Questcor Submits Supplemental New Drug Application to FDA for H.P. Acthar Gel for Treatment of Infantile Spasms
UNION CITY, Calif., March 17, 2009 (GLOBE NEWSWIRE) --
Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) 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(r) (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.
"We have worked closely with the FDA for the past 18 months to gather and present necessary data to support the sNDA and we look forward to working with the FDA during the review process of our resubmission,"said Don M. Bailey, President and CEO of Questcor.
About Questcor
Questcor Pharmaceuticals, Inc. is a pharmaceutical company that markets two commercial products, H.P. Acthar(r) Gel ("Acthar") and Doral(r).Acthar (repository corticotropin injection) is an injectable drug that is approved for the treatment of certain disorders with an inflammatory component, including the treatment of exacerbations associated with multiple sclerosis ("MS") and to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that is due to lupus erythamatosus. In addition, Acthar is not indicated for, but is used in treating patients with infantile spasms ("IS"), a rare form of refractory childhood epilepsy, and opsoclonus myoclonus syndrome, a rare autoimmune-related childhood neurological disorder. Doral is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. For more information, please visit www.questcor.com.
Note: Except for the historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties and are subject to certain factors, which may cause Questcor's results to differ from those reported herein. Factors that may cause such differences include, but are not limited to:
-- Questcor's ability to continue to successfully implement its Acthar-centric business strategy, including its expansion in the MS marketplace;
-- Questcor's ability to manage its sales force expansion;
-- FDA approval of and the market introduction of competitive products and our inability to market Acthar in IS prior to approval of IS as a labeled indication,
-- Regulatory changes or actions including possible outcomes relating to a July 2008 Congressional hearing regarding orphan drug pricing;
-- Questcor's ability to accurately forecast the demand for its products;
-- The gross margin achieved from the sale of its products;
-- Questcor's ability to estimate the quantity of Acthar used by government entities and Medicaid-eligible patients;
-- That the actual amount of rebates and chargebacks related to the use of Acthar by government entities and Medicaid-eligible patients may differ materially from Questcor's estimates;
-- Its expenses and other cash needs for upcoming periods;
-- The inventories carried by Questcor's distributors, specialty pharmacies and hospitals,
-- Volatility in Questcor's monthly and quarterly Acthar shipments and end-user demand;
-- Questcor's ability to obtain finished goods from its sole source contract manufacturers on a timely basis if at all;
-- Questcor's ability to attract and retain key management personnel;
-- Questcor's ability to utilize its NOLs to reduce income taxes on taxable income;
-- Research and development risks, including risks associated with Questcor's sNDA for IS and its preliminary work in the area of nephrotic syndrome;
-- Uncertainties regarding Questcor's intellectual property;
-- The uncertainty of receiving required regulatory approvals in a timely way, or at all;
-- Uncertainties in the credit and capital markets and the impact a further deterioration of these markets could have on Questcor's investment portfolio;
-- As well as the risks discussed in Questcor's annual report on Form 10-K for the year ended December 31, 2008 and other documents filed with the Securities and Exchange Commission. The risk factors and other information contained in these documents should be considered in evaluating Questcor's prospects and future financial performance.