Knobias Clip Report (07-11-2008) MNTA
Submitted By Knobias ClipReport
MNTA: CEO Discusses FDA Acceptance of ANDA Application for Generic Copaxone(R)
By Fain Hughes, fhughes@knobias.com
Momenta Pharmaceuticals, Inc. (MNTA) announced that the FDA has accepted for review the Abbreviated New Drug Application (ANDA) for a generic version of Copaxone(R)(glatiramer acetate injection), submitted by Sandoz Inc., Momenta’s 50/50 development and commercialization partner for this product.
Copaxone is indicated for the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (MS). Teva Pharmaceutical Industries, Ltd. (TEVA) reported U.S. sales of $1.1 billion for Copaxone for the twelve months ended 2007.
Craig A. Wheeler, President and CEO of Momenta, commented in a conference call today, “Clearly, a generic version of Copaxone represents a significant market opportunity for us.”
He added, “This ANDA provides additional evidence of our ability to apply our technology to the characterization of complex mixtures.”
Teva stated today that it intends to file a patent infringement lawsuit against Momenta/Sandoz. Teva believes the suit will stay the ANDA filed by Momenta/Sandoz.
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