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Questcor Pharmaceuticals Responds to Questions From Investor Blog
Date:1/16/2012

n also occur due to lupus erythematosus.

The entire Acthar label, including each individual indication, went through a very detailed review by the FDA in 2010.  This process included confirmation by FDA that the current indication related to the treatment of proteinuria in nephrotic syndrome was appropriate and should remain on label.  The Company is thus permitted to promote Acthar per the approved label. In addition, all Acthar promotional materials are submitted to FDA for their review. For purposes of communicating with investors, Questcor uses the term "nephrotic syndrome" to encompass the conditions within the Acthar label.

16. How much scientific evidence does Questcor have to support Acthar as an effective treatment for NS?  Please describe any modern clinical studies (such as the Bomback case review) that have been completed in this area so far.

Questcor Response:  In addition to a formal approval from FDA , there is a growing body of more recent scientific data supporting the use of Acthar to treat proteinuria in nephrotic syndrome.  For example, a retrospective case series publication by Bomback et al. which included a review of treatment results for patients treated with Acthar via prescription showed that in a subset of 10 patients with nephrotic syndrome due to idiopathic membranous nephropathy, 80% achieved a complete or partial remission of proteinuria.  More recently, at the 44th Annual Meeting of the American Society of Nephrology in November 2011, Boston University Assistant Professor of Medicine Dr. Laurence H. Beck, Jr., M.D., Ph.D. presented results from a study which found that Acthar may induce a remission of proteinuria in patients with nephrotic syndrome due to idiopathic membranous nephropathy by suppressing production of antibodies to the phospholipase A2 receptor.  Separately, results from a prospective clinical study at Columbia University conducted by Appel et al.,
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SOURCE Questcor Pharmaceuticals, Inc.
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