Novel UV protecting drug delivered by the picogram

Melbourne, Australia, July 8, 2010 - Melbourne’s Clinuvel Pharmaceuticals today signed with a commercial US partner to manufacture its world’s first photoprotective drug, SCENESSE®, under an exclusive arrangement. Following eight years of development, Clinuvel has selected Surmodics, Inc., 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® for an indefinite period. SCENESSE® 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® 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® to provide systemic photoprotection, shielding skin from UV and light in affected patient populations” said Clinuvel’s CEO, Dr Philippe Wolgen.

SCENESSE® 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® 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® has been safely administered to over 500 patients worldwide. To date, SCENESSE® 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®, 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.”

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For more information contact: Australia Europe Lachlan Hay Daniela Schaefer Head of Global Network and Communications Head of Business Operations Europe Clinuvel Pharmaceuticals Limited Clinuvel AG T: +61 3 9660 4900 T: +41 44 253 75 00 E: investorrelations@clinuvel.com

About SCENESSE® (afamelanotide) SCENESSE® is a first-in-class therapeutic being developed by Clinuvel, with the generic name (or INN) afamelanotide. An analogue of α-MSH, SCENESSE® 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® is administered underneath the skin as a dissolvable implant approximately the size of a grain of rice. SCENESSE® is a registered trademark of Clinuvel Pharmaceuticals Ltd. For more information see 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 surmodics.com.

About Clinuvel Pharmaceuticals Limited 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 five groups of patients with a clinical need for photoprotection. 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 is currently testing SCENESSE® in five clinical indications:

Indication

Description

Clinical Trial Status

Erythropoietic Protoporphyria (EPP)

Absolute sun/UV intolerance

Phase III trial full results due

Confirmatory Phase III trial approved August 2009

Actinic Keratosis (AK) and Squamous Cell Carcinoma (SCC) in Organ Transplant Recipients (OTRs)

Skin cancer in transplant patients

Phase II trial started October 2007

Polymorphic Light Eruption (PLE / PMLE)

Severe sun/UV poisoning

Phase III trial preliminary results reported December 2009

Solar Urticaria (SU)

Acute anaphylactic reaction to sun/UV

Phase II trial results reported July 2009*

Photodynamic Therapy (PDT) - systemic

Phototoxicity following cancer treatment

Phase II trial results reported December 2009*

*Program deferred February 2010.

Phase I and II human clinical trials using SCENESSE® 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®. For more information see clinuvel.com.

Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following: · actual results may and often will differ materially from these forward-looking statements; · no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE can or will be achieved; · no assurances can be given by Clinuvel that, even if its development programme for SCENESSE is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place

Level 11 / 330 Collins Street T +61 3 9660 4900 clinuvel.com Melbourne, Victoria 3000 F +61 3 9660 4999 Australia
 

Posted: July 2010

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