Leverkusen, Germany, July 23, 2021 (GLOBE NEWSWIRE) —
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
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
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
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.
Pamela Keck, Head of Investor Relations
Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics.
The Germany-based company, with over 150 employees worldwide, develops and markets innovative products for the care, protection and treatment of the skin. The company’s lead product is the combination of Ameluz
, a topical prescription drug, and medical device BF-RhodoLED
for the photodynamic therapy of certain superficial skin cancers and their precursors. Ameluz
has been marketed in the EU since 2012 and in the United States since May 2016. In addition, the company markets the prescription medication Xepi
for the treatment of impetigo in the United States. In the EU, the company also sells the dermocosmetics series Belixos
, which offers specialized care for damaged or diseased skin.
Biofrontera is the first German founder-led pharmaceutical company to receive a centralized European and a US approval for a drug developed in-house. The Biofrontera Group was founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on the US NASDAQ.
Forward-Looking Statements: Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the public offering and the intended use of proceeds from the offering.
These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate” and “intend,” among others. Such forward-looking statements are based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of the Company, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and other factors are set forth in the annual report on Form 20-F filed with the SEC, including Item 3.D. “Key Information – Risk Factors,” and in future reports filed with the SEC. Given these risks, uncertainties and other factors, prospective investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake an obligation to update or revise any forward-looking statement.