Momenta Pharmaceuticals, Inc.’s (MNTA) oncology candidate, necuparanib, has received fast track designation from the FDA for the first-line treatment of metastatic pancreatic cancer in combination with Abraxane and Gemzar.
Fast track status is granted to candidates that are being developed as treatments for serious health conditions and are considered to have the potential to fulfill an unmet medical need. This designation facilitates the development of such candidates and expedites its review process. Moreover, a candidate with fast track designation may become eligible for priority review or receive accelerated approval in the U.S. Additionally, the FDA may consider portions of the marketing application for review before the complete submission of the application.
With fast track status for necuparanib, Momenta can now interact with the FDA often for discussing various issues including the study design, the required level of data regarding safety of the candidate to support its approval and the structure and content of a new drug application. Necuparanib also has orphan drug designation in the U.S. for the treatment of pancreatic cancer.
Momenta is currently evaluating necuparanib (plus Abraxane and Gemzar) in the part B (phase II proof-of-concept) portion of a randomized, controlled phase I/II study to evaluate the anti-tumor activity of the combination when compared to Abraxane and Gemzar alone. The company expects to complete patient enrolment in the fourth quarter of 2015. Data from the part B portion of the study should be out in the first half of 2017.
We remind investors that Momenta had revealed top-line results from the part A portion of the phase I/II study on necuparanib in Oct 2014.
Meanwhile, Momenta is working on the development of its biosimilars pipeline. On its R&D day in Oct 2014, Momenta stated that it intends to initiate a study on its most advanced biosimilar candidate, M923 (biosimilar version of AbbVie’s (ABBV) Humira), by the end of 2015. M923 is being developed for the treatment of inflammatory and autoimmune diseases. Momenta has a collaboration with Baxter International Inc. (BAX) for the development and commercialization of biosimilar candidates.
Momenta carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Biogen Idec, Inc. (BIIB), carrying a Zacks Rank #1 (Strong Buy). AbbVie carries a Zacks Rank #2 (Buy).
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