Momenta Pharmaceuticals, Inc. MNTA and Mylan N.V. MYL have announced that the companies will initiate a patient clinical trial of M710 — a proposed biosimilar of Regeneron Pharmaceuticals’ REGN Eylea — in the first half of 2018.
The trial will be a randomized, double-blind, active-control, multi-center study in patients with diabetic macular edema to compare the safety, efficacy and immunogenicity of M710 with the reference drug.
We note that Eylea, a vascular endothelial growth factor (VEGF) inhibitor, has been approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema, following retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema. Sales of the drug in 2016 came in at $5.2 million.
Momenta and Mylan have entered into an agreement to develop, manufacture and commercialize six of Momenta’s biosimilar candidates, including M834, a proposed biosimilar of Orencia.
Concurrent with the third-quarter earnings, Momenta announced that M834 did not meet its primary pharmacokinetic end points in a phase I study to compare the pharmacokinetics, safety and immunogenicity of M834 to Orencia in normal healthy volunteers.
Meanwhile, a potential entry of biosimilars will impact Eylea’s sales, with the drug being Regeneron’s growth driver.
Shares of Momenta have declined 10% over the past year compared with the industry’s rally of 5.9%.
Momenta has had a rough ride, of late. The company suffered a setback when Mylan won the FDA approval for a generic version of Teva Pharmaceuticals TEVA Copaxone 40 mg. Notably, this is the first generic of Copaxone that has been approved. Since Mylan was one of the first applicants to submit a substantially complete ANDA for glatiramer acetate Injection, 40 mg/mL, containing a Paragraph IV certification, the company and other first filers might be eligible for 180 days of generic drug exclusivity. On the other hand, Momenta’s ANDA approval is contingent on the satisfactory resolution of the compliance observations stated in the warning letter issued by the FDA, resulting in a delay of approval.
Currently, Momenta’s M923, a biosimilar version of Humira, is being evaluated in a phase III study in patients suffering from moderate-to-severe chronic plaque psoriasis.
Zacks Rank
Momenta currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
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