By Matthew Willett

Novirio Pharmaceuticals Ltd. CEO Jean-Pierre Sommadossi¿s plans to tap into one of the world¿s largest hepatitis B markets made the $46 million development and distribution deal with Japan¿s biggest hepatitis C marketer a natural.

Tokyo-based Sumitomo Pharmaceuticals Co. Ltd. and privately held Novirio, of Cambridge, Mass., are disclosing the deal today that gives Sumitomo marketing rights to LdT for hepatitis B in Japan, China, Taiwan and South Korea for $46 million in up-front payments and milestones, as well as what Sommadossi called a substantial royalty rate on sales.

Sommadossi told BioWorld Today the deal for LdT, a mirror of an endogenous human nucleoside now in Phase II testing, lets Novirio take advantage of an entrenched sales structure in Asia without wasting precious time.

¿Asia and Japan is a major market, and we don¿t anticipate being able to build the sales structure we¿ll need to have rapid market penetration,¿ Sommadossi said. ¿We¿re pleased to announce that on Friday we¿ll sign an agreement with Sumitomo, the largest marketer of interferon for hepatitis C in Japan. In addition, Sumitomo is building more and more of a presence in China. They¿re the ideal partner for us.¿

Novirio will retain all rights, for the time being at least, for LdT commercialization in the rest of the world, Sommadossi said, and Sumitomo will chip in for worldwide development costs, splitting the clinical and regulatory expense with Novirio ¿about equally.¿

Sommadossi said the company, which raised $44 million though a private placement two months ago, could seek a marketing partner for European or North American distribution and marketing in the near future. (See BioWorld Today, May 8, 2001.)

The deal comes none too soon for Novirio, Sommadossi said, since clinical development for LdT is moving at a fast pace. Novirio, he said, is on a track that could lead to global registration by mid-2004. LdT will enter Phase III trials early next year, he said.

Sommadossi said the key to the quick development for the drug, a novel antiviral that binds to a different site than hepatitis B therapeutics, is ¿people, people, people.¿

¿The management that has joined Novirio since we were founded has more than 150 years of experience, and experience in antivirals, eight new drug applications in HIV, hepatitis B and hepatitis C, and 10 investigational new drug applications under its belt,¿ Sommadossi said. ¿Management with experience in managing sales forces and each at the prime of their career who left big pharma and joined Novirio in the last 24 months.¿

In fact, Sommadossi said, Novirio¿s senior vice president of hepatitis clinical affairs, Ned Brown, was a major player in the global registration of the antiviral lamivudine (3TC), which is approved for treatment of HIV and hepatitis.

Sommadossi founded Novirio in 1998, and his plans for antivirals center on potency and specificity. ¿A key in the lock,¿ he calls the strategy.

¿The model is to bring drugs to the clinic that are already bioavailable, that can be dosed once daily, and those drugs have to be very specifically active on only the selected virus,¿ he explained. LdT¿s mechanism of action, different than the current hepatitis B therapy lamivudine, will be detailed at a scientific meeting in the fall, he added.

Novirio¿s drug discovery operations are conducted in Montpellier, France, and Cagliari, Italy, with the rest of the operation in Cambridge. Its pipeline includes LdC for the treatment of HBV, which is in Phase I/II trials, and several clinical candidates in late-stage preclinical evaluation for HCV and HIV/AIDS.

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