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Clinuvel Pharmaceuticals Limited (CUV) announced that the United States Patent and Trademark Office (USPTO) has granted Clinuvel pivotal patent protection for the delivery of melanocortins as photoprotective agents in transdermal formulations. Clinuvel has two melanocortin drugs in development (afamelanotide and CUV9900), both of which are analogues of the naturally occurring hormone alpha-Melanocyte Stimulating Hormone (alpha-MSH). Patent 20110263508 grants Clinuvel exclusive rights for compositions of alpha-MSH analogues and transdermal delivery systems and methods of inducing melanogenesis by topical administration.

Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg, said, “This has been a long time coming but our program has demonstrated the importance of melanocortins in inducing melanogenesis and thus protecting skin. This patent will allow the company a further extension of the use of afamelanotide and CUV9900 in non-invasive formulations. This patent enhances the value of our current portfolio of intellectual property in the major markets of the world. ”

Clinuvel Pharmaceuticals Ltd (CUV) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the  interaction of light and human skin, the company has identified three groups of patients with a clinical need for photoprotection and another group with a need for repigmentation. These patient groups range in size from 10,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), is in Phase II and III trials in the US and Europe, and is expected to be filed before the end of 2011 for review by the European Medicines Agency. Based in Melbourne, Australia, Clinuvel has operations in Europe and the US.

www.clinuvel.com

http://www.traderdealer.com.au/fundamentals/cuv

Clinuvel Pharmaceuticals Limited (CUV) announced that IP Australia had granted Clinuvel protection under patent 2005269244 for the exclusive use and manufacture of formulations of alpha melanocyte stimulating hormone (alpha-MSH) analogues until early 2025. Clinuvel’s novel drug SCENESSE® is a controlled-release injectable implant formulation of afamelanotide, an alpha-MSH analogue, which activates melanin in skin (melanogenesis), protecting skin from ultraviolet (UV) and visible light. Patent 2005269244 covers the use of alpha-MSH analogue formulations to induce melanogenesis and prevent UV radiation induced damage in humans, as well as the manufacture of medicaments and the use of pharmaceutical compositions containing alpha-MSH analogues for these purposes. SCENESSE® has been shown in clinical trials to provide photoprotection through increased melanogenesis in fair-skinned patients diagnosed with UV and light related skin disorders. The FDA has also approved trials of the drug as a repigmentation therapy in nonsegmental vitiligo; a pigmentary disorder affected over 45 million individuals worldwide.

“We have invested significant time and over A$20 million into the current innovative SCENESSE® formulation,” Clinuvel’s CEO, Dr Philippe Wolgen said. “This latest patent provides additional evidence that Clinuvel will be able to capitalise on its investment in an increasingly competitive global pharmaceutical market. This invention and patent application is currently also pending with the United States Patent and Trademark Office.”

Clinuvel Pharmaceuticals Ltd is a leading and innovative Australian company focused on the development of SCENESSE® (afamelanotide), its proprietary first-in-class photoprotective drug. Clinuvel has identified a number of groups of patients with a clinical need for photoprotection and one with a need for repigmentation therapy. Currently, Clinuvel is in its final stages to complete testing of SCENESSE® in Phase II and III trials in Australia, Europe and the United States. Clinuvel’s ongoing focus is to demonstrate the safety and efficacy of SCENESSE®. Pending positive clinical results, Clinuvel aims to file SCENESSE® for its first market approval for the orphan indication porphyria (EPP). Clinuvel will work closely with global regulators to facilitate marketing approval of SCENESSE®.

www.clinuvel.com

http://www.traderdealer.com.au/fundamentals/cuv