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Biotech / Medical : Celltech Group (NYSE: CLL) -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (43)	9/5/2002 5:00:25 PM
From: keokalani'nui	Read Replies (1) \| Respond to of 123

Altana shares dive after lung-drug filing delay Thursday September 5, 12:06 pm ET By Steven Silber (Adds comments by board member on Roflumilast, Bayer) FRANKFURT, Sept 5 (Reuters) - Germany's Altana AG (XETRA:ALTG.DE - News) postponed its European filing for regulatory approval of a key respiratory drug on Thursday, battering its shares on concerns a potential blockbuster may not come to market. Altana's shares, which had roughly tripled in value over 2-1/2 years as investors priced in the R&D successes of the company, dropped as much as 18.9 percent to a 15-month low. Altana, Germany's third-largest drugs group in terms of market value, postponed its European filing for Roflumilast by about one year to the end of 2003, around which time it plans to file in the United States. The firm said at an R&D presentation it wanted to collect more testing data and ensure the quality of this new kind of drug for asthma and "smoker's lung". Neither the regulatory authorities nor its U.S. partners had requested the delay. "We have not been asked by any agency in Europe to postpone our filing date, it is merely our own decision to get a broader data package because it is a new therapy," management board member for pharmaceuticals Hans-Joachim Lohrisch told Reuters. "We did not see any negative data, the clinical development is on schedule." Altana upped its global peak sales forecast for Roflumilast, a once-daily tablet, to about one billion euros ($993 million) from 800 million, but this failed to cheer investors. "Particularly when a firm places high hopes in terms of sales on a drug and delays the launch by a year, then that's deadly in this kind of market. People read about the delay and sell the stock right away," a trader at a big foreign bank said. Altana said the latest late-stage test data for Roflumilast and Ciclesonide -- a steroid drug used in asthma inhalers -- confirmed their efficacy. Roflumilast will be co-marketed by U.S.-based Pharmacia Corp. (NYSE:PHA - News), which is being taken over by Pfizer Inc. (NYSE:PFE - News). Roflumilast treats asthma and chronic obstructive pulmonary disease (COPD) -- "smoker's lung", encompassing emphysema and chronic bronchitis. QUANDT FAMILY OWNS MAJORITY By 1525 GMT, Altana shares fell 12.3 percent to 40.25 euros versus a 0.1 percent rise on the DJ Stoxx health index (Zurich:^SXDP - News). The shares, just over half of which are held by Germany's Quandt family, hit a life high of 65.34 euros on April 15. The stock transfers to the blue-chip DAX index (XETRA:^GDAXI - News) on September 23 from the mid-cap MDAX (XETRA:^MDAXI - News). "I suppose that after analysing the Phase III data they've decided to make a bigger product out of Roflumilast, to extend the test data and enable very aggressive marketing," said Bankgellschaft Berlin analyst Meng Si. Roflumilast is a PDE-4 inhibitor drug, none of which have yet reached the market after failures by rivals such as Germany's Bayer AG (XETRA:BAYG.DE - News). PDE-4 inhibitors cut inflammation in white blood cells and smooth muscle in the lungs. ABN Amro said in a research note the Roflumilast delay could benefit GlaxoSmithKline Plc (London:GSK.L - News), whose Ariflo PDE-4 inhibitor for COPD is expected to be filed both in Europe and the United States in the second half of this year. Lohrisch meanwhile denied speculation by some analysts that Altana might be one of the companies with which Bayer was talking to form a pharmaceuticals tie-up. "I'm not aware of any negotiations between Bayer and ourselves," Lohrisch told Reuters. Altana also took a step in building its sales force by announcing it would co-promote Pharmacia's incontinence drug Detrol in the United States from October. Merrill Lynch analyst Andreas Schmidt said he expected Detrol to achieve U.S. sales of $618 million this year, reaching $1.1 billion by 2006. The two lung drugs, candidates to achieve blockbuster status, are set to transfer Altana from a one-product shop offering ulcer drug Pantoprazole into a respiratory powerhouse. Ciclesonide, to be marketed in the United States with Franco-German Aventis SA (Paris:AVEP.PA - News) under the name Alvesco, was filed for regulatory approval in Europe in June. Altana's peak sales forecast for Ciclesonide, which also treats hay fever, is around one billion euros. The company plans to file for U.S. approval in the second quarter of next year. Citing two late-stage studies, Altana said Ciclesonide was better for treating asthma than comparable leading products budesonide and fluticason, while showing better tolerability. Budesonide is used in AstraZeneca Plc's (London:AZN.L - News) Pulmicort. (additional reporting by Hannfried von Hindenburg)