* Co says unclear what additional info FDA requires
Jan 28 (Reuters) - Theravance Inc said U.S. health regulators have deemed incomplete additional data that the company had submitted in support of its pneumonia drug, sending its shares down as much as 20 percent after the bell.
In November, the U.S. Food and Drug Administration issued a complete response letter for its drug Telavancin in treatment of nosocomial pneumonia, and asked for additional data to approve the drug.
On Thursday, the company said the FDA also suggested a design for new clinical trial(s) and suggested the company request a meeting with the agency.
'It is unclear at this point what additional information the FDA will require to complete their review of the nosocomial pneumonia new drug application,' Theravance Chief Executive Rick Winningham said in a statement.
There was no guidance provided regarding the primary clinical efficacy endpoint suitable for approval, the size or number of additional studies required, or statistical methods for evaluation of clinical results, the company added.
Telavancin is already approved as a treatment for complicated skin and skin structure infections (cSSSI)
Shares of Theravance were trading down at $12.01 in after-hours trade, after closing at $13.50 Thursday on Nasdaq.
(Reporting by Jennifer Robin Raj in Bangalore; Editing by Anthony Kurian) Keywords: THERAVANCE/ (aruna.jennifer@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging:aruna.jennifer.reuters.com@reuters.net) 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.
Jan 28 (Reuters) - Theravance Inc said U.S. health regulators have deemed incomplete additional data that the company had submitted in support of its pneumonia drug, sending its shares down as much as 20 percent after the bell.
In November, the U.S. Food and Drug Administration issued a complete response letter for its drug Telavancin in treatment of nosocomial pneumonia, and asked for additional data to approve the drug.
On Thursday, the company said the FDA also suggested a design for new clinical trial(s) and suggested the company request a meeting with the agency.
'It is unclear at this point what additional information the FDA will require to complete their review of the nosocomial pneumonia new drug application,' Theravance Chief Executive Rick Winningham said in a statement.
There was no guidance provided regarding the primary clinical efficacy endpoint suitable for approval, the size or number of additional studies required, or statistical methods for evaluation of clinical results, the company added.
Telavancin is already approved as a treatment for complicated skin and skin structure infections (cSSSI)
Shares of Theravance were trading down at $12.01 in after-hours trade, after closing at $13.50 Thursday on Nasdaq.
(Reporting by Jennifer Robin Raj in Bangalore; Editing by Anthony Kurian) Keywords: THERAVANCE/ (aruna.jennifer@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging:aruna.jennifer.reuters.com@reuters.net) 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.