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Momenta Pharmaceuticals Reports Financial Results for the Second Quarter of 2009

CAMBRIDGE, Mass., Aug. 6, 2009 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA - News), a biotechnology company specializing in the characterization and engineering of complex drugs, today reported its financial results for the quarter ended June 30, 2009.

For the second quarter of 2009, the Company reported a net loss of $16.8 million, compared with a net loss of $15.0 million for the same period last year. At June 30, 2009, the Company had cash, cash equivalents, and marketable securities of $72.1 million, compared with $108.5 million at December 31, 2008.

"In the second quarter we made substantial progress in the novel drug development side of our business, advancing both our novel anticoagulant, M118 and our novel oncology product candidate, M402. We are very pleased that the M118 EMINENCE Phase 2a study achieved its primary endpoint," said Craig A. Wheeler, President and Chief Executive Officer. "On the generic side of the business, we and Sandoz are actively working to progress the FDA's review of the ANDAs for M-Enoxaparin and M356," he concluded.

Second Quarter 2009 Financial Results

Revenue for the second quarter of 2009 was $6.6 million, compared to the $3.6 million revenue for the same period last year. The increase in revenue was due to increased reimbursable expenditures on our collaborative programs partnered with Sandoz. Research and development expenses for the second quarter of 2009 were $17.7 million, compared to $12.9 million for the same period last year. The increase in research and development expenses principally resulted from increased manufacturing, process development and third-party research costs in support of the M356 program.

General and administrative expenses for the second quarter of 2009 totaled $5.8 million, compared with $6.3 million for the same period last year. The decrease in general and administrative expenses was primarily due to decreased professional fees.

The change in cash and marketable securities for the second quarter of 2009 totaled $15.8 million. The change in cash for the second quarter of 2009 would have been $13.3 million if adjusted for a payment of $2.5 million due in June 2009 under a collaborative agreement that was not received until July 2009.

Recent Corporate Developments

In June, the Company announced top line results from the M118 EMINENCE (Evaluation of M118 in Percutaneous Coronary Intervention) trial. The Phase 2a trial of the novel anticoagulant enrolled approximately 500 patients undergoing percutaneous coronary intervention (PCI). Patients were randomly assigned to receive treatment with one of three doses of intravenous M118 or a standard dose of unfractionated heparin (UFH).

The primary endpoint of the study was the combined incidence of clinical events defined as the composite of death, myocardial infarction, repeat revascularization, and stroke (over thirty days); incidence of bleeding and thrombocytopenia (over the first 24 hours); and bailout use of glycoprotein IIb/IIIa inhibitors and catheter thrombus (during the procedure). The primary analysis in the study provided evidence of non-inferiority of the combined M118 group (combining all three doses) as compared to the UFH group within the parameters of the prospectively defined analysis. The observed incidence of the composite endpoint was lower in all M118 treatment groups than in the UFH group; however it should be noted that the study was not designed or powered to detect statistically significant differences between treatments. The incidence of serious and non-serious adverse events was comparable in all treatment groups.

In June the Company announced the appointment of Bruce L. Downey to its Board of Directors, effective June 11, 2009. Mr. Downey is the former Chairman and Chief Executive Officer of Barr Pharmaceuticals, Inc. and a former Chairman of the Generic Pharmaceutical Association (GPhA). He succeeds Momenta co-founder Robert S. Langer, who has served on our board for over eight years. Dr. Langer continues to advise the company as a scientific consultant.

In April, the Company presented results from preclinical studies of the Company's novel oncology product candidate, M402, at the American Association of Cancer Research meeting in Denver, CO. One of the key findings was that M402, in combination with chemotherapeutic agents, inhibited spontaneous tumor metastasis in a murine metastatic breast carcinoma model.

Conference Call Information

Management will host a conference call on Thursday, August 6, 2009 at 10:00 am EDT to discuss these results and provide an update on the Company. To access the call, please dial [phone] (domestic) or [phone] (international) prior to the scheduled conference call time and provide the access code 1438216. A replay of the call will be available approximately two hours after the call and will be accessible through August 18, 2009. To access the replay, please dial [phone] (domestic) or [phone] (international) and provide the access code 1438216.

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 20, 2009.