The drugs group Medeva has signed the first development and marketing deal for its novel hepatitis B vaccine and treatment, Hepagene. Janssen Pharmaceutica International, a subsidiary of the US drugs giant Johnson & Johnson, will take on all marketing of Hepagene in the Asia-Pacific region outside Japan and conduct clinical trials on the drug, which has yet to receive official approval for sale.
Medeva is currently embroiled in patent infringement litigation with Biogen, a US company which produces and sells a rival drug, and the latest deal will give a boost to the chances of Hepagene coming to the market. Medeva's shares rose 8p to 275p yesterday as dealers welcomed the news.
No figures were being put on the deal, but Janssen is the biggest multi- national drugs group in Korea and China, the two biggest markets in the region. With around 200 million carriers of hepatitis B in the Asia-Pacific area outside Japan, the potential for Hepagene is substantial. Bill Bogie, Medeva's chief executive, said: "Hepatitis B is prevalent in the Asia- Pacific region and this is one of our key target markets. We believe Janssen's presence and capabilities in the region make them an excellent partner in developing and commercialising our product there."
Janssen will undertake clinical trials, make regulatory submissions and provide marketing in the Asia-Pacific region. Medeva will make and supply the drug and will receive staged payments as regulatory submissions are made and approvals received.
Hepagene, acquired in 1992 from Epitec, a Swiss company, is currently being developed for both the prevention and cure of hepatitis. In its preventative vaccine form, the drug is already being tested on human patients in advanced phase-three trials, which are expected to end next year. Assuming no further tests are required, regulatory approval could be expected one or two years later, suggesting the drug could be on the market as a vaccine in 1997 or 1998.
The therapeutic form of Hepagene is still going through earlier-stage tests in the UK, intended to prove whether in principle the compound works on the disease in humans.Reuse content