UNION CITY, Calif., Sept 08, 2010 /PRNewswire via COMTEX News Network/ -- Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) today announced that the U.S. Food and Drug Administration (FDA) has informed Questcor that the FDA will require additional time beyond the current action date of September 11, 2010 to complete its review of Questcor's supplemental new drug application (sNDA) for H.P. Acthar(R) Gel (repository corticotropin injection) in the treatment of infantile spasms (IS). In conjunction with the FDA's review of this sNDA, Questcor and the FDA have been updating and modernizing the product label for Acthar, which has not been modified since 1978, when multiple sclerosis was added to the label. This step of the review process is now complete. Questcor has been notified that the FDA needs some additional time to finalize the wording on the label, review the proposed medication guide, and define post-approval commitments, if any, for the IS indication.
"We are pleased to be nearing the finish line and look forward to the FDA finalizing its review of our sNDA," said Don M. Bailey, President and Chief Executive Officer of Questcor. "Our business strategy and plans for Acthar remain intact, based on the direction that the FDA appears to be taking not only with our sNDA but also with the additional updates to the Acthar label. We expect to continue executing our plans for the multiple sclerosis and nephrotic syndrome markets, including the significant expansion of our sales force."
"To date, third quarter 2010 prescription and sales levels are encouraging. Despite the significant organizational focus on the effort to double our sales force, MS new paid prescriptions reached a monthly record in August. In the first two months of the third quarter, these prescriptions have increased modestly compared to the first two months of the second quarter of 2010. At the current quarterly run rate, vial shipments by Questcor in the third quarter of 2010 would exceed the record just set in the second quarter. Of note, so far, with a majority of state Medicaid bills for the second quarter of 2010 (the first full quarter in which all Medicaid managed care organizations were participating in the Medicaid rebate program) received, our sales reserve provision appears adequate," Mr. Bailey concluded.
Investors are cautioned that the statements above are based on interim information; however, the FDA may or may not approve Acthar for the treatment of IS, may or may not require additional significant changes to the label, and may or may not impose other requirements on Questcor. Also, interim sales and Medicaid usage results in the third quarter of 2010 are not necessarily indicative of full quarter results. While Questcor believes that its Medicaid rebate provision is sufficient, this provision ultimately might prove to be inadequate. Please refer to the cautionary statements later in this press release and a full description of the risks of investing in Questcor in its filings with the Securities and Exchange Commission.
Questcor has scheduled a conference call on Thursday, September 9, 2010 at 9:00 a.m. Eastern Time, 6:00 a.m. Pacific Time to discuss the recent developments as well as provide insight on the third quarter sales performance to date. The conference call will be simultaneously web cast under "Events & Presentations" on the Investor Relations section of the Questcor web site at www.questcor.com. The conference call will be archived for future review until October 9, 2010.
Conference call details: Date: Thursday, September 9, 2010 Time: 9:00 a.m. ET / 6:00 a.m. PT Dial-in (U.S.): 877-941-8632 Dial-in (International): 480-629-9820 Web cast: http://ir.questcor.com/ To access an audio replay of the call: Access number (U.S.): 800-406-7325 Access number (International): 303-590-3030 Replay Passcode #: 4362089
About H.P. Acthar Gel(R)
H.P. Acthar Gel(R) is a natural adrenocorticotropic hormone (ACTH) designed to provide a prolonged release after intramuscular or subcutaneous injection. Acthar is currently approved in the U.S. for the treatment of acute exacerbations of multiple sclerosis, nephrotic syndrome, and several other diseases and disorders. The FDA is in the final stages of reviewing the sNDA application for the use of Acthar in the treatment of patients with infantile spasms. For more information, please visit www.acthar.com.
Questcor Pharmaceuticals, Inc. is a biopharmaceutical company with products that help patients with serious, difficult-to-treat medical conditions. Questcor markets H.P. Acthar(R) Gel (repository corticotropin injection), which is approved for the treatment of certain disorders with an inflammatory component, including the treatment of exacerbations associated with multiple sclerosis 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, Questcor plans to market Acthar for the treatment of patients with infantile spasms, a rare form of refractory childhood epilepsy, in the event Questcor's sNDA receives FDA approval. Acthar is not indicated for, but is used in treating opsoclonus myoclonus syndrome, a rare autoimmune-related childhood neurological disorder. The Company also markets Doral(R) (quazepam), which 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 that have been made pursuant to the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "if," "should," "would," "forecasts," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions. Actual events or results may differ materially. Factors that could cause or contribute to such differences include, but are not limited to, the following:
The risk factors and other information contained in these documents should be considered in evaluating Questcor's prospects and future financial performance.
Questcor undertakes no obligation to publicly release the result of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
SOURCE Questcor Pharmaceuticals, Inc.
Copyright (C) 2010 PR Newswire. All rights reserved