Clinuvel sells EpiPharm, announces EPP trail

Clinuvel Pharmaceuticals has entered into a heads of agreement with Genepharm Australasia for the sale of Clinuvel's EpiPharm range of pharmaceutical products.

Genepharm will acquire the rights, licenses and stock of EpiPharm at a cost of $1 million.

A Clinuvel spokesperson said the divestment of EpiPharm follows its decision to concentrate exclusively on the development of its photo-protective drug CUV1647 for the treatment of UV-related skin disorders.

Clinuvel has also announced the commencement of its Phase II open label trial to evaluate the safety and efficacy of subcutaneous implants of CUV1647 in patients with erythropoietic protoporphyria (EPP). The clinical trial for Clinuvel's leading drug CUV1647 will be conducted in Zurich, Switzerland on nine patients suffering from the rare and currently incurable skin disorder.

The study will test the ability of CUV1647 to alleviate the symptoms of EPP. The trial will use a controlled light source to emulate exposure of the skin to natural sunlight. Patients with clinically confirmed EPP will be administered CUV1647 via one subcutaneous implant every two months for a period of 12 months. The final report on the clinical trial is expected in 18 months.

"Clinuvel aims to provide a prophylactic treatment for this debilitating and incurable skin disorder, and this trial will further test the safety and efficacy of CUV1647," Clinuvel's CEO, Dr Philippe Wolgen, said.

This Phase II trial for the prophylactic treatment of EPP is one of four indications that Clinuvel is investigating in selecting a lead indication to pursue for first market approval of CUV1647.

When the results are available for this trial and the trials for the prevention of precursors to skin cancer (actinic keratosis, or AK) in organ transplant patients and 'sun poisoning' (polymorphous light eruption, PLE), one or more of these indications will be eligible to proceed to Phase III trials and eventually first market approval, most likely to be in Australia and Europe, followed by the US.

EPP is a rare inherited porphyrin metabolism disorder that affects one in 750,000 people. This skin disorder causes a chemical known as protoporphyrin IX to accumulate in the skin. When the skin is exposed to the sun, these molecules undergo a chemical reaction that results in swelling, excruciating pain and scarring.

CUV1647 stimulates the body to make eumelanin, the dark pigment of the skin which is known to have protective effects on the skin from exposure to UV radiation. It is a photoprotective agent that acts by increasing the levels of eumelanin in the skin.

Source: Clinuvel Pharmaceuticals