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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: John Carragher who wrote (8491)	9/10/2003 8:47:05 AM
From: John Carragher	Respond to of 9523

Roflumilast, thought to have blockbuster potential. Reuters UPDATE - Altana lung drug trial data positive, shares soar Wednesday September 10, 8:24 am ET By Mark Thompson and Sitaraman Shankar (Adds more analyst comment, context, updates shares) FRANKFURT, Sept 10 (Reuters) - German drugmaker Altana AG (XETRA:ALTG.DE - News) said on Wednesday a Phase III trial of its key asthma and smoker's cough drug roflumilast had produced positive results, sending its shares up as much as 11.6 percent. "An analysis of the data shows positive results, which also confirm data from earlier trials," the company said in a statement. Phase III is the final phase of clinical trials before a drug can be brought to market. The announcement came just days after a U.S. Food and Drug Administration (News - Websites) (FDA) panel recommended that the regulator reject approvals for a similar GlaxoSmithKline (London:GSK.L - News) drug, Ariflo, and analysts said this might have lifted Altana shares more than expected. "The news is encouraging, but we're surprised the shares are up as much as they are as there's little data on Phase III," said John Reeve, analyst at BNP Paribas in London. "The real issue is that Altana has commented that the data is encouraging, and (also) this comes soon after the problems GSK had with the FDA panel," said Reeve, who has an "outperform" rating on the stock and a price target of 62 euros. Altana shares, a constituent of the blue-chip DAX index (XETRA:^GDAXI - News), came off a high of 57.70 euros and were trading at 54.91 euros at 1209 GMT, still up 6.19 percent and outperforming the benchmark index, which was down one percent. "There's obviously a large amount of relief at Altana's success after GSK...roflumilast is one of the company's top products and is not fully in the share price," said Alexander Groschke, analyst at Landesbank Rheinland-Pfalz. Altana said it would present detailed results of the late-stage trial, carried out on 1,400 patients suffering from chronic obstructive pulmonary disease, or smoker's cough, at a conference of the European Respiratory Society later this month in Vienna. EUROPEAN APPROVAL The firm said it planned to file an application for approval for the drug in Europe towards the end of the year. It has said in the past that it aims to file for U.S. approval in 2004 or 2005. The drug is being developed worldwide, with the exception of Japan, in partnership with Pfizer Inc (NYSE:PFE - News). In Japan, Altana's partner is Tanabe Seiyaku Co. Ltd (Tokyo:4508.T - News). Altana said the drug would be marketed worldwide under the brand name Daxas. Roflumilast, along with asthma drug ciclesonide, is one of two drugs in Altana's pipeline thought to have blockbuster potential. It belongs to a class of drugs called phosphodiestrase-4 (PDE-4) inhibitors, which are thought to combat lung inflammation. No PDE-4 inhibitors, however, have yet been approved by the FDA and many analysts are sceptical about the value of the class. GSK was not the first company to have a setback with a PDE-4 inhibitor. In April, Merck & Co, Inc. (NYSE:MRK - News) announced it was dropping development of a PDE-4 inhibitor because of safety concerns.