SILVER SPRING, Md., April 7 (Reuters) - A U.S. advisory panel rejected an experimental lung drug from Forest Laboratories Inc and Nycomed on Wednesday, saying Forest had not provided enough evidence to support approval of the drug, and its shares fell 8 percent.
The committee voted 10-5 in its decision on Daxas, used for maintenance treatment of chronic obstructive pulmonary disease (COPD).
The Food and Drug Administration usually follows panel recommendations.
Shares of Forest had surged 6.5 percent ahead of the market close after the advisory panel voted that Daxas was safe and effective in separate 9-6 votes.
In opposing approval, some panelists said the benefits of Daxas were small and did not outweigh risks.
'The benefit of this drug, although it's there, it's meager,' said Dr. Richard Honsinger of Los Alamos Medical Center Clinic in New Mexico.
'The drug does have side effects,' he added.
The fate of Daxas, a once-daily pill, is key to Forest as the company tries to build its portfolio ahead of the 2012 patent expiration for its huge-selling antidepressant Lexapro.
Daxas was developed by Nycomed, a privately held Swiss drugmaker aiming for an initial public offering. Forest holds U.S. rights to the drug.
(Reporting by Lisa Richwine; Editing by Gary Hill) Keywords: FOREST DAXAS/ (lisa.richwine@thomsonreuters.com; + 1 202 310 5691; www.twitter.com/ReutersLisaRx) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
The committee voted 10-5 in its decision on Daxas, used for maintenance treatment of chronic obstructive pulmonary disease (COPD).
The Food and Drug Administration usually follows panel recommendations.
Shares of Forest had surged 6.5 percent ahead of the market close after the advisory panel voted that Daxas was safe and effective in separate 9-6 votes.
In opposing approval, some panelists said the benefits of Daxas were small and did not outweigh risks.
'The benefit of this drug, although it's there, it's meager,' said Dr. Richard Honsinger of Los Alamos Medical Center Clinic in New Mexico.
'The drug does have side effects,' he added.
The fate of Daxas, a once-daily pill, is key to Forest as the company tries to build its portfolio ahead of the 2012 patent expiration for its huge-selling antidepressant Lexapro.
Daxas was developed by Nycomed, a privately held Swiss drugmaker aiming for an initial public offering. Forest holds U.S. rights to the drug.
(Reporting by Lisa Richwine; Editing by Gary Hill) Keywords: FOREST DAXAS/ (lisa.richwine@thomsonreuters.com; + 1 202 310 5691; www.twitter.com/ReutersLisaRx) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.