* FDA asks for more data to grant mktg exclusivity
* Co needs to prove drug's clinical superiority
(Adds details, analyst comments, share movement)
Feb 15 (Reuters) - Depomed Inc said U.S. health regulators have sought more details on the clinical superiority of its recently approved pain drug to grant it a 7-year marketing exclusivity on the drug, sending its shares down 9 percent on Tuesday morning.
The drug, Gralise, approved on Jan. 28 for the treatment of pain after healing shingles rash, has an orphan drug status from the U.S. Food and Drug Administration.
'Shares are down on concerns if they (Depomed) will run new trials but the FDA just wants a cross-study comparison, a meta-analysis of Gralise, not any new trials,' Caris & Company analyst James Molloy said.
Analyst Molloy said the FDA likely wants some more data on the comparative analysis of the drug's side-effects.
Depomed will now need to submit additional evidence to prove the clinical superiority of Gralise based on improved safety to obtain the exclusivity.
The FDA grants orphan drug designation to drugs or biologics that treat a condition affecting less than 200,000 Americans.
Shares of Depomed were down 7.3 percent at $8.88 in morning trade on Tuesday on Nasdaq. They touched a low of $8.69 in early trade.
(Reporting by Esha Dey and Rajarshi Basu in Bangalore; Editing by Unnikrishnan Nair and Gopakumar Warrier) Keywords: (rajarshi.basu@thomsonreuters.com)(within U.S. +1 646 223 8780)(outside U.S. +91 80 4135 5800)(Reuters Messaging: rajarshi.basu.thomsonreuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2011. 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.
* Co needs to prove drug's clinical superiority
(Adds details, analyst comments, share movement)
Feb 15 (Reuters) - Depomed Inc said U.S. health regulators have sought more details on the clinical superiority of its recently approved pain drug to grant it a 7-year marketing exclusivity on the drug, sending its shares down 9 percent on Tuesday morning.
The drug, Gralise, approved on Jan. 28 for the treatment of pain after healing shingles rash, has an orphan drug status from the U.S. Food and Drug Administration.
'Shares are down on concerns if they (Depomed) will run new trials but the FDA just wants a cross-study comparison, a meta-analysis of Gralise, not any new trials,' Caris & Company analyst James Molloy said.
Analyst Molloy said the FDA likely wants some more data on the comparative analysis of the drug's side-effects.
Depomed will now need to submit additional evidence to prove the clinical superiority of Gralise based on improved safety to obtain the exclusivity.
The FDA grants orphan drug designation to drugs or biologics that treat a condition affecting less than 200,000 Americans.
Shares of Depomed were down 7.3 percent at $8.88 in morning trade on Tuesday on Nasdaq. They touched a low of $8.69 in early trade.
(Reporting by Esha Dey and Rajarshi Basu in Bangalore; Editing by Unnikrishnan Nair and Gopakumar Warrier) Keywords: (rajarshi.basu@thomsonreuters.com)(within U.S. +1 646 223 8780)(outside U.S. +91 80 4135 5800)(Reuters Messaging: rajarshi.basu.thomsonreuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2011. 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.