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PTA-News: Biofrontera AG: Biofrontera AG obtains notice of allowance for U.S. patent on nanoemulsion formulation

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Leverkusen, Germany (pta012/06.09.2022/09:50) - Biofrontera AG (Frankfurt Stock Exchange: B8F, US-OTC: BFAGY), an international biopharmaceutical company, announces that its wholly owned subsidiary Biofrontera Bioscience GmbH has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for the patent application "Nanoemulsion formulation with improved stability and cell penetration" (US12/520759). The granted patent protects the formulation technology of the drug Ameluz® in the U.S.

The U.S. patent application was filed on June 22, 2009 as a nationalization of the worldwide PCT application PCT/EP2007/011404 with a priority date of December 21, 2007. Because the examination of the patent required several years, there is the possibility that the patent term is likely to be adjusted by the USPTO such that it may extend beyond its original 20-years term calculated from the priority date of the parent application.

The granted patent application describes the composition, preparation, and use of a nanovesicle-based innovative pharmaceutical formulation. Specifically, the patent claims the composition of the active ingredient 5-aminolevulinic acid, the nanoemulsion and certain excipients, and is thus suitable to protect the product Ameluz® in the U.S.. The invention is characterized by ensuring optimized penetration of 5-aminolevulinic acid (the active pharmaceutical ingredient in Ameluz®) into the target tissue, while improving the stability of the active ingredient and the formulation itself.

"Biofrontera is pursuing a broad patent strategy to protect Ameluz® from generic competition. The granting of the U.S. patent is another very important piece of the puzzle in brand protection and demonstrates once again that Biofrontera has developed innovative approaches in its research and development to turn these into advanced products," explains Paul Böckmann, Executive Board member at Biofrontera AG.


About Biofrontera:

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).

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 words such as "will," "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, including, but not limited to, the risk that the termination of the ADS Level 1 Program or the deregistration with the SEC may not occur or may be delayed, 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. 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.


emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
country: Germany
contact person: Investor Relations
phone: +49 (0) 214 87 63 20

ISIN(s): DE0006046113 (share)
stock exchanges: regulated market in Frankfurt, Dusseldorf; free market in Stuttgart, free market in Munich; open market in Berlin, Tradegate
other stock exchanges: US OTC

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