Questcor Pharmaceuticals, Inc. announced it would commence a phase II study to evaluate H.P. Acthar for the treatment of patients with amyotrophic lateral sclerosis (ALS).
As per information provided by the ALS Association, patients affected by ALS (also referred to as Lou Gehrig's disease) have an average life expectancy of about 2-5 years from the time of diagnosis.
Around 40 patients will be enrolled in this 8-week, randomized, open-label study designed to evaluate the safety and tolerability of Acthar across four doses. Patients who successfully complete the initial 8 weeks of trial will have the option to participate in a 28-week open-label extension with a 3-week taper and 1-week follow-up period.
Acthar, an injectable drug, is the lead product at Questcor. It is approved by the U.S. Food and Drug Administration for as many as 19 indications such as nephrotic syndrome, dermatomyositis, polymyositis, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis relapses and infantile spasms. Questcor is also evaluating Acthar in other indications such as diabetic nephropathy.
The company shipped 4,830 vials of Acthar during the first quarter of 2013, up 17.5% year over year but down sequentially by 23.7%. In Apr 2013, Questcor shipped a record 2,550 vials of Acthar to its distributor. In the first quarter, Acthar’s new paid prescriptions were about 1,725 - 1,750, up 16% year over year.
Questcor carries a Zacks Rank #3 (Hold). Right now, Jazz Pharmaceuticals Public Limited Company looks well positioned with a Zacks Rank #1 (Strong Buy). Other companies like Avanir Pharmaceuticals, Inc. and Lannett Company, Inc. are also attractive with a Zacks Rank #2 (Buy).