Benzinga | Dec 7, 2020 09:15AM EST

Biofrontera Enters Into A License And Supply Agreement With Galenica AB For The Marketing Of Ameluz In Scandinavia

Leverkusen, Germany, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Biofrontera Pharma GmbH, a wholly owned subsidiary of Biofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F))))), and Galenica AB, Malm?, Sweden, today signed an exclusive license and supply agreement for the marketing of both Ameluz(r) and BF-RhodoLED(r) in Sweden, Norway, Denmark, Finland and Iceland.



According to the agreement, Galenica AB of Malm?, Sweden, receives exclusive distribution rights for the Nordic regions, whereby Biofrontera will supply Ameluz(r) to Galenica at a transfer price of 50% of the expected net revenues. Furthermore, Biofrontera will be responsible for the marketing authorization as well as manufacturing and quality control, while Galenica will handle all aspects of commercialization, local registration and reimbursement in the Scandinavian countries. Both companies will collaborate on regulatory compliance regarding drug safety (pharmacovigilance). After the amicable termination of the agreement between Biofrontera and the former distribution partner for some of these regions, Galenica is now working towards the reintroduction of the products in Denmark, Sweden and Norway and their initial launch in Finland and Iceland by the middle of next year. In addition, Galenica has a right of first refusal for commercialization in the Baltic States.

Ronnie Wallin, CEO of Galenica AB: "Due to the increasing number of cases as well as the growing attention, sun-induced skin cancers today are a major cause for visits to dermatologists. We are therefore very pleased to be able to offer this excellent drug for the treatment of actinic keratosis and basal cell carcinoma to dermatologists in our region."

Prof. Dr. Hermann L?bbert, CEO of Biofrontera AG, commented: "Following the recent highly focused development and expansion of our own sales structures, and naturally the need to limit our efforts to selected countries, we are now particularly pleased to have a new strong partner on our side, who will again successfully commercialize Ameluz(r) in the Scandinavian countries."

Galenica AB was established in 1999 at Medeon Science Park, Malm?, Sweden and is now, as a leading pharmaceutical company in Scandinavia, active in the development of new pharmaceutical products. Galenica AB has a successful track record in pharmaceutical development, from early stage formulation concepts all the way to products on the market. Galenica AB has two products on the market. Ovixan(r) is an improved prescription mometasone cream for the treatment of psoriasis and eczema, and Oviderm(r) is a moisturizer for the treatment of dry skin. With this deal, Galenica will add Ameluz(r) to its dermatology portfolio in the Nordics.

Background:

In 2011, the prescription drug Ameluz(r) received a centralized EU marketing authorization from the European Commission, which since then has repeatedly been expanded. Ameluz(r) is approved for use in photodynamic therapy (PDT) of mild to moderate actinic keratoses, field cancerization, and superficial and nodular basal cell carcinomas. Ameluz(r) is approved for the use in conventional PDT with a special red-light lamp as well as for daylight PDT. Ameluz(r) is the only PDT drug worldwide that is approved for the treatment of field cancerization, i.e. continuous surfaces with actinic keratoses and other sun damage, and is not restricted to the treatment of individual keratoses only.