To: Miljenko Zuanic who wrote (42 ) 6/22/2001 12:21:01 AM From: Miljenko Zuanic Read Replies (1) | Respond to of 126 Can't confirm, but if true it is good news for Corvas c2 protein. AstraZeneca Denies Problems With Experimental Thrombin Drug -------------------------------------------------------------------------------- LONDON (Reuters Health) Jun 20 - AstraZeneca Plc said on Wednesday that it does not anticipate liver toxicity problems with an experimental anti-thrombosis drug, after Bank of America downgraded the stock on concerns about the issue. "Liver enzymes have been monitored in clinical studies and there appears to be no cause for concern," a spokesman said. The oral thrombin inhibitor, known by the code H376, is one of five potential blockbusters which AstraZeneca hopes will revitalise sales following the demise of best-selling ulcer pill Losec. It is still several years from reaching the market. BoA downgraded the shares to "market perform" from "buy" and cut peak sales forecasts for H376 to $1 billion a year from $2 billion following new data from a phase II study presented at the World Congress of Neurology this week. Pharmaceuticals analyst Mark Purcell noted the study had found eight patients with elevated liver enzyme levels. Of those patients, three people — representing an overall incidence of 1.6% — were taken off the medicine because enzyme levels were eight to nine times the upper level of normal. AstraZeneca said that H376, like other anti-coagulants, could produce a "transient" increase in liver enzymes, but that this is not a matter for serious concern. Purcell argued, however, that it could become an issue if the problem resurfaces in phase III trials. AstraZeneca has not given sales forecast for H376 but has dubbed the drug a potential "megabrand," implying peak sales of over $1 billion. The Anglo-Swedish company expects to file the product for regulatory approval for the prevention of stroke in patients with atrial fibrillation in 2003. The current standard treatment for atrial fibrillation, a condition characterized by rapid heartbeats, is the drug warfarin. Warfarin is difficult to use since excessive dosing can cause serious bleeding and patients require costly monitoring.