EyePoint Pharmaceuticals (vorher: PSIVIDA) startet durch !! - Älteste Beiträge zuerst (Seite 1154)
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Sollte Alimera wirklich so gut verdienen, wie dieser Analyst ( Herr One) glaubt, dann kann das für Psivida nur gut sein. Immerhin sind sie am Umsatz von Iluvien beteiligt. 
- Alimera Sciences Inc. -- Alimera Sciences bereitet die Veröffentlichung seiner Ergebnisse für das am 31. März 2015 beendete Geschäftsquartal am 6. Mai 2015 vor und Thomson One schätzt, dass das Unternehmen einen Umsatz von 3,9 Millionen USD in dem Quartal melden wird. Diese Schätzung stellt einen Anstieg von 317,11 % gegenüber dem entsprechenden Vorjahresquartal dar. Im letzten Berichtsquartal hatte das Unternehmen ein Umsatzwachstum von 86,20 % und im vorherigen Berichtsjahr von 349,95 % gegenüber dem Vorjahr verzeichnet. Die Aktie von Alimera Sciences hat sich im Lauf der Zeit ebenfalls positiv entwickelt, was die starken Fundamentaldaten des Unternehmens wiederspiegelt. Allein in 2014 legte die Aktie um 86,81 % zu. Den kompletten Research-Bericht über Alimera Sciences Inc. können Sie kostenlos herunterladen auf: http://register.performancefinancial.de/ de/?c=Alimera%20Sciences&d=24-Apr-2015&s=US0162591038 --
- Alimera Sciences Inc. -- Alimera Sciences bereitet die Veröffentlichung seiner Ergebnisse für das am 31. März 2015 beendete Geschäftsquartal am 6. Mai 2015 vor und Thomson One schätzt, dass das Unternehmen einen Umsatz von 3,9 Millionen USD in dem Quartal melden wird. Diese Schätzung stellt einen Anstieg von 317,11 % gegenüber dem entsprechenden Vorjahresquartal dar. Im letzten Berichtsquartal hatte das Unternehmen ein Umsatzwachstum von 86,20 % und im vorherigen Berichtsjahr von 349,95 % gegenüber dem Vorjahr verzeichnet. Die Aktie von Alimera Sciences hat sich im Lauf der Zeit ebenfalls positiv entwickelt, was die starken Fundamentaldaten des Unternehmens wiederspiegelt. Allein in 2014 legte die Aktie um 86,81 % zu. Den kompletten Research-Bericht über Alimera Sciences Inc. können Sie kostenlos herunterladen auf: http://register.performancefinancial.de/ de/?c=Alimera%20Sciences&d=24-Apr-2015&s=US0162591038 --
Antwort auf Beitrag Nr.: 49.613.297 von binda am 21.04.15 20:10:04Viele unserer Patienten sind mit Büros ihrer Ärzte von der Notwendigkeit für häufige Injektionen angewiesen, um ihre Sehschärfe zu erhalten. Ein Implantat, das ein Medikament über mehrere Jahre mit nur einer Injektion liefern kann mit Iluvien, ist eine große Verbesserung für jeden Behandlungsplan, sagte Dr. Dugel. Ich glaube, das Iluvien eine neue, effektive Behandlungsmöglichkeit für DME + bringt, wenn die Patienten optische Verbesserungen als Folge des Implantats verspüren können.
Neben Dr. Holekamp, enthalten andere Webinar Moderatoren: Dr. David Brown, Retina Consultants von Houston, Houston, Texas; Dr. Pravin Dugel, Retinal Consultants von Arizona, Phoenix, Arizona; Dr. Alexander Eaton, Retina Health Center, Fort Myers, Florida; Dr. Victor Gonzalez, Tal Retina Institute, McAllen, Texas; Dr. Peter Kaiser, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Dr. Szilard Kiss, Weill Cornell Medical College, New York-Presbyterian Hospital, New York, New York; Dr. Baruch Kupper, UC Irvine Medical Center, Orange, Kalifornien; und Dr. Thomas Mundorf, Mundorf Eye Center, Novant Health Presbyterian Medical Center, Charlotte, North Carolina.
Danke Binda, muss man da nachkaufen??
Neben Dr. Holekamp, enthalten andere Webinar Moderatoren: Dr. David Brown, Retina Consultants von Houston, Houston, Texas; Dr. Pravin Dugel, Retinal Consultants von Arizona, Phoenix, Arizona; Dr. Alexander Eaton, Retina Health Center, Fort Myers, Florida; Dr. Victor Gonzalez, Tal Retina Institute, McAllen, Texas; Dr. Peter Kaiser, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Dr. Szilard Kiss, Weill Cornell Medical College, New York-Presbyterian Hospital, New York, New York; Dr. Baruch Kupper, UC Irvine Medical Center, Orange, Kalifornien; und Dr. Thomas Mundorf, Mundorf Eye Center, Novant Health Presbyterian Medical Center, Charlotte, North Carolina.
Danke Binda, muss man da nachkaufen??
Sciences, Inc. (ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it will release its first quarter 2015 financial results after the market close on Thursday, May 7, 2015. An investor conference call will follow on the same day at 4:30 p.m. ET.
Dan Myers, President and Chief Executive Officer, and Rick Eiswirth, Chief Operating Officer and Chief Financial Officer, will host the conference call, during which they will discuss the results and provide commercial and other business updates.
Dan Myers, President and Chief Executive Officer, and Rick Eiswirth, Chief Operating Officer and Chief Financial Officer, will host the conference call, during which they will discuss the results and provide commercial and other business updates.
ne good way to conceptualize pSivida is as a biotechnological application of Moore's Law. Moore's Law has to do with the processing power of computer chips. It is the 1965 observation by Gordon Moore of Intel (NASDAQ:INTC) that the number of transistors on a given area of a computer chip will tend to double every 2 years. Or in other words, that the processing power of computer chips will double every two years as chip manufacturing technology progresses. This observation has proven to be accurate, limited only by quantum mechanics where spaces get so small that reality itself becomes uncertain. Beyond that there is literally no more room to increase processing power.
pSivida, similar to ever smaller and smaller computer chips, is in the business of ever smaller microinserts. The idea is to fill tiny injectible inserts with drugs already on the market for sustained release over a long period of time. Instead of returning to the doctor's office, say, for monthly injections of a given drug, one injection of a pSivida microinsert loaded with that drug would suffice for months or even years.
pSivida already has third generation inserts on the market, with its fourth (and possibly final) generation insert in preclinical development. Going back to the microchip analogy, just as the computer revolution did not really take hold until processing power reached a certain threshold in the 80's but then took off and changed everything, pSivida's limited success until now may simply be a function of a threshold for its microinserts not yet reached.
pSivida's third generation of inserts brought ILUVIEN to market, an intraocular insert about the size of a grain of rice built to deliver sustained release corticosteroids for up to three years for the treatment of diabetic macular edema. Current treatment of DME usually involves monthly injections, which is often impractical and prohibitively expensive. ILUVIEN was approved by the FDA in September for patients who did not record an increase in intraocular pressure during previous treatment with corticosteroids.
That qualifier is due to the fact that one of the side effects of ILUVIEN is known to be an increase in pressure, which itself is dangerous to the eye.
While certainly a sign of success for its technology, ILUVIEN is not expected to be anything near blockbuster for pSivida mainly because it is licensed out to Alimera Sciences (NASDAQ:ALIM) who will be getting the lion's share of the profits. pSivida, though, did get a significant and very much needed $25M milestone payment upon FDA approval, and now has enough cash to get it through 2017 at current burn rate.
So in the immediate sense, pSivida is financially stable. Over the short-to-medium term though, what is most important for pSivida is FDA approval of Medidur, which is exactly the same thing as ILUVIEN - same insert, same corticosteroid drug delivery - just for a different indication. That is, posterior uveitis, or inflammation of the back side of the eye. Posterior uveitis has no known cause and affects 175,000 people in the US, causing 30,000 cases of permanent blindness every year. It usually requires systemic steroidal treatment to keep the inflammation down.
While anterior uveitis is usually successfully treated with topical eyedrops, posterior uveitis, since it is in the back of the eye, cannot be treated topically and requires strong systemic steroidal treatment because injections often do not work either. This means orally where the whole body is exposed, which can often lead to systemic side effects including cancer. pSivida believes that sustained release corticosteroids from Medidur can help prevent the need for systemic treatment with sustained internal targeting of the medication just to the eye.
Medidur is currently undergoing a pivotal phase 3 trial, fully enrolled, with results expected in one year. Medidur, unlike ILUVIEN, is not a partnered product, so all sales will go to pSivida instead of just royalties.
Medidur - One Phase3 Trial or Two?
Which takes us to the most immediate catalyst that could significantly lift pSivida's shareprice. Getting ILUIVEN FDA approved was a war. A long period of back and forth letter-writing between pSivida and the FDA dragged on and on, and pSivida had to eventually conduct a second phase 3 trial due to issues of intraocular pressure. This time, it may not be as difficult and only one phase 3 may be required since the FDA has conceded that safety data can be taken from the previous phase 3 trials for ILUVIEN, given that it's the same product. The final answer we will find out very soon, with FDA guidance on the Medidur clinical pathway due any day now. If only one phase 3 is required, that means approval of Medidur is possible by next year, and pSivida shares could jump on the news.
Further on the side of FDA approval is the fact that pSivida already has a posterior uveitis microinsert treatment on the market, Retisert, marketed by Bausch and Lomb. Retisert is a generation behind Medidur and requires a full surgical procedure to insert as it is much larger, unlike Medidur which is simply injected in a single office visit. For this reason and the inconvenience of surgical procedures generally, Retisert is not a big seller though it is effective, and only nets pSivida just over $1M in royalties annually from Bausch and Lomb.
Tethadur - The Quantum Limit of Sustained Release Inserts
As important as Medidur is both in the short and medium term for pSivida, it is not going to put it on par with a company like Regeneron. For that to have any chance of happening, its fourth generation product needs to succeed. Returning once more to Moore's Law, the limit of increased processing power is on the atomic level, at a point where you can no longer get any smaller. pSivida's fourth generation insert is called Tethadur, and in the words of CEO Paul Ashton, it is akin to a molecular honeycomb, each comb between 20 and 300 angstroms wide.
To give perspective, the size of a typical monoclonal antibody is 150 angstroms. Each honeycomb can be tailored to a specific size, which controls the rate of release. Ashton used the example of tennis balls in a tennis ball can. Since the can is fitted to the balls, the balls have to be shaken out and only come out slowly - molecular sustained release. Additionally, since each comb houses only one molecule, things like proteins or monoclonal antibodies are housed individually, separated so they don't clump up and become deactivated, which is a major problem in antibody delivery.
Unlike third generation Medidur or ILUVIEN, Tethadur is so small that it can theoretically be used as a sustained release capsule for any drug anywhere in the body. Abbvie's (NYSE:ABBV) Humira, for example, a monoclonal antibody set to become the bestselling drug of all time, requires biweekly injections, and in some cases weekly injections. A nano-sized sustained release capsule like Tethadur may not only be able to get that down to once every 6 months, it may even help Abbvie regain its patent on its bestselling megablockbuster. It is set to expire next year.
The Pfizer Wild Card
With that possibility being 5 to 10 years out, there is still one more blockbuster possibility for pSivida using its current 3rd generation technology. The insert technology behind ILUVIEN and Medidur is called Durasert, and Pfizer (NYSE:PFE) has an option with pSivida to collaborate on a latanoprost product using Durasert. Latanoprost is Pfizer's blockbuster Xalatan for glaucoma, and Pfizer's active interest here is clear in the fact that it owns 6.3% (page 9) of pSivida. According to the agreement, pSivida would be clear for a milestone payment of $20M in the event that phase 2 trials are initiated for the latanoprost product and succeed in proof of concept.
With the company currently putting most of its focus on Medidur and Tethadur, the collaboration with Pfizer probably won't progress until pSivida at least knows if it needs to conduct a second phase 3 on Medidur or not. If it doesn't, it would be clear to pursue the Pfizer option, so good news from the FDA on Medidur, due any time now in terms of the clinical way forward, could clear the way not only for Medidur itself, but for exercising the Pfizer option on a potentially blockbuster Pfizer latanoprost product.
Conclusion
From the time Regeneron began clinically testing EYLEA, it took 10 years to reach approval and another 4 years for the Regeneron stock to explode. If you are a biotech investor taking small positions looking for the next Regeneron, there is of course no guarantee by any means that pSivida will be that company. But its focus on the same niche of opthalmics, its collaboration with Big Pharma, and its fourth generation Tethadur technology could, 8-10 years from now, conceivably bring the company to that level, if Tethadur and its Pfizer collaboration both succeed.
And if more modest, short-to-medium term gains are what you're looking for, then watch out for any FDA word on the way forward for Medidur, as an official FDA letter requiring only one phase 3 trial could have a big effect on pSivida's stock.
pSivida, similar to ever smaller and smaller computer chips, is in the business of ever smaller microinserts. The idea is to fill tiny injectible inserts with drugs already on the market for sustained release over a long period of time. Instead of returning to the doctor's office, say, for monthly injections of a given drug, one injection of a pSivida microinsert loaded with that drug would suffice for months or even years.
pSivida already has third generation inserts on the market, with its fourth (and possibly final) generation insert in preclinical development. Going back to the microchip analogy, just as the computer revolution did not really take hold until processing power reached a certain threshold in the 80's but then took off and changed everything, pSivida's limited success until now may simply be a function of a threshold for its microinserts not yet reached.
pSivida's third generation of inserts brought ILUVIEN to market, an intraocular insert about the size of a grain of rice built to deliver sustained release corticosteroids for up to three years for the treatment of diabetic macular edema. Current treatment of DME usually involves monthly injections, which is often impractical and prohibitively expensive. ILUVIEN was approved by the FDA in September for patients who did not record an increase in intraocular pressure during previous treatment with corticosteroids.
That qualifier is due to the fact that one of the side effects of ILUVIEN is known to be an increase in pressure, which itself is dangerous to the eye.
While certainly a sign of success for its technology, ILUVIEN is not expected to be anything near blockbuster for pSivida mainly because it is licensed out to Alimera Sciences (NASDAQ:ALIM) who will be getting the lion's share of the profits. pSivida, though, did get a significant and very much needed $25M milestone payment upon FDA approval, and now has enough cash to get it through 2017 at current burn rate.
So in the immediate sense, pSivida is financially stable. Over the short-to-medium term though, what is most important for pSivida is FDA approval of Medidur, which is exactly the same thing as ILUVIEN - same insert, same corticosteroid drug delivery - just for a different indication. That is, posterior uveitis, or inflammation of the back side of the eye. Posterior uveitis has no known cause and affects 175,000 people in the US, causing 30,000 cases of permanent blindness every year. It usually requires systemic steroidal treatment to keep the inflammation down.
While anterior uveitis is usually successfully treated with topical eyedrops, posterior uveitis, since it is in the back of the eye, cannot be treated topically and requires strong systemic steroidal treatment because injections often do not work either. This means orally where the whole body is exposed, which can often lead to systemic side effects including cancer. pSivida believes that sustained release corticosteroids from Medidur can help prevent the need for systemic treatment with sustained internal targeting of the medication just to the eye.
Medidur is currently undergoing a pivotal phase 3 trial, fully enrolled, with results expected in one year. Medidur, unlike ILUVIEN, is not a partnered product, so all sales will go to pSivida instead of just royalties.
Medidur - One Phase3 Trial or Two?
Which takes us to the most immediate catalyst that could significantly lift pSivida's shareprice. Getting ILUIVEN FDA approved was a war. A long period of back and forth letter-writing between pSivida and the FDA dragged on and on, and pSivida had to eventually conduct a second phase 3 trial due to issues of intraocular pressure. This time, it may not be as difficult and only one phase 3 may be required since the FDA has conceded that safety data can be taken from the previous phase 3 trials for ILUVIEN, given that it's the same product. The final answer we will find out very soon, with FDA guidance on the Medidur clinical pathway due any day now. If only one phase 3 is required, that means approval of Medidur is possible by next year, and pSivida shares could jump on the news.
Further on the side of FDA approval is the fact that pSivida already has a posterior uveitis microinsert treatment on the market, Retisert, marketed by Bausch and Lomb. Retisert is a generation behind Medidur and requires a full surgical procedure to insert as it is much larger, unlike Medidur which is simply injected in a single office visit. For this reason and the inconvenience of surgical procedures generally, Retisert is not a big seller though it is effective, and only nets pSivida just over $1M in royalties annually from Bausch and Lomb.
Tethadur - The Quantum Limit of Sustained Release Inserts
As important as Medidur is both in the short and medium term for pSivida, it is not going to put it on par with a company like Regeneron. For that to have any chance of happening, its fourth generation product needs to succeed. Returning once more to Moore's Law, the limit of increased processing power is on the atomic level, at a point where you can no longer get any smaller. pSivida's fourth generation insert is called Tethadur, and in the words of CEO Paul Ashton, it is akin to a molecular honeycomb, each comb between 20 and 300 angstroms wide.
To give perspective, the size of a typical monoclonal antibody is 150 angstroms. Each honeycomb can be tailored to a specific size, which controls the rate of release. Ashton used the example of tennis balls in a tennis ball can. Since the can is fitted to the balls, the balls have to be shaken out and only come out slowly - molecular sustained release. Additionally, since each comb houses only one molecule, things like proteins or monoclonal antibodies are housed individually, separated so they don't clump up and become deactivated, which is a major problem in antibody delivery.
Unlike third generation Medidur or ILUVIEN, Tethadur is so small that it can theoretically be used as a sustained release capsule for any drug anywhere in the body. Abbvie's (NYSE:ABBV) Humira, for example, a monoclonal antibody set to become the bestselling drug of all time, requires biweekly injections, and in some cases weekly injections. A nano-sized sustained release capsule like Tethadur may not only be able to get that down to once every 6 months, it may even help Abbvie regain its patent on its bestselling megablockbuster. It is set to expire next year.
The Pfizer Wild Card
With that possibility being 5 to 10 years out, there is still one more blockbuster possibility for pSivida using its current 3rd generation technology. The insert technology behind ILUVIEN and Medidur is called Durasert, and Pfizer (NYSE:PFE) has an option with pSivida to collaborate on a latanoprost product using Durasert. Latanoprost is Pfizer's blockbuster Xalatan for glaucoma, and Pfizer's active interest here is clear in the fact that it owns 6.3% (page 9) of pSivida. According to the agreement, pSivida would be clear for a milestone payment of $20M in the event that phase 2 trials are initiated for the latanoprost product and succeed in proof of concept.
With the company currently putting most of its focus on Medidur and Tethadur, the collaboration with Pfizer probably won't progress until pSivida at least knows if it needs to conduct a second phase 3 on Medidur or not. If it doesn't, it would be clear to pursue the Pfizer option, so good news from the FDA on Medidur, due any time now in terms of the clinical way forward, could clear the way not only for Medidur itself, but for exercising the Pfizer option on a potentially blockbuster Pfizer latanoprost product.
Conclusion
From the time Regeneron began clinically testing EYLEA, it took 10 years to reach approval and another 4 years for the Regeneron stock to explode. If you are a biotech investor taking small positions looking for the next Regeneron, there is of course no guarantee by any means that pSivida will be that company. But its focus on the same niche of opthalmics, its collaboration with Big Pharma, and its fourth generation Tethadur technology could, 8-10 years from now, conceivably bring the company to that level, if Tethadur and its Pfizer collaboration both succeed.
And if more modest, short-to-medium term gains are what you're looking for, then watch out for any FDA word on the way forward for Medidur, as an official FDA letter requiring only one phase 3 trial could have a big effect on pSivida's stock.
Trading Spotlight
Entschuldigung wollte eigentlich das reinstellen
http://seekingalpha.com/article/3135676-psivida-moores-law-p…
http://seekingalpha.com/article/3135676-psivida-moores-law-p…
Antwort auf Beitrag Nr.: 49.705.383 von lson3 am 04.05.15 18:25:26http://seekingalpha.com/article/3135676-psivida-moores-law-p…
Ich wollte eigentlich den Link reinsetzen, aber als der Editor immer wieder nach dem antippen verschwand, habe ich abgebrochen. Dass der Beitrag trotzdem reingestellt wurde habe ich erst heute morgen gesehen.
Habt ihr auch solche Probleme mit den Editor. Mir ist es schon ein paar mal passiert.
http://seekingalpha.com/article/3135676-psivida-moores-law-p…
Habt ihr auch solche Probleme mit den Editor. Mir ist es schon ein paar mal passiert.
http://seekingalpha.com/article/3135676-psivida-moores-law-p…
Antwort auf Beitrag Nr.: 49.635.365 von binda am 24.04.15 10:31:36
Da lag er ja gar nicht so schlecht. Der Q1 für Alimera ist raus:
http://www.sec.gov/Archives/edgar/data/1267602/0001267602150…
Net revenue increased by approximately $1.8 million, or 86%, to $3.9 million for the first quarter of 2015, compared to net revenue of $2.1 million in the first quarter of 2014. This increase was primarily driven by U.S. sales of ILUVIEN of $2.4 million following the U.S. launch in February 2015, offset by a decrease in sales in Germany
Zitat von binda: Sollte Alimera wirklich so gut verdienen, wie dieser Analyst ( Herr One) glaubt, dann kann das für Psivida nur gut sein. Immerhin sind sie am Umsatz von Iluvien beteiligt.
- Alimera Sciences Inc. -- Alimera Sciences bereitet die Veröffentlichung seiner Ergebnisse für das am 31. März 2015 beendete Geschäftsquartal am 6. Mai 2015 vor und Thomson One schätzt, dass das Unternehmen einen Umsatz von 3,9 Millionen USD in dem Quartal melden wird. Den kompletten Research-Bericht über Alimera Sciences Inc. können Sie kostenlos herunterladen auf: http://register.performancefinancial.de/ de/?c=Alimera%20Sciences&d=24-Apr-2015&s=US0162591038 --
Da lag er ja gar nicht so schlecht. Der Q1 für Alimera ist raus:
http://www.sec.gov/Archives/edgar/data/1267602/0001267602150…
Net revenue increased by approximately $1.8 million, or 86%, to $3.9 million for the first quarter of 2015, compared to net revenue of $2.1 million in the first quarter of 2014. This increase was primarily driven by U.S. sales of ILUVIEN of $2.4 million following the U.S. launch in February 2015, offset by a decrease in sales in Germany
Dan Myers, president and chief executive officer of Alimera commented, “We launched ILUVIEN in the U.S. in the first quarter and our U.S. sales of ILUVIEN contributed over half of our total sales, demonstrating the significance of the U.S. market to our business.
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