Questor Meets FDA Snag (QCOR)
Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) was a mere 48 hours away from an FDA drug decision for the review of Questcor’s supplemental new drug application for H.P. Acthar® Gel in the treatment of infantile spasms. The key work now is “WAS” in the reference.
The FDA just today informed Questcor that it requires additional time beyond the current action date of September 11, 2010. During the supplemental new drug application review period, 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 infantile spasms indication.
Shares did fall on this, although it is worth noting that the company called this “nearing the finish line and look forward to the FDA finalizing its review of our sNDA…”
The CEO claims that the 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.”
The company also notes that third quarter 2010 prescription and sales levels are encouraging. The company is also engaged in an effort to double its sales force and the company said that its MS new paid prescriptions reached a monthly record in August.
In the first two months of the third quarter, those 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 and it also claims that its sales reserve provision appears adequate.
TheStreet.com noted an analyst expected FDA’s full approval and that it could add $10 to $15 million to sales and that it could add on $0.04 to $0.09 to earnings per share. FULL ARTICLE FROM THESTREET.COM
Questcor was halted briefly for the news. The after-hours session had shares down 8% at $9.55 after a $10.38 close and the first hour after the close has seen more than 100,000 shares trade hands. The regular session had shares up 7.9% at $10.38 today.
JON C. OGG
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