliste:

INCY
ARRY
ANDS

Ligand Pharmaceuticals Inc. (LGND.PK) ist an der OTC mit ca. 1 Millarde bewertet - warum sind die nicht an der Nasdaq

Die restlichen Werte sind interessant, habe da jedenfalls auf den ersten Blick nichts negatives gefunden. Mein englisch ist allerdings sehr beschränkt und ich muss immer die Übersetzungsprogramme benutzen...

Die Homepage von KATG ist sehr umfangreich, ich muss gestehen, da blicke ich nicht mehr durch. Dyax Corp. (DYAX) ist ebenfalls auf dem Gebiet tätig, kannst Dir ja mal anschauen (hatte ich mal im Depot).

Ich muss jetzt aufpassen, dass ich vor lauter Biotechs nicht den Überblich verliere, habe jetzt 111 auf der WL.

Gruß Cyberhai

[ipollit]

[posting]20.186.334 von cyberhai am 13.02.06 19:29:32[/posting]LGND wurde wegen formalen Problemen mit irgendwelchen Berichten delistet... die werden wieder regulär an der Nasdaq gelistet sein, wenn diese Sachen behoben sind - wirkt sich jedenfalls nicht negativ auf deren Geschäft aus.

DYAX kenne ich prinzipiell (müsste ich mir allerdings genauer ansehen), setze da aber grundsätzlich auf MOR... CATG finde ich nur wegen Cash + Blockbusterroyalties interessant.

MOR ist ja heute schön weiter gelaufen... ich denke, ab 60-65 werde ich schwach - eine 20-25% Übergewichtung ist jedenfalls nicht sinnvoll.

Bei über 100 Werten würde ich auch den Überblick verlieren ... ich suche nach Werten mit einer vielversprechenden Pipeline (möglichst in PIII). Was sind den deine Favoriten?

mfg ipollit

[ipollit]

So habe mir eine Position VSGN zugelegt... morgen gibt es da Zahlen, da könnte es nochmal runter gehen - ansonsten bietet sich vielleicht am 12.3. eine Nachkaufgelegenheit... ansonsten können sie auch gerne hochlaufen. (Es besteht allerdings auch das Risiko eines heftigen Crashs)



(der Chart erlaubt ebenfalls ein Wegbrechen nach unten)


Anteil Aktie Symbol Kurs KK Gewinn
20,7% Morphosys MOR.de 53,95 EUR 20,43 + 164%
15,0% GPC GPC.de 12,11 EUR 7,31 + 66%
7,5% Medigene MDG.de 8,8 EUR 7,34 + 20%
6,7% OSI Pharm OSIP 31,42 USD 25,53 + 23%
5,3% Arena ARNA 14,88 USD 9,77 + 52%
5,2% Pain Therap PTIE 9,78 USD 7,08 + 38%
3,9% Indevus IDEV 5,42 USD 7,11 - 24%
3,8% Imclone IMCL 35,81 USD 31,41 + 14%
3,3% Atherogenics AGIX 15,36 USD 18,56 - 17%
3,0% Cardiome CRME 12,1 USD 9,95 + 22%
3,0% Nektar NKTR 20,64 USD 15,96 + 29%
2,9% YM Bioscience YMI 5,13 USD 4,44 + 16%
2,6% Vasogen VSGN 3 USD 3,06 - 2%
2,3% Paion PA8 8,99 EUR 9,14 - 2%
2,3% Telik TELK 19,77 USD 15,15 + 30%
2,0% DOV Pharma DOVP 18,87 USD 15,75 + 20%
1,9% Onyx ONXX 27,13 USD 25,45 + 7%
1,9% Encysive ENCY 9,04 USD 8,80 + 3%
1,9% Discovery Labs DSCO 7,4 USD 7,46 - 1%
1,1% KOS Pharma KOSP 45,64 USD 68,41 - 33%
1,1% Millennium MLNM 10,18 USD
1,1% Introgen INGN 4,93 USD 8,23 - 40%



Performance 2006
Depot (EUR, netto) 14,0%
NBI (EUR) 1,3%
BTK (EUR) 0,7%
TecDax 18,6%

morgen werde ich wohl noch INGN verkaufen...

mfg ipollit

[cyberhai]

Hier meine Hautinvestments:

"CYTOS
BIOTECHN. NA
SF-,10 " 804352

"GERON CORP.
(DEL.) DL-001 " 902213

"BIOLITEC AG
AKTIEN O.N. " 521340

"NABI BIOPHA.
DL-,10 " 856797

"NOVAVAX INC.
DL-,01 " 898527

PEREGRINE PH. 868886

"SIRNA
THERAPEUTICS
DL-,01 " 120096

"ALNYLAM
PHARMACE.DL-,0
001 " A0CBCK

Cytos ist mein größter Posten, haben Impfmittel gegen Nikotinsucht in Phase II, weitere Mittel gegen Alzheimer, Bluthochdruck, Fettsucht, usw. in der Pipeline, siehe: http://www.cytos.com/doc/Product%20Pipeline_December14.pdf

Pain Therap. hatte ich bis vor ein paar Wochen auch noch, habe ich wegen Cashbedarf verkauft.

Gruß Cyberhai

[puhvogel]

@ipollit:
Kleiner Tipp: IDEV mag zwar 90 Millionen $ Cash haben, aber dafür haben die auch 70 Millionen in Form von convertibles (Wandelanleihen) zum wandelrecht 6.6 $ emittiert.
Netto bleibt also wenig übrig....

[cyberhai]

Bei der Pipeline dürfte Indevus keine Probleme mit einer weiteren Finanzierung haben:



Gruß Cyberhai

[ipollit]

so... habe Paion aufgestockt und eine Position PANC und ANDS (letzteres leicht übergewichtet) zugelegt.

Anteil Aktie Symbol Kurs KK Gewinn
18,7% Morphosys MOR.de 53,6 EUR 20,43 + 162%
14,3% GPC GPC.de 12,76 EUR 7,31 + 75%
6,8% Medigene MDG.de 8,8 EUR 7,34 + 20%
6,0% OSI Pharm OSIP 30,55 USD 25,53 + 20%
5,5% Arena ARNA 16,83 USD 9,77 + 72%
5,3% Pain Therap PTIE 10,93 USD 7,08 + 54%
4,3% Paion PA8 9,14 EUR 9,12 + 0%
4,0% Indevus IDEV 6,12 USD 7,11 - 14%
3,7% Imclone IMCL 37,49 USD 31,41 + 19%
3,1% Atherogenics AGIX 15,93 USD 18,56 - 14%
2,8% Nektar NKTR 21,26 USD 15,96 + 33%
2,7% Cardiome CRME 11,93 USD 9,95 + 20%
2,6% YM Bioscience YMI 4,97 USD 4,44 + 12%
2,4% Vasogen VSGN 3,08 USD 3,06 + 1%
2,3% Anadys ANDS 11,99 USD 11,94 + 0%
2,1% Telik TELK 20,4 USD 15,15 + 35%
1,9% DOV Pharma DOVP 19,09 USD 15,75 + 21%
1,8% Discovery Labs DSCO 7,95 USD 7,46 + 7%
1,8% Onyx ONXX 27,64 USD 25,45 + 9%
1,8% Encysive ENCY 9,1 USD 8,80 + 3%
1,5% Panacos PANC 7,92 USD 8,24 - 4%
1,1% KOS Pharma KOSP 50,21 USD 68,41 - 27%
1,1% Introgen INGN 5,75 USD 8,23 - 30%
1,1% Millennium MLNM 10,75 USD


Performance 2006
Depot (EUR, netto) 16,5%
NBI (EUR) 6,0%
BTK (EUR) 6,0%
TecDax 19,1%

*********

jetzt steht noch auf meiner Kaufseite CNVX, KERX... auf meiner Watch RIGL und INCY, ARRY, SNUS, LGND.

mfg ipollit

[whyso]

vorerst nur mein *lesezeichen*...

[hasi22]

Hallo Kenner, welche Firma könnte hier gemeint sein ?
herzlichen Dank Hasi

******************************************************

Nur ein kleines, bisher unbekanntes Biotech-Unternehmen hat erkannt: China steckt in einer echten Gesundheitskrise

Anleger, die dieses Jahrhundert-Investment nutzen, werden mit dem derzeit 0,20$-Unternehmen auf bis zu 2,90$ katapultiert ...
Liebe "Trader`s Daily"-Leser,
ja, Sie haben richtig gelesen: Diese kleine Biotech-Firma hat, unbemerkt von allen Pharmagiganten, in China bereits den Fuß in der Türe und beste Aussichten, Monopolist auf ihrem Gebiet zu werden. Wir haben diesen Wert bisher mehrere Mal getradet und dabei innerhalb von Stunden gigantische Kursgewinne von bis zu 107% erlebt.

*****************************************************

[nkelchen]

[posting]20.268.162 von whyso am 18.02.06 10:56:44[/posting]

Hallo whyso, alles im Lack?!

Habe den Thread eben entdeckt.
Ich führe auch ein Biotech Depot, allerdings mit einem etwas speziellen Ansatz.


Wen es interessiert:
Thread: Fragen & Antworten...........

Gruss
nk
*werde mich nun erst mal hier einlesen*

[nkelchen]

habe es mal in kompakter Form nach hier verschoben:
Thread: The fallen Angel...( Biotech-Rebound Depot )

nk

[ipollit]

ANDS und besonders PANC sind ja nach meinem Kauf erstmal durchgestartet... leider in die falsche Richtung ... naja, ich kaufe halt meistens long.

kurzfristiger habe ich da heute meine GPC Position noch ein wenig angehoben in der Hoffnung, dass hier in der nächsten Zeit ein paar % zu holen sind... danach werde ich wieder leicht reduzieren und mich KERX, RIGL und CNVX zuwenden... AGIX könnte man aufstocken, ebenfalls ARNA und Paion.

nach wie vor läuft es dieses Jahr mehr als rund... mal sehen, wo das noch hinführt. PTIE wurde von Cramer hochgepuscht, MOR könnte die Tage einen Strategiewechsel ankündigen, GPC bleibt auf Kurs nach oben... in den nächsten Monaten stehen einige Zulassungen und Studienergebnisse an... VSGN, IMCL, DOVP, DSCO, ENCY


Anteil Aktie Symbol Kurs KK Gewinn
18,3% Morphosys MOR.de 54,17 EUR 20,43 + 165%
16,0% GPC GPC.de 13,09 EUR 7,94 + 65%
6,6% Medigene MDG.de 8,73 EUR 7,34 + 19%
5,8% OSI Pharm OSIP 30,6 USD 25,53 + 20%
5,4% Pain Therap PTIE 11,42 USD 7,08 + 61%
5,1% Arena ARNA 16,22 USD 9,77 + 66%
4,2% Paion PA8 9,25 EUR 9,12 + 1%
4,0% Indevus IDEV 6,4 USD 7,11 - 10%
3,6% Imclone IMCL 38,19 USD 31,41 + 22%
3,0% Atherogenics AGIX 16,01 USD 18,56 - 14%
2,8% YM Bioscience YMI 5,48 USD 4,44 + 23%
2,7% Nektar NKTR 21,76 USD 15,96 + 36%
2,7% Cardiome CRME 12,14 USD 9,95 + 22%
2,4% Vasogen VSGN 3,13 USD 3,06 + 2%
2,2% Anadys ANDS 11,7 USD 11,94 - 2%
2,1% Telik TELK 20,4 USD 15,15 + 35%
1,8% Discovery Labs DSCO 8,25 USD 7,46 + 11%
1,8% Onyx ONXX 28,37 USD 25,45 + 11%
1,8% DOV Pharma DOVP 18,79 USD 15,75 + 19%
1,7% Encysive ENCY 9,03 USD 8,80 + 3%
1,4% Panacos PANC 7,41 USD 8,24 - 10%
1,1% Introgen INGN 5,91 USD 8,23 - 28%
1,1% KOS Pharma KOSP 49,77 USD 68,41 - 27%
1,0% Millennium MLNM 10,46 USD


Performance 2006
Depot (EUR, netto) 17,7%
NBI (EUR) 6,7%
BTK (EUR) 7,0%
TecDax 23,3%





mfg ipollit

[ipollit]

naja, ein wenig nüchterner wäre mir lieber gewesen, Herr "a hell of a company" God(dard)... hoffe mal, dass die Zahlen nicht genau so blumig sind, sondern auch mal Realität werden...

BOSTON, Feb 23 (Reuters) - The chief executive of OSI Pharmaceuticals Inc. (OSIP.O: Quote, Profile, Research) on Thursday said annual sales of the company`s lung and pancreatic cancer drug Tarceva could reach $1 billion by 2008 and double to $2 billion by 2010 to 2011.

He said the drug, which is sold in partnership with Genentech Inc. (DNA.N: Quote, Profile, Research) and had U.S. sales last year of $275 million, will be bolstered by surging demand in Europe and Japan, and by expanded uses of the drug.

"I think European sales of Tarceva will be bigger than U.S. sales by 2008 to 2008," OSI Chief Executive Colin Goddard told reporters at the Reuters Biotechnology Summit in Boston.

"We think Tarceva is going to be a blockbuster. We`ve never varied from that belief," he said of the drug, which is sold in Europe by Roche Holding AG (ROG.VX: Quote, Profile, Research) with royalties going to OSI.

Goddard said OSI expects to gain Tarceva approval in Japan for lung cancer by next year, and that Japan will become another big market for the company`s cancer pill.

OSI is also hoping that Tarceva will eventually gain approval to treat lung cancer at an earlier stage of the disease -- it is currently approved as a 2nd and 3rd line treatment for non-small cell lung cancer -- as a treatment following surgery and for use against a wide range of cancers.

The company is studying the drug in head and neck cancer, ovarian cancer, brain tumors and colon cancer. Goddard said Tarceva appears to be particularly effective in non-small cell lung cancer among patients who were not smokers.

"We`re doing a study to draw that out," Goddard said. "Tarceva is the engine that drives us," he added.

But Goddard said Wall Street was vastly underestimating the long-term sales potential of Macugen, a treatment for the leading cause of blindness in the elderly that the company acquired with its controversial recent purchase of biotechnology company Eyetech.

OSI`s shares were battered last year when the Eyetech deal was announced over concerns that Macugen would not fare favorably against Lucentis, a possibly more potent drug being developed by Genentech that is expected to get U.S. approval this year.

Goddard said he believes Macugen will hold on to a 20 percent to 40 percent share of the age-related macular degeneration market after Lucentis is launched, and that a 10 percent share would justify the Eyetech purchase.

He expects that with its lower risk profile, Macugen may well be used as a long-term maintenance treatment in patients who initially receive Lucentis.

Still, Goddard admitted that it has been tough going dealing with shareholder dissatisfaction, in large part because they had no say in the Eyetech deal.

The company addressed a potential shareholder revolt earlier this month by changing its bylaws to allow shareholders a vote in future acquisitions -- a move that some still view as "too little, too late," Goddard admitted.

Goddard believes he can regain investor trust over time and promised more transparency with the investor community.

He also said on Thursday that shareholders will not be faced with any more large-scale acquisitions.

"There will be no more major strategy forming M&A. We`ve built the framework," he said, adding that it will take up to three years to judge whether Eyetech was the right decision.

"If we execute on this plan," Goddard said, "we`ve built a hell of a company."

OSIP halte ich jedenfalls erstmal als viertgrößte Position mit Ziel 40 USD...



KOSP... Zahlen unter den Erwartungen - aber wie sieht die Zukunft aus? Könnte ein straker Turnaround werden, wenn die Konkurrenz nicht ganz so mühelos vorran kommt, wie vom Markt erwartet - mal sehen



DSCO... im Aufwärtstrend... wird hier das FDA-OK für Surfaxin (das so gut wie sicher ist) schon eingepreist, oder ist es bereits in den Kursen enthalten?



PTIE... der alte Pusher Cramer war am Werk... mir soll es egal sein, Hauptsache der Markt honoriert das Potential...



ANDS... die Richtung gefällt mir schon besser!



der GPC Ausbruch lässt noch auf sich warten... bin aber zuversichtlich.

mfg ipollit

[whyso]

>>>der GPC Ausbruch lässt noch auf sich warten... bin aber zuversichtlich<<<<
Ich allerdings auch

Mein Biotech Depot 2006: (ohne nähere Angaben zum Kauf)

Novavax (NVAX) heute 4,12€
Combimatrix (CMBX)heute 1,50€
Genaera Corporation (GENR) 1,42€
GPC Biotech (GPCB) 13,00€
Genta (GNTA) 2,17€

Viel Glück & viele grüße sendet dir,
Whyso

[ipollit]

[posting]20.353.317 von whyso am 23.02.06 23:08:38[/posting]Hi Whyso!

GENR hatte ich auch im Depot... laufen ja gerade hoch. Bist du im Plus? Also ich traue diesem Laden nicht mehr... Evizon wird nie auf den Markt kommen, wenn du mich fragst. Die Aktie wird nur noch getradet.

GNTA... wenn es doch noch klappt mit Genease oder wie das heißt, dann hast du einen Vervielfacher im Depot. Die Sache ist aber sehr riskant, denn dieser Kandidat ist schon ganz schön gecrasht in anderen PIIIs, so dass der Partner (war es BMS?) trotz eines 2 Mrd Deals abgesprungen ist.

GPC ist da schon der sichere Hafen!

Viele Grüße und viel Erfolg!
ipollit

[nort.]

Lesezeichen

[ipollit]

na, was soll man dazu sagen...

da läuft GPC endlich nach oben (mit dem Hopp Investment habe ich nicht gerechnet... da gehört auch ein wenig Glück dazu), aber unter dem Strich ist mein Depot nur leicht im Plus. Danke MOR! ... eine Tasche rein, andere Tasche raus. Habe MOR (noch) nicht reduziert, aber GPC ist jetzt die größte Position im Depot.





auf meiner Watchliste gibt es auch einen Schub nach oben (RIGL)... und bin wie immer nicht dabei!


mfg ipollit

[ipollit]

Der Februar ist insgesamt genauso gut gelaufen wie der Januar... sehr schön! ... habe mein Jahresziel von +25% inkl. Neuinvestition schon fast erreicht (aktuell +24,2%) Ich rechne aber nicht damit, dass das jetzt die nächsten Monate so weiter läuft. Vielleicht sind nochmal 20% drin, aber es wird sicherlich auch mal eine Zeit lang runter gehen. GPC hat MOR mit 18,1% zu 16,4% überrundet.

Anteil Aktie Symbol Kurs KK Gewinn
18,1% GPC GPC.de 14,83 EUR 7,94 + 87%
16,4% Morphosys MOR.de 48,61 EUR 20,43 + 138%
6,6% Medigene MDG.de 8,81 EUR 7,34 + 20%
6,1% OSI Pharm OSIP 32,48 USD 25,53 + 27%
5,6% Arena ARNA 17,72 USD 9,77 + 81%
5,1% Pain Therap PTIE 10,79 USD 7,08 + 52%
4,0% Paion PA8 9 EUR 9,12 - 1%
3,8% Indevus IDEV 6,04 USD 7,11 - 15%
3,6% Imclone IMCL 38,41 USD 31,41 + 22%
3,0% Atherogenics AGIX 16,05 USD 18,56 - 14%
2,6% YM Bioscience YMI 5,23 USD 4,44 + 18%
2,6% Nektar NKTR 20,91 USD 15,96 + 31%
2,6% Cardiome CRME 11,93 USD 9,95 + 20%
2,5% Anadys ANDS 13 USD 11,94 + 9%
2,2% Telik TELK 22,12 USD 15,15 + 46%
2,2% Vasogen VSGN 2,94 USD 3,06 - 4%
1,8% DOV Pharma DOVP 19,25 USD 15,75 + 22%
1,8% Onyx ONXX 28,5 USD 25,45 + 12%
1,7% Encysive ENCY 9,14 USD 8,80 + 4%
1,7% Discovery Labs DSCO 7,59 USD 7,46 + 2%
1,4% Panacos PANC 7,28 USD 8,24 - 12%
1,1% Introgen INGN 5,93 USD 8,23 - 28%
1,0% Millennium MLNM 10,46 USD 0,00 - 0%
1,0% KOS Pharma KOSP 43,87 USD


Performance 2006
Depot (EUR, netto) 17,8%
NBI (EUR) 8,1%
BTK (EUR) 7,8%
TecDax 24,6%

der NBI ist nach oben ausgebrochen...




mfg ipollit

[ipollit]

ein weiterer für mich interessanter Kandidat, den ich auf meine Watchliste setze...

COLY
MK 390 Mio USD
Cash 143 Mio USD
EV 249 Mio USD

letztes Jahr erst IPO... für den weitesten Kandidaten ProMune gegen Krebs (u.a. NSCLC) in PIII wurde ein 500 Mio USD Deal mit Pfizer geschlossen.

vom yahoo-board:

Very informative presentation this morning at Merrill conference:

1) Actilon Phase I top line interim data will be released in the Spring. Previously it was indicated around mid-year so this seems to indicate earlier release.

2) They are starting another Phase I trial(3 arm-30 patients per arm) and this interim data will be released in Oct at major conference. This will be a 48 week trial.

3) Based on these two trials they will quickly move into the Phase II. [das ist gerade erfolgt]

4) Considering that the PFE NSCLC drug is in Phase III testing (around the world sites) I was unaware that COLY`s major and original thrust was in infectious diseases and the CEO stated they were getting back to concentrating on this area...making me think they have a degree of confidence in this arena of work.

5) What seemed as an aside the CEO stated that the held-up Sanofi program would again launch a Phase testing program within the next two months. This is in the respiratory disease area. This would indicate they have finalized the second generation drug and FDA hold will be lifted. This should be a positive for the stock...three drugs in Phase testing.

6) PFE trial in Phase III is for NSCLC but CEO stated that PFE is ready to move into other major cancer indications with the drug. This indicates to me that PFE has a real commitment to this drug.

The CEO of COLY said that PFE would use NSCLC for colon and breast cancer. When this drug gets FDA approval COLY stock will skyrocket. Reminds me of Imclone four years ago.

When should we expect initial Phase III data from the lung cancer trial?

I would "guess" that it will be mid-2007 to late 2007. Remember there are two trials of about 800 patients and survival is the end point so it will take at least a year to see if this occurs...and enrollment only started in late 2005. You might think of this as goodnews/ bad news...bad it will take so long to get data but good that patients are living longer!!

COLY will release Actilon data in May at medical conference being held in Los Angeles.

Good strategy to announce at major conference...if data is good!



weitere Watchliste: RIGL, KERX, CNVX, (INCY, ARRY, LGND)

TELK läuft ganz gut... mit 1,16 Mrd USD MK nicht mehr billig


IDEV... wohin geht es?


mfg ipollit

[ipollit]

ein paar Tage noch

[ipollit]

ein weiterer interessanter Kanditat für meine Watchlist ist die Schweizer Speedel...

MK ca. 875 Mio USD





Ed: The number of patients with hypertension in the 7 major markets is expected to rise from 190 million in 2004 to 206 million in 2012. There is currently no curative medication for hypertension and instead the goal of treatment is to lower blood pressure to safer levels. Unfortunately, more than 50% of patients undergoing treatment with current therapies do not reach targeted blood pressure levels, and so there is a considerable unmet medical need. An estimate based on IMS sales figures indicates that the antihypertensive market was valued at $31 billion in 2003 reflecting a 13% rise since the previous year. Genericization has seen the continued demise in cash terms of the four major antihypertensive classes - ACE inhibitors, calcium channel blockers (CCBs), beta blockers and diuretics - while in prescription terms beta blockers and diuretics actually increased. This has meant that the net growth in the value of the hypertension market over the last five years has been attributable almost entirely to the ongoing rise of the angiotensin II receptor blocker (ARB) class. Analysts predict that the strong growth of the ARB Diovan (valsartan) will make it the leading global antihypertensive by 2007 with estimated sales of $3.3 billion. For further information on antihypertensives in development and their market see "Antihypertensives - Emerging therapeutic classes and combination strategies"The use of combination therapy is set to increase significantly over the next 8 years, based on the new guidelines promoting their earlier use and growing acceptance that patients cannot be controlled on monotherapy. Speedel`s lead compound SPP100 (Aliskiren), the subject of the press release is a first-in-class renin inhibitor being developed as a treatment of hypertension. Three pilot clinical studies have been conducted by Speedel in 2001 and 2002 investigating the safety and efficacy of SPP100 in combination with the ACE-inhibitor (ramipril), the diuretic (hydrochlorothiazide - HCTZ) and the ARB (irbesartan), in hypertensive patients. Experts believe that the next blockbuster class in hypertension will be oral renin inhibitors, with SPP100 leading the way. By targeting the Renin Angiotensin System earlier than either Angiotensin Converting Enzyme (ACE) inhibitors or Angiotensin II Receptor blockers (ARBs), it is likely to have potentially greater efficacy and fewer side effects. It is expected that SPP100 will have its US and EU launch in late 2006 and to date, there is little to suggest this product will be anything less than a blockbuster. Analysts estimate that SPP100 will exceed $1 billion in sales by 2008 and reach total sales of $3.6 billion by 2012.

ich kenne allerdings nicht die genaue Höhe der Royalties... SPP301 will Speedel selbst vermarkten.

SPEEDEL BEGINNT PHASE III-STUDIE MIT SPP301 GEGEN DIABETISCHE NEPHROPATHIE
Speedels Pipeline hat jetzt zwei potenzielle Blockbuster in Phase III
07 July 2005, Basel/Schweiz und Bridgewater NJ/USA


Speedel gab heute den Start der Phase III-Studie mit SPP301 bekannt. SPP301 ist Speedels oraler Endothelin-A-Rezeptorantagonist (ERA) zur einmal täglichen Einnahme für die Behandlung von diabetischer Nephropathie (diabetische Niereninsuffizienz). Die ASCEND1-Studie hat, wie im März 2005 bei Bekanntgabe des erfolgreichen Abschlusses der klinischen Phase II-Studie angekündigt, wie geplant mit der Behandlung der ersten Patienten begonnen.

Dr. Alice Huxley, CEO von Speedel, kommentierte: „Dies ist ein Meilenstein von herausragender strategischer Bedeutung für Speedel. SPP301 ist das erste Medikament, das wir in eigener Regie in die Phase III geführt haben, und es birgt eine beachtliche kommerzielle Chance. In unserer ausgereiften und vielseitigen Pipeline befinden sich nun zwei Präparate in der klinischen Phase III, welche Blockbuster-Potenzial in der Bekämpfung weitverbreiteter Krankheiten haben. Dies sind SPP100, das mit Novartis zur Behandlung von Bluthochdruck entwickelt wird, und SPP301 gegen diabetische Niereninsuffizienz. Beide Produkte haben das Potenzial in der jeweiligen Indikation führend in ihrer Klasse zu werden. Dies untermauert Speedels Engagement für innovative Therapien in grossen und wachsenden Märkten der Herz-Kreislauf- und Stoffwechselkrankheiten.“

Dr. Jessica Mann, Medizinische Direktorin von Speedel, fügte hinzu: „Die Verbreitung von diabetischer Nephropathie hat, bedingt durch die weltweit steigende Anzahl von Diabetes-Patienten, drastisch zugenommen. Diabetische Nephropathie ist eine Krankheit mit hoher Sterblichkeitsrate. Circa 8 Millionen2 Diabetes-Patienten in den USA, in Japan und in grossen europäischen Ländern sind davon betroffen. Die Therapiemöglichkeiten sind zur Zeit begrenzt. Wir sind davon überzeugt, mit der Entwicklung von SPP301 einen Durchbruch in der Behandlung erzielen zu können, der für die von dieser Krankheit betroffenen Menschen von medizinisch entscheidendem Nutzen sein kann.“

Die entscheidende Phase III-Studie namens ASCEND1 ist eine randomisierte, Plazebo-kontrollierte Mortalitäts- und Morbiditätsstudie mit über 2’000 Patienten. Als primäre Wirksamkeitsendpunkte werden die Zeit bis zur Verdoppelung des Serumkreatininwertes, bis zum Erreichen der terminalen Niereninsuffizienz oder bis zum Tode bei Typ 2-Diabetespatienten, die an fortgeschrittener diabetischer Nephropathie3 leiden, bewertet.

Den Patienten wird entweder 25mg oder 50mg SPP301 oder Plazebo (Scheinpräparat) einmal täglich zusätzlich zu Standardmedikamenten gegen diabetische Nephropathie verabreicht. Die Studie, die von der FDA (Federal Drug Administration, US-Gesundheitsbehörde) und der EMEA (Europäische Arzneimittel-Behörde) abgestimmt und genehmigt wurde, wird in ca. 260 medizinischen Einrichtungen in Europa, in den USA und weiteren Ländern durchgeführt. Es handelt sich um eine „ereignisgesteuerte“ Studie, die nach heutiger Schätzung ca. 3.5 Jahre benötigt, um eine ausreichende Anzahl Ereignisse in den Wirksamkeitsendpunkten mit statistischer Relevanz darzustellen.

Angesichts des grossen medizinischen Bedarfs in der Indikation der diabetischen Nephropathie hat SPP301 von der FDA den Status „Fast Track“4 erhalten, und das Studienprotokoll der ASCEND-Studie durchlief ein sogenanntes Special Protocol Assessment durch diese Behörde5. Dies bedeutet, dass das Genehmigungsverfahren beschleunigt wird und SPP301 bei erfolgreicher Zulassung in den USA im Jahre 2009 und in anderen Ländern in 2010 auf den Markt kommen könnte.

ich schätze mal, dass Speedel in den nächsten Jahren Potential für eine 2-3 Mrd USD MK hat... allerdings leiden die ständig unter Geldknappheit. SPP100 halte ich mit dem Partner Novartis für sehr aussichtsreich.



mfg ipollit

[ipollit]

[posting]20.564.376 von ipollit am 08.03.06 00:10:18[/posting]habe wie geplant meine VSGN-Position verdoppelt... es war nicht zu erwarten, dass die abgebrochene PIII den primären Endpunkt erreicht. Hier sind aber trotzdem einige abgesprungen, so dass ich dankbar zugreifen darf. Nun hängt alles von den CHF-Daten Ende April ab... 75% Crash oder 100-400% Gewinn... alles ist drin - ich schätze es als hochriskant ein, eine positive PIII ist keinesfalls sicher. Allerdings könnten die Kurse zumindest vor den Daten entsprechend anziehen, da meiner Meinung nach die positiven Erwartungen überwiegen sollten... mal sehen.

Vasogen`s Celacade Fails Test

By Althea Chang
TheStreet.com Staff Reporter
3/12/2006 7:42 PM EST
Click here for more stories by Althea Chang


ATLANTA -- A clinical trial of Vasogen`s (VSGN:Nasdaq - commentary - research - Cramer`s Take) Celacade technology failed its main goal of increasing the distance that patients with peripheral arterial disease can walk.

The phase III trial, dubbed Simpadico, was a follow-up to an earlier trial that showed that Celacade did improve walking distance. The latest trial studied more patients -- 553 vs. the earlier study`s 85. Vasogen presented its results Sunday at the American College of Cardiology meeting here.

Peripheral arterial disease causes poor circulation in the legs and pelvis. It can also cause blood clots to travel to the lungs and block blood flow there, a condition known as a pulmonary embolism.

While the Celacade trial did miss its primary goal, the results gave the company and at least one analyst hope for its use elsewhere. Celacade seems to reduce a marker of serious heart problems and inflammation called high sensitivity C-reactive protein. This implies that the drug could reduce a patient`s risk of stroke, heart attack and heart failure, said Vasogen CEO David Elsley.

Celacade is currently being tested in 2,400 patients with chronic heart failure and the company expects to report results of that study in late April or early May.

"PAD is a difficult disease," said biotech and pharmaceuticals analyst Dr. Mark Monane of Needham & Co. Any negative interpretations of the latest data probably will be tempered by the reality that investors` expectations for the trial were already modest, he added.

Monane doesn`t own any Vasogen shares but Needham has an investment banking relationship with the company.

Vasogen stock closed Friday down a nickel at $3.03.


mfg ipollit

[puhvogel]

Das sind so die Gründe, warum ich selbst den besten veröffentlichten Daten nicht traue.
Deine Wette mit ENCY könnte gut hinhauen.

Ich besitze keine VSGN Anteile mehr, dafür aber DOVP. Ich muss mir , wenn ich mal ein wenig Ruhe finde, die neuesten Meldungen und ihre Konsequenzen mal zu Gemüte führen.

[ipollit]

[posting]20.706.219 von puhvogel am 15.03.06 19:04:43[/posting]@puhvogel

danke für den Link... mal sehen, was der Markt zu ENCY nach einer Zulassung sagt.

Aus welchem Grund bist du denn in DOVP investiert?

Bei DSCO stehen in der nächsten Zeit auch Daten an.

VSGN ist sehr spekulativ... aber mit hohen Chancen. Ebenfalls im Cardio...usw-Markt CRME und AGIX (AGIX könnte auch günstig sein). Speedel würde ich als sicheren Hafen aufbauen. KOSP muss ich mir noch einmal ansehen... Merck hat etwas von Problemen gemeldet, Pfizer hat Probleme... hier könnte der Markt falsch liegen.

mfg ipollit

[ipollit]

ANDS... erneuter Ausbruch



aus dem yahoo-board...

i am glad we are past the competition
by: pinvestment 03/16/06 11:56 am
Msg: 329 of 333

argument

i think that wall street is just waking up to anadys

the 380 results are nice - and barring any toxicity issues should make it to market for hep B and compete favorably with barraclude, tenofovir and others - resistance to single treatments will become common - I hope that at some point the initial multi-agent treatment of hepB is accepted - it is much harder to develop resistance to multiple drugs at one time - overall plenty of market here - and plenty of potential sales to value ANDS at 16$ in my opinion

i really like this section from the latest 10-K

AN 025-1
In 2006 we also expect to nominate a new preclinical candidate, a non-nucleoside NS5B polymerase inhibitor, for the treatment of chronic HCV infection. Non-nucleoside polymerase inhibitors are an example of direct antivirals. Direct antivirals act against the hepatitis C virus itself in contrast to immunomodulators which activate the body’s immune system to attack the virus. The NS5B polymerase is a virally encoded enzyme essential to replication of HCV in the body. Anadys has identified a specific site on this enzyme that we believe is preferred as a drug target. Within the AN 025-1 program we have identified non-nucleoside compounds that bind to this specific location. These compounds directly inhibit replication of HCV in laboratory experiments at concentrations that are achievable with potentially useful doses. We are encouraged by the properties of these compounds and are optimizing multiple characteristics of these compounds in order to identify a pre-clinical candidate to develop as an orally administered drug.

these will become hot compounds - especially with the amgen interest - from pubmed

Novel Inhibitors of Hepatitis C Virus RNA-dependent RNA Polymerases.

Lee G, Piper DE, Wang Z, Anzola J, Powers J, Walker N, Li Y.

Amgen Inc., 1120 Veterans Blvd., South San Francisco, CA 94080, USA.

Hepatitis C virus (HCV) is a major cause of chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma worldwide-and is the main cause of adult liver transplants in developed nations. We have identified a class of novel and specific inhibitors of HCV NS5B RNA-dependent RNA polymerase (RdRp) activity in vitro. Characterization of two such inhibitors, COMPOUND1 (5-(4-chlorophenylmethylene)-3-(benzenesulfonylamino)-4-oxxo-2-thionothiazolidine) and COMPOUND2 (5-(4-bromophenylmethylene)-3-(benzenesulfonylamino)-4-oxxo-2-thionothiazolidine), is reported here. With IC(50) values of 0.54muM and 0.44muM, respectively, they are reversible and non-competitive with nucleotides. Biochemical and structural studies have suggested that these compounds can inhibit the initiation of the RdRp reaction. Interestingly, these inhibitors appear to form a reversible covalent bond with the NS5B cysteine 366, a residue that is not only conserved among all HCV genotypes and a large family of viruses but also required for full NS5B RdRp activity. This may reduce the potential resistance of the viruses to this class of inhibitors.

ANA975 looks very promising also - read below from pubmed - of course the almost 3 log drop in HepC titers is still a log off from the vertex drug VX-950, but this was a shorter trial and as in HepB - resistance to single agents in Hep C will develop and a multi-drug strategy will be involved - that means that the market will be split among the multiple drug companies and that the entire market should grow substantially

Isatoribine, an agonist of TLR7, reduces plasma virus concentration in chronic hepatitis C infection.

Horsmans Y, Berg T, Desager JP, Mueller T, Schott E, Fletcher SP, Steffy KR, Bauman LA, Kerr BM, Averett DR.

Cliniques Universitaires Saint-Luc, Universite Catholique de Louvain, Unit de Pharmacologie Clinique, Brussels, Belgium.

Immune-based therapy is the mainstay treatment for chronic hepatitis C virus (HCV) infection but causes multiple side effects and achieves durable viral clearance in only approximately 50% of patients. Most new investigational anti-HCV compounds are direct-acting antivirals for which durability of response and risk of viral mutations and resistance are not yet known. Therefore, continuing discovery and development of new immune-based treatments is desirable. Toll-like receptors (TLRs) are pathogen recognition receptors that initiate the innate immune response. The responsiveness of HCV or other ongoing chronic systemic infections to treatment with a selective TLR agonist has not been reported. Isatoribine is a selective agonist of TLR7. In a proof-of-concept study, we found that once-daily 7-day treatment with intravenous isatoribine 800 mg caused a significant (P = .001) reduction of plasma HCV RNA (mean, -0.76; range, -2.85 to +0.21 log(10) units) in otherwise untreated patients (n = 12) who were chronically infected with HCV. Viral load reduction occurred in patients infected with genotype 1 as well as non-genotype 1 HCV. The reduction of viral load was correlated with induction of markers of a heightened immune antiviral state, including 2`-, 5`- oligoadenylate synthetase levels in whole blood. This treatment was well tolerated, with a low frequency of mild to moderate adverse events. In conclusion, systemic administration of the selective TLR7 agonist isatoribine resulted in dose-dependent changes in immunologic biomarkers and a statistically significant antiviral effect with relatively few and mild side effects.

so ANDS has plenty in the pipeline which is pretty exciting - I guess i would like to see novartis step up and partner 380 in a deal that is very favorable for ANDS - that would bring more cash and speed up development of the other drugs

so the ball in the court of ANDS management to bring these drugs quickly through clinical trials and move to get fast track status on many of them but i see tons of potential - also consider that VRTX added almost 4 billion in market cap on the strength of one HepC drug and that anadys may have something similar to it - i just want to see longer trials of 975 to see if they can eclipse the VX-950 results - then i believe to the moon might be a good term for ANDS

but either through a deal with novartis for 380 or a secondary offering I think they need to speed up the development of the whole pipeline in order to unlock its vast potential

aktuelle MK 451 Mio USD, EV 318 Mio USD

mfg ipollit

[ipollit]

The race for a new heart treatment has investors thumping their chests over two small biotechs.

Some Wall Streeters believe that Encysive Pharmaceuticals (ENCY:Nasdaq) will secure approval for a new drug by the end of this month. Yet shares in rival Myogen (MYOG:Nasdaq) have left Encysive in the dust.

Both companies have spent years developing treatments for pulmonary arterial hypertension, or PAH, a rare but potentially fatal disorder affecting the heart and lungs. Encysive hopes to win approval of its PAH drug, known as Thelin, in less than two weeks. But Myogen has convinced investors that its competing drug, ambrisentan, can overcome Thelin`s head start because of its superior clinical results.

So while Encysive has lost about 20% of its value over the past year, Myogen has rocketed 370%. Encysive CEO Bruce Given said Tuesday that he is surprised by the cold shoulder the market has given his stock. He says company insiders remain "pretty pumped up" during this "very exciting time."

Meanwhile, some outsiders have started to question whether Myogen really deserves the favorable treatment. Encysive`s stock fell 11 cents to $8.84 on Tuesday, while Myogen`s shares continued their climb, rising 92 cents to $36.66.

"At current valuations, we believe the market is pricing a best-case scenario for Myogen and a worst-case scenario for Encysive," Oppenheimer & Co. analyst Cory Kasimov wrote last week. "While it is still too early to crown ambrisentan the king of PAH, we concur with popular opinion that [recent] data could position ambrisentan as a best-in-class drug. ... [But] we stress that even if ambrisentan does indeed become best-in-class, that does not spell the end for Thelin -- which, we believe, will still be a worthwhile competitor in this rapidly growing market."

Matthew Kaplan, an analyst with Punk, Ziegel & Co., has gone a step further by indicating that ambrisentan may not emerge as the clear market winner at all. Notably, he claims that Myogen used less conservative methods for testing the liver toxicity of its PAH treatment than Encysive and another competitor used for their own drugs. Thus, he suggests, ambrisentan may prove to be less safe than it currently seems.

While neither Kasimov nor Kaplan has any formal rating on Myogen`s stock, both analysts recommend buying Encysive. Their firms both make a market in Encysive securities.

Playing the Odds

To be fair, Encysive could fail to win regulatory approval for Thelin by the established target date of March 24. If that happens, Encysive`s stock chart could look a bit like NPS Pharmaceuticals` (NPSP:Nasdaq) did on Friday -- when the stock plunged 38% after a decision on its osteoporosis drug was delayed.

But Kasimov gives Encysive a 95% chance of securing approval for Thelin on schedule. During clinical trials, he notes, patients on Thelin showed "significant improvement" over patients on a placebo during the crucial six-minute-walk test.

Moreover, he says, they performed at least as well as patients on Tracleer -- an existing PAH treatment sold by Actelion (ALIOF:Pink Sheets) -- but with better safety and tolerance results.

During the company`s most recent presentation, given at a health care conference over the weekend, Encysive CFO Stephen Mueller seemed optimistic that Thelin would be approved on time. He said Encysive took extra steps in advance -- by actually designing its study with input from regulators -- that should help Thelin win approval as planned.

Kaplan applauds the company`s trials. He stresses that Encysive actually compared its own drug to Actelion`s Tracleer -- instead of just a placebo -- and should be better positioned than Myogen as a result.

"When ambrisentan comes to market, it will ... be at a disadvantage based on its lack of head-to-head data versus Tracleer or Thelin," Kaplan predicted on Monday. "Comparative head-to-head data is one of the focus metric items in the European market and also for managed care organizations in the U.S. We also believe the clinical and regulatory risks for Thelin are very low versus those for ambrisentan."
Defining Toxicity

Perhaps most noteworthy, however, are Kaplan`s recent observations about the liver toxicity of various PAH drugs.

Importantly, Kaplan says, both Encysive and Actelion reported liver toxicity when patients taking their drugs saw their liver enzymes reach three times the upper limit of normal levels on just one reading. In contrast, he says, Myogen reported liver toxicity only when patients taking ambrisentan reached that same threshold on a second reading as well.

"Based on conversations we have had with Actelion, they noted if they utilized the method requiring a confirmatory reading which is being used for ambrisentan, it would likely result in a 50% reduction in the rate of liver toxicity observed with Tracleer," Kaplan says. "Consequently, we believe investors should be cautious when evaluating the ambrisentan liver-toxicity data."

In the meantime, Kaplan notes, Thelin`s liver-toxicity rate has come in even lower than that of the placebo during crucial clinical trials.

Given offered similar views on the toxicity studies. He told TheStreet.com on Tuesday that Encysive "absolutely" used different standards for testing the liver toxicity for Thelin than Myogen did for ambrisentan and that, in his opinion, the Street has yet to pick up on that issue.

But Myogen spokesman Derek Cole said that no patients using ambrisentan suffered from liver toxicity in initial tests -- so no second tests were needed -- in the most recent study. Yet those favorable results, which have sent the company`s shares higher, contrast with earlier outcomes. They also come after only 12 weeks of testing, as opposed to the longer periods used to evaluate competing drugs.

Looking ahead, Kasimov suspects that ambrisentan -- like the rest -- will display some liver toxicity in the end.

"We would like to see if liver tox emerges with subsequent follow-up beyond 12 weeks, as (enzyme elevation) appears to peak at 14 to 18 weeks," Kasimov wrote last week. "Either way, we do expect ambrisentan`s eventual label to contain a warning for liver toxicity, as this issue is a class effect and has appeared in prior ambrisentan clinical trials."
Hitting the Market

But for now, at least, things seem to be going Myogen`s way.

Just last week, for example, Myogen announced that the Food and Drug Administration had granted "fast-track" designation to ambrisentan because the drug has been designed to address the unmet medical needs of patients suffering from an incurable, life-threatening disease. Rodman & Renshaw analyst Navdeep Jaikaria quickly portrayed the decision as a victory for Myogen -- and a setback for its competitors -- because it could shorten the time that ambrisentan must wait for approval before hitting the market.

According to information published on the FDA`s own Web site, however, fast-track status simply allows companies to better interact with the agency and remains separate from the "priority" reviews that pave the way for accelerated approval.

Myogen`s stock, weakened by an unpopular deal with GlaxoSmithKline (GSK:NYSE ADR) and other investor concerns, actually fell on the day the company announced fast-track designation for its PAH drug. And Kaplan has since predicted that Myogen`s drug will not hit the market until 18 months after Encysive`s does.

For its part, Myogen has offered a simple catch-up strategy. Cole said the company "will look to let the clinical data speak for itself" when ambrisentan finally is approved.

In the meantime, the PAH market itself remains somewhat unclear. Pharmaceutical giant Pfizer (PFE:NYSE) , which markets a special version of Viagra as a treatment for PAH, has estimated that 100,000 patients suffer from the disease. Myogen has -- perhaps somewhat aggressively -- portrayed a market twice that size. For its part, Encysive has simply assumed that the market could lie between those two extremes.

Still, those who do suffer from the deadly disease will no doubt pay high prices in order to treat it. Kasimov has predicted that the new medications will go for at least $30,000 a year. Thus, even based on the more conservative estimates of PAH sufferers, he sees a $3 billion market opportunity for players in the group.

Last fall -- when heralding Thelin as the best-in-class PAH drug before ambrisentan boasted greater results -- WR Hambrecht analyst Patrick Flanigan predicted that Thelin would be raking in annual sales of $298 million by 2009. More recently, even in spite of the favorable ambrisentan data, Kasimov has estimated peak worldwide sales of Thelin at $325 million annually. Specifically, Kasimov believes that Encysive can sell $175 million worth of Thelin in the U.S. -- and another $150 million worth outside it -- on an annual basis down the road.

Unlike Myogen, which recently sold the non-U.S. rights to its own PAH drug, Encysive still plans to handle its European marketing efforts itself. During its presentation over the weekend, the company once again reiterated that strategy by explaining that it has already hired and trained more than 50 veteran salespeople to market Thelin to the select group of physicians who might prescribe it.

Thus, Kasimov believes that Encysive will soon hit the market running. Kaplan tends to agree.

"We continue to believe investors have lost perspective with respect to Encysive as an investment opportunity and need to remember Thelin is in a strong competitive position versus Tracleer and ambrisentan for a number of reasons," Kaplan wrote on Monday. Therefore, "we strongly reiterate our buy recommendation on Encysive with a price target of $21" on the stock.





mfg ipollit

[whyso]

[posting]20.353.559 von ipollit am 23.02.06 23:37:47[/posting]"GNTA... wenn es doch noch klappt mit Genease oder wie das heißt, dann hast du einen Vervielfacher im Depot. Die Sache ist aber sehr riskant, denn dieser Kandidat ist schon ganz schön gecrasht in anderen PIIIs, so dass der Partner (war es BMS?) trotz eines 2 Mrd Deals abgesprungen ist."

http://www.pennysleuth.com/GregGuenthner.html

Der Partner war damals "Sanofi Aventis" & sie haben das Projekt mit 480MIO$ mit "gesponsert", vielleicht lassen sie sich bis kommende Oktober wieder blicken...

Ipollit:
hier ist ein sehr interessanter Bericht/ Empf für NVAX http://library.corporate-ir.net/library/71/711/71178/items/1… von Rodman & Renshaw...man achte auf das kleingedrückte Hier Ensteht ein Powerhouse...

Bis die Tage & viele Grüße,
Whyso

[ipollit]

ich habe mal die Pipeline meiner Depotwerte zusammengetragen (kein Anspruch auf Vollständigkeit)... denke, dass das eine oder andere dabei rum kommt

(NKTR habe ich außen vor gelassen, da ihre Technologie in vielen Produkten steckt)

Markt
ENCY Argatroban # Heparin Thrombosen
IMCL Erbitux # Krebs (EGFR: colorectal, NHC)
IDEV Sanctura # Inkontinenz
IDEV Delatestryl # Testosteronmangel
IDEV Sarafem # prämenstruelles Syndrom
KOSP Niaspan # Cholesterin (HDL)
KOSP Advicor # Cholesterin (HDL)
KOSP Azmacort # Asthma
KOSP Cardizem LA # Bluthochdruck
KOSP Teveten (HCT) # Bluthochdruck
MDG.de Eligard # Krebs (HSPC)
MLNM Velcade # Krebs (MM)
MLNM Integrilin # Blutgerinnung
ONXX Nexavar # Krebs (Niere)
OSIP Tarceva # Krebs (NSCLC, pancreatic)
OSIP Macugen # Erblindung (AMD)
OSIP Novantrone # Schmerz
OSIP Gelclair # Entzündung

NDA
CRME RSD1235 IV # Herzrhythmusstörung
DSCO Surfaxin # Lunge Kleinkinder (RDS)
DOVP Indiplon # Schlafstörungen
ENCY Sitaxsentan (Thelin) # Lungenhochdruck
MDG.de Polyphenon # Genitalwarzen

Phase III
AGIX AGI-1067 # Arteriosklerose
DOVP Bicifadine # Schmerz
GPC.de Satraplatin # Krebs (HRPC)
IMCL Erbitux # Krebs (EGFR: colorectal, pancreatic, NSCLC)
IDEV Sanctura XR # Inkontinenz
IDEV Nebido # Testosteronmangel
IDEV PRO 2000 # HIV Prävention
KOSP Niaspan # Cholesterin (HDL)
KOSP Advicor # Cholesterin (HDL)
KOSP Azmacort # Asthma
ONXX Nexavar # Krebs (NSCLC, MM, Leber)
OSIP Macugen # Erblindung (DME)
PTIE Oxytrex # Schmerz
PTIE Remoxy # Schmerz
PA8.de Desmoteplase # Schlaganfall
TELK Telcyta # Krebs (Ovarian, NSCLC)
VSGN Celacade # Herzfehler
YMI Tesmilifene # Krebs (MBC)

Phase II
ANDS ANA380 # Hepatitis B
ARNA APD356 # Fettsucht
CRME RSD1235 oral # Herzrhythmusstörung
DSCO Surfaxin # Lunge Kleinkinder (CLD)
DSCO Aerosurf # Lungenerkankungen
DSCO SRT # akute Atemnot (ARDS)
DOVP DOV 21,947 # Depression
DOVP DOV 216,303 # Depression
DOVP DOV 102,677 # Alkoholabhängigkeit
ENCY Bimosiamose # Asthma, Schuppenflechte
GPC.de Satraplatin # Krebs (NSCLC, MBC)
IMCL Erbitux # Krebs (EGFR)
IMCL CDP-791 # Krebs (VEGFR-2/KDR)
IDEV Pagclone # Stottern
MDG.de Polyphenon # Hautkrebs (AK)
MDG.de EndoTAG # Krebs (pancreatic)
MDG.de HSV # Krebs (Leber)
MLNM Velcade # Krebs (NSCLC, NHL)
MLNM MLN518 # Krebs (AML)
MLNM MLN1202 # MS, Artherosklerose
ONXX Nexavar # Krebs (Brust)
OSIP Tarceva # Krebs
OSIP Macugen # Erblindung (RVO)
OSIP CP-547,632 # Krebs
OSIP PSN9301 # Diabetis
PA8.de Desmoteplase # Lungenembolie
PA8.de Enecadin # Schlaganfall
PANC PA-457 # HIV
TELK Telcyta # Krebs (Darm, Brust)
TELK Telintra # MDS (Krebs)
YMI Tesmilifene # Krebs (HRPC)
YMI Norelin TM # Krebs (HSPC)
YMI Nimotuzumab # Krebs (Pancreatic, HNC, Gehirn)
YMI AeroLEF # Schmerz

Phase I
ANDS ANA975 # Hepatitis B+C
ARNA APD125 # Schlafstörungen
ARNA Niacin # Cholesterin (HDL)
AGIX AGI-1096 # Transplantationsabstoßung
DSCO aSRT # Asthma
ENCY TBC3711 # Lungenhochdruck
GPC.de Satraplatin # Krebs (MBC, solid)
GPC.de 1D09C3 # Krebs (NHL)
IMCL IMC-11F8 # Krebs (EGFR)
IMCL IMC-A12 # Krebs (IGF-1R)
IMCL IMC-18F1 # Krebs (VEGFR-1)
IMCL IMC-1121b # Krebs (VEGFR-2/KDR)
IDEV IP 751 # Schmerz, Entzündung
IDEV Aminocandin # Pilzinfektion
MDG.de EndoTAG # Krebs (Prostata)
MDG.de HSV # Krebs (Gehirn)
MLNM Velcade # Krebs
MLNM MLN8054 # Krebs
MLNM MLN3897 # RA
MLNM MLN3701 # RA
MOR.de 1D09C3 # Krebs (NHL)
MOR.de R1450 # Alzheimer
ONXX Nexavar # Krebs
ONXX PD 332991 # Krebs (CDK)
OSIP OSI-930 # Krebs
OSIP CP-868,596 # Krebs
OSIP CP-724,714 # Krebs
OSIP PSN357 # Diabetis
OSIP PSN010 # Diabetis
PA8.de Solulin # Schlaganfall
VSGN VP025 # Alzheimer, Parkinson

Präklinisch
ANDS ANA773 # Krebs
ARNA 19AJ/1 & 2 # Diabetis
ENCY VLA-4 Antagonist # Asthma
GPC.de CDK-Inhibitor # Krebs
IMCL IMC-3G3 # Krebs (PDGFRa)
MOR.de MOR202 # Krebs (CD38)
MOR.de MOR103 # RA
PANC Maturation Inhibitor # HIV

mfg ipollit

[ipollit]

ich denke, ich werde mir ein paar OXGN zulegen... das Risiko ist hoch, doch ist die Bewertung extrem im Keller - außerdem gibt es signifikante Insiderkäufe.

laut yahoo...
MK 84 Mio USD
EV 22 Mio USD
Cash 59 Mio USD







zwei Kandidaten gegen Krebs CA4P und OXi4503... CA4P soll nicht die Bildung von Blutgefäßen hemmen, sondern die existierenden zerstören, wenn ich das richtig verstanden habe.

OXiGENE to Commence a Randomized Clinical Trial in the United States to Evaluate CA4P for the Treatment of Patients with Non Small Cell Lung Cancer (NSCLC)
Friday February 3, 8:00 am ET


WALTHAM, Mass.--(BUSINESS WIRE)--Feb. 3, 2006--OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN)
Combretastatin A4P (CA4P) will be Evaluated with Concurrent Chemoradiotherapy, a Widely-Accepted Treatment Regimen in the United States--
Trial Endpoint Targets a One-Year Survival Benefit in Patients with All Histological Types of Unresectable, Stage IIIa/IIIb NSCLC--
Distinct Clinical Trials in the US and Europe Could Maximize the Market Opportunity for CA4P in Key Oncology Indication--
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a leading developer of biopharmaceutical compounds designed to treat cancer and certain ophthalmologic diseases, today announced that it plans to commence a Phase II clinical trial in the United States for the treatment of Stage IIIa/IIIb Non Small Cell Lung Cancer (NSCLC). The Company will evaluate its lead clinical candidate, Combretastatin A4P (CA4P), in combination with concurrent chemoradiotherapy, a widely accepted standard in the United States for the treatment of patients with all histological types of unresectable Stage IIIa/IIIb NSCLC. The trial will be conducted under OXiGENE`s Investigational New Drug (IND) application on file with the United States Food and Drug Administration.

The Phase II clinical trial will commence by enrolling approximately 12 patients to assess the tolerability of the protocol and to establish the recommended dose of intravenously administered CA4P. This trial will be the first in which CA4P is administered to patients in combination with concurrent chemoradiotherapy. In other ongoing clinical trials, CA4P has been paired with chemotherapy or radiation therapy with no observed side effects beyond those typically experienced with either treatment.

The Phase II clinical trial will then proceed as a randomized, open label, multi-center trial that will compare two cohorts of patients -- an investigational group and an active control group. Approximately 66 patients who have not had prior treatment for NSCLC will be randomized 2:1 into the two groups. Patients enrolled in the investigational group will be treated with radiotherapy and seven cycles of chemotherapy plus CA4P, followed by maintenance chemotherapy plus CA4P. The objective of the Phase II clinical trial is to evaluate the survival benefit in patients achieved at one year. The response rate will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).

The announcement of this randomized Phase II clinical trial with CA4P in the United States follows OXiGENE`s recent announcement of receipt of regulatory clearance from the Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase III clinical trial of CA4P in the United Kingdom in patients with inoperable Stage IIIb/IV NSCLC, a subset of patients not deemed suitable for curative treatment with concurrent radiotherapy.

"We believe this Phase II clinical trial to be a key stepping stone in the path towards potential commercialization of CA4P for the treatment of NSCLC," commented Frederick Driscoll, President and CEO of OXiGENE. "We expect that the commencement of this trial in the United States, combined with the Phase III clinical trial which we plan to commence in Europe for the treatment of patients with Stage IIIb/IV NSCLC, may provide a springboard for OXiGENE to maximize its registrational opportunities in a key oncology indication, and with standards of therapy most often selected by oncologists for each subset of patients. Strategically, this is a key clinical achievement for the Company."

About Non Small Cell Lung Cancer

Non small cell lung cancer accounts for 75% of all lung cancer,(1) making it the most widespread form of lung cancer. Approximately 350,000 cases are expected to be diagnosed globally each year.(2) Stage IIIa NSCLC is one of the largest growing segments of the disease, due to newer tests that enable earlier detection of the disease.(3), (4) Approximately 56% of patients with Stage IIIa/IIIb live for one year when treated with concurrent radiotherapy.(5)

About Combretastatin A4P (CA4P)

CA4P leads a novel class of small-molecule drug candidates called vascular disrupting agents (VDAs). CA4P works via two potentially synergistic processes that selectively target pericyte-depleted neovessels, which lack ensheathment from smooth muscle support cells. CA4P is a potent and reversible tubulin depolymerizing agent that causes newly formed endothelial cells that line blood vessels to change shape, round up and detach from the vessel wall. Recent preclinical research has also shown that CA4P disrupts the molecular engagement of VE-cadherin, a junction protein important for endothelial cell survival and function, and inhibits the associated (beta)-catenin/AKT signaling pathway, leading to rapid vascular collapse and tumor cell death, or necrosis. These complementary mechanisms block the flow of blood to a tumor and deprive it of oxygen and nutrients essential to its survival. Similarly, in eye diseases that are characterized by abnormal blood vessel growth, CA4P has been shown in preclinical studies to suppress development and induce regression of these unnecessary blood vessels.

About OXiGENE, Inc.

OXiGENE is an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases. The Company`s major focus is the clinical advancement of drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life saving and enhancing medicines to patients.


mfg ipollit

[ipollit]

GPC... normalerweise interessieren mich die Analystenmeinungen nicht. Doch scheint auch hier langsam die Erkenntnis sich durchzusetzen, dass Satraplatin kein Nischenprodukt sein könnte. Meiner Meinung besitzt Satraplatin Blockbuster-Potential, was über sie nächsten 2 Jahren eingepreist werden sollte. Problematisch ist vielleicht, dass das Patent recht früh ausläuft und dass die nachfolgende Pipeline doch recht dünn ist.

ANALYSE/CS erhöht GPC-Kursziel auf 19,50 (15) EUR - " Outperf."
===
Einstufung: Bestätigt " Outperform"
Kursziel: Erhöht auf 19,50 (15,00) EUR
Schätzung Gew/Aktie 2005: -2,08 EUR
2006: 0,53 EUR
===
Die Erhöhung des Kursziels erfolge in erster Linie auf Grund der Ende
Dezember mit Pharmion unterzeichneten ROW Marketing-Vereinbarung, sagt die
Credit Suisse (CS). Der momentane Aktienkurs spiegele das Umsatzpotenzial des
Onkologieprodukts von mehr als 500 Mio USD nicht wider, insbesondere vor dem
Hintergrund, dass es bereits in Phase III sei und somit ein relativ niedriges
Risikoprofil habe. Insgesamt habe sich GPC durch Vorwärtsintegration erfolgreich
zu seinem aktuellen Geschäftsmodell gewandelt und verfüge über eine interessante,
organische Pipeline.
DJG/arw/reh/ros

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 20.885.870 von ipollit am 21.03.06 13:00:29

bei DSCO steht die (sichere) Zulassung von Surfaxin gegen RDS Anfang April an und täglich ist mit den PII Daten zur wichtigeren Indikation ARDS zu rechnen...

Discovery Laboratories initiated with "buy"

Thursday, March 23, 2006 4:27:22 AM ET
Pac. Growth Equities

NEW YORK, March 23 (newratings.com) - Analyst Y Katherine Xu of Pacific Growth Equities initiates coverage of Discovery Laboratories Inc (DSCO.NAS) with a "buy" rating.

In a research note published yesterday, the analyst mentions that the approval of the company's Surfaxin drug for the first indication, respiratory distress syndrome in premature infants, is expected in early April. Discovery Laboratories’ Surfaxin franchise has a billion dollar potential, the analyst believes. There is upside to the company’s share price on account of multiple potential catalysts in FY06, Pacific Growth Equities says.

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 20.930.538 von ipollit am 24.03.06 00:39:40

vielleicht sollte ich TELK gegen OXGN tauschen... ich finde eine MK von 1 Mrd USD auch nicht gerade billig für TELK.

March 22, 2006

Downgrading to SELL on Flawed Studies

We are downgrading TELK to SELL from NEUTRAL as we believe the risk/reward is negative. Although data from three Telcyta studies are expected in mid-’06 we believe the studies may be insufficient for approval because the trial designs are flawed or the endpoint will be difficult to hit. And, we do not believe the market opportunity for the drug is meaningful.

ASSIST-3’s Primary Endpoint May Not Be Clinically Important

ASSIST-3, which is testing Telcyta in 2nd line ovarian cancer is unlikely to be sufficient for approval because the primary endpoint is response rate, not survival. A recent FDA panel stated that in the setting of 2nd line ovarian cancer, survival data is needed for approval because response rate does not correlate with survival.

ASSIST-2 Flawed Due to Comparator

ASSIST-2, testing Telcyta in 3rd-line lung cancer vs. Iressa, is also a flawed study because Iressa is no longer used in that setting because the drug failed to show a survival benefit in a Phase III trial. Even if Telcyta is superior to Iressa, it is meaningless because Iressa does not work in 3rd line lung cancer.

ASSIST-1 Targeting Small Market

ASSIST-1, testing Telcyta’s ability to improve survival in 3rd line ovarian cancer as a single agent vs. chemotherapy is unlikely to show a benefit. Telcyta has shown only a modest response rate as a single agent and no single agent drug has shown a significant survival benefit in 3rd line ovarian cancer. Also, we estimate the potential US market for 3rd line ovarian cancer is only $60-160 MM.

$5 of Upside, $13-14 of Downside Depending on Outcomes

If all three trials succeed, we estimate there is only $5 of upside in the stock, but if all three fail, there could be $13-14 of downside. --Eric Ende

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 20.930.556 von ipollit am 24.03.06 00:46:59

ENCY nachbörslich 10% im Minus nachdem TBC3711 in PI von der FDA angehalten wurde... entscheidender finde ich aber die anstehende Zulassung von Thelin - man könnte nachkaufen, aber ich habe dafür keinen Cash frei...

AP
Encysive: FDA Puts Drug Trial on Hold
Thursday March 23, 6:24 pm ET
Encysive Pharmaceuticals Says Human Trial of Drug Candidate Delayed Pending Review


HOUSTON (AP) -- Encysive Pharmaceuticals Inc. on Thursday said it has put an early clinical trial of a drug candidate on hold following a Food and Drug Administration decision, after a rat dosed with the drug showed abnormalities.
Encysive said a single rat showed "abnormalities" following dosing with intravenous TBC3711, which is being tested as a selective endothelin receptor antagonist. Endothelin regulates blood vessel constriction and growth of smooth muscle in blood vessels.

Encysive said the FDA wants to further review the drug before going on to patient dosing. The biopharmaceutical company said in a statement that it agrees with the FDA's decision and is working to resolve the issue.

Shares of Encysive fell 2 cents to close at $9.45 on the Nasdaq before losing 84 cents or 8.9 percent in after-hours trading. The stock has traded between $6.85 and $13.29 over the past year.

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 20.930.556 von ipollit am 24.03.06 00:46:59

Speedel (habe ich für den Aufbau von sicheren Positionen vorgesehen) hat erfolgreich eine KE durchgeführt...

LODH Raises Speedel Target To CHF232

Thursday, March 23, 2006 7:12:13 AM ET
Dow Jones Newswires


1104 GMT [Dow Jones]--Lombard Odier Darier Hentsch bumps up Speedel's (SPPN.EB) target to CHF232 from CHF190, following successful public offering of 500,000 registered treasury shares. "The offering takes away a major market concern of the company running out of cash in early 07, providing Speedel roughly one additional year of cash to further develop its promising pipeline thereby capturing more value before seeking large pharmaceutical development and commercialization partners." Shares +0.6% at CHF168.50. (HJS)

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 20.930.583 von ipollit am 24.03.06 00:59:11

BTW... ich habe die kleine INGN-Position und eine Restposition November Anfang der Woche verkauft...

mfg ipollit

[puhvogel]

Antwort auf Beitrag Nr.: 20.731.593 von ipollit am 16.03.06 11:43:49

@ipollit:
Kurze Antwort, die ich bisher verweigert hatte.
DOVP hatte ich mal nach einem kurzen Sturz Richtung 11 Euro gekauft. Mir hat die relativ breite Pipeline gefallen, und seine ziemlich rückschlagsfreie Geschichte.
Außerdem wollte ich mal irgendwie im Schmerzmarkt vertreten sein. Learning bei investing sozusagen.
Ich hatte gestern mal versucht, eine ehrliche Bewertung des Unternehmens zu starten, aber gerade bei diesem Unternehmen muss man richtig Arbeit investieren.

Uns beide unterscheidet fundamental, dass Du ernsthaft versuchst Marktpotenziale zu berechnen/abzuschätzen. Wie ich schon mal bei Paion sagte, bei kleinen Änderungen der Ausgangsparameter bekommst Du Schwankungen um den Faktor 10, den die Analysten auch weidlich ausnutzen. Die Psychologie, die hinter dem Wert steckt ist mir wesentlich wichtiger. Ein schönes Beispiel ist Ency <--> Myogen.

[ipollit]

Antwort auf Beitrag Nr.: 20.932.089 von puhvogel am 24.03.06 09:04:54

@puhvogel

jein... Marktpotentiale/Pipeline/Cash/Bewertung als das Fundamentale soll nur einen Anhaltspunkt für den "wahren" Wert eines Unternehmens aktuell und in der Zukunft geben. Das die Psychologie des Marktes den entscheidenen Faktor für den Kurs bildet habe ich auch erkannt. Dann orientierst du dich eher am Trend... schön ist es, wenn beides stimmt (z.B. ARNA). Wenn z.B. die Marktmeinung meiner Meinung nach falsch liegt (z.B. ENCY), ist es ein Chance "günstig" einzusteigen. Aber ganz so einfach ist es nicht, denn man kann auch davon ausgehen, dass Insider und starke Hände die Kurse mit beeinflussen. Wenn also ein Kurs vermeindlich günstig ist, so kann das auch gute Gründe haben... so könnte z.B. GENR 10mal höher stehen, wenn Evizon funktionieren würde - dass GENR aber eine MK von unter 100 Mio USD hat, signalisiert, dass die Wahrscheinlichkeit des Erfolgs von Evizon ziemlich niedrig ist. OXGN hat ein Enterprise Value von gerade mal 28 Mio USD trotz eines Kandidaten in PIII, der breit in der Klinik ist und größeres Potential besitzt. Irrt der Markt? Insider kaufen... das muss auch kein 100% Indikator sein - offensichtlich ist das Risiko auch hier sehr hoch. Aber auf diesem niedrigen Niveau können auch schon kleine Erfolge große Wirkung haben. Interessant sind vielleicht auch Überreaktionen, wenn z.B. das wichtigste Produkt scheitert, aber die Pipeline damit noch nicht tot ist... z.B. hat RIGL trotz eines größeren Anstiegs immer noch ein EV von 112 Mio USD. Ja und worauf soll man sich nun verlassen? Den Trend alleine zu nehmen, kann sich lohnen... man kann sich aber auch irren, wenn man eine Übertreibung nach oben erwischt. Also ich versuche beides zu berücksichtigen. Meine größten Gewinne ABGX und ADLR habe ich fundamental gekauft... mit etwas Glück kam dann auch der Trend. Bei Biotechs hat man Glück oder Prech und man macht innerhalb kürzester Zeit 100% Gewinn oder 70% Verlust... das lässt sich kaum vorher berechnen, weshalb eine große Streuung vorteilhaft ist. Dann gibt es meiner Meinung aber auch die Dauer-Läufer, die sich ständig in eine Richtung bewegen... z.B. VTRX, ARNA. VPHM ist auch so einer und trotzdem wurde dieser Wert in den letzten Tagen um fast 50% zerissen. KOSP sah für mich eine zeitlang gut aus... bis zum Einbruch. Auch als Trendfolger braucht man Glück...

zu DOVP...
zuerst finde ich die Indiplon-Royalties positiv: "Of course, there is DOV's no-cost participation in Indiplon, from which they receive a 3.5% royalty, plus $2.5 million when the NDA is filed, $5 million upon approval." ... wenn Indiplon z.B. 2 Mrd USD Umsatz erzielt, erhält DOVP leicht verdiente 70 Mio USD p.a. Die Zahlen für 05 waren 8,6 Mio USD Umsatz und 54 Mio USD Verlust bei (laut yahoo) 97 Mio USD Cash und 80 Mio USD Schulden. Indiplon ist gut, um die eigene Pipeline zu finanzieren.

NDA Indiplon: Schlafstörungen
PIII Bicifadine: Schmerz
PII DOV 21,947: Depression
PII DOV 216,303: Depression
PII DOV 102,677: Alkoholabhängigkeit

Nov 05...

DOV Pharmaceutical (Nasdaq: DOVP) -- $15.18
There are several product candidates here that could take flight for investors. The company has licensed out the rights for a new insomnia drug, indiplon, to Neurocrine Biosciences and Pfizer (NYSE: PFE), and approval could be forthcoming in 2006.

And if that isn't enough to ease investors' pain, bicifadine could help. This drug has shown encouraging results in studies of acute post-surgical pain and chronic lower back pain and could be worth close to half a billion in sales in 2009 if development stays on track. Better still, a host of early-stage candidates for depression, anxiety, addiction, obesity, attention deficit, and angina round out the roster.
http://www.fool.com/news/commentary/2005/commentary05110409.…

Wenn Bicifadine 2009 500 Mio USD Umastz generieren sollte, so dürften die peak sales nochmal deutlich darüber liegen, denn die NDA's sind erst für 2007 geplant, so dass Bicifadine frühestens Ende07 oder 2008 auf dem Markt sein kann.

13.02.2006 02:14
DOV Pharmaceutical, Inc. Announces Updates for Bicifadine Chronic Pain Program

HACKENSACK, N.J., Feb. 12 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, (Nachrichten) Inc. announced today that it held a DOV-initiated strategy meeting with the U.S. Food and Drug Administration (FDA) regarding DOV's chronic pain program for bicifadine, its novel analgesic.

Significant outcomes of the meeting include: * DOV's current Chronic Low Back Pain (CLBP) program design - including the long term safety database - will be sufficient for the Company to submit the planned New Drug Application (NDA) for bicifadine * DOV confirmed that the use of a single primary endpoint in its two pivotal Phase III clinical trials (study 020 and 021) of bicifadine in CLBP - reduction in pain from baseline to end of treatment as measured by the Visual Analog Scale - is acceptable to the FDA * DOV will perform a QTc study in humans as it appears this is an emerging standard for all New Molecular Entities - a QTc study measures intervals in the QT portion of an electrocardiogram and assesses a drug's potential to produce changes in cardiac rhythm. To date, there have been no electrocardiogram - or other - safety concerns in DOV's preclinical studies or in clinical studies involving more than 2,500 subjects treated with bicifadine.

As a result of the meeting, DOV reiterates its expectation to submit its NDA for bicifadine in the first half of 2007.

"This was a key first meeting with the newly-merged FDA division responsible for analgesia drugs," said Dr. Leslie Hudson, CEO of DOV. "The meeting and its outcomes represent an important milestone in our development of bicifadine. To date, we have seen very encouraging data from our open label Phase III trial and we continue to believe that bicifadine could meet a very significant medical need for a safe and effective analgesic."

The ongoing results from DOV's long term open label trial (study 022) of bicifadine in CLBP suggest that bicifadine is at least as effective as standard of care in treating CLBP and is safe and well-tolerated. The data trends reported by DOV at its Third Annual Scientific Symposium in October and in a year-end update provided by the Company in December 2005 are continuing, with dosing now spanning 12 months and total patients enrolled in study 022 exceeding 700.

As part of its ongoing bicifadine development plan, DOV also announced that it has closed the highest dose arm - 400 mg t.i.d. - in its second pivotal Phase III clinical trial (study 021) of bicifadine in CLBP because open label data from the Company's long term safety and efficacy trial (study 022) of bicifadine in CLBP indicate no incremental benefit at this higher dose. Closing this study arm will allow DOV to focus its development efforts on the dosing regimens it believes show the highest likelihood of success in CLBP - 200 mg, 300 mg and 400 mg b.i.d. The closing of the 400 mg t.i.d. arm will shorten the time to completion of the clinical trial and DOV now expects to report the results of the 021 study earlier in the fourth quarter of 2006 than previously planned.

Bicifadine is currently being evaluated in four Phase III clinical trials: three in CLBP patients and one in patients suffering pain after vaginal hysterectomy and two Phase II clinical trials: one in patients with osteoarthritis of the hip or knee and one in patients with painful diabetic peripheral neuropathy. Phase III clinical trials have already demonstrated that bicifadine is effective in treating severe to moderate pain following dental surgery and bunionectomy.

***********

03.02.2006 00:20
DOV Pharmaceutical, Inc. Announces Completion of Enrollment in its Phase III Clinical Trial of Bicifadine in Chronic Low Back Pain

HACKENSACK, N.J., Feb. 2 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, (Nachrichten) Inc. announced today that it completed enrollment in its first pivotal Phase III clinical trial (study 020) of bicifadine, its novel analgesic, in Chronic Low Back Pain (CLBP) in January 2006. The trial is a multi-center, double-blind study comparing three dose regimens of bicifadine (200, 300, 400 mg b.i.d.) to placebo administered for three months to patients with CLBP. The Company expects to announce results from the trial in the second quarter of 2006, as planned.

In accordance with previous guidance, DOV expects to accumulate all required safety data from its Phase III open label long term safety and efficacy trial (study 022) on schedule for an NDA filing for CLBP in the first half of 2007.

***********

03.11.2005 13:56
DOV Pharmaceutical, Inc. Presents New Bicifadine Data and Pipeline Review at Third Annual Scientific Symposium

HACKENSACK, N.J., Nov. 3 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, (Nachrichten) Inc. held its Third Annual Scientific Symposium on Friday, Oct. 28, 2005 in New York City. The event featured presentations from DOV's senior management team regarding the Company's strategies and timelines for its leading product candidates, new data from its late stage clinical development programs and updates about its preclinical pipeline. There were more than 120 attendees on site and participating in the live Webcast.

Bicifadine in the Treatment of Chronic Low Back Pain

Significant new data were presented and timelines were confirmed for DOV's novel, non-opiate analgesic bicifadine as a treatment for chronic low back pain (CLBP). Data collected during the first six months of dosing in DOV's ongoing open label CLBP trial indicate that the efficacy of bicifadine 800 mg/day in reducing pain and improving behavioral functioning is at least equivalent to standard of care (an average of 2.5 concurrent medications). These open label trial data also show that the subset of patients who "rolled over" following completion of a prior three-month DOV Phase III double-blind placebo-controlled clinical trial of bicifadine in CLBP entered the open label trial with a mean pain score of approximately 40 on a visual analog scale (VAS). This is compared to a mean VAS score of about 70 for de novo (newly- enrolled, bicifadine-naive) patients. Further, the de novo patients showed marked improvement over the first two weeks, to a VAS score of approximately 50, and continued to lower their collective scores down to about 30 during 18 weeks of dosing. Additionally, the open label trial data collected demonstrate that bicifadine was well-tolerated. After presenting these data, DOV reaffirmed its plans to submit a CLBP NDA filing in the first half of 2007. As part of its market expansion strategy for bicifadine, the Company announced that it will initiate Phase II pilot trials in osteoarthritis and neuropathic pain in the fourth quarter of 2005.

Additional Data and Timelines Presented * Bicifadine in the Treatment of Acute Pain -- Three acute pain placebo-controlled trials have been completed with each demonstrating a statistically superior analgesic effect for bicifadine. -- One of these three trials is the recently-completed Phase III double-blind trial in patients with moderate to severe pain following bunionectomy surgery. This trial demonstrated the efficacy of bicifadine and an active control (tramadol) relative to placebo: bicifadine's analgesic action showed rapid onset within approximately 30 minutes, was superior to placebo, comparable to that of tramadol and well-tolerated. -- DOV plans to submit an sNDA filing for acute pain during the fourth quarter of 2007. * Triple Reuptake Inhibitor Program -- Phase II trial data presented show that patients with moderate to severe depression who were dosed for up to two weeks with either DOV 216,303 or citalopram (Celexa) demonstrated reductions of greater than 40% from baseline in the total Hamilton Depression rating scores; adverse event rates were similar for these two groups. -- A Phase II efficacy trial with DOV 21,947 in major depression will be initiated in 2006. -- DOV presented data indicating that 102,677 produced a potent and robust reduction in the volitional consumption of alcohol in a well-established preclinical model of alcohol abuse. Based on these data, DOV has decided to start a pilot Phase II trial for DOV 102,677 in alcohol abuse in 2006. * GABAA Modulator Program -- Development of ocinaplon has been discontinued for generalized anxiety disorder due to an unacceptable rate of liver enzyme elevations. DOV will select a follow-on candidate from one of the back-up compounds in its preclinical program. * Indiplon -- DOV partnered this compound in 1998 to Neurocrine and is entitled to receive 3.5% on net worldwide sales. -- PDUFA dates are February and March 2006 for the two NDAs filed for the use of indiplon for the treatment of insomnia. ... hat sich bei Indiplon etwas verschoben?

********

Dov Pharmaceuticals, Inc.
Dov's lead candidate is bicifadine, a chemically distinct molecule with a unique profile of pharmacological activity. It enhances and prolongs the actions of serotonin and norepinephrine by inhibiting the transport proteins that terminate their physiological actions, similar to the mechanism of action of duloxetine. Preclinical studies and clinical trials indicate that these actions may account for the analgesic properties of bicifadine in chronic pain conditions including neuropathic pain.

**********

Endo's Lidoderm may compete for COX-2 void
By STEVE MITCHELL
UPI Senior Medical Correspondent

WASHINGTON, Nov. 16 (UPI) -- Endo Pharmaceuticals is making a bid for its painkiller patch Lidoderm to fill some of the void left in the wake of the safety issues with COX-2 inhibitors that emerged last year.

Endo, based in Chadds Ford, Pa., released data from a clinical trial at the American College of Rheumatology meeting in San Diego Wednesday that it said shows that patients with chronic low-back pain got the same or better relief from Lidoderm than Celebrex, Pfizer's COX-2 inhibitor.

Analysts said the market is open to new pain killers due to the withdrawal of two of the three COX-2 inhibitors. Merck withdrew Vioxx last September after it was found to be associated with an increased risk of heart attack and stroke, and Pfizer later took Bextra off the market. Celebrex is the only COX-2 inhibitor still on the market.

"The pain field has a huge void in it due to the COX-2 problems," Scott Henry, an analyst with Oppenheimer & Co. in Boston, told United Press International.

Celebrex "is really flat," Henry said, adding that "it could be a growth product." At the same time, the void left by the removal of Vioxx and Bextra will have to be filled with other products, and "Lidoderm is a possible alternative."

Drugs that could fill that niche by providing effective yet safe pain relief "could be a blockbuster," Henry said. "The trick is to have the efficacy without the side effects," he said.

Another candidate that looks promising, he said, is Dov Pharmaceutical's bicifadine, which is currently in phase 3 studies.

But Michelle Grady, an analyst for Decision Resources in Waltham, Mass., said the void left by the withdrawn COX-2s will predominantly be supplanted by reformulations of currently existing medications rather than new drugs coming down the pipeline.

"Nothing really novel in terms of mechanism of action is expected to dramatically impact the market over the next 10 years," Grady told UPI.

She said she expects there to be an increasing use of anti-epileptic drugs, such as Pfizer's Neurontin, and anti-depressant drugs, such as Lilly's Cymbalta, for treating pain as physicians start to avoid COX-2s.

Lidoderm, however, will probably fill some of the COX-2 void, growing from 2 percent of the global market in 2004 to a projected 6 percent by 2014, Grady said.

One factor that could increase Lidoderm's market share is its anticipated approval as a treatment for more forms of chronic pain, she said. Currently, Lidoderm is only approved in the United States for the treatment of the pain of post-herpetic neuralgia.

Also, physicians tend to like the patch for the treatment of pain. "Physicians in Europe are telling us they're eagerly awaiting the introduction of the Lidoderm patch," she said.

In the Endo study, 36 patients with chronic low-back pain were treated with Lidoderm and compared to 38 patients who were taking Celebrex. The study was halted last fall before the target enrollment goal of 200 patients was reached due to the safety issues that emerged with the COX-2 inhibitors.

Endo analyzed the data after four weeks of treatment and found that 50 percent of the patients receiving Lidoderm reported a 30-percent or greater improvement in daily pain intensity compared with 42 percent of the Celebrex group.

Approximately 36 percent of the Lidoderm patients reported that their pain intensity had improved by 50 percent or more, compared with only 26 percent of the Celebrex participants.

Satisfaction levels with the treatment were high in both groups, with about 76 percent of the Lidoderm group and 72 percent of the Celebrex group saying they were satisfied or very satisfied.

Both groups also reported an improvement in mood, walking ability and sleep after four weeks of treatment.

Endo did not return a phone call from UPI requesting comment.

*******

Bicifadine is a novel analgesic with an unidentified mechanism of action. It is understood, however, to enhance and prolong the activity of norepinephrine and serotonin and is a functional antagonist at a subset of excitatory glutamate receptors. It is under development for a broad pain indication and has been under clinical investigation for several different pain conditions, including moderate to severe postsurgical dental pain and chronic lower-back pain.

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 20.934.965 von ipollit am 24.03.06 11:20:11

für ENCY scheint es heute so weit zu sein... daher ist heute vom AH-Drop kaum noch etwas zu sehen... mal sehen, was die FDA zu Thelin sagt??? Laut Marktbewegung ist es offen...



Actelion braced for FDA decision on rival
Fri Mar 24, 2006 4:56 AM ET
ZURICH, March 24 (Reuters) - Actelion (ATLN.S: Quote, Profile, Research) was braced on Friday for U.S. regulators to decide whether to approve a rival drug for the same indication as the Swiss biotech company's top-selling Tracleer treatment.

The Swiss company relies heavily on Tracleer to sustain growth but analysts worry that the medicine -- indicated to treat a rare form of lung disease known as pulmonary arterial hypertension (PAH) -- faces increasing competition.

In 2005, Actelion recorded 663.6 million Swiss francs ($504.2 million) in total revenues, of which 633.2 million came from sales of Tracleer.

U.S. Food and Drug Administration (FDA) regulators are due to decide on Friday whether to approve Thelin, made by U.S. firm Encysive (ENCY.O: Quote, Profile, Research) as the third treatment on the market for PAH.

Pfizer's (PFE.N: Quote, Profile, Research) Revatio, which contains the same active ingredient as Viagra, was the second drug approved for the indication.

"We expect Thelin to be approved today, so any delay would provide an upside to our Tracleer forecasts," Kepler Equities analyst Denise Anderson said in a note to clients.

Shares in Actelion were 0.3 percent higher at 123.90 Swiss francs by 0932 GMT.

A fourth drug for PAH called ambrisentan is being developed by U.S. firm Myogen Inc (MYOG.O: Quote, Profile, Research).

An estimated 200,000 people suffer from PAH, which causes extreme shortness of breath as the heart struggles to pump against high pressure in the lungs.




mfg ipollit

[puhvogel]

Antwort auf Beitrag Nr.: 20.934.965 von ipollit am 24.03.06 11:20:11

@ipollit:
Diversifikation ist das Wichtigste beim Investieren, noch umso mehr in einem hochvolatilen Feld wie Biotech. So mancher verliebt sich in seinen Biotech-wert und kennt nichts anderes. Das ist der Beste und schnellste Weg in die Beinahe-Pleite, von der man sich nur ganz schwer wieder erholt.

Dov Pharma mit Bicifadine ist ein schönes Beispiel, wie frustrierend solche Marktchancenanalysen für einen Privatinvestor sind. Der Markt an sich ist riesig (8 Mrd $), durch den Fall von Vioxx und Bextra ist Platz für Neuentwicklungen. Mache ich mir es einfach und sage einfach nach Gefühl, 10 % des Marktes wäre doch nicht schlecht, dann kann man gar nichts anderes als Dov zu kaufen. Leider ist es nicht so einfach, und dieses Feld ist Ziel von anderen Wettbewerbern, Generika und auch Parallelentwicklungen. Wie ein Medikament in einem hochkompetetiven Umfeld ankommt hängt in großem Maße vom Nebenwirkungsprofil, von den Krankenkassen und nicht zuletzt von der Sales Force ab.

500 Millionen $ für 2009 schreibt der "fool", begründet es aber nicht mal ansatzweise. Wenn ich mir solche Analystenberechnungen dann mal anschaue, dann kann ich nahezu jeden Anfangsparameter halbieren oder auch verdoppeln, dann haut dass meist auch noch mit der Realität hin. Meistens ist nicht mal die halbwegs genaue Zahl der Zielgruppe der Patienten bekannt. Diese Zahl ist meistens aber die noch am einfachsten zu recherchierende Größe. Das Thema Marktanteil und Behandlungskosten pro Patient und Jahr sind nochmal schwieriger zu bestimmen.

Um wie viel einfacher gestaltet es sich für einen Kleininvestoren, den Optimismus oder Pessimismus bei einem Aktienwert herauszufiltern. Wurden die letzten Nachrichten im Verhältnis zur Gesamtlage überbewertet? Ist überhaupt in der Bewertung wirklich mittelfrist überhaupt noch Platz für positive Phantasie (MYGN)? Viele Biotechs haben sich in den letzten 6 Monaten verdoppelt, und einige davon haben sich nach schlechten Phase 3 Daten wieder halbiert. Sind die nun billig?
Selbst mechanische Systeme wie das von nkelchen performen wirklich gut, aber das geht aber auch nur in dem jetzigen guten Marktumfeld gut.

Wenn ein Kurs nachrichtenlos wie jetzt CVTX fällt, ob dann sich eine Insider austobt oder ob da jemand aus seiner Position raus will, weil die Geliebte ihn erpresst, weiß ich auch nicht. Dann stehe ich auch im Dunkeln, da hilft mir aber auch nicht die Kenntnis des echten Marktpotenzials wirklich weiter.

[ipollit]

Antwort auf Beitrag Nr.: 20.940.677 von puhvogel am 24.03.06 17:09:17

puhvogel,

alles schön und gut, aber was ist dann dein Ansatz? Reine Charttechnik oder nur mit dem Trend gehen? Ist das etwa besser?... wenn es so einfach wäre, würde das System nicht funktionieren, denn es lebt nunmal davon, dass man entsprechend der Chance etwas zu gewinnen auch das Verlustrisiko trägt, bzw. den glücklichen Gewinnern stehen immer entsprechende Verlierer gegenüber. Ein sicheres System gibt es nicht. Der "fundamentale Wert" ist für mich eine Bezugsgröße, die unabhängig von der Marktlage ist, wenn man die einzelnen Unternehmen untereinander vergleichen will. Natürlich ist der Markt in einer guten Phase bereit, mehr für ein fundamental starkes Unternehmen zu zahlen. Mit den "Berechnungen" wie z.B. die 500 Mio USD in 2009 will ich ja auch keine exakte Angabe haben, aus der ich 2009 den und den Kurs ableiten kann. Ich möchte nur grob wissen, ob ein Medikament wie z.B. Medigene's Eligard ein Blockbuster ist oder nur ein Nischenprodukt. Denn wie kommt die Bewertung von Biotechs zustande? Für mich spielt die Phantasie und Risikobereitschaft eine entscheidene Rolle. Und da bietet u.U. DOVPs Bicifadine mehr Phantasie als Polyphenon von Medigene... natürlich spielt es dann eine große Rolle, ob das vom Markt auch so gesehen wird, ob die Aktie schläft oder gerade die Indikation onvogue ist. Nicht nur absolute Bwertungen sind interessant, sondern auch die relativen. Wenn Actelion praktisch nur mit Tracleer auf eine MK von aktuell 1,7 Mrd EUR kommt, ist dann nicht für ENCY mit Thelin und einer MK von 542 Mio USD noch Platz nach oben? Okay... es hängt davon ab, ob Thelin Tracleer Konkurrenz bieten kann. Naja und MYOG mit 1,46 Mrd USD??? Was spielt der Markt da? Wenn es im Wesentlichen auf Ambrisentan basiert und ich, wie ich ja mal sagte, eine Fehleinschätzung des Marktes bezügl. Thelin vermute, so ist meiner Meinung nach ENCY fundamental unterbewertet (oder entsprechend die anderen überbewertet) und ich setze auf einen Ausgleich. Was der faire Wert ist, was die einzelnen Medikamente bringen, wieviel eine Pipeline wert ist, kann man nie genau sagen... das zeigt sich erst im Nachhinein und dann ist es bereits uninteressant.

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 20.942.125 von ipollit am 24.03.06 18:42:45

Encysive Cuts to Chase

By Melissa Davis
Senior Writer
3/24/2006 1:01 PM EST
Click here for more stories by Melissa Davis


Encysive (ENCY:Nasdaq - commentary - research - Cramer's Take) investors are hoping to get some good news along with the bad.

All week, Wall Street has been waiting for the biotech to report that its new pulmonary arterial hypertension drug Thelin has finally won approval from the Food and Drug Administration. But late Thursday, the Bellaire, Texas, company shared some unexpected bad news instead.

Rather than announcing Thelin's approval, Encysive said the FDA has stalled clinical trials of TBC3711 -- a next-generation drug that's even more potent than Thelin -- due to problems in a recent animal study.

Specifically, Encysive said that human trials of TBC3711 have been placed on hold due to "an unusual finding following dosing with intravenous TBC3711 in a single rat that had displayed abnormalities at baseline." Encysive hopes to test both IV and oral versions of TBC3711 for the treatment of resistant hypertension.

Unlike PAH, which Thelin aims to address, resistant hypertension afflicts a large population of patients. Encysive has portrayed development of its new resistant hypertension drug as a "top priority" for the company.

The company's stock slid 17 cents Friday to $9.28.

PAH Players
Analysts have widely predicted that Encysive will secure approval for Thelin by Friday, the company's established target.

If so, Thelin will follow two other oral PAH treatments onto the market but with evidence of superior performance. Moreover, Thelin will enjoy a big head start against highly touted ambrisentan -- a new PAH drug under development by Myogen (MYOG:Nasdaq - commentary - research - Cramer's Take) -- that has already been deemed "best-in-class" by some.

Recent clinical trials have indicated that ambrisentan could prove safer than other PAH drugs that hit the market sooner. But some people believe that ambrisentan has yet to be tested long enough for problems -- particularly with liver toxicity -- to show up.

Encysive CEO Bruce Given suggested as much during a conference call last month.

"What I heard was that their study was only 12 weeks," Given said. "If they're only recording 12-week data ... it's kind of uninterpretable. Our experience with these Tracleer relapses is, again, many or most of them occur beyond 12 weeks."

Tracleer, manufactured by Swiss drug maker Actelion, ranks as the best-selling oral medication for PAH currently on the market. It generated $500 million in revenue for Actelion last year and, if the company achieves its goals, will become an even bigger seller going forward.

Head-to-Head
But Encysive has performed head-to-head studies showing that its own Thelin works better, with far less liver toxicity, than Tracleer does. Moreover, the company claims that it has already enjoyed a warm reception from managed care companies -- which foot the bill for expensive PAH treatments -- as a result.

"Usually, about halfway during the presentation, they sort of look up and say, 'We've been pounding the table for years to try to get Big Pharma to give us more comparative data. And here you guys are with an orphan drug, and you come (with) comparative data. This is what we want.'"

Apparently, many believe, regulators in the U.S. and Europe want exactly the same thing. And so far, they say, Encysive has emerged as the only company offering the kind of PAH drug comparisons those regulators are seeking.

For its part, Encysive believes that it has taken the right steps necessary to win approval of Thelin but has stopped short of guaranteeing victory nonetheless.

"While we continue to feel good about our prospects for FDA approval of Thelin, we have no way of knowing if and when we will receive that approval," CFO Gordon Busenbark told analysts during a conference call last month. "Similarly, we continue to feel good about our prospects for European approval of Thelin (in Europe) later this year. But we have the same issue in that there is no way of knowing if and when that approval will be forthcoming."

Version of Viagra
In the meantime, Pfizer (PFE:NYSE - commentary - research - Cramer's Take) has already rolled out an oral PAH treatment of its own.

Last year, Pfizer won approval to market Revatio -- which relies on the same active ingredient as its blockbuster Viagra -- for the treatment of PAH in both the U.S. and Europe. Since then, WR Hambrecht analyst Patrick Flanigan suggested this week, Revatio has started to win over physicians and could threaten Thelin's performance going forward.

"We find it unlikely that physicians will add Thelin to patients who are well controlled on Revatio," wrote Flanigan, who has a hold recommendation on Encysive's stock. So "absent Tracleer failures, Thelin is left to compete against Revatio for treatment-naive patients -- a population where physician response is overwhelmingly positive for Revatio use."

Actually, doctors could choose to use both drugs together instead. Actelion has laid out plans to test its own PAH drug with Revatio as an effective treatment for the disease.

Moreover, many believe, biotechs like Encysive and Myogen will spend far more energy marketing their PAH drugs than will pharmaceutical giants, like Pfizer, which have much broader focuses.

Marketing Muscle
Certainly, Encysive has been gearing up for a big launch. The company has hired more than 50 veteran salespeople -- each at a cost of about $250,000 annually -- in anticipation of Thelin's regulatory approval.

The company has also indicated that Myogen's new drug could help, rather than hurt, its own marketing efforts in the end.

"Part of the reason this has been such a small market is because there hasn't been much promotional activity," Given said. "So part of what's going to make this market achieve the potential that we think the market has is the marketing and selling activity that's going to be thrown against this disease. And I think, assuming Myogen does come (out with ambrisentan) in the future, that is only going to help this market grow even faster."

Experts believe that PAH afflicts roughly 100,000 patients, most of them yet to be diagnosed. They have estimated that new treatments for the disease, like those being developed by both Encysive and Myogen, could easily sell for more than $30,000 a year.

Clearly, Encysive believes that its own efforts could finally start to pay off.

"While 2005 was our busiest year yet, we see no letup for 2006," Given said last month. "In fact, 2006 is shaping up to be the year where much hard work and investor patience is finally rewarded."

Der PAH-Markt hat demnach ein maximales Potential von über 3 Mrd USD... Thelin könnte am Ende noch das best-in-class Medikament werden oder sich dies mit Ambrisentan teilen.

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 20.943.802 von ipollit am 24.03.06 21:28:47

immer der selbe Mist... "approvable letter" aber keine Zulassung ... gleiches Spielchen wie mit DSCOs Surfaxin - was denkt sich die FDA dabei?

UPDATE 2-US FDA seeks more trial work on Encysive lung drug
Fri Mar 24, 2006 8:48 PM ET
(Recasts with company comment)

WASHINGTON, March 24 (Reuters) - Encysive Pharmaceuticals Inc. (ENCY.O: Quote, Profile, Research) said Friday U.S. regulators have requested additional clinical trial work before approving its drug Thelin for an often-fatal lung condition, and its shares fell 8 percent in extended trade.

The Houston-based company is seeking permission to sell Thelin as a treatment for treat pulmonary arterial hypertension (PAH), which causes severe shortness of breath and often kills.

The Food and Drug Administration sent an "approvable letter" to the company saying Thelin could be cleared if certain conditions were met, FDA spokeswoman Susan Cruzan said. She did not disclose the conditions.

Encysive said in a statement the letter contained "concerns and observations that must be satisfied prior to achieving approval, including a request for additional clinical trial work."

President and Chief Executive Officer Bruce Given said Encysive would work with the FDA "to clarify the path forward."

"We are hopeful that this can be accomplished without the need for additional clinical work, but that will require discussion with the agency before we can be sure," Given said.

Shares of Encysive fell 73 cents to $8.35 in after-hours trade on the Inet network, after closing down 3.9 percent at $9.08 in regular Nasdaq trade.

The failure to win full approval for Thelin will likely be viewed as positive for Swiss biotechnology company Actelion (ATLN.S: Quote, Profile, Research), which relies heavily on its PAH treatment Tracleer to sustain growth.

"Any delay would provide an upside to our Tracleer forecasts," Kepler Equities analyst Denise Anderson said in a note to clients.

While Tracleer once had the PAH market pretty much to itself, it is now facing increased competition from Pfizer Inc.'s (PFE.N: Quote, Profile, Research) Revatio, which contains the same active ingredient as Viagra.

Thelin would be another direct competitor for treating the rare condition that often leads to the need for a heart and lung transplant.

A fourth drug for PAH called ambrisentan is being developed by Myogen Inc. (MYOG.O: Quote, Profile, Research).

mfg ipollit

[amorphis]

hola ipollit...

auch ich lasse mich mal wieder blicken...viele interessante werte dabei...die hier bisher schon diskutiert wurden...

wollte mal auf xoma hinweisen...die letzten news waren ja nicht von schlechten eltern...http://biz.yahoo.com/bizj/060309/1244942.html?.v=1

am freitag gabs dann den ausbruch über die 2$ marke...das volumen hat auch deutlich angezogen....

Volume: 5,164,452
Avg Vol (3m): 677,064

bin am freitag mit dem break der 2$ rein...erstmal nur als trade...obs mehr wird...wird die zukunft zeigen...

hat hier jemand erfahrung mit xoma?worauf sollte man bei dem wert achten?waren die letzten news nur eine eintagsfliege...oder gibts ne wirkliche wende aus fundamentaler sicht?was meint ihr?

greez

[ipollit]

Antwort auf Beitrag Nr.: 20.948.569 von amorphis am 25.03.06 22:10:11

hallo amorphis,

ich habe mich noch nicht näher mit XOMA befasst, aber irgendwann habe ich diese mal als uninteressant verworfen, weiß allerdings nicht mehr den Grund.

Wie sieht denn die Pipeline aus... haben die eigene Produkte oder nur Partnerprojekte? Das aktuelle positive Ergebnis könnte auf Einmaleffekte beruhen und schnell wieder ins Negative drehen. Eine feste Größe sind wohl die DNA-Royalties für Raptiva: "Beginning on January 1, 2005, we are earning a mid-single digit royalty on worldwide sales of RAPTIVA." ... das dürfte also im Bereich 4-6% liegen. Die Frage ist nun, wie sich Raptiva entwickelt und da sieht es, wenn ich mich recht entsinne nicht ganz so positiv aus. Die bisherigen Umastzzahlen in Mio USD sind...

Q1
Q2
Q3
Q4
Year Total

2005
$ 24.1
$ 24.9
$ 21.5
$ 23.6
$ 94.1

2004
$ 6.3
$ 13.4
$ 18.0
$ 18.6
$ 56.3

2003
-
-
-
$ 1.4
$ 1.4

also ca 100 Mio USD p.a., was Royalties von etwa 5 Mio USD für XOMA entspricht. Würde Raptiva sich zu einem Blockbuster entwickeln, so dürfte sich die Sache für XOMA lohnen... danach sieht es aber gar nicht aus, eher, dass die Umsätze auf aktuellem Niveau stagnieren.

Na ich weiß es nicht genau, aber so sehe ich im Moment keinen Kaufgrund.



nach einem Trading-Signal sieht es allerdings schon aus...

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 20.948.775 von ipollit am 25.03.06 23:12:45

Bei ANDS bin ich ganz optimistisch, wo es jetzt ja bei IDIX nicht so gut läuft. TELK könnte ich durch OXGN ersetzen und für einen Kauf von Speedel IDEV/PTIE/MDG reduzieren und/oder NKTR verkaufen. MLNM steht ebenfalls auf der Verkaufsseite - auf der Watchliste noch KERX, RIGL, CNVX(Micromet) und u.U. COLY, LGND, ARRY, SNUS.


Anteil Aktie Symbol Kurs KK Gewinn
17,4% GPC GPC.de 13,77 EUR 7,94 + 73%
16,7% Morphosys MOR.de 47,71 EUR 20,43 + 134%
6,5% Medigene MDG.de 8,4 EUR 7,34 + 14%
6,0% OSI Pharm OSIP 30,92 USD 25,53 + 21%
5,6% Arena ARNA 17,42 USD 9,77 + 78%
5,2% Pain Therap PTIE 10,78 USD 7,08 + 52%
4,2% Paion PA8 8,95 EUR 9,12 - 2%
4,1% Indevus IDEV 6,3 USD 7,11 - 11%
3,3% Vasogen VSGN 2,24 USD 2,67 - 16%
3,3% Imclone IMCL 34,25 USD 31,41 + 9%
3,1% Atherogenics AGIX 16,17 USD 18,56 - 13%
3,1% YM Bioscience YMI 5,98 USD 4,44 + 35%
3,1% Anadys ANDS 15,91 USD 11,94 + 33%
2,7% Cardiome CRME 12,08 USD 9,95 + 21%
2,5% Nektar NKTR 19,68 USD 15,96 + 23%
2,0% Telik TELK 19,11 USD 15,15 + 26%
1,8% Discovery Labs DSCO 7,86 USD 7,46 + 5%
1,8% Encysive ENCY 9,08 USD 8,80 + 3%
1,7% Onyx ONXX 26,46 USD 25,45 + 4%
1,6% DOV Pharma DOVP 16,66 USD 15,75 + 6%
1,5% Panacos PANC 7,98 USD 8,24 - 3%
1,1% KOS Pharma KOSP 48,83 USD 68,41 - 29%
1,0% Millennium MLNM 10,11 USD

Performance 2006
Depot (EUR, netto) 13,8%
NBI (EUR) 4,7%
BTK (EUR) 2,7%
TecDax 22,8%

mfg ipollit

[smartcash]

Antwort auf Beitrag Nr.: 20.950.560 von ipollit am 26.03.06 13:40:32

ipollit

warum taucht Combimatrix (CBMX) nicht bei Dir auf ? Sind zwar bereist gut gelaufen in den letzten vier Wochen, aber die Rebound auf dei alten Hochs hat m.E. gerade erst begonnen. Gute Cashposition, sehr guter Newsflow und sehr gute technische Situation.

Ein Blick lohnt sich

Gruß
smartcash

[ipollit]

Antwort auf Beitrag Nr.: 20.950.693 von smartcash am 26.03.06 14:02:41

smartcash,

CBMX ist mir zuviel Tec und zu wenig Biotech... ich interessiere mich in erster Linie für Medikamentenentwickler (mit einer klinischen Pipeline) - aber trotzdem danke für den Tipp.

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 20.946.204 von ipollit am 25.03.06 10:55:42

na Klasse, ein 50% "haircut"... das macht mir Spaß

und natürlich MYOG 5% rauf... habe ich etwa etwas falsch verstanden - die Ambrisentan-Daten sind zwar besser, aber keinesfalls fundierter... so wie ENCY nun unter die Räder gekommen ist, wie will MYOG das umgehen????

MYOG 1,55 Mrd USD - ENCY 284 Mio USD... nicht einmal ein Sechstel der MK????

Ich habe noch nie geshortet, MYOG wäre ein schöner Kandidat. Eigentlich will ich nicht noch mehr in ENCY stecken, aber die Sache scheint eine gute Gelegenheit zu sein... was soll denn noch passieren?



Pain Spreads at Encysive

By Melissa Davis
Senior Writer
3/27/2006 11:53 AM EST
Click here for more stories by Melissa Davis


Encysive (ENCY:Nasdaq - commentary - research - Cramer's Take) looks like it overplayed its hand.

Prior to a bombshell announcement this weekend, the company had managed to convince investors that approval of Thelin -- its new drug for pulmonary arterial hypertension -- was essentially a sure thing. Instead, the company now faces a delayed launch of Thelin at best. Without sharing any major details, Encysive disclosed Friday night that the Food and Drug Administration has asked for more information about Thelin -- including additional clinical trial work -- before it can approve the new PAH drug.

Shares of Encysive plummeted 46% to a multiyear low of $4.94 on the report. Meanwhile, shares of Myogen (MYOG:Nasdaq - commentary - research - Cramer's Take) -- which is developing a PAH drug of its own -- rose 4.1% to $36.41.

Encysive had previously been hoping for first-run approval of Thelin and, in turn, a big headstart against Myogen's ambrisentan. But that perceived advantage has now diminished.

Brean Murray Carret analyst Jonathan Aschoff promptly downgraded Encysive from accumulate to hold as a result.

The FDA's response "was almost entirely unexpected by the Street," Aschoff wrote on Monday. "Barring significant ambrisentan delays, we no longer believe that Thelin will have any meaningful lead time to market over competitor ambrisentan and will therefore have to fight it out with ambrisentan for market share on relatively equal ground without enjoying more than perhaps a few months lead time."

In the meantime, Encysive has offered few clues about its surprising regulatory setback. Rather, when repeatedly questioned by analysts on Monday, Encysive insisted that the company would be best served by dealing with the FDA in a "quiet and confidential" manner. Some have speculated that Encysive ran into some class-wide challenges that could ultimately hinder Myogen as well.

Notably, the FDA recently ordered stricter guidelines for a PAH drug already on the market. Moreover, Encysive suggested on Monday that the FDA could treat "anybody that potentially follows us" in a similar manner.

For now, however, JP Morgan analyst Geoffrey Meacham has ruled out a similar setback for Myogen at least.

"Given ambrisentan's best-in-class clinical profile thus far, we do not believe that Thelin's approvable letter raises the regulatory risk for ambrisentan," Meacham wrote on Monday. "Myogen could also launch ambrisentan ... potentially ahead of Thelin, putting Encysive at a competitive disadvantage."

Meacham has a neutral rating on Encysive and an overweight rating on Myogen. His firm counts both companies as investment banking clients and owns shares of both stocks, including a major position in the latter.

But Robert Lawton, vice president of Westport, Conn.-based Source Capital, sees no good reason to own either stock right now. Indeed, Lawton holds a large short position in Myogen -- which, he says, could grow further if the stock climbs above $40 again.

In the meantime, Lawton says he sold the Encysive stock he bought as an added bet against Myogen prior to the FDA action.

"Thank God, I didn't own very much," he says. "It's always too much when the stock gets cut in half on a Monday. But it definitely could have been worse."

mfg ipollit