Traderboersenboard - Einzelnen Beitrag anzeigen - Merck

Tester32 · 30-10-2004, 10:34

Reuters, Fri Oct 29, 2004 11:06 AM ET
(Updates with analyst comment, share price)

NEW YORK, Oct 29 (Reuters) - Merck & Co. (MRK.N: Quote, Profile, Research) on Friday said U.S. regulators won't approve its experimental arthritis drug Arcoxia until the company provides more data showing it is safe and effective.

Arcoxia is a successor to Merck's arthritis drug Vioxx, which the company withdrew from the market after it was shown to double the risk of heart attack and stroke in patients who had been taking it for at least 18 months.

Investors had not expected the U.S. Food and Drug Administration to immediately approve Arcoxia, which, like Vioxx, is in a class of drugs known as COX-2 inhibitors. The withdrawal of Vioxx, which generated some $2.5 billion in annual sales, has cast a cloud over the entire class, including Celebrex and Bextra, made by Pfizer Inc.

"Arcoxia will not see the light of day until at least 2007, if it gets to market," said Barbara Ryan, an analyst at Deutsche Bank. "Even then, its future annual sales will probably not exceed $200 million because the drug has a lot of properties similar to Vioxx."

Merck did not say exactly what new data the FDA has requested, or whether the company needs to begin entirely new trials. Raymond Gilmartin, the company's chief executive officer, said the company plans to work with the agency to "address what steps need to be taken before the application may be approved."

Arcoxia has been launched in 48 countries around the world, including Europe, Latin America and Asia. Merck said it will continue to work with regulatory agencies in those countries to determine whether changes need to be made to the drug's prescribing label.

Before the recall of Vioxx, analysts had expected Arcoxia to generate annual sales of about $1 billion by 2008. Merck was counting on Arcoxia to help fill the financial void caused by the disappearance of Vioxx, which accounted for more than 10 percent of Merck's revenue in 2003.

Arcoxia could have a long road ahead of it. The only trial in which the drug has been tested against placebo lasted 12 weeks, though a one-year study of osteoarthritis patients taking the drug showed they had no greater incidence of heart attacks than patients taking diclofenac, a standard treatment.

Merck's shares rose 23 cents, less than 1 percent, to $31.81 on the New York Stock Exchange.

30-10-2004, 10:34	#45
Tester32 TBB Family Registriert seit: Jan 2004 Beiträge: 2.209	UPDATE 2-FDA holds off approval of new Merck arthritis drug Reuters, Fri Oct 29, 2004 11:06 AM ET (Updates with analyst comment, share price) NEW YORK, Oct 29 (Reuters) - Merck & Co. (MRK.N: Quote, Profile, Research) on Friday said U.S. regulators won't approve its experimental arthritis drug Arcoxia until the company provides more data showing it is safe and effective. Arcoxia is a successor to Merck's arthritis drug Vioxx, which the company withdrew from the market after it was shown to double the risk of heart attack and stroke in patients who had been taking it for at least 18 months. Investors had not expected the U.S. Food and Drug Administration to immediately approve Arcoxia, which, like Vioxx, is in a class of drugs known as COX-2 inhibitors. The withdrawal of Vioxx, which generated some $2.5 billion in annual sales, has cast a cloud over the entire class, including Celebrex and Bextra, made by Pfizer Inc. "Arcoxia will not see the light of day until at least 2007, if it gets to market," said Barbara Ryan, an analyst at Deutsche Bank. "Even then, its future annual sales will probably not exceed $200 million because the drug has a lot of properties similar to Vioxx." Merck did not say exactly what new data the FDA has requested, or whether the company needs to begin entirely new trials. Raymond Gilmartin, the company's chief executive officer, said the company plans to work with the agency to "address what steps need to be taken before the application may be approved." Arcoxia has been launched in 48 countries around the world, including Europe, Latin America and Asia. Merck said it will continue to work with regulatory agencies in those countries to determine whether changes need to be made to the drug's prescribing label. Before the recall of Vioxx, analysts had expected Arcoxia to generate annual sales of about $1 billion by 2008. Merck was counting on Arcoxia to help fill the financial void caused by the disappearance of Vioxx, which accounted for more than 10 percent of Merck's revenue in 2003. Arcoxia could have a long road ahead of it. The only trial in which the drug has been tested against placebo lasted 12 weeks, though a one-year study of osteoarthritis patients taking the drug showed they had no greater incidence of heart attacks than patients taking diclofenac, a standard treatment. Merck's shares rose 23 cents, less than 1 percent, to $31.81 on the New York Stock Exchange.