Biofrontera in deal with Medac for marketing of Ameluz® in Poland

 Biofrontera Pharma GmbH, a wholly owned subsidiary of Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F), and Medac Gesellschaft für klinische Spezialpräparate mbH. (Medac), signed an exclusive license and supply agreement for the marketing of both Ameluz® and BF-RhodoLED® in Poland. The agreement has a term of 5 years commencing with the start of sales in Poland.

Under the terms of the agreement, Medac will make an immediate one-time upfront payment of EUR 50,000 to the Company, plus an additional one-time payment of EUR 150,000 following receipt of the drug's reimbursement eligibility from the Polish health insurance providers. According to the agreement, Medac receives exclusive distribution rights for Poland. Once reimbursement eligibility has been granted in Poland, Biofrontera will supply Ameluz® to Medac at a fixed transfer price based on the expected net revenues.

As with all of the company's other licensing agreements, Biofrontera will be responsible for regulatory affairs as well as manufacturing and quality control, while Medac will handle all aspects of commercialization and local regulatory and reimbursement in Poland.

Prof. Dr. Hermann Lübbert, CEO of Biofrontera AG, commented, "We are pleased to have a strong partner on our side to offer photodynamic therapy for the treatment of actinic keratosis and basal cell carcinoma by using Ameluz® and the BF-RhodoLED® in Poland."

Medac Gesellschaft für klinische Spezialpräparate mbH is a global pharmaceutical company based in Germany, which has been specializing in the treatment and diagnosis of oncological, urological and autoimmune diseases. In Poland, Medac operates a leading sales structure in dermatology and, with this agreement, expands its dermatology portfolio with the addition of Ameluz®.

Background:

In 2011, the prescription drug Ameluz® received a centralized EU marketing authorization from the European Commission, which since then has repeatedly been expanded. Ameluz® is approved for use in photodynamic therapy (PDT) of mild to moderate actinic keratoses, field cancerization, and superficial and nodular basal cell carcinomas. Ameluz® is approved for the use in conventional PDT with our special red-light lamp BF-RhodoLED® as well as for daylight PDT.

https://www.yahoo.com/now/biofrontera-enters-license-supply-agreement-081500376.html