April 26, 2012 -- Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that SCENESSE® (afamelanotide 16mg implant) has been accepted by two leading health insurers in Switzerland for full reimbursement for the prophylactic treatment of patients with erythropoietic protoporphyria (EPP), a rare genetic disease causing extreme intolerance of skin to light.
SCENESSE® can be supplied with immediate effect to physicians who treat approximately 50 EPP patients in Switzerland. The costs of supply will be covered in full by the insurance companies. This is the second country where SCENESSE® is fully reimbursed for EPP. The drug has been available on prescription in Italy since 2010. Both countries have allowed supply of the drug under specific laws prior to formal European approval.
In February 2012 Clinuvel filed a marketing authorisation application with the European Medicines Agency (EMA) for EPP. EMA approval would allow Clinuvel to market SCENESSE® in all 27 European Union member states as well as Norway, Iceland and Liechtenstein. The company will shortly initiate a Phase III trial of the drug in the USA.
"This is excellent news for the Swiss EPP patients, who have proven to be very motivated and compliant during the past six years of continuous treatment in trials and under compassionate use schemes," Clinuvel's Chief Scientific Officer, Dr Hank Agersborg said. "The reimbursement will enable the collection of further long term patient data adding to our scientific dossier."
"After the first Italian reimbursement in 2010, this welcome decision by Swiss insurers confirms the need to treat these patients who currently do not receive any pharmaceutical or medical assistance," Clinuvel's CEO, Dr Philippe Wolgen said. "In today's pharmaceutical climate this acknowledgement supports companies whose R&D efforts focus on developing first-in-class therapies for smaller patient populations with high unmet medical need."
Swiss Legislation Enabling Reimbursement
Under a 2011 amendment of Swiss Law (Verordnung der Krankenversicherung, art. 71), health insurers have the option of recommending reimbursement of medicinal products for the treatment of severe or life-threatening diseases prior to their formal approval in Switzerland. Two prominent Swiss health insurers have agreed to fully reimburse the cost of the drug for the treatment of Swiss EPP patients. It is anticipated that other insurers will follow their lead. SCENESSE's safety and clinical efficacy profile together with the lack of existing alternative treatments were decisive factors leading to this decision.
Swiss Orphan Drug Designation
In 2008 SCENESSE® received an orphan drug designation for EPP from Swissmedic, Switzerland's regulatory authority. The orphan designation, a regulatory status recognising potential of a drug to treat a rare disease, entitles Clinuvel to a simplified marketing authorisation application process in Switzerland, which it plans to initiate upon successful approval by the EMA.
Swiss EPP patients
EPP patients in Switzerland were the first in the world to receive the drug as a prophylactic treatment in a Phase II trial (CUV010) in 2006. Zurich's Triemli Hospital, which acts as the National Porphyria Centre for Switzerland, was also involved in Clinuvel's first Phase III trial of the drug (CUV017) and has subsequently treated adult EPP patients under compassionate use programs. Thus far approximately 300 doses of the drug have been administered to Swiss EPP patients over the course of six years at Triemli Hospital. SCENESSE® is administered as a subcutaneous, dissolving implant approximately the size of a rice grain. Increased pigmentation of the skin appears two days after drug administration and lasts up to two months.
Erythropoietic protoporphyria (EPP)
EPP is a rare genetic disease found mainly in fair-skinned people. It is characterised by severe phototoxicity (intolerance to light) of the skin resulting in intolerable pain, swelling and scarring, usually of exposed areas such as the face, hands and feet. Symptoms can vary from mild to extreme lasting pain requiring hospitalisation. Patients often lead an indoors and sheltered life, avoiding light and UV exposure to prevent symptoms. Presently there is no known effective treatment for EPP, which affects approximately 10,000 people globally.
Pivotal trials (CUV029 and CUV030) showed SCENESSE® could reduce the severity of EPP symptoms and enable patients to lead more normal lives. A marked improvement in Quality of Life was also reported. Thus far no serious safety concerns have been identified from the use of afamelanotide in more than 650 patients, including more than 250 EPP patients, involved in various clinical trials.