Momenta Pharmaceuticals Says U.S. FDA Rejects its Generic Lovenox
CAMBRIDGE, Mass., Nov. 6, 2007 -- Momenta Pharmaceuticals, Inc. (NasdaqGM:MNTA - News) today announced that its collaboration partner, Sandoz Inc. (``Sandoz''), a division of Novartis, had received a letter from the U.S. Food and Drug Administration (``FDA'') on November 5, 2007, stating that Sandoz' abbreviated new drug application (``ANDA'') for Enoxaparin Sodium Injection is not approvable.
The FDA's letter stated that the ANDA was not approvable because the application does not adequately address the potential for immunogenicity of the drug product and recommended that Sandoz and Momenta meet with the Office of Generic Drugs to determine what additional information should be provided to adequately address this concern. Sandoz and Momenta are working together to identify the additional information that is necessary to obtain approval of the ANDA.
``In a follow-up call, the FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product. We believe that we can address what we anticipate to be the FDA's concerns, based on our detailed characterization of enoxaparin and on the current medical and scientific literature,'' said Craig A. Wheeler, President and Chief Executive Officer. ``Our path forward will be determined in conjunction with Sandoz and the FDA.''
Conference Call Information
Management will host a conference call today at 8:30 a.m. EST to discuss the FDA's letter. To access the call, please dial (888) 230-5549 (domestic) or (913) 312-1272 (international) prior to the scheduled conference call time and provide the access code 5144605. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through November 13, 2007. To access the replay, please dial (888) 203-1112 (domestic) or (719) 457-0820 (international) and provide the access code 5144605.
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 An archived version of the webcast will be posted on the Momenta website approximately two hours after the call and will be available through December 1, 2007.
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex mixture drugs. Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs. The Company's most advanced product candidate, M-Enoxaparin is designed to be a technology-enabled generic version of Lovenox(r). Momenta's first novel drug candidate is M118, a rationally engineered anticoagulant specifically designed for acute coronary syndromes. Within the Company's discovery program, it is seeking to discover and develop novel therapeutics by applying its technology to better understand sugars' functions in biological processes, with an initial focus in oncology. Momenta was founded in 2001 based on technology initially developed at 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.
Forward Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the Company's ability to address the FDA's concerns with respect to the ANDA for M-Enoxaparin, 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-Enoxaparin 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 June 30, 2007 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.