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Leverkusen, Germany (pta023/14.03.2022/12:30) - Biofrontera (ISIN: DE0006046113, US OTC: BFAGY), an international biopharmaceutical company, announces that the U.S. Food and Drug Administration (FDA) has added the patent of novel RhodoLED® XL lamp (see press release 08.12.2021) to the FDA Orange Book and further that Biofrontera Pharma has now been approved by the FDA as a contract laboratory for batch control and stability testing for Ameluz®.
Patents listed in the Orange Book are patents that protect products approved by the U.S. Food and Drug Administration (FDA). If a generic product were to be approved by the FDA, Biofrontera would be informed immediately due to the patent listing, so that a patent infringement could be examined, and a lawsuit filed could be immediately. Photodynamic therapy with the combination of Ameluz® and BF-RhodoLED® XL is thus protected from generic products until October 2040 via the approved patent.
The recognition of Biofrontera Pharma as a contract laboratory, which has now been granted by the FDA and previously by the European Medicines Agency (EMA), provides a broader basis for the quality assessment of Ameluz®. Previously, quality control was entirely conducted by Biofrontera's contract manufacturers in collaboration with third-party providers, but now Biofrontera Pharma can perform part of this necessary testing of production batches in Leverkusen itself. This reduces the dependence on third-party suppliers and the risk of downtime in production.
"The protection against generics resulting from the registration in the Orange Book will strengthen our market presence over the next decades," commented Ludwig Lutter, CFO of Biofrontera AG. "Biofrontera is establishing itself more and more broadly as an independent pharmaceutical company, which significantly reduces third-party dependence as well."
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 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.
emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
contact person: Investor Relations
phone: +49 (0) 214 87 63 20
ISIN(s): DE0006046113 (share)
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