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Momenta/Shire’s Humira Biosimilar Meets Study Objective

Zacks

Momenta Pharmaceuticals, Inc. MNTA announced positive data from a confirmatory phase III study on its biosimilar candidate, M923. Shares inched up 1.1% on the news.

The company’s share price has gained 28.9% ever since the company released its third-quarter results on Nov 2. The share price rally was even better than the Zacks classified Medical-Biomed/Genetics market of 9.1%.

M923, a biosimilar version of AbbVie Inc.’s ABBV flagship drug, Humira (adalimumab), is being developed for the treatment of patients with moderate-to-severe chronic plaque psoriasis.

The study evaluated the safety, efficacy and immunogenicity of M923 in adult patients with moderate-to-severe chronic plaque psoriasis, who received M923, Humira or Humira alternating with M923 for up to 48 weeks.

Results demonstrated that the proportion of patients who met the primary endpoint was equivalent on the M923 and Humira arm. The primary endpoint was at least 75% reduction on an index of psoriasis severity, following 16 weeks of treatment.

Momenta expects to present full data from this study at future conferences and in publications.

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 the first nine months of 2016, Humira raked in worldwide sales of $11.8 billion, up 14.6%.

Note that in September, Amgen Inc.’s AMGN biosimilar version of Humira, Amjevita, was approved in the U.S. for the same indications as the reference product. Amjevita is the first biosimilar version of Humira to be approved by the FDA. However, Amgen is unlikely to launch Amjevita in 2017 due to the ongoing litigation with AbbVie.

We remind investors that Momenta had a collaboration agreement with Shire plc’s SHPG Baxalta for the development and commercialization of M923. However, in Sep 2016, Shire exercised its right to terminate their collaboration agreement and is currently in the process of transitioning M923 to Momenta.

MOMENTA PHARMA Price

Momenta currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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