Clinuvel Pharmaceuticals : to Launch SCENESSE® in USA in April

CLINUVEL PHARMACEUTICALS LTD today announced plans to launch its novel drug SCENESSE^® (afamelanotide) in the USA, with the first patient to be treated after 15 April 2020. SCENESSE^® was approved by the US Food and Drug Administration in October 2019 to increase pain free light exposure in adult patients with a history of phototoxic reactions from the rare metabolic disorder erythropoietic protoporphyria (EPP).

USA DISTRIBUTION SCENESSE^®
The distribution of SCENESSE^® is planned in three phases. During Phase I, three selected hospitals and medical centers will be able to provide treatment to EPP patients. For Phase II, Medicare-Medicaid will need to complete its review of the SCENESSE^® dossier and provide an opinion on National and Local Coverage for the treatment, as to be confirmed by the Centers for Medicare & Medicaid Services. The last phase will consist of direct distribution of the drug to a target maximum of 30 centers who will be trained and accredited by CLINUVEL.

INSURANCE COVERAGE SCENESSE^®
During the first phase of distribution commencing 15 April 2020, patients will be able to receive treatment under Prior Authorization [PA]. PA is a decision by a payor that a healthcare service, treatment plan, prescription drug, or durable medical equipment is medically necessary and is included in a member's (patient's) coverage.

CLINUVEL CO-PAYMENT SAVINGS PROGRAM
CLINUVEL will establish for American EPP patients a CLINUVEL Co-Payment Savings Program. Individual applications will need to be made, whereby terms & conditions will apply to each patient on a case by case basis. EPP patients with commercial or private health insurance may be eligible, depending on the terms of each insurance policy. Reference is made to the Power Point slide deck released concomitantly today.

COMMENTARY
'Contrary to our predictions that the drug would be made available during the 4th quarter of this year, our teams have managed to complete the entire process working closely with the Food and Drug Administration' CLINUVEL's CEO, Dr Philippe Wolgen said. 'In times where our thoughts go out to the many lives lost and families affected by COVID-19, it is somewhat satisfying to be able to serve our patient population facilitating them a freedom to live without inhibition and handicap.'

^{EPP - absolute light intolerance
EPP is an inherited metabolic disorder of the haem biosynthesis pathway which causes lifelong phototoxicity due to the accumulation and storage of the compound protoporphyrin IX (PPIX) in the blood and tissues. When exposed to visible light and near-visible ultraviolet radiation, PPIX is activated, causing damage to surrounding tissue. Patients report they experience excruciating burning pain underneath their skin which can last days or weeks and forces them to avoid all further exposure to light. It is estimated that there are 5,000 to 10,000 EPP patients worldwide.
SCENESSE}® binds to the melanocortin-1 receptor on skin cells and sets in motion a cascade of cellular events, one of which is the activation of the pigment melanin to provide a physical barrier to visible and invisible light in EPP patients. The drug is administered as a 16mg controlled-release injectable implant, designed to provide protection for up to 60 days.

^{1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. Information on the product, including the approved prescribing information, can be found on CLINUVEL's website at www.clinuvel.com.}

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