EyePoint Pharmaceuticals (vorher: PSIVIDA) startet durch !! (Seite 201)

[N424671]

Antwort auf Beitrag Nr.: 44.866.723 von takeProfit am 18.06.13 02:15:22

In April 2012, Matusow quoted Ashton as saying that while “the back of the eye space can be addressed with a small sales force ... this space now has the attention of a lot of the big players 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.”

Possible suitors mentioned include Pfizer Inc. and Bausch & Lomb.

Since the beginning of 2013, pSivida has been on a massive upswing, having nearly tripled in value. As of 2 p.m. Monday, the company’s stock was up more than 9 percent for the day to $3.75.

Related links:Biotech, Watertown
Industries:Technology, Health Care

[takeProfit]

huiii nett heute ... bin heute rein! und gleich ordentlich hoch!

Bin gespannt wo das ding in ein paar Jahren sein wird!

[gogo26]

Heut zieht das Ding aber an!

[N424671]

Die Avastin-Behandlungskosten im Vergleich:

Erstaunlicherweise räumt bei Roche der Teamleiter Oncology Pricing ein, dass der Preis der Kombinationstherapie Herceptin plus Perjeta kaum mehr zu rechtfertigen ist. In der Personalzeitung sagt er: «Wir sind uns bewusst, dass für unsere innovativen biologischen Arzneimittel die aktuelle Methode zur Preiserhebung, die auf der Anzahl benutzter Ampullen beruht, zu Situationen führt, in denen die Gesamtkosten einer Therapie nicht mehr unbedingt mit dem Nutzen übereinstimmen, der dem Patienten geboten wird.» Nun arbeite man mit den Kostenträgern zusammen, um Lösungen zu finden.

Hierzulande ist ein Kompromiss gefunden worden: Roche gewährt einen «Rabatt» von 46 400 Franken, sodass der Preis bei den genannten 160 000 Franken liegt. Es stellt sich allerdings die Frage, wie nachvollziehbar der Verhandlungspreis von 208000 Franken war. Zum Vergleich: Eine bisherige Standardbehandlung kostete 56 700 Franken.

Zur eingangs erwähnten Studie sagt Roche: «Die Studie zeigte klinisch einen klaren Vorteil für die weitergehende Behandlung mit Avastin.» Man sei sich im Übrigen bewusst, dass die Ressourcen im Gesundheitssystem begrenzt seien und effizient eingesetzt werden müssten. «Deswegen gibt es in der Schweiz ein Programm, bei dem die Avastin-Behandlungskosten, beispielsweise bei Brustkrebs, gedeckelt werden.» Doch das Gesundheitssystem gewinnt dadurch nur etwas Luft. Die Fortschritte der Krebsmedizin und damit auch deren Preise greifen auf andere Krankheitsgebiete über.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 44.855.099 von N424671 am 15.06.13 11:28:06

Was ist schon sicher?

[N424671]

Antwort auf Beitrag Nr.: 44.850.367 von Magnetfeldfredy am 14.06.13 13:29:31

Könnte so laufen bin mir aber noch nicht sicher

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 44.849.829 von binda am 14.06.13 12:36:19

Super Meldung für psivida, Erstattung in Sichtweite, Riesenmarkt und im Oktober evt. USA-Zulassung!

[binda]

14.06.2013 | 12:32
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PR Newswire · Mehr Nachrichten von PR Newswire
Alimera Sciences Announces Issuance Of A Positive Appraisal Recommendation On ILUVIEN For Consultation In The United Kingdom
-- Patient Access Scheme meets cost-effectiveness thresholds for subgroup of DME patients

ATLANTA, June 14, 2013 /PRNewswire/ --Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Appraisal Committee of the United Kingdom's National Institute for Health and Care Excellence (NICE) has issued a positive Appraisal Consultation Document (ACD) on ILUVIEN® for the treatment of pseudophakic patients with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. The ACD recommends a change to the published guidance issued by NICE on January 29, 2013, and takes into consideration a simple patient access scheme (PAS) that was submitted by Alimera for rapid review.

The NICE Appraisal Committee has reconfirmed ILUVIEN's clinical effectiveness in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In the ACD, the Appraisal Committee reiterated "that the technology had been shown to meet a clinical need in people whose disease is unresponsive to available therapies."

Additionally, the committee noted that, based on the PAS, the cost-effectiveness threshold has been met for a subgroup of chronic DME patients who are pseudophakic, or have already undergone cataract replacement surgery.

"I am delighted that the Appraisal Committee has reconsidered the NICE guidance on ILUVIEN," said Mr. Winfried Amoaku, an associate professor and consultant ophthalmologist with Nottingham University Hospitals NHS Trust. "Chronic DME patients who are pseudophakic are now one step closer to receiving this crucial sight-saving treatment from the National Health Service. We cannot put a price on eyesight. Anything we can do to treat or prevent vision loss is essential. I welcome the Appraisal Committee's recommendation on the pseudophakic subgroup. It is hoped that NICE will update its recommendation in the fullness of time to allow access for a wider population of people with chronic DME."

"We are pleased with the Appraisal Committee's recommendation to provide access to ILUVIEN for pseudophakic DME patients, which is an important step in making this treatment available. We are optimistic that this ACD will lead to a change in the final published guidance. We believe that ILUVIEN is also effective in other groups of DME patients, and we plan to continue to work with NICE to broaden access to ILUVIEN to include all chronic DME patients who could benefit from the treatment," said Dan Myers, Alimera's president and chief executive officer.

About ILUVIEN®

ILUVIEN (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound.

In July 2010, Alimera submitted a Marketing Authorization Application (MAA) to seven European countries via the Decentralized Procedure (DCP) with the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) serving as the Reference Member State (RMS). The MAA included data from two Phase 3 pivotal clinical trials (collectively known as the FAME' Study) for ILUVIEN conducted by Alimera. The trials involved 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN for the treatment of DME. At the end of the DCP, a consensus was reached by the RMS and the other six countries that the MAA for ILUVIEN was approvable. To date, six of the seven countries, Austria, the United Kingdom, Portugal, France, Spain and Germany have granted national licenses for ILUVIEN. ILUVIEN has not been approved by the United States Food and Drug Administration.

[N424671]

Antwort auf Beitrag Nr.: 44.785.605 von Mystical75 am 04.06.13 20:37:34

Die Quartalszahlen zeigen gar nichts. pSivida ist ein Versuchsbetrieb; ein Labor; und die Aktionäre müssen hier sehr lang Geduld aufbringen.

[Mystical75]

Wann stehen denn die nächsten Quartalszahlen bei Psivida an, aus denen dann wohl die ersten Umsätze u. Gewinne von Illuvien ersichtlich werden sollten?

Vielen Dank im Voraus.