Clinuvel can now commence clinical trials in the US, the world’s largest pharmaceutical market. This extends Clinuvel’s clinical program, currently well advanced in Europe, Australia and Switzerland.
Clinuvel’s first US trial will consist of a confirmatory pharmacokinetic trial using the final product selected by Clinuvel for commercial development, a controlled release formulation.
In July 2008, afamelanotide was granted Orphan Drug Designation (ODD) for the treatment of erythropoietic protoporphyria (EPP) by the FDA. This allows for an accelerated review process by the FDA, seven-year market exclusivity in the United States upon obtaining marketing authorization, tax benefits, and exemption from the Prescription Drug User Fee Act filing fees, which are often in excess of $US1 million.
Last week Clinuvel announced positive interim results from a Phase III EPP trial in Europe, which is due to be completed later this year.
The IND review process, performed by FDA’s Division of Dermatology and Dental Products, involved comprehensive assessment of quality, safety and clinical data on afamelanotide, generated by the company to date.
Clinuvel is developing afamelanotide as a prophylactic treatment for a range of UV and light-related skin disorders as well as cancer related treatments. The company has identified five UV and light related skin disorders where clinical use of afamelanotide serves the needs of patients who suffer severe and chronic symptoms.
“Today’s IND gives us recognition to years of hard work,” Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg said. “I am pleased that we will be able to make afamelanotide available for testing in the US with the ultimate objective of registering the drug for patients who most need photoprotection. We will continue to scrutinize safety of our drug during the remaining phases of development to registration.”
“The FDA’s decision is a landmark event in Clinuvel’s growth,” Clinuvel’s CEO, Dr Philippe Wolgen said. “Today’s progress reflects some of the choices we had to make in our program early on in 2006 when changing the direction of the company. One of those choices resulted in the emphasis on clinical safety of afamelanotide as a new molecule. “I am thinking of the US patients who have asked us for the drug in the past months. I am also thinking of all the shareholders who have funded the company to date as we enter the world’s largest pharmaceutical market. IND status will offer Clinuvel greater visibility and will be an important catalyst for the commercial way forward,” Dr Wolgen said.
For more information contact: Colin Mackie Head of Corporate Development Clinuvel Pharmaceuticals Limited Tel: +61 3 9660 4900 investorrelations@clinuvel.com
About afamelanotide
Afamelanotide stimulates the body’s natural ability to produce eumelanin, the dark pigment of the skin which is known to have photoprotective properties, thus providing skin protection against UV radiation (UVR). Increased pigmentation of the skin appears a few days after administration of afamelanotide and lasts up to two months. Afamelanotide is administered underneath the skin as a biodegradable implant approximately the size of a grain of rice.
About Clinuvel Pharmaceuticals Limited Clinuvel Pharmaceuticals Limited is an Australian biopharmaceutical company with offices in San Francisco and Zürich developing its photoprotective drug afamelanotide as a preventative treatment for a range of UV-related skin disorders as well as cancer related treatments.
