Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Momenta Pharmaceuticals, Inc. (MNTA) recently got some good news when the company received Orphan Drug Designation for its oncology candidate, necuparanib (formerly M402), from the U.S. Food and Drug Administration (:FDA) for the treatment of pancreatic cancer.
The designation from the FDA provides certain incentives, including federal grants, tax credits, waiver of filing fees and a seven-year marketing exclusivity period against competition once the candidate is approved.
Momenta expects to complete part A of its ongoing phase I/II study on necuparanib in combination with Abraxane and Gemzar. Data from the study is expected later in 2014. Momenta also expects to advance the candidate into the phase II of the study in the second half of 2014.
Momenta operates in three business areas- generics, biosimilars and drugs. Momenta's first commercial product was Enoxaparin sodium Injection, a generic version of Lovenox. It was developed in collaboration with Novartis' (NVS) Sandoz. The generic was approved in Jul 2010.
Meanwhile, Momenta's generic version of Teva Pharmaceutical Industries Ltd.’s (TEVA) Copaxone (M356) is currently under FDA review. On Mar 31, 2014, Teva announced that the U.S. Supreme Court will hear its appeal against a federal court decision that invalidated the claim of U.S. Patent 5,800,808 covering Copaxone. An outcome is expected by the fourth quarter of 2014.
Momenta carries a Zacks Rank #3 (Hold). Right now, Gilead Sciences (GILD) look attractive with a Zacks Rank #1 (Strong Buy).