EyePoint Pharmaceuticals (vorher: PSIVIDA) startet durch !! (Seite 209)

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[wonner]

WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ:PSDV - News), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced today that the U.S. Food and Drug Administration (FDA) acknowledged receipt of the resubmission of the New Drug Application (NDA) for ILUVIEN® for treatment of chronic diabetic macular edema (DME) and stated that the resubmission was considered a complete, class 2 response to the FDA's November 2011 complete response letter. The new Prescription Drug User Fee Act (PDUFA) goal date is October 17, 2013.

pSivida's licensee Alimera Sciences reported that in the resubmission it responded to the FDA's complete response letter and provided additional analyses as well as new information to support that ILUVIEN is safe and effective in the treatment of patients with chronic DME.

Using data from Alimera's two completed pivotal Phase 3 clinical trials (collectively the FAME™ Study), the resubmission focused on the safety aspects of ILUVIEN and the subgroup population of patients with chronic DME, the same subgroup for which marketing approval for ILUVIEN has been granted in six countries in the European Union. Additionally, Alimera reported that data was submitted from the completed physician utilization study for the ILUVIEN applicator and from a special reading center assessment of photographs of the fundus, or interior surface of the eye, which were collected during the FAME™ Study.

At month 36, the treatment effect for the chronic DME subgroup (i.e. the difference in the proportion of 15 Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart letter responders between ILUVIEN and the sham control) was more than twice that seen for the overall population. Given that the risks associated with the chronic DME subgroup are similar to the risks in the overall population, Alimera reported its belief that the benefit to risk for this subgroup is optimized with ILUVIEN treatment.

Alimera further reported its belief that the FDA resubmission package includes important new information that demonstrates the safety and efficacy of ILUVIEN for patients suffering from chronic DME and that a clearer positioning now exists for ILUVIEN in the treatment of patients with chronic DME since a first-line pharmacotherapy for DME was approved by the FDA last year.

"We are very pleased with the FDA's acceptance of the resubmission of the NDA and the new PDUFA date for ILUVIEN," said Dr. Paul Ashton, President and CEO of pSivida Corp. "If the FDA approves ILUVIEN, we would be entitled to an additional $25 million milestone payment from Alimera as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera. We are entitled to the same net profit share on sales of ILUVIEN for DME by Alimera in the EU, where Alimera has already launched in the UK and reported plans to launch in Germany in 2013."

[N424671]

Antwort auf Beitrag Nr.: 44.534.317 von wuenschmirwas am 29.04.13 18:37:43

Alimera verkauft neu das geprüfte Produkt von pSivida in England und pSivida ist in Amerika bekannter als Alimera. Die Patente von pSivida haben viel mehr Chancen irgendwann gross herauszukommen.

Das ist eine "Statistische" Erklärung

[wuenschmirwas]

Kann irgend jemand die beiden Ausreißer bei Psivida und Alimera erklären?

Psivida 631990 St. zu 2,25 $
Alimera 12560 St. zu 2,87 $

Ausreißer von dem Volumen her gemeint.
Bei den Mengen müßte es doch eine wesentlich größere Kursbewegung geben.
http://www.nasdaq.com/symbol/psdv/real-time

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Alimera reported that the NICE Appraisal Committee is scheduled to meet on May 15, 2013 to discuss the ILUVIEN PAS submission with an expected 30-day review period to follow.

[wonner]

WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ:PSDV; ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced ILUVIEN® , the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema (DME), is now available in the UK for treatment of private pay and privately insured patients, as reported by its licensee, Alimera Sciences.

Alimera also reported that it has recently submitted a simple Patient Access Scheme (PAS) to the United Kingdom's National Institute for Health and Care Excellence (NICE) for consideration of the guidance under rapid review. The NICE Appraisal Committee will assess the likely impact of the ILUVIEN PAS and determine whether an update to NICE's previously issued final guidance is warranted, according to Alimera. If the PAS is accepted by NICE, Alimera further reported that ILUVIEN would be funded for chronic DME patients in England and Wales through the National Health Service (NHS). Alimera reported that the NICE Appraisal Committee is scheduled to meet on May 15, 2013 to discuss the ILUVIEN PAS submission with an expected 30-day review period to follow.

"We are pleased that ILUVIEN is now available in the UK," said Dr. Paul Ashton, pSivida president and CEO. "This marks the first availability of a sustained release therapy for patients who suffer from DME and who have not responded to conventional therapies. We believe it provides a welcome additional treatment option for retinal specialists in the UK treating private pay and privately insured patients. We are hopeful that the Patient Access Scheme will be approved and make ILUVIEN available to a larger group of chronic DME patients who are considered insufficiently responsive to available therapies."

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Zitat von wonner: http://seekingalpha.com/article/1364741-for-iluvien-the-fda-isn-t-the-issue-european-sales-are?source=yahoo

Zitat:
....

"The way I see it, investors overreacted to the latest FDA rejection, and this presents a buying opportunity. Why? The answer is Lucentis. Lucentis is Iluvien's competitor drug marketed in Europe by Novartis (NVS). Lucentis sales in 2012 were $2.4B (page 114), making Lucentis Novartis' third biggest blockbuster. Zero of that blockbuster figure came from the US. Granted, much of it comes from wet macular degeneration treatment rather than DME, much less chronic DME, but since Iluvien is approved in the EU for patients that do not respond to Lucentis, sales could be quite healthy. Besides, pSivida and Alimera combined are 8.29 x 10-4 times the size of Novartis, so they don't need anything close to $2.4B annual sales to justify and vastly increase their market caps.

PSDV and ALIM may drop down further if the FDA rejects Iluvien yet again, so don't buy assuming that approval is in the bag because of the "chronic" thing. But if they do drop down it will be even more of a buying opportunity, as sales from Europe should start coming in this year and if successful, investors will wake up and forget about the FDA, and the stocks will come snapping back, probably to pre-November 2011 levels."

[wonner]

http://seekingalpha.com/article/1364741-for-iluvien-the-fda-…

[N424671]

http://www.thechairmansblog.com/paul-ashton/2013-04/transfor…

Das ist natürlich ein stolzer Verkaufspreis, aber frühzeitig für Krebs örtlich injektiert ohne Nebenwirkungen für andere Organe ev. kaufenswert.

[wonner]

Antwort auf Beitrag Nr.: 44.458.799 von wonner am 18.04.13 11:48:58

http://www.thechairmansblog.com/paul-ashton/2013-04/transfor…