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ISIN: AU000000PVA7 · WKN: A0Q4DA
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aa:
Also, noch kein Erfolg in Aussicht.
Also, noch kein Erfolg in Aussicht.
Zitat von wonner: Antwort auf die Frage wie erfolgreich diese Aktion sein kann.
We don’t know if it will be successful or not – what we do know is that if/when the FDA accepts the submission they will assign the PDUFA date (normally six months) and then we’ll know – one would think that after meeting with the FDA Alimera has some better idea of what it might take to get approval – but then, it’s Alimera’s business – we are the licensee and will reap benefits if approved, but we have absolutely no control on how they conduct themselves with the FDA.
Best,
we are the licensee and will reap benefits if approved, but we have absolutely no control on how they conduct themselves with the FDA.
Antwort auf Beitrag Nr.: 44.340.067 von wonner am 01.04.13 16:37:47Antwort auf die Frage wie erfolgreich diese Aktion sein kann.
We don’t know if it will be successful or not – what we do know is that if/when the FDA accepts the submission they will assign the PDUFA date (normally six months) and then we’ll know – one would think that after meeting with the FDA Alimera has some better idea of what it might take to get approval – but then, it’s Alimera’s business – we are the licensee and will reap benefits if approved, but we have absolutely no control on how they conduct themselves with the FDA.
Best,
We don’t know if it will be successful or not – what we do know is that if/when the FDA accepts the submission they will assign the PDUFA date (normally six months) and then we’ll know – one would think that after meeting with the FDA Alimera has some better idea of what it might take to get approval – but then, it’s Alimera’s business – we are the licensee and will reap benefits if approved, but we have absolutely no control on how they conduct themselves with the FDA.
Best,
pSivida Corp. (PSDV)(PVA.AX), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported the submission of its response to the second Complete Response Letter from the U.S. Food and Drug Administration (FDA) with respect to ILUVIEN® for chronic diabetic macular edema (DME).
Alimera reported in its 10-K filing that it submitted the response, which includes additional analyses of the risks and benefits of ILUVIEN based on the clinical data available from the previously completed Phase III studies (FAME), following a meeting with the FDA in the second quarter 2012. Alimera said that the resubmission focuses on the safety aspects of ILUVIEN and the population of patients with chronic DME. This is the same group for which marketing approval of ILUVIEN has been granted in six EU countries thus far. Alimera reported that it will communicate the Prescription Drug User Fee Act (PDUFA) date once it is known from the FDA and that Alimera does not plan to conduct additional trials for ILUVIEN for DME at this time.
“We are pleased to see the resubmission of the NDA to the FDA,” said Dr. Paul Ashton, president and CEO of pSivida Corp. “To date, we have received over $30m from Alimera from its license of ILUVIEN for DME, and if the FDA approves ILUVIEN, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera.”
pSivida is entitled to the same net profit share on sales of ILUVIEN for DME by Alimera in the EU. Alimera has announced its intent to commercially launch ILUVIEN in Germany and for private patients in the UK in the second quarter of 2013, upon approval of the commercial batch size.
About pSivida Corp.
Alimera reported in its 10-K filing that it submitted the response, which includes additional analyses of the risks and benefits of ILUVIEN based on the clinical data available from the previously completed Phase III studies (FAME), following a meeting with the FDA in the second quarter 2012. Alimera said that the resubmission focuses on the safety aspects of ILUVIEN and the population of patients with chronic DME. This is the same group for which marketing approval of ILUVIEN has been granted in six EU countries thus far. Alimera reported that it will communicate the Prescription Drug User Fee Act (PDUFA) date once it is known from the FDA and that Alimera does not plan to conduct additional trials for ILUVIEN for DME at this time.
“We are pleased to see the resubmission of the NDA to the FDA,” said Dr. Paul Ashton, president and CEO of pSivida Corp. “To date, we have received over $30m from Alimera from its license of ILUVIEN for DME, and if the FDA approves ILUVIEN, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera.”
pSivida is entitled to the same net profit share on sales of ILUVIEN for DME by Alimera in the EU. Alimera has announced its intent to commercially launch ILUVIEN in Germany and for private patients in the UK in the second quarter of 2013, upon approval of the commercial batch size.
About pSivida Corp.
Im Durchschnitt dauert es über 13 Jahre, um ein neues Medikament zu entwickeln. Von 20.000 neuen Wirkstoffkandidaten ist die Genehmigungszeit aufwendig und die durchschnittlichen Kosten belaufen sich weit über $ 1 Milliarde pro erfolgreich eingeführtem Medikament. Die Idee von pSivida ist das Medikament vom Arzt direkt eingeführt mit ca. 3 Jahre Wirkung.
Die Idee ist gut.
Die Idee ist gut.
Trading Spotlight
Paul hat einen Blog aufgemacht.
The Pharma world is all about innovation: new treatments, better treatments and methods that transform the way diseases are treated. Innovations that achieve this transformational change in therapy are what drive research, and can be massively profitable.
Developing new drugs to achieve transformational change, Big Pharma’s traditional path, is very time consuming, risky and expensive. On average it takes over 13 years to develop a new drug, fewer than 1 in 20,000 new drug candidates ever make it to approval and the average cost is well over $1 billion. Fewer than 25% of approved drugs even cover their own development costs. New drug discovery is a daunting undertaking, but when successful the rewards for drugs that provide transformational change can be huge.
There is another way to achieve this: Strategic Drug Delivery.
Strategic Drug Delivery companies can make products that provide transformative change AND make money. They can also do it at fractions of the time, risk and cost of developing a new drug molecule. Strategic Drug Delivery looks for the therapeutic gaps in clinical practice and applies currently available drugs plus new delivery technology to fill those gaps and to create transformational change. You can consider it as a mathematical equation
Therapy Gap + (Current Drug X Technology) = Transformational Change
Take away anything on the left of the equation and it’s hard to achieve the right of the equation.
A great example of Strategic Drug Delivery is Concerta. Before Concerta ADHD therapy wasn’t much good, pills needed to be taken 3 times a day, something children find hard to do when they are at school. A once a day sustained release pill that the parents could give at breakfast was a game changer and a multi-billion dollar product (Concerta). Therapy Gap + (Current Drug X Technology) = Transformational Change. Alza, the maker of Concerta, was subsequently acquired by JNJ for over $10B.
pSivida is a Strategic Drug Delivery Company with a history of not only coming up with products that provide Transformational Change, but also of getting them approved. Our main focus is on ophthalmology and diseases of the back of the eye. That’s where there are a lot of therapy gaps. Many eye diseases, many drugs that potentially work, and no convenient way to get them to the back of the eye. The two leading drugs for eye disease right now (Eylea and Lucentis sharing a $4 billion+ market) have to be injected into the eye every 1-2 months…..indefinitely.
We make sustained delivery systems that provide Transformational Change for the treatment of blinding eye diseases.
Our first product Vitrasert (partnered with Bausch and Lomb) was the first FDA approved drug for a back of the eye disease. This implantable device releases an anti-viral to treat CMV retinitis, a blinding AIDS associate disease.
Our second approved drug Retisert, partnered Bausch and Lomb and approved by the FDA in 2005, was the first approved therapy for posterior uveitis, a blinding autoimmune disease that’s the third or fourth largest cause of blindness in the developed world.
Our most recent product ILUVIEN (partnered with Alimera Sciences and approved in the EU) is the first long term implant approved for Diabetic macular edema, one of the most common causes of vision loss. This implant is a big step forward. It releases medication for three years after a SINGLE injection. It’s scheduled to go on sale (initially in Germany) at the end of this month. There is a lot of focus on this product and rightly so given its importance for patients (one injection per three years versus an injection every 4-6 weeks) the size of the market (about 1 million in the EU) and the very large economic upside for us (we have received $30m from Alimera thus far and will take a sizable piece of profits.
In my next blog I look forward to updating you on the commercial launch of ILUVEIN, EU pricing and the progress towards US approval, and share my own take on developments in the Pharma World.
The Pharma world is all about innovation: new treatments, better treatments and methods that transform the way diseases are treated. Innovations that achieve this transformational change in therapy are what drive research, and can be massively profitable.
Developing new drugs to achieve transformational change, Big Pharma’s traditional path, is very time consuming, risky and expensive. On average it takes over 13 years to develop a new drug, fewer than 1 in 20,000 new drug candidates ever make it to approval and the average cost is well over $1 billion. Fewer than 25% of approved drugs even cover their own development costs. New drug discovery is a daunting undertaking, but when successful the rewards for drugs that provide transformational change can be huge.
There is another way to achieve this: Strategic Drug Delivery.
Strategic Drug Delivery companies can make products that provide transformative change AND make money. They can also do it at fractions of the time, risk and cost of developing a new drug molecule. Strategic Drug Delivery looks for the therapeutic gaps in clinical practice and applies currently available drugs plus new delivery technology to fill those gaps and to create transformational change. You can consider it as a mathematical equation
Therapy Gap + (Current Drug X Technology) = Transformational Change
Take away anything on the left of the equation and it’s hard to achieve the right of the equation.
A great example of Strategic Drug Delivery is Concerta. Before Concerta ADHD therapy wasn’t much good, pills needed to be taken 3 times a day, something children find hard to do when they are at school. A once a day sustained release pill that the parents could give at breakfast was a game changer and a multi-billion dollar product (Concerta). Therapy Gap + (Current Drug X Technology) = Transformational Change. Alza, the maker of Concerta, was subsequently acquired by JNJ for over $10B.
pSivida is a Strategic Drug Delivery Company with a history of not only coming up with products that provide Transformational Change, but also of getting them approved. Our main focus is on ophthalmology and diseases of the back of the eye. That’s where there are a lot of therapy gaps. Many eye diseases, many drugs that potentially work, and no convenient way to get them to the back of the eye. The two leading drugs for eye disease right now (Eylea and Lucentis sharing a $4 billion+ market) have to be injected into the eye every 1-2 months…..indefinitely.
We make sustained delivery systems that provide Transformational Change for the treatment of blinding eye diseases.
Our first product Vitrasert (partnered with Bausch and Lomb) was the first FDA approved drug for a back of the eye disease. This implantable device releases an anti-viral to treat CMV retinitis, a blinding AIDS associate disease.
Our second approved drug Retisert, partnered Bausch and Lomb and approved by the FDA in 2005, was the first approved therapy for posterior uveitis, a blinding autoimmune disease that’s the third or fourth largest cause of blindness in the developed world.
Our most recent product ILUVIEN (partnered with Alimera Sciences and approved in the EU) is the first long term implant approved for Diabetic macular edema, one of the most common causes of vision loss. This implant is a big step forward. It releases medication for three years after a SINGLE injection. It’s scheduled to go on sale (initially in Germany) at the end of this month. There is a lot of focus on this product and rightly so given its importance for patients (one injection per three years versus an injection every 4-6 weeks) the size of the market (about 1 million in the EU) and the very large economic upside for us (we have received $30m from Alimera thus far and will take a sizable piece of profits.
In my next blog I look forward to updating you on the commercial launch of ILUVEIN, EU pricing and the progress towards US approval, and share my own take on developments in the Pharma World.
Antwort auf Beitrag Nr.: 44.311.707 von Peter_02 am 27.03.13 10:31:30Sorry, kenne pSivida schon 10 Jahre
@ Binda,
N424671 ist nicht im Thema, daher nicht wundern.
N424671 kennt nicht den Unterschied zwischen dem Wirkstoff und dem Spediteur.
Mal abwarten wie die Verkäufe von Iluvien in D so anlaufen.
In 6 Monaten wissen wir mehr.
Ich habe BEV mal gefragt, ob PSIMedica verkauft ist.
Ihre Antwort:
I know that long-term shareholders have been talking about this because of their familiarity with BrachySil. The company decided several years ago that although BrachySil is a very interesting product, the road to approval, etc. would be long, costly and something that management is not as familiar with as they are in the eye space….so a decision was made to try and outlicense the technology to someone else to be able to commercialize it. This release indicates they’ve done that – but management has not released something at our end only because legal has said until the deal closes it would be premature – and while it is agreed, it has not yet closed. Sorry I can’t be more helpful on this one at this point.
pSivida has ABSOLUTELY NOT sold pSiMedica!!!! That is a wholly owned subsidiary of pSivida and frankly is very, very important because it is where the bulk of the Tethadur (based on biosilicon platform) work is being done. Please correct anyone who is thinking this is the case – it is NOT. pSivida media has NOT sold pSiMedica. What they are licensing is only the BrachySil technology (and it is not comparable to Tethadur by the way)
N424671 ist nicht im Thema, daher nicht wundern.
N424671 kennt nicht den Unterschied zwischen dem Wirkstoff und dem Spediteur.
Mal abwarten wie die Verkäufe von Iluvien in D so anlaufen.
In 6 Monaten wissen wir mehr.
Ich habe BEV mal gefragt, ob PSIMedica verkauft ist.
Ihre Antwort:
I know that long-term shareholders have been talking about this because of their familiarity with BrachySil. The company decided several years ago that although BrachySil is a very interesting product, the road to approval, etc. would be long, costly and something that management is not as familiar with as they are in the eye space….so a decision was made to try and outlicense the technology to someone else to be able to commercialize it. This release indicates they’ve done that – but management has not released something at our end only because legal has said until the deal closes it would be premature – and while it is agreed, it has not yet closed. Sorry I can’t be more helpful on this one at this point.
pSivida has ABSOLUTELY NOT sold pSiMedica!!!! That is a wholly owned subsidiary of pSivida and frankly is very, very important because it is where the bulk of the Tethadur (based on biosilicon platform) work is being done. Please correct anyone who is thinking this is the case – it is NOT. pSivida media has NOT sold pSiMedica. What they are licensing is only the BrachySil technology (and it is not comparable to Tethadur by the way)
Zitat von N424671: pSivida ist eine Firma in Australien, die Forschung betreibt für die Medizinaltechnologie.
Alimera sollte das Zeugs dann verkaufen. In Australien haben diese Leute wenig Chancen aber in Amerika könnte das Eine oder das Andere Patent zum Renner werden. Alle Verprechungen waren bis heute "Absichtserklärungen" Für Anleger nicht geeignet und für Zocker auch nicht mehr, denn die Anwendungsmöglichkeiten werden von Roche und Pfizer geklaut, umgewandelt und in Tropfenflaschen angepriesen.
Antwort auf Beitrag Nr.: 44.297.743 von wonner am 25.03.13 18:20:52pSivida ist eine Firma in Australien, die Forschung betreibt für die Medizinaltechnologie.
Alimera sollte das Zeugs dann verkaufen. In Australien haben diese Leute wenig Chancen aber in Amerika könnte das Eine oder das Andere Patent zum Renner werden. Alle Verprechungen waren bis heute "Absichtserklärungen" Für Anleger nicht geeignet und für Zocker auch nicht mehr, denn die Anwendungsmöglichkeiten werden von Roche und Pfizer geklaut, umgewandelt und in Tropfenflaschen angepriesen.
Alimera sollte das Zeugs dann verkaufen. In Australien haben diese Leute wenig Chancen aber in Amerika könnte das Eine oder das Andere Patent zum Renner werden. Alle Verprechungen waren bis heute "Absichtserklärungen" Für Anleger nicht geeignet und für Zocker auch nicht mehr, denn die Anwendungsmöglichkeiten werden von Roche und Pfizer geklaut, umgewandelt und in Tropfenflaschen angepriesen.
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