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

To: Henry Niman who wrote (1406)	2/9/1999 5:59:00 PM
From: blake_paterson	Respond to of 1722

Henry: Ever hear of these guys? Can you tell me what compound class this "DIAB II" is from? Thanks in advance, BP Biotech Holdings' Type II Diabetes Drug is not Affected by Safety Concerns That Have Led to New FDA Probe of Rezulin January 28, 1999 07:59 AM VANCOUVER, Jan. 28 /PRNewswire/ -- Biotech Holdings' oral diabetes drug DIAB II is not affected by the safety concerns that have arisen around Warner-Lambert's Rezulin, Biotech President Robert Rieveley explained today, noting that DIAB II and Rezulin both treat Type II Diabetes but work through different pathways and are not chemically related. "Laboratory and human patient studies," Mr. Rieveley added, "have shown DIAB II to be effective and benign. DIAB II has been available to the public for the past eighteen months during which there have been no reported cases of dangerous side effects. DIAB II was recently awarded the distinction of being the 'Best New Drug in China' by The China Consumers Association, an independent branch of the government." Mr. Rieveley also stated that "We believe that the effectiveness and safety record of DIAB II in the treatment of Type II Diabetes will have a major impact on the market for our product in the near future and will make it the medication of choice." The market for insulin-sensitizing drugs, as a treatment for Type II or Adult-Onset Diabetes, is very large. Sales for this class of drugs are projected to show rapid growth, to over $5 billion (US) in annual sales by the year 2003, states a market analysis published by Deutsche Morgen Grenfell. One example of the demand for insulin sensitizing drugs is sales of Rezulin by Warner Lambert which reached $748 million in 1998. Traditionally diabetes has been treated with medications that increase production of insulin, the hormone that controls blood sugar levels, or decrease formation of glucose. DIAB II targets insulin resistance as a means of managing the chronically high blood sugar levels that characterize diabetes. DIAB II and Rezulin both improve the patient's sensitivity to insulin but are otherwise not related. Rezulin, known chemically as troglitazone, is a member of the "glitazone" family of drugs, known to be potentially toxic to the liver. Rezulin has been associated with 33 deaths since its approval in the U.S. in 1997. The FDA decision to re-assess Rezulin was instigated by the fact that, recently, two patients who had successfully passed their required monthly liver toxicity test, died soon after. SmithKline Beecham's insulin-sensitizing drug Avandia, known chemically as rosiglitazone, is also a member of the "glitazone" chemical family. DIAB II is not chemically related to Rezulin or Avandia and has a different mode of action. Mr. Rieveley points out that "DIAB II is the only insulin sensitizing drug that is presently on the market or submitted for approval internationally that is not a glitazone." The need for a new class of drugs that improve on current Type II Diabetes treatment regimens has long been recognized. Although Biotech has not yet applied to the FDA for approval for DIAB II, the company has been in discussions with a number of international pharmaceutical companies to examine partnering potential. Biotech has focused its efforts on exploring possibilities for a joint venture that would submit DIAB II for approval to the FDA as part of a distribution and/or licensing agreement for North America and Western Europe. The company currently sells DIAB II in China and has been invited to have the drug included in that country's national health plan, which would give close to 29 million Type II Diabetics access to the medication. In addition to China, the company has focused its distribution efforts on Latin America where there are an estimated 26 million Type II Diabetics who have access to the health care systems in their countries. In Brazil, Biotech has signed a licensing agreement with Biobras, S.A., the fourth largest insulin producer in the world, to market and distribute DIAB II. Biotech will continue to develop its position in the global market place through the use of strong local strategic partners in regions of the world were Type II Diabetes affects large segments of the population. SOURCE Biotech Holdings Ltd.