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Swissmedic approves Ameluz® in combination with daylight photodynamic therapy in Switzerland

Leverkusen, Germany, Oct. 01, 2018 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F), an international biopharmaceutical company, announced today that Swissmedic, the Swiss national approval and supervisory authority for drugs and medical products, has approved the extension of the label of Ameluz® to its use in combination with photodynamic daylight therapy (daylight-PDT).

The Swiss approval of Ameluz® with daylight-PDT follows the EU approval by the European Commission in March 2018. Ameluz is marketed in Switzerland by Louis Widmer, which also functions as local marketing authorization holder. The approval of the label extension is now followed by the submission of documents for reimbursement in order to include Ameluz® in combination with daylight-PDT in the Swiss Federal Office of Public Health’s list of specialties. This would provide patients in Switzerland with an almost painless treatment option that offers high efficacy and excellent cosmetic results as an insurance benefit. Biofrontera and Louis Widmer expect a sales effect for the summer months of 2019 comparable to the one experienced in the German market this year.


About Biofrontera:

Biofrontera AG is an international biopharmaceutical company specializing in the development and commercialization of a platform of pharmaceutical products for the treatment of dermatological conditions and diseases caused primarily by exposure to sunlight that results in sun damage to the skin. Biofrontera’s approved products focus on the treatment in the U.S. and Europe of actinic keratoses, which are skin lesions that can sometimes lead to skin cancer, as well as the treatment of certain forms of basal cell carcinoma in the European Union. American Depositary Shares representing Biofrontera’s ordinary shares are listed on the NASDAQ Capital Market under the symbol “BFRA”, and Biofrontera’s ordinary shares are listed in the Frankfurt Stock Exchange (B8F, ISIN: DE0006046113). Information is also available at 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 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 Registration Statement on Form F-1 filed with the SEC, including in the section "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.