Medivir and Janssen Pharmaceutica are combining their respective expertise in protease inhibitor discovery and development for a collaboration centered on dengue virus prophylactics and therapeutics. The partnership will focus on inhibiting dengue NS3 protease activity.
Under terms of the deal the firms will contribute equal resources to the research phase of the program. Medivir will have an option to continue to contribute equal funding going forward through the preclinical and clinical development stages. Dependent on the level of funding provided by prespecified decision points, Medivir and Janssen will each have the option to take relevant products through development and commercialization. In the even both firms stay in the collaboration until product approval, Janssen will have responsibility for commercialization, with Medivir receiving pre-agreed royalties on net sales.
Medivir is focused on the development of polymerase and protease inhibitors primarily against infectious diseases. The firm has one marketed product, Xerese™/Xerclear®, which has been approved in the U.S. and Europe as a topical treatment for cold sores. As a prescription drug it is sold by Meda in North America. Medivir has retained the prescription rights for Xerclear® in Sweden and Finland.
The development of Xerese/Xerclear as an OTC product is separately being partnered with GlaxoSmithKline (GSK) in Europe, Japan, Australia, and Russia. Under terms of this deal, signed in June 2010, GSK is responsible for funding ongoing and future commercial development of Xerclear™ in all relevant territories.
Medivir’s clinical pipeline is headed by the HCV therapy candidate, TMC435, partnered with Tibotec. The HCV protease inhibitor is currently undergoing a number of Phase IIb studies. in November 2010, Medivir reported positive top-line 24-week interim data from the Phase IIb Aspire (C206) study evaluating TMC435 in hepatitis C patients who had previously received other treatments for their disease.
Just last week Medivir announced the start of a Phase Ia study with another Tibotec-partnered chronic HCV therapy candidate, TMC649128. Additional partnered or outlicensed clinical programs include candidates for hepatitis B and shingles. Medivir’s preclinical pipeline includes partnered programs for HIV and in-house programs for nonviral disorders including bone diseases, pain, and Alzheimer disease.