Momenta Pharmaceuticals Inc. (MNTA) has offered to sell 7.25 million shares of its common stock to the public at a price of $19.00 each. The underwriters have an option to purchase up to an additional 1.08 million shares of the company's common stock, exercisable for 30 days.
At March 31, 2015, Momenta had cash of roughly $198.7 million.
Last month, the FDA approved once-daily Glatopa, developed under a collaboration agreement between Momenta and Sandoz, for the treatment of patients with relapsing-forms of multiple sclerosis. Glatopa is a generic equivalent of Teva's daily COPAXONE 20 mg.
Momenta and Sandoz are embroiled in a patent suit with Teva over the generic COPAXONE. The Court of Appeals for the Federal Circuit, or the CAFC, in 2013 found that several of the daily COPAXONE (20 mg/mL injection) patents held by Teva were invalid for being indefinite, including the one remaining patent which expires on September 1, 2015.
Earlier this year, the United States Supreme Court vacated the 2013 decision of the CAFC, and sent the case back to the CAFC to be reheard under the new deference standard. Sandoz and Momenta have sent the appeals court a request for an expedited decision with a full opinion to follow later. Momenta expects the appeals court to issue a decision at any time.
The ANDA for a three-times-a-week generic COPAXONE 40 mg, submitted by Sandoz, is under FDA review.
A randomized, double-blind, single-dose study initiated by Momenta and Baxter in healthy volunteers to compare the pharmacokinetics, safety, tolerability and immunogenicity of M923, a biosimilar version of HUMIRA, versus HUMIRA is underway. Data from this study are expected in the fourth quarter of 2015. The target date for the first regulatory submission for approval is 2017.
Momenta is also evaluating its drug candidate Necuparanib in metastatic pancreatic cancer. A phase II trial of Necuparanib is ongoing, and the company expects to have clinical data available as early as the end of 2016 or in the first half of 2017.
MNTA closed Tuesday's trading at $19.31, down 4.50%.
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