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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (867)	10/7/1998 10:57:00 AM
From: Anthony Wong	Respond to of 1722

Glaxo Wins FDA Panel Backing for Drug for Hepatitis (Update1) Bloomberg News October 6, 1998, 3:07 p.m. ET Glaxo Wins FDA Panel Backing for Drug for Hepatitis (Update1) (Adds panel action.) Silver Spring, Maryland, Oct. 6 (Bloomberg) -- Glaxo Wellcome Plc's AIDS drug lamivudine should be approved for expanded use in patients suffering from hepatitis B, members of a U.S. Food and Drug Administration advisory panel said. The FDA panel voted unanimously to back use of the drug, originally discovered by Canada's BioChem Pharma Inc., in patients with chronic hepatitis B. Glaxo, the world's second biggest drugmaker, currently sells the drug in a different dose as the anti-HIV treatment known as 3TC or Epivir. If the FDA follows the advice of the panel as it usually does, the once-daily tablet will become the first oral therapy approved in the U.S. to fight hepatitis B. ''I think this is an important advance, an important drug,'' said Sam Lee, a guest member of the panel from the University of Calgary. Glaxo's American depositary receipts rose 1 11/16 to 54 1/8 in recent trading, while shares of BioChem were halted. BioChem will receive royalties on Glaxo's sales of the drug in hepatitis as it does in AIDS, where the drug is a top seller. Some 300 million to 350 million people around the world -- the vast majority in Asia -- suffer from hepatitis B, a debilitating liver disease which can cause problems such as cirrhosis and liver cancer. In the U.S., the Hepatitis B Foundation estimates that one out of 20 people become infected at some point in their lives. Most adults clear the virus themselves after a brief infection. Still, more than 1 million people are left as chronic carriers of the disease. $3 Bln Market Analysts say the worldwide market for effective drugs to treat hepatitis B could easily top $3 billion, with lamivudine bringing in as much as $1 billion a year. Glaxo has filed for approval of the drug in more than 30 countries and has already won approval in the Philippines. Hepatitis B is one of three main forms of viral hepatitis. Hepatitis A is usually caused by unsanitary conditions and can be spread through food, yet is generally easily overcome. Hepatitis C, a more recently identified virus, is spread mainly through contact with infected needles or blood transfusions and is tough to treat. Hepatitis B, however, is rougher on the body than hepatitis A and more infectious than hepatitis C. Hepatitis B is 100 times more infectious than HIV, and the virus can live for at least seven days outside of an infected person. The infection is the ninth leading cause of deaths, claiming about 1 million lives annually. Immunization Rates Low There are vaccines available to prevent hepatitis B made by companies including Merck & Co. and SmithKline Beecham Plc. Still, even though more children in the U.S. are getting vaccinated every year, worldwide immunization rates are still relatively low. If approved, lamivudine would offer an alternative treatment to immune system-boosting medicines known as interferons, sold by companies including Roche Holding AG and Schering-Plough Corp. Mainstays of hepatitis B therapy, these injected drugs still aren't taken by many patients because they're expensive, have nasty side effects and are often ineffective in the long run. During a company presentation today, Glaxo officials presented studies showing that lamivudine could reduce liver inflammation and other problems while greatly reducing the hepatitis virus in the body. The drug also appeared to have fewer side effects, such as fatigue, headache and fever, than interferon, the company said. Several patients during an open public hearing pleaded with the panel to approve the new use for lamivudine. Scott Lincoln, 35, credited the drug with allowing him to return to a semi- normal life and work for the first time in six years. ''My health had dramatically improved,'' he said. Some Concerns FDA officials voiced some concern about patients who initially saw their virus levels decline and then saw them increase later in the study. They also voiced concern about the fact that some patients had flare-ups of their hepatitis after ending treatment and others ended up with mutated forms of the virus that could be drug-resistant. Panel members said they had concerns about these things. Still, they found the drug was safe and effective and provided a critical new option for patients. Lamivudine may be the just the first in a wave of promising developments for hepatitis B patients. Companies including SmithKline, Bristol-Myers Squibb Co. and Protein Design Labs Inc. are all developing or testing treatments that could provide new options. Meanwhile, SciClone Pharmaceuticals Inc. sells its injectable Zadaxin hepatitis drug in several countries including China. --Kristin Jensen in Silver Spring, Maryland and Kristin Reed in

To: Anthony Wong who wrote (867)	10/7/1998 10:57:00 AM
From: Anthony Wong	Respond to of 1722

Pfizer Inc. Reiterated 'Strong Buy' at SG Cowen Bloomberg News October 7, 1998, 9:49 a.m. ET Princeton, New Jersey, Oct. 7 (Bloomberg Data) -- Pfizer Inc. (PFE US) was reiterated ''strong buy'' by analyst Stephen Scala at SG Cowen.