CAMBRIDGE, Mass., Feb. 15, 2013 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today reported its financial results for the fourth quarter and year ended December 31, 2012. For the fourth quarter of 2012, the company reported a net loss of $(17.7) million, or $(0.35) per share compared to a net loss of $(1.3) million, or $(0.02) per share for the same period in 2011. For the year ended December 31, 2012, the company reported a net loss of $(58.6) million, or $(1.16) per share compared to net income of $180.4 million, or $3.55 per diluted share, for the same period in 2011. At December 31, 2012, the company had cash, cash equivalents, and marketable securities of $340.6 million compared to $348.4 million at December 31, 2011. "In 2012, we made significant advances across our development programs," said Craig Wheeler, president and chief executive officer of Momenta Pharmaceuticals. "We have invested in our capabilities to develop multiple biosimilars, advanced an innovative sialylation technology that could have broad applicability and initiated clinical studies of our novel drug M402 for metastatic pancreatic cancer. The advancement of M356, our generic version of Copaxone®, is a key priority and the FDA's review of the ANDA is moving forward. We remain confident that the data submitted as part of the ANDA support approval under the 505(j) pathway as an interchangeable generic Copaxone." Mr. Wheeler continued, "Royalty revenues from sales of enoxaparin sodium injection rebounded nicely in the fourth quarter and we believe will continue to provide important cash flow to Momenta." Fourth Quarter and Recent Events Complex Generics Program: M356, generic version of Copaxone® (glatiramer acetate injection)
- The ANDA for M356 is under active review by the U.S. FDA.
- In the patent litigation brought by Teva Pharmaceuticals against Momenta and Sandoz, appellate briefing is expected to be completed in the first quarter. Oral arguments are expected to be heard by the U.S. Court of Appeals for the Federal Circuit in the second quarter of 2013, with the appellate decision expected in the second half of the year.
- In the fourth quarter of 2012, Momenta earned $10.8 million in product revenues on net sales of enoxaparin sodium injection based on Sandoz reported net sales of $85 million.
- In November 2012, the U.S. Court of Appeals for the Federal Circuit denied en banc review of its decision in Momenta Pharmaceuticals vs. Amphastar Pharmaceuticals, Inc. Momenta plans to file this month a petition for a writ of certiorari for a review by the Supreme Court.
- The stay on the District Court proceedings has been lifted. Amphastar has filed a Motion for Summary Judgment and the Court has set a briefing schedule.
- Three biosimilar products are being developed by Momenta under the collaboration -- M923 and M834, which are targeted for the treatment of autoimmune and other inflammatory indications, and M511, a monoclonal antibody for oncology. Momenta expects to submit an IND (Investigational New Drug) application in 2014 for its lead biosimilar, M923, and is also targeting achievement of development criteria that would generate a license payment or milestone payment for M511 and M834 in 2014.
- Momenta is conducting a Phase 1/2 proof-of-concept trial for M402 in people with advanced metastatic pancreatic cancer. Data from Part A of the two-part study, which is designed to investigate the safety and antitumor activity of M402, are expected in 2013. M402 is a novel oncology candidate designed to inhibit tumor angiogenesis, progression, and metastasis.
- Momenta continues to make significant research progress in demonstrating that the sialylation of Fc enhances anti-inflammatory effects. The company expects to generate more data in 2013 that will guide its research efforts toward optimizing a drug candidate to take into the clinic.