MNTA: Momenta Pharmaceuticals Announces Filing of Abbreviated New Drug Application With a Paragraph IV Certification for Generic Version of Copaxone Friday July 11, 6:00 am ET Company to Host Conference Call At 8:30 am Eastern Time
CAMBRIDGE, Mass., July 11, 2008 (PRIME NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NasdaqGM:MNTA - News), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration (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 development and commercialization partner for this product. ADVERTISEMENT
``Advancing the M356 program for the development of a generic version of Copaxone is one of Momenta's top priorities, and we are pleased that the ANDA has been accepted for review,' said Craig A. Wheeler, President and Chief Executive Officer of Momenta.
About Copaxone
Copaxone is indicated for the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (MS). Teva Pharmaceutical Industries, Ltd. reported U.S. sales of $1.1 billion for Copaxone for the twelve months ended 2007.
Conference Call Information
Management will host a conference call today at 8:30 a.m. EDT to discuss the M356 ANDA submission. To access the call, please dial (877) 675-4757 (domestic) or (719) 325-4895 (international) prior to the scheduled conference call time and provide the access code 8383147. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through July 18, 2008. To access the replay, please dial (888) 203-1112 (domestic) or (719) 457-0820 (international) and provide the access code 8383147.
A live audio webcast of the call will be available on the ``Investors' section of the Company's website, http://www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call and will be available through August 15, 2008.
About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed characterization and engineering of complex drugs. Momenta is applying its technology to create technology-enabled generic versions of complex drug products, develop improved versions of existing drugs, and discover novel drugs and new biological processes. Momenta was founded in 2001 based on technology initially developed at the Massachusetts Institute of Technology and is headquartered in Cambridge, MA.
To receive additional information about Momenta, please visit the website at http://www.momentapharma.com, which does not form a part of this press release.
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