Veregen®: Distribution rights granted to various marketing partners

The first-in-class topical drug for the treatment of genital warts, Veregen® is based on a defined extract from green tea leaves produced in a highly complex and specifically developed process. Veregen® was the first, and is one of a very small number of innovative botanical drugs approved by the US Food and Drug Administration (FDA).

Medigene conducted the preclinical and clinical development of Veregen® and successfully obtained market approval by the FDA as well as in Europe and further countries.

Veregen® is currently on the market in the USA and Canada, in 20 European countries, and in Taiwan. Numerous marketing agreements for Veregen® are in place with international distribution partners and Medigene generates revenue from royalties, product sales, and milestone payments.

In December 2017, Medigene sold the US rights of Veregen® to Fougera Pharmaceuticals, USA, and still holds all rights outside the US.

RhuDex®: Outlicensed to Dr. Falk Pharma GmbH

RhuDex® is an oral, disease modifying agent to treat autoimmune diseases. It is a CD80 antagonist that blocks undesired T-cell activation and production and therefore has both an immune-modulating and anti-inflammatory effect. The safety and tolerability of RhuDex® have been demonstrated in a number of Phase I clinical trials. Medigene has successfully completed a pilot Phase IIa trial in the indication rheumatoid arthritis. In 2013, Medigene outlined preparations for a further clinical development of RhuDex® in the indication of primary biliary cirrhosis (PBC).

Medigene has a license agreement with the pharmaceutical company Dr. Falk Pharma GmbH, Freiburg, for the development and marketing rights to RhuDex® for hepatology and gastroenterology indications. Falk Pharma will assume responsibility and all costs relating to the clinical development and marketing of RhuDex® in these therapeutic areas.

Falk Pharma has initially concentrated on development in primary biliary cirrhosis (PBC). Medigene retains the rights for RhuDex® in rheumatoid arthritis, psoriasis and other autoimmune diseases.