By Krishnakali Sengupta
BANGALORE, Dec 24 (Reuters) - Questcor Pharmaceuticals Inc said U.S. health regulators have accepted its filing for marketing approval for its drug Acthar's additional indication to treat infantile spasms and set an action date of June 11, 2010.
Shares of the company rose as much as 27 percent to $5.50.
Analyst Yale Jen of Maxim Group estimates that there will be an advisory panel meeting prior to the review date, towards the late first quarter, or early second quarter.
'And there is a good likelihood that the outcome of the meeting will be positive and the panel would recommend an approval,' the analyst added.
Acthar is currently approved to treat acute attacks of multiple sclerosis and Questcor is pursuing approval for the treatment of infantile spasms, a rare form of childhood epilepsy.
Questor had two 'mishaps' in terms of regulatory filing and both the times the FDA declined to accept the filing, which was originally filed in 2006, requesting the company to submit additional data.
'However, third time's a charm and today's announcement makes up for the lost territory in share price,' Jen said over the phone.
The drug has an orphan status for the treatment of infantile spasms, which implies that the drugmakers will have a marketing exclusivity of seven years in the United States, upon approval.
The Union City, California-based company's shares were trading up about 20 percent at $5.17 Thursday afternoon on Nasdaq.
(Reporting by Krishnakali Sengupta in Bangalore; Editing by Maju Samuel) Keywords: QUESTCOR/ (krishnakali.sengupta@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: krishnakali.sengupta.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. 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.
BANGALORE, Dec 24 (Reuters) - Questcor Pharmaceuticals Inc said U.S. health regulators have accepted its filing for marketing approval for its drug Acthar's additional indication to treat infantile spasms and set an action date of June 11, 2010.
Shares of the company rose as much as 27 percent to $5.50.
Analyst Yale Jen of Maxim Group estimates that there will be an advisory panel meeting prior to the review date, towards the late first quarter, or early second quarter.
'And there is a good likelihood that the outcome of the meeting will be positive and the panel would recommend an approval,' the analyst added.
Acthar is currently approved to treat acute attacks of multiple sclerosis and Questcor is pursuing approval for the treatment of infantile spasms, a rare form of childhood epilepsy.
Questor had two 'mishaps' in terms of regulatory filing and both the times the FDA declined to accept the filing, which was originally filed in 2006, requesting the company to submit additional data.
'However, third time's a charm and today's announcement makes up for the lost territory in share price,' Jen said over the phone.
The drug has an orphan status for the treatment of infantile spasms, which implies that the drugmakers will have a marketing exclusivity of seven years in the United States, upon approval.
The Union City, California-based company's shares were trading up about 20 percent at $5.17 Thursday afternoon on Nasdaq.
(Reporting by Krishnakali Sengupta in Bangalore; Editing by Maju Samuel) Keywords: QUESTCOR/ (krishnakali.sengupta@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: krishnakali.sengupta.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. 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.