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PTA-News: Biofrontera AG: Commercial launch of Ameluz® in Finland

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Leverkusen; Germany (pta021/19.12.2022/14:05) - Biofrontera AG (ISIN: DE0006046113), an international biopharmaceutical company, announces that its Scandinavian licensing partner Galenica AB, Malmö, Sweden, has now started the commercialization of Ameluz® and BF-RhodoLED® in Finland.

After Galenica had already successfully launched the Ameluz®-PDT in Sweden, Norway and Denmark by mid-2021 under a licensing agreement entered into at the end of 2020, Ameluz® is now also being actively marketed in Finland.

Ms. de la Huerta, CFO of Biofrontera AG, commented: "It is our goal to develop and provide effective actinic keratosis treatment for all people around Europe and the launch in Finland is another milestone on that journey. We are very pleased to have Galenica as a licensing partner at our side, who is actively and successfully driving the expansion of marketing in this region and thus establishing Ameluz® as an excellent drug for the treatment of actinic keratoses. The revenue generated by us and our partners in Europe is expected to gain in importance and thus the regional expansion is a further piece of the puzzle in Biofrontera's commercialization strategy."

Non-melanoma skin cancers are on the rise in the Finnish market, they already represent a main reason for visits to dermatologists and are among the top five most costly cancers and major cost drivers for health care. The actinic keratosis (AK) is strongly represented among these diseases with a share of about 25%. [ Soini EJ et al. Adv. Ther. 2015;32:455-476 ]

As currently only a limited number of patients suffering from actinic keratosis are receiving photodynamic therapy the region holds a large growth potential in the long term. It is estimated that around 15,000 AK patients are receiving a treatment each year which represents only about 50% of what is observed in other European countries.

In Norway, Sweden, and Denmark, Galencia has already realized a significant market growth in PDT treatments. In the last 12 months about 2,500 patients received treatment with Ameluz® which represents almost a five-fold number compared to 2021.

"Galenica has already been able to realize significant PDT market growth in the Scandinavian countries, which reinforces our assumption that we are far from having exhausted the full potential of Ameluz® in Europe. Already this year, the share of sales generated for by the European business has increased significantly, and in mid-term we will be developing our European marketing efforts even more significantly in this region," Ms. de la Huerta further explains.

In Finland Ameluz® can be used in line with the European approval for the treatment of actinic keratoses and basal cell carcinoma with the BF-RhodoLED® lamp as part of conventional photodynamic therapy or as daylight therapy.


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 and is listed on the Frankfurt Stock Exchange (Prime Standard).

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

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Biofrontera AG – an attractive investment

We are experts in photodynamic therapy. With our innovative products and treatment methods, we make our contribution to skin health and at the same time create value for our investors.

Biofrontera is listed on the Frankfurt Stock Exchange (B8FK).