Key Developments For Questcor Pharmaceuticals, Inc.
Questcor Pharmaceuticals, Inc. (QCOR.O) (Consolidated Issue listed on NASDAQ Global Market)
Questcor Pharmaceuticals, Inc. Resubmits Supplemental New Drug Application To FDA For H.P. Acthar Gel For Treatment Of Infantile Spasms
Questcor Pharmaceuticals, Inc. announced that it has resubmitted its filing to the U.S. Food & Drug Administration (FDA) for its supplemental New Drug Application (sNDA) seeking approval to market H.P. Acthar Gel (repository corticotrophin injection) for the treatment of infantile spasms. The resubmission follows the FDA's request in May 2009 for the filing to include additional statistical analysis relating to data from one secondary study within the Company's filing. Acthar is currently approved in the U.S. for the treatment of MS exacerbations, nephrotic syndrome and many other conditions. Acthar is not approved in the U.S. for the treatment of IS, a potentially life-threatening disorder that typically begins in the first year of life. However, pursuant to guidelines published by the American Academy of Neurology and the Child Neurology Society, many child neurologists use Acthar to treat infants afflicted with this condition. Questcor is currently pursuing FDA approval for Acthar in the treatment of IS. Previously, the FDA granted Orphan Designation to Acthar for the treatment of IS.
Questcor Pharmaceuticals, Inc. Increases Share Repurchase Program Authorization
Questcor Pharmaceuticals, Inc. announced that its Board of Directors has increased the Company's common share repurchase program authorization by an additional 6.5 million shares. In late February 2008, the Board authorized the repurchase of up to 7.0 million shares. Under this original authorization, as of June 1, 2009, the Company has repurchased approximately 5.9 million shares, including 1.3 million in the first quarter of 2009, and 1.0 million to date during the second quarter of 2009. The additional 6.5 million share authorization represents approximately 10% of the Company's outstanding common stock. As of March 31, 2009, Questcor had 64.6 million common shares outstanding.
FDA Asks For More Data On Questcor Pharmaceuticals, Inc.'s Epilepsy Drug-Reuters
Reuters reported that Questcor Pharmaceuticals, Inc. said U.S. health regulators asked it to perform some additional analyses related to the marketing approval for its drug to treat infantile spasms. The drug, Achthar, is currently approved to treat acute attacks of multiple sclerosis and the Company is pursuing approval to treat infantile spasms, a rare form of childhood epilepsy.
Questcor Pharmaceuticals, Inc. Submits Supplemental New Drug Application to FDA for H.P. Acthar Gel for Treatment of Infantile Spasms
Questcor Pharmaceuticals, Inc. announced that it has completed its filing to the U.S. Food & Drug Administration (FDA) for its supplemental New Drug Application (sNDA) seeking approval to market H.P. Acthar Gel (repository corticotrophin injection) for the treatment of infantile spasms. In June 2006 Questcor submitted a sNDA to the FDA and in May 2007 the FDA determined the sNDA was not approvable in the form submitted in 2006. Subsequently, Questcor met with the FDA to review the Company's plans for resubmission.
Questcor Pharmaceuticals, Inc. Comments On FY 2009 Guidance
Questcor Pharmaceuticals, Inc. announced that its internal plan indicates that sales and operating income for fiscal 2009 will also increase from fiscal 2008 levels. The Company reported revenue of $95.2 million for fiscal 2008. According to Reuters Estimates, analysts were expecting the Company to report revenue of $106.5 million and EBIT of $62.84 million for fiscal 2009.
