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Biofrontera AG: Biofrontera's license partner Louis Widmer receives an extension of its marketing authorization for Ameluz®
Leverkusen, Germany (pta034/08.06.2022/14:15 UTC+2)
Biofrontera AG (ISIN: DE0006046113), an international biopharmaceutical company, announces that its license partner and marketing authorization holder in Switzerland, Louis Widmer SA, has successfully obtained an extension of its marketing authorization for the treatment of actinic keratosis in extremities, trunk and neck with Ameluz®.
The use of Ameluz® PDT for actinic keratosis also in the body periphery, which has already been approved by the European Medicines Agency, EMA, since 2020, was submitted separately by Louis Widmer to the Swiss Medicines Authority, Swissmedic. Louis Widmer had adapted the European marketing authorization documents and submitted an application to the authority for an extension of the marketing authorization. Following the approval that has now been granted, the Swiss product label of Ameluz® covers the same range of applications that has already been approved in the countries of the European Union and the United Kingdom since 2020.
An exclusive licensing agreement for the marketing of Ameluz® and BF-RhodoLED® in Switzerland and Liechtenstein has been in existence between Biofrontera and Louis Widmer since 2014, under which Louis Widmer began marketing Ameluz® in 2016, following the granting of approval by Swissmedic. In addition to the expansion to include the treatment of actinic keratosis on the trunk, neck, and extremities, Louis Widmer had previously added the use of Ameluz® in daylight, field cancer, and superficial inoperable forms of basal cell carcinoma to its Swiss approval.
Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics. The Leverkusen-based company develops and markets innovative products for the treatment, protection and care of the skin. Its key products include Ameluz®, a prescription drug for the treatment of non-melanoma skin cancer and its precursors. Ameluz® has been marketed in the EU since 2012 and in the USA since May 2016. In Europe, the company also markets the Belixos® dermocosmetic series, a specialty care product for damaged skin. Biofrontera is one of a few German 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 Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on US OTC market (BFAGY). www.biofrontera.com
Forward-looking statements: Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "anticipate", "believe", "predict", "estimate" and "intend", among others. Such forward-looking statements are based on current estimates and assumptions made by Biofrontera AG's management to the best of its knowledge and belief, which in their opinion are 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 to be materially different from any future results, financial condition, performance or achievements expressed or implied by such forward-looking statements. No undue reliance should be placed on such statements. Forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update or revise any forward-looking statements.
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