Clinuvel Pharmaceuticals Limited (ASX:CUV) Novel UV Protecting Drug Delivered By The Picogram

Melbourne, July 8, 2010 AEST (ABN Newswire) - Melbourne's Clinuvel Pharmaceuticals Limited (ASX:CUV) (PINK:CLVLY) today signed with a commercial US partner to manufacture its world's first photoprotective drug, SCENESSE (R), under an exclusive arrangement. Following eight years of development, Clinuvel has selected Surmodics, Inc. (NASDAQ:SRDX), a leading Minnesota-based provider of proprietary drug delivery technologies to the healthcare industry, as its first manufacturing partner.

Under the exclusive arrangement, SurModics will commercially manufacture and supply Clinuvel with the proprietary product SCENESSE (R) for an indefinite period. SCENESSE (R) will be manufactured by SurModics at its recently opened, FDA certified facilities in Birmingham, Alabama. During the past eight years, Clinuvel and SurModics have been fully committed to the development of this particular formulation resulting in SurModics being selected as its lead manufacturer.

The agreement follows Clinuvel's first commercial success of supplying SCENESSE (R) to light and UV intolerant patients diagnosed with the rare genetic disease porphyria (EPP) in Italy as was made public in May.

"The announced partnership forges a formidable relationship for Clinuvel, allowing us to capitalise on the commercial opportunities for SCENESSE (R) to provide systemic photoprotection, shielding skin from UV and light in affected patient populations" said Clinuvel's CEO, Dr Philippe Wolgen.

SCENESSE (R) controls the release of its active ingredient, afamelanotide (16mg), in picogram concentration, one trillionth of a gram. The innovative product is injected as a controlled-release subcutaneous formulation, a dissolvable implant the size of a grain of rice. SCENESSE (R) activates skin pigment, melanin, and provides photoprotection for up to 60 days.

Currently in late stage clinical trials in Europe, Australia and the USA, SCENESSE (R) has been safely administered to over 500 patients worldwide. To date, SCENESSE (R) has been shown in Phase II and III clinical trials to provide systemic skin protection to patients with severe UV and light related skin conditions.

"We have perfected controlled-release of the drug from an injectable implant which helps provide protection from UV and light to those who need it most," said Clinuvel's Chief Scientific Officer, Dr Hank Agersborg. "Now, following a decade of refinement of the afamelanotide molecule and development of SCENESSE (R), we have signed a manufacturing agreement with confidence in our final commercial product."

"Today's agreement between Clinuvel and SurModics is part of a logical sequence in our lengthy development," Dr Wolgen said. "Of particular relevance is that this agreement marks Clinuvel's first commercial steps in Europe, as made public last month".

"With SurModics as our elected manufacturing partner, we are confident of our ability to manage scale-ability associated with both ongoing trials and commercial supplies. The signing of this partnership enables us to provide a bespoke and innovative solution for severely UV-affected patients worldwide."

About SCENESSE (R) (afamelanotide)
SCENESSE (R) is a first-in-class therapeutic being developed by Clinuvel, with the generic name (or INN) afamelanotide. An analogue of a-MSH, SCENESSE (R) is a linear peptide which activates the skin to release eumelanin, the dark pigment which is known to have photoprotective properties (providing skin protection against light and UV radiation). SCENESSE (R) is administered underneath the skin as a dissolvable implant approximately the size of a grain of rice. SCENESSE (R) is a registered trademark of Clinuvel Pharmaceuticals Ltd. For more information see http://www.scenesse.com.

About SurModics
SurModics' vision is to extend and improve the lives of patients through technology innovation. The Company partners with the world's foremost medical device, pharmaceutical and life science companies to develop and commercialize innovative products that result in improved diagnosis and treatment for patients. Core offerings include: drug delivery technologies (coatings, micro particles, nanoparticles, and implants). SurModics is headquartered in Eden Prairie, Minnesota and its SurModics Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more information about the Company, see http://www.surmodics.com.

Background
Clinuvel Pharmaceuticals Ltd is a leading and innovative Australian company focused on the development of SCENESSE (R) (afamelanotide), its proprietary first-in-class photoprotective drug. Clinuvel has identified five groups of patients with a clinical need for photoprotection. Currently, Clinuvel is in its final stages to complete testing of SCENESSE (R) 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 (R). Pending positive clinical results, Clinuvel aims to file SCENESSE (R) for its first market approval for the orphan indication porphyria (EPP).

Clinuvel is currently testing SCENESSE (R) in five clinical indications:

-------------------------------------------------------------Indication         Description        Clinical Trial Status-------------------------------------------------------------Erythropoietic     Absolute sun/UV    Phase III trial full  Protoporphyria     intolerance        results due Confirmatory (EPP)                                 Phase III trial approved                                       August 2009-------------------------------------------------------------Actinic Keratosis  Skin cancer        Phase II trial(AK) and Squamous  in transplant      started October 2007Cell Carcinoma     patients(SCC) in Organ Transplant Recipients (OTRs)	 	-------------------------------------------------------------Polymorphic Light  Severe sun/UV      Phase III trial  Eruption           poisoning          preliminary results (PLE / PMLE)                          reported December 2009-------------------------------------------------------------Solar Urticaria   Acute anaphylactic  Phase II trial results(SU)              reaction to sun/UV  reported July 2009*-------------------------------------------------------------Photodynamic      Phototoxicity       Phase II trial resultsTherapy (PDT) -   following cancer    reported December 2009*systemic          treatment	 -------------------------------------------------------------

*Program deferred February 2010.

Phase I and II human clinical trials using SCENESSE (R) have demonstrated that the drug is well tolerated and no significant safety concerns have been identified to date. Following successful conclusion of the development program, Clinuvel will work closely with global regulators to facilitate marketing approval of SCENESSE (R). For more information see http://www.clinuvel.com.

Contact

Australia Lachlan Hay Head of Global Network and Communications Clinuvel Pharmaceuticals Limited Tel: +61-3-9660-4900 Email: investorrelations@clinuvel.com Europe Daniela Schaefer Head of Business Operations Europe Clinuvel AG Tel: +41-44-253-7500