DGAP-News: Dermapharm takes legal action against approval of a competitor product

Dermapharm takes legal action against approval of a competitor product
 

Grünwald, November 16, 2018 - Dermapharm Holding SE (WKN A2GS5D, ISIN DE000A2GS5D8), a leading manufacturer of patent-free branded pharmaceuticals for selected therapeutic areas in Germany with a growing international presence, is taking legal action against the approval of the generic drug "Colecalciferol 20,000 I.E. ARISTO". The Company is of the opinion that the competing product to Dermapharm's vitamin D preparation "Dekristol 20,000 I.E." in the package size of 50 capsules was unlawfully notified and should therefore not have been part of the approval by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).

Dermapharm has taken and will continue to take all necessary legal action regarding the marketing approval for "Colecalciferol 20,000 I.E. ARISTO" in the package size of 50 capsules. In the opinion of the Company, the approval of the competitive product has no effect on the sales expectations for Dekristol 20,000 I.E. in the current financial year. In the event that the competitor's product is likely to be sold permanently, Dermapharm has formed initial scenarios for potential effects on the financial figures. Even in a worst-case scenario, the company does not currently expect a significant impact on the Group's profitability in the coming financial year. In this case, Group EBITDA should only be affected in the low single-digit percentage range.

With Dekristol, Dermapharm has a very strong brand that has been established among self-payers for decades. From the Company's point of view, it is not to be expected that self-payers will switch to an unknown generic on a larger scale. It should also be noted that pharmacists or doctors in this market are in no way obliged to sell or prescribe cheaper generic products. Overall, Dermapharm has a very broad portfolio with strong branded products that have developed very well in the current financial year. Examples of this are the brands Keltican^(R), Solacutan^(R), Tromcardin^(R), bite away^(R), Herpotherm^(R) or the newly introduced and patented care range Physiotop^(R).
 

Company profile:

Dermapharm - Pharmaceutical Excellence "Made in Germany"

Dermapharm is a leading manufacturer of patent-free branded pharmaceuticals for selected markets in Germany. Founded in 1991, the company is based in Grünwald near Munich and has its main manufacturing facility in Brehna near Leipzig. The company's integrated business model comprises in-house development, in-house production and distribution of pharmaceuticals and other healthcare products for specifically targeted markets by a medical and pharmaceutical sales force. Dermapharm holds approximately 950 marketing authorizations (Arzneimittelzulassungen) for more than 250 active pharmaceutical ingredients, which are marketed as pharmaceuticals, dietary supplements or supplemental balanced diets. This assortment makes the company unique. In addition to Germany, the company's core markets also include Austria and Switzerland. The company plans to further expand its international presence. Dermapharm's business model also includes a parallel import business, which operates under the "axicorp" brand. Based on revenues, Dermapharm was among the top five parallel import companies in Germany in the first half-year 2018.

With a consistent development strategy and numerous successful product and company acquisitions over the past 25 years, Dermapharm has continuously optimized its business and provided external growth impulses in addition to organic growth. Dermapharm intends to continue this profitable growth course in the future. The company is focusing on three strategic growth drivers: in-house development of new products, increase of its international footprint and further acquisitions. These include the acquisition of the pharmaceuticals manufacturer and distributor Trommsdorff in January 2018, whose portfolio includes the well-known brands Keltican^(R) forte and Tromcardin^(R) complex.

Contact

cometis AG
Claudius Krause
Phone: +49 (0)611 - 205855-28
Fax: +49 (0)611 - 205855-66
E-mail: ir@dermapharm.de