CAMBRIDGE, Mass., Jul 11, 2008 (PrimeNewswire via COMTEX News Network) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), 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.
"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.
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, 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 An archived version of the webcast will be posted on the Momenta website approximately two hours after the call and will be available through August 15, 2008.
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 www.momentapharma.com, which does not form a part of this press release.
Forward Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to M356 and the M356 ANDA, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "hope," "target," "project," "goals," "potential," "predict," "might," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. In particular, management's expectations regarding M-356 could be affected by, among other things, unexpected regulatory actions or delays or governmental regulation generally; competition in general; and other risk factors referred to in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2008 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Momenta is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.
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SOURCE: Momenta Pharmaceuticals
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