Questcor Pharmaceuticals provides update on sNDA for H.P. Acthar Gel

Sep 9 2010

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® 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.