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Biotech / Medical : Biochem Pharma (BCHE) -- Ignore unavailable to you. Want to Upgrade?

To: Marc Fortier who wrote (468)	10/6/1998 5:44:00 PM
From: Richard Haugland	Read Replies (1) \| Respond to of 783

Epivir recommended for approval!!! Up tomorrow to ??? Dow Jones Online News, Tuesday, October 06, 1998 at 15:42 WASHINGTON -(Dow Jones)- A Food and Drug Administration advisory panel Tuesday endorsed Glaxo Wellcome PLC's AIDS drug Epivir as a treatment for hepatitis B. The Antiviral Drugs Advisory Committee unanimously recommended the full FDA approve the drug for treating chronic hepatitis B. The agency isn't bound by the panel's vote but usually heeds the advice of its panels. Epivir, also called 3TC, received FDA approval in November 1995 to be used in combination with Glaxo's Retrovir, or AZT, to treat patients with HIV or AIDS. Epivir, generically known as lamivudine, is one of several drugs that block production of an essential viral protein known as reverse transcriptase. Both HIV and hepatitis B use this enzyme. Last year, Epivir had sales of $302.9 million, and the drug recorded $139.2 million in sales in the first half of 1998, according to IMS Health, a pharmaceutical market research company. Currently, injected interferon is the only approved hepatitis B treatment. If approved, Glaxo will sell its drug in tablet form under the name Epivir HBV. The drug already is approved to treat hepatitis B in the Philippines, New Zealand and Pakistan. Hepatitis B is a highly infectious disease that attacks the liver and is transmitted via bodily fluids. Most people are able to fight off the infection, while less than 10% will develop chronic hepatitis B, which causes liver inflammation, scarring and in some cases, liver cancer. The disease has few symptoms in its early stages. Once it has progressed, there are flu-like symptoms and extreme fatigue. In the U.S., the American Liver Foundation estimates, 1.2 million people are infected with hepatitis B, with 200,000 new cases annually. World-wide, there are an estimated 300 million cases, mostly in Asian countries. Analyst Neil Sweig, who follows Glaxo for Southeast Research Partners, estimates the U.S. sales of Epivir HBV could peak at or above $300 million in three to five years. Global sales could reach $1 billion, Sweig said. Glaxo Wellcome (GLX) licensed Epivir from its discoverer, Quebec-based BioChem Pharma Inc. (BCHE), of which Glaxo owns a 15% stake.