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Biotech / Medical : Clinuvel Pharmaceuticals Ltd

CLVLY 7.350

-2.3%

Oct 31 9:30 AM EST

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To: caly who wrote (29)	11/8/2010 7:47:31 PM
From: caly	of 52

Company Announcement Tuesday 9th November 2010 Melbourne, Australia FDA provides positive guidance on Clinuvel’s EPP program Clarification given on regulatory requirements for final US development of novel drug for erythropoietic protoporphyria (EPP) Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced it has had a positive meeting with the US Food and Drug Administration (FDA). The discussion, with FDA’s Division of Dermatology and Dental Products (DDDP), provided clear guidance on the data package required to file a New Drug Application (NDA) for Clinuvel’s drug SCENESSE® (afamelanotide). An approved NDA allows sponsoring companies to market drugs in the US. FDA meeting outcomes The meeting was held at FDA headquarters with the DDDP in Silver Spring, Maryland, on October 27. Clinuvel’s objective was to seek clarification on the US clinical and preclinical requirements to file afamelanotide for marketing authorisation. The DPPP panel recognised EPP – a rare lifelong metabolic disorder causing absolute intolerance to light – as a severe disease in children and adults with no current effective treatments. Based on the preclinical and clinical results to date, the FDA did not raise any safety concerns for afamelanotide. The toxicology studies presented on afamelanotide were considered sufficient for registration of the product. Significantly, the FDA’s stance on safety is similar to the response provided by the European Medicine Agency (EMA). The Director General of the DDDP emphasised that the FDA will regard Patient Reported Outcomes (PROs) as a significant part of assessing the clinical efficacy of afamelanotide in these patients, who are reported to be conditioned since childhood to avoid outdoor exposure. Clinuvel has used PROs in its EPP program to assess the impact of afamelanotide treatment on the severity of phototoxic reactions and patients’ quality of life. The company was invited to further the dialogue with the FDA to ensure successful approval of afamelanotide. Commentary Clinuvel’s Chief Scientific Officer, Dr Agersborg said: “Clinuvel is focusing on a novel therapeutic area where the FDA is required to evaluate medicinal photoprotection proposed by a pharmaceutical therapy for light intolerance in EPP patients. We are very pleased by the reception to Clinuvel’s program and the cooperation of the agency. “We have repeatedly stated that safety is a fundamental part of our program and conditional to be able to commercialise afamelanotide. It is rewarding to learn that drug safety appears to have been met. We will continue our program in EPP and other diseases to generate more safety and efficacy data in preparation of registration of afamelanotide in the US. We are well on our way to demonstrating that we are able to improve the quality of life in EPP patients by facilitating a normal existence for these patients.” Clinuvel’s Phase II US confirmatory trial of afamelanotide in EPP (CUV030) is underway and results are expected in early 2011. In Europe, Clinuvel is conducting a confirmatory Phase III EPP trial (CUV029) which is expected to be complete in the first half of the 2011.

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