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Noch ne Nachricht von Alimera:
Frankreich hat Europäische Zulassung bestätigt.
July 18, 2012
pSivida Corp. Announces France Grants ILUVIEN® Marketing Authorization for the Treatment of Chronic Diabetic Macular Edema
WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the National Security Agency of Medicines and Health Products (L'Agence Nationale de Sécurité du Médicament et des Produits de Santé) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
This marketing authorization follows the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State (RMS), delivered a positive outcome for ILUVIEN along with six Concerned Members States (CMS), specifically Austria, France, Germany, Italy, Portugal and Spain. The French authorization is the fourth national approval in the EU, preceded by Austria, Portugal and the UK.
"We are pleased our product has received marketing authorization in France. We now have marketing authorization in four of the seven targeted EU countries," said Dr. Paul Ashton, president and chief executive officer of pSivida. "We look forward to ILUVIEN receiving approval in the three remaining CMS countries, Germany, Italy and Spain, in the coming months."
The International Diabetes Federation estimates that more than 4,300,000 people are currently living with diabetes in France, and according to Alimera's estimates, more than 220,500 people suffer from vision loss associated with DME.
ILUVIEN is an injectable, sustained-release intravitreal insert that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. pSivida is developing an insert of the same design for the treatment of uveitis affecting the posterior of the eye.
Nun für uns Psividianer sind beides gute Nachrichten. Die erste Nachricht garantiert einen solventen Partner und die zweite ist ein weiterer Schritt auf dem europäischen Markt. Fehlen noch Deutschland, Italien und Spanien.
Dass den Alimera-Aktionären die erste Nachricht nicht so schmeckt, sieht man am Kursverlauf. Eine Kapitalerhöhung ist meistens nicht gut für den Kurs.
Frankreich hat Europäische Zulassung bestätigt.
July 18, 2012
pSivida Corp. Announces France Grants ILUVIEN® Marketing Authorization for the Treatment of Chronic Diabetic Macular Edema
WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the National Security Agency of Medicines and Health Products (L'Agence Nationale de Sécurité du Médicament et des Produits de Santé) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
This marketing authorization follows the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State (RMS), delivered a positive outcome for ILUVIEN along with six Concerned Members States (CMS), specifically Austria, France, Germany, Italy, Portugal and Spain. The French authorization is the fourth national approval in the EU, preceded by Austria, Portugal and the UK.
"We are pleased our product has received marketing authorization in France. We now have marketing authorization in four of the seven targeted EU countries," said Dr. Paul Ashton, president and chief executive officer of pSivida. "We look forward to ILUVIEN receiving approval in the three remaining CMS countries, Germany, Italy and Spain, in the coming months."
The International Diabetes Federation estimates that more than 4,300,000 people are currently living with diabetes in France, and according to Alimera's estimates, more than 220,500 people suffer from vision loss associated with DME.
ILUVIEN is an injectable, sustained-release intravitreal insert that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. pSivida is developing an insert of the same design for the treatment of uveitis affecting the posterior of the eye.
Nun für uns Psividianer sind beides gute Nachrichten. Die erste Nachricht garantiert einen solventen Partner und die zweite ist ein weiterer Schritt auf dem europäischen Markt. Fehlen noch Deutschland, Italien und Spanien.
Dass den Alimera-Aktionären die erste Nachricht nicht so schmeckt, sieht man am Kursverlauf. Eine Kapitalerhöhung ist meistens nicht gut für den Kurs.
Neueste Nachrichten über Alimera.
http://investors.psivida.com/releasedetail.cfm?ReleaseID=692…
Noch mehr Info#´s und neueste Studie über Illuvien und Europa über die Hompa von Alimera Sience
http://investors.psivida.com/releasedetail.cfm?ReleaseID=692…
Noch mehr Info#´s und neueste Studie über Illuvien und Europa über die Hompa von Alimera Sience
Antwort auf Beitrag Nr.: 43.373.768 von nanotechnolog am 11.07.12 13:03:48Schon ein paar Tage alt, aber gut.
By Scott Matusow, Contributor
Wednesday, 27 June 2012 00:00
This small cap company looks very interesting as a long term speculative buy. We asked the CEO of the company some questions as part of our standard Due Diligence and later in this article, you will find the answers provided by CEO, Dr. Paul Ashton
The following is a question and answer session with Dr. Paul Ashton. I asked the standard questions I normally do when I am considering making an investment in a small cap growth company.
Scott: Hello Dr. Ashton, thank you for taking the time to answer my questions for Seeking Alpha readers.
Dr. Ashton: You are welcome Scott.
1. Where do you feel the true value in your company is where Investors should focus on?
2. I notice you have established a nice royalty base, do you plan to use this revenue to reinvest into the future of the company?
3. What do you find is the toughest challenge for a small company like yours to overcome?
4. While we know predicting the future is hard and many factors are uncertain, but where would you like to see the company in say, 5 years from now? What is the mission goal of the company in that time frame?
5. Do you feel your company has what it takes to eventually market your top line products on your own, is that your ultimate goal; using royalty revenue to eventually attempt to become a top line company?
Dr. Ashton's answers below in sequential order:
1. I think there is a lot of focus on Iluvien for Diabetic macular edema and appropriately so, however people may be overlooking the real upside.
1a. Our program in posterior uveitis (3rd largest cause of blindness in the US). In uveitis we are planning to develop an injectable implant delivering the steroid Fluocinolone acetonide. This is the exact same implant already successfully reviewed by the EU regulators for DME but rejected by the FDA. Why are we so confident? This insert delivers the exact same drug as Retisert (already approved by the FDA), the new inserts are injectable while Retisert is surgically inserted and the side effect profile of the new inserts is significantly better than that of Retisert. Also we can develop this product ourselves. Also based on our discussions with the FDA we believe we can proceed directly to phase iii clinical trials with these devices, referencing all the data from the DME application (a BIG time/money saver).
1b. The glaucoma program hasn't received any attention. This is another low risk, high reward opportunity. We are using a bio-erodible version of the Durasert technology (that underlies the Iluvien device) to deliver latanoprost, Pfizer's billion dollar glaucoma drug until the patent expired. So, it's an effective drug with a proven delivery system going after a very large market opportunity. It's in early clinical trials but as clinical data emerges I think it will get more attention.
1c. It's becoming increasingly apparent (see Alcon's (ACL) recent failure of a topical drug for geographic atrophy (a form of dry-AMD) Allergan's (AGN) failure of an oral for glaucoma,) that a drug delivery system is needed to treat back of the eye diseases. We are the only company with a proven back of the eye delivery technology
Dr. Ashton: Sorry that's a long answer, but we have a lot going on!
Scott: Understandable, I think as much detail as possible for investors to consider is a good thing.
2. Yes, historically we have used our royalties and cash from license fees etc to minimize our cash burn.
3. One of the biggest challenges we have is getting on the radar screen of investors. We have a couple of approved products earning royalties, a product pending marketing authorization in EU, we expect to have phase 3 ready product for uveitis very shortly and a glaucoma product already in the clinic. That seems pretty compelling to me, certainly better than many companies with a much higher market cap. I've been told many times "if your market cap was higher you would be worth more".
4. We are planning to evolve into a specialty pharma focused on ophthalmology. We plan to develop some of our own products (like for uveitis) and work with partners to develop others.
Dr. Ashton: We plan to out-license non-ophthalmic applications of our technologies.
5. We have the best technology and we are fortunate in that we are going after a new area (diseases of the back of the eye) where none of the big guys has a dominant position in the market. Also the back of the eye space can be addressed with a small sales force, there are only 1,500 retina specialists in the US. However this space now has the attention of a lot of the big players (Merck (MRK), Roche,(RHHBY.PK) Glaxo Smith Kline (GSK) etc) and there is a lot of consolidation, so I'd imagine that we'd likely be acquired before we get there. We are not planning this, but it seems to be the way things sometimes work.
Scott: Thank you Dr. Ashton for taking the time to answer my questions.
Dr.Ashton: You are welcome Scott.
Key points in my opinion why pSivida has a legit shot to become a larger cap company over time in my opinion:
Very low cash burn rate; about two million a quarter. The company tries to have agreements (evaluation agreements and license agreements) basically cover their costs on their programs.
Nice capital structure; only about 20 million shares outstanding with an additional 5 million warrants and those are going down as groups of them expire. No debt. Cash that takes them with present programs through 2013.
Opthalmology is a big area of interest as the population ages; take into account the success of Lucentis, which was developed by Genentech and is marketed in the United States by Genentech and elsewhere by Novartis (NVS). Also Regeneron's (REGN) eElea is having great success.
Technologies that while obviously are for opthalmology now are adaptable for other parts of the body. (There is currently an evaluation agreement with the Hospital for Special Surgery in NYC for example, and their focus is orthopaedics). The uveitis program and the bioerodible version of the underlying technology of Iluvien for glaucoma with Pfizer (Pfizer is the second largest shareholder with about eight percent and have held the shares since 2007).
Since Pfizer already owns around 7% of the company's stock, pSivida is an acquisition target for them in my opinion. How strong of an acquisition target I really do not know.
Final opinion and price target opinions:
I see a short term move to near $2.75-$3.00 setting up for the short term. I also see a catalyst run up occurring as Alimera gets closer to 3 more EU countries marketing approval for ILUVIEN. A move to $5 a share by the end of the year is not out of the question. Where the price goes from there will be dependent on many factors including what Pfizer decides to do with its arrangement with pSivida. I like the CEO here as his team wiped off all the toxic financing the prior management left for them. Dr. Ashton is straight forward and to the point. Again, having top management in a small cap company is the number one key in determining future success of the company. It is my opinion pSivida is a strong long term buy and hold for investors who wish to be patient and wait for large long term gains.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
By Scott Matusow, Contributor
Wednesday, 27 June 2012 00:00
This small cap company looks very interesting as a long term speculative buy. We asked the CEO of the company some questions as part of our standard Due Diligence and later in this article, you will find the answers provided by CEO, Dr. Paul Ashton
The following is a question and answer session with Dr. Paul Ashton. I asked the standard questions I normally do when I am considering making an investment in a small cap growth company.
Scott: Hello Dr. Ashton, thank you for taking the time to answer my questions for Seeking Alpha readers.
Dr. Ashton: You are welcome Scott.
1. Where do you feel the true value in your company is where Investors should focus on?
2. I notice you have established a nice royalty base, do you plan to use this revenue to reinvest into the future of the company?
3. What do you find is the toughest challenge for a small company like yours to overcome?
4. While we know predicting the future is hard and many factors are uncertain, but where would you like to see the company in say, 5 years from now? What is the mission goal of the company in that time frame?
5. Do you feel your company has what it takes to eventually market your top line products on your own, is that your ultimate goal; using royalty revenue to eventually attempt to become a top line company?
Dr. Ashton's answers below in sequential order:
1. I think there is a lot of focus on Iluvien for Diabetic macular edema and appropriately so, however people may be overlooking the real upside.
1a. Our program in posterior uveitis (3rd largest cause of blindness in the US). In uveitis we are planning to develop an injectable implant delivering the steroid Fluocinolone acetonide. This is the exact same implant already successfully reviewed by the EU regulators for DME but rejected by the FDA. Why are we so confident? This insert delivers the exact same drug as Retisert (already approved by the FDA), the new inserts are injectable while Retisert is surgically inserted and the side effect profile of the new inserts is significantly better than that of Retisert. Also we can develop this product ourselves. Also based on our discussions with the FDA we believe we can proceed directly to phase iii clinical trials with these devices, referencing all the data from the DME application (a BIG time/money saver).
1b. The glaucoma program hasn't received any attention. This is another low risk, high reward opportunity. We are using a bio-erodible version of the Durasert technology (that underlies the Iluvien device) to deliver latanoprost, Pfizer's billion dollar glaucoma drug until the patent expired. So, it's an effective drug with a proven delivery system going after a very large market opportunity. It's in early clinical trials but as clinical data emerges I think it will get more attention.
1c. It's becoming increasingly apparent (see Alcon's (ACL) recent failure of a topical drug for geographic atrophy (a form of dry-AMD) Allergan's (AGN) failure of an oral for glaucoma,) that a drug delivery system is needed to treat back of the eye diseases. We are the only company with a proven back of the eye delivery technology
Dr. Ashton: Sorry that's a long answer, but we have a lot going on!
Scott: Understandable, I think as much detail as possible for investors to consider is a good thing.
2. Yes, historically we have used our royalties and cash from license fees etc to minimize our cash burn.
3. One of the biggest challenges we have is getting on the radar screen of investors. We have a couple of approved products earning royalties, a product pending marketing authorization in EU, we expect to have phase 3 ready product for uveitis very shortly and a glaucoma product already in the clinic. That seems pretty compelling to me, certainly better than many companies with a much higher market cap. I've been told many times "if your market cap was higher you would be worth more".
4. We are planning to evolve into a specialty pharma focused on ophthalmology. We plan to develop some of our own products (like for uveitis) and work with partners to develop others.
Dr. Ashton: We plan to out-license non-ophthalmic applications of our technologies.
5. We have the best technology and we are fortunate in that we are going after a new area (diseases of the back of the eye) where none of the big guys has a dominant position in the market. Also the back of the eye space can be addressed with a small sales force, there are only 1,500 retina specialists in the US. However this space now has the attention of a lot of the big players (Merck (MRK), Roche,(RHHBY.PK) Glaxo Smith Kline (GSK) etc) and there is a lot of consolidation, so I'd imagine that we'd likely be acquired before we get there. We are not planning this, but it seems to be the way things sometimes work.
Scott: Thank you Dr. Ashton for taking the time to answer my questions.
Dr.Ashton: You are welcome Scott.
Key points in my opinion why pSivida has a legit shot to become a larger cap company over time in my opinion:
Very low cash burn rate; about two million a quarter. The company tries to have agreements (evaluation agreements and license agreements) basically cover their costs on their programs.
Nice capital structure; only about 20 million shares outstanding with an additional 5 million warrants and those are going down as groups of them expire. No debt. Cash that takes them with present programs through 2013.
Opthalmology is a big area of interest as the population ages; take into account the success of Lucentis, which was developed by Genentech and is marketed in the United States by Genentech and elsewhere by Novartis (NVS). Also Regeneron's (REGN) eElea is having great success.
Technologies that while obviously are for opthalmology now are adaptable for other parts of the body. (There is currently an evaluation agreement with the Hospital for Special Surgery in NYC for example, and their focus is orthopaedics). The uveitis program and the bioerodible version of the underlying technology of Iluvien for glaucoma with Pfizer (Pfizer is the second largest shareholder with about eight percent and have held the shares since 2007).
Since Pfizer already owns around 7% of the company's stock, pSivida is an acquisition target for them in my opinion. How strong of an acquisition target I really do not know.
Final opinion and price target opinions:
I see a short term move to near $2.75-$3.00 setting up for the short term. I also see a catalyst run up occurring as Alimera gets closer to 3 more EU countries marketing approval for ILUVIEN. A move to $5 a share by the end of the year is not out of the question. Where the price goes from there will be dependent on many factors including what Pfizer decides to do with its arrangement with pSivida. I like the CEO here as his team wiped off all the toxic financing the prior management left for them. Dr. Ashton is straight forward and to the point. Again, having top management in a small cap company is the number one key in determining future success of the company. It is my opinion pSivida is a strong long term buy and hold for investors who wish to be patient and wait for large long term gains.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Trading Spotlight
Hier die neueste Meldung von Psivida. Anschließend in Deutsch aus der Übersetzungsmaschine.
Meiner Meinung aber auch nicht der Auslöser für den Kurssprung.
Ich denke eher, dass irgend ein Investor sich einkaufen möchte. Aber nur eine Vermutung.
http://investors.psivida.com/releasedetail.cfm?ReleaseID=687…
pSivida Corp kündigt Einschreibung der ersten Patienten in
Uveitis Testversion
Watertown, MA - (BUSINESS WIRE) - pSivida
Corp (NASDAQ: PSDV) (ASX: PVA), ein führendes Unternehmen in
Entwicklung verzögerter Freisetzung, Drug-Delivery-Produkte für
Behandlung von Rücken-of-the-Augen-Erkrankungen, gab heute bekannt,
die Aufnahme des ersten Patienten in einer Prüfarzt-
gesponsert klinischen Studie seiner injizierbaren verzögerter Freisetzung
Gerät im posterioren Uveitis.
"Wir sind sehr erfreut, dass der erste Patient wurde
in diese Studie ", sagte Dr. Ashton, Präsident und
CEO von pSivida. "Dieser Versuch, in den USA durchgeführt, wird
Studie die Verwendung von injizierbaren Mikroeinsätze zu behandeln
hintere Uveitis, einem häufig blendenden Krankheit. Diese
gleichen Einsätze haben vor kurzem in mehreren EU zugelassen
Ländern für die Behandlung von chronischen diabetischen Makula-
Ödeme und wird es von unserem Partner vermarktet werden
Alimera Sciences. Wir sind jetzt unabhängig voneinander entwickeln
die gleichen Geräte für den Einsatz im posterioren Uveitis. "
Der Einsatz ist eine kleine Röhre, die etwa die Größe eines ist
Wimpern mit dem Steroid Fluocinolonacetonid
, das mit einer konsistenten Rate über einen Zeitraum von Freigabe
ca. 36 Monate. Die Mikro-Einsatz wird in plaziert
die Rückseite des Auges während einer Reise durch das Büro
Verwendung von einer feinen Nadel. Hintere Uveitis ist eine
entzündliche Erkrankung eine der Schichten des Auges. Es
wird geschätzt, dass die drittgrößte Ursache für Erblindung in sein
die USA und betrifft etwa 175.000 Menschen, von denen
rund 30.000 sind blind.
Meiner Meinung aber auch nicht der Auslöser für den Kurssprung.
Ich denke eher, dass irgend ein Investor sich einkaufen möchte. Aber nur eine Vermutung.
http://investors.psivida.com/releasedetail.cfm?ReleaseID=687…
pSivida Corp kündigt Einschreibung der ersten Patienten in
Uveitis Testversion
Watertown, MA - (BUSINESS WIRE) - pSivida
Corp (NASDAQ: PSDV) (ASX: PVA), ein führendes Unternehmen in
Entwicklung verzögerter Freisetzung, Drug-Delivery-Produkte für
Behandlung von Rücken-of-the-Augen-Erkrankungen, gab heute bekannt,
die Aufnahme des ersten Patienten in einer Prüfarzt-
gesponsert klinischen Studie seiner injizierbaren verzögerter Freisetzung
Gerät im posterioren Uveitis.
"Wir sind sehr erfreut, dass der erste Patient wurde
in diese Studie ", sagte Dr. Ashton, Präsident und
CEO von pSivida. "Dieser Versuch, in den USA durchgeführt, wird
Studie die Verwendung von injizierbaren Mikroeinsätze zu behandeln
hintere Uveitis, einem häufig blendenden Krankheit. Diese
gleichen Einsätze haben vor kurzem in mehreren EU zugelassen
Ländern für die Behandlung von chronischen diabetischen Makula-
Ödeme und wird es von unserem Partner vermarktet werden
Alimera Sciences. Wir sind jetzt unabhängig voneinander entwickeln
die gleichen Geräte für den Einsatz im posterioren Uveitis. "
Der Einsatz ist eine kleine Röhre, die etwa die Größe eines ist
Wimpern mit dem Steroid Fluocinolonacetonid
, das mit einer konsistenten Rate über einen Zeitraum von Freigabe
ca. 36 Monate. Die Mikro-Einsatz wird in plaziert
die Rückseite des Auges während einer Reise durch das Büro
Verwendung von einer feinen Nadel. Hintere Uveitis ist eine
entzündliche Erkrankung eine der Schichten des Auges. Es
wird geschätzt, dass die drittgrößte Ursache für Erblindung in sein
die USA und betrifft etwa 175.000 Menschen, von denen
rund 30.000 sind blind.
Antwort auf Beitrag Nr.: 43.331.446 von binda am 28.06.12 15:31:02na, die kleine weiß aber heute nicht wo sie hin will
Im premarket sieht es ja schon ganz gut aus.
2,54 $
2,54 $
Antwort auf Beitrag Nr.: 43.331.232 von N424671 am 28.06.12 14:46:38Zwischen "Erwartungen" und Deinem Satz " die haben wieder ein Land dazu bekommem", ist aber ein großer Unterschied.
Bisher gab es von Psivida immer unverzüglich eine PR , wenn ein weiteres Land dazu kam, deshalb glaube ich nicht, dass das jetzt ohne Meldung geschehen sein soll.
Gruß binda
Bisher gab es von Psivida immer unverzüglich eine PR , wenn ein weiteres Land dazu kam, deshalb glaube ich nicht, dass das jetzt ohne Meldung geschehen sein soll.
Gruß binda
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