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Momenta to Regain Rights to Humira Biosimilar from Shire

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Momenta Pharmaceuticals Inc. (MNTA - Free Report) announced that Shire plc (SHPG - Free Report) has exercised its right to terminate their collaboration agreement for the development and commercialization of M923, a biosimilar version of AbbVie Inc.’s (ABBV - Free Report) flagship drug, Humira (adalimumab).

Currently, M923 is in a phase III study for the treatment of chronic plaque psoriasis. The study is evaluating the safety, efficacy and immunogenicity of the candidate in comparison to Humira. Top-line data from the study are expected in late 2016.

As per terms of the agreement, the collaboration will end in 12 months of the termination notice. Shire will continue to fund the program till termination. We remind investors that Shire had acquired the rights to M923 following the acquisition of Baxalta Incorporated in Jun 2016.

Humira is approved for the treatment of autoimmune/inflammatory diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis. In 2015, Humira had raked in worldwide sales of $14 billion.

Note that several pharma and biotech companies are involved in the development of biosimilars. Late last week, Amgen Inc.’s (AMGN - Free Report) Amjevita (adalimumab-atto), a biosimilar of Humira, was approved in the U.S. across all eligible indications of the reference product. (Read more:  Amgen's Biosimilar of Abbvie's Humira Gets FDA Approval)

Going forward, we expect investor focus to remain on the successful development of M923 by Momenta. Investors should also keep an eye on further updates related to the termination of the agreement with Shire.

Both Momenta and Shire carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.

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