Momenta Pharma (NASDAQ: MNTA) presented at the 2009 UBS Global Life Sciences Conference about two weeks ago and outlined several key developments for the Company, including an update on the FDA status for M-Enoxaparin.

In late September, the Company raised net proceeds of approximately $46.7 million through a public offering of 4.6 million shares of common at $10.75 per share (compared to a current share price hovering around $9.50). Momenta provided guidance for ending the year with about $90-100 million in cash, providing adequate liquidity for 18-24 months. However, the most important development is a potential FDA decision for the long-standing abbreviated new drug application (ANDA) for M-Enoxaparin as a generic equivalent to the multi-billion dollar blood thinner Lovenox.

In late 2007, all three applicants with pending ANDAs for generic forms of Lovenox received a request for more information from the FDA regarding the potential for immunogenicity of their products. Momenta's partner, the Sandoz division of Novartis (NYSE: NVS), submitted a major amendment on 9/26/08 for the M-Enoxaparin ANDA to address these concerns by the Agency. Most recently, the FDA conducted reviews of heparin suppliers in China to ensure a safe supply chain as part of the manufacturing process.

Sandoz has four heparin suppliers in China and a processing facility in Austria that have successfully completed inspections by the Agency. In addition, no patent litigation or other legal hurdles remain for Sandoz to launch M-Enoxaparin following FDA approval of the ANDA. Because the Generic Division of the FDA does not issue PDUFA action dates, the timing for an M-Enoxaparin decision is uncertain. However, Momenta feels that the Agency has all the necessary information required to make a final decision on the ANDA and believes a response from the FDA is possible before year-end.

The major uncertainty for financial projections this year is the status and timing of the M-Enoxaparin ANDA approval and launch. MNTA is set receive much higher royalties if M-Enoxaparin is the only generic form of Lovenox which is approved, as opposed to much lower royalties (e.g. 10%-15%) if competing ANDAs by Amphastar / Watson (NYSE: WPI) and Teva Pharma (NASDAQ: TEVA) are approved.