FDA Alert Questcor Pharma

FDA Decision Alert: Questcor Pharma

QCOR: Google Finance Profile

(RTTNews) - In less than a week, the Food and Drug Administration will take a final decision on Questcor Pharmaceuticals Inc.'s (QCOR) H.P. Acthar Gel for the proposed expanded indication of infantile spasms.

The regulatory agency was originally scheduled to rule on Acthar's expanded indication in June. But the deadline was extended in order to review information regarding labeling and potential post-approval commitments that they solicited from Questcor.

Infantile spasm, or IS, is a seizure disorder of early childhood also known as West Syndrome. The onset is predominantly in the first year of life, typically between 3 to 6 months. The typical pattern of IS is a sudden bending forward and stiffening of the body, arms and legs, although there can also be arching of the torso.

Sabril is the first and the only FDA-approved drug for infantile spasms. The drug developed by Danish pharmaceutical company H.Lundbeck A/S (HLUKY.PK) was approved last August and was launched in the U.S. last September with an extensive REMS (Risk Evaluation Mitigation Strategy) program as required by the FDA.

The proposed indication of Questcor's H.P. Acthar Gel for infantile spasms cleared the penultimate regulatory hurdle by winning the FDA panel backing this May. The regulatory agency's Advisory Committee for Peripheral and Central Nervous System Drugs voted 22 to 1 in favor of H.P. Acthar Gel's efficacy as a treatment for patients with IS, and voted 20 to 1 in favor of the drug's safety at an effective dosing regimen.

H.P. Acthar gel is an injectable drug that is already approved in the U.S. by the FDA 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. 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 infantile spasms.

The FDA usually follows the recommendations of its panel though not mandatory. A final decision on whether or not to approve H.P. Acthar Gel for infantile spasm is slated to be taken by the FDA by September 11. Upon approval, the company plans to launch Acthar in the treatment of IS during the Child Neurology Society Annual Meeting in October.

Having had many years of off-label usage of Acthar in the treatment of infantile spasm, though there is some incremental growth to be had in this indication, infantile spasm is not expected to be a major growth driver in the future, according to the company.

Acthar accounts for a major part of the company's total net sales. Though Acthar prescriptions for IS also account for a significant percentage, of late, there has been a continued improvement in sales of Acthar in the multiple sclerosis market.

A sales breakdown of Acthar shows that in the second quarter ended June 30, 2010, MS accounted for about 50% of the drug's sales, IS about 40% or just a little bit higher, Nephrotic Syndrome, or NS, about 5%, and other indications accounted for the remaining 5%.

The company initiated a small pilot selling effort of Acthar in NS in April 2010 and has begun to successfully generate the first few prescriptions from this effort. The company continues to fund 12 clinical studies evaluating Acthar as a treatment for NS, and early data from some of these studies are expected to become available later this year and in early 2011.

In 2009, net sales of Acthar declined to $87.6 million from $94.4 million due to higher sales reserves in 2009 for Medicaid rebates, other government program rebates and chargebacks, and co-pay assistance programs.

The Healthcare Reforms Act passed this year has had the effect of reducing the Medicaid rebate for Acthar from approximately 110% to 100% of the company's average manufacturer's price for Acthar. This has benefited Questcor's results in the first two quarters of 2010.

Net sales of Acthar for the six months ended June 30, 2010 increased to $54.3 million from $48.2 million during the same period last year. During the first half of 2010, new paid Acthar prescriptions for the treatment of MS exacerbations increased by about 165% from the year-ago period.

Questcor has planned to double its sales force during this quarter and believes that the MS market will continue to be its growth driver.

QCOR has thus far hit a low of $3.33 and a high of $11.63 over the one-year period. The stock closed Friday's trading at $9.84 on a volume of 1.10 million shares.
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