Leverkusen, Germany (pta030/06.12.2021/12:50) - Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F), an international biopharmaceutical company, is pleased to announce that it has commenced patient enrollment for its phase I safety study to evaluate the safety and tolerability of photodynamic therapy (PDT) for the treatment of mild-to-severe actinic keratosis (AK) on the face and scalp using three tubes of Ameluz® together with the new BF-RhodoLED® XL lamp.
"Our focus remains on expanding the FDA approval of Ameluz®," says Hermann Lübbert, CEO of Biofrontera AG. "This study paves the way to allow the U.S. product information for Ameluz® to be amended to allow the use of up to three tubes per treatment, as it currently limits the use to one tube of Ameluz® per treatment. This is a prerequisite for the alignment of reimbursement modalities compared to the competitor product in the US and thus an increase of the competitiveness of Ameluz® in this important market."
The non-randomized, open-label, multicenter study evaluates the safety and tolerability of Ameluz® in the treatment of AK located on the face and scalp with PDT together with the new BF-RhodoLED® XL lamp. The study includes 100 patients with mild to severe AK. Each patient will receive the content of 3 tubes of Ameluz® for a field-directed treatment of AK.
This study comes on the back of a maximal-usage pharmacokinetics (PK) clinical study completed in early 2021. As announced in June, the study results from that PK study were presented to the FDA. In the meeting the FDA requested another safety study focusing on transient adverse events before amending the product information to allow the simultaneous use of up to three tubes per treatment. A total of eight clinical sites are participating in the study.
Ameluz® together with the PDT-lamp BF-RhodoLED® and its successor model BF-RhodoLED® XL is being marketed by Biofrontera Inc, a US-based affiliate of Biofrontera AG under an exclusive license and supply agreement for the United States.
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Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics.
The Germany-based company 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 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.
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.(end)
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