Biochem Pharma To File NDA For 3TC In June

Biochem Pharma will file a US New Drug Application for 3TC (also known as lamivudine) for first-line therapy of HIV infection in combination with Glaxo Wellcome's Retrovir (zidovudine) in June, according to Michael Grey, president and chief executive of the company's Biochem Therapeutic subsidiary, speaking at last week's Hambrecht & Quist conference (see also page 19).

In addition, he said, other international regulatory filings will be made shortly after the US filing, and a first approval is expected by year-end. For the hepatitis B virus indication, further data from a six-month Phase II trial of lamivudine will be presented at the European Association for the Study of Liver Diseases meeting in Copenhagen in August. The Phase III program (in both alpha interferon-naive and treated patients) has been underway since July 1994 and should be completed next year, said Mr Grey. A filing for the HBV indication is anticipated in fourth-quarter 1996, with a launch pencilled in for 1997.