Momenta Pharmaceuticals, Inc. MNTA announced that the FDA classified the outcome of fourth-quarter 2017 reinspection of Pfizer, Inc.’s PFE McPherson facility as Voluntary Action Indicated (“VAI”).
Glatopa 20 mg/mL was approved by the FDA in 2015. Glatopa 20 mg/mL is the first "AP" rated, substitutable generic equivalent of once-daily Copaxone. The generic was developed and is being commercialized in collaboration with Sandoz AG, or Sandoz, the generic arm of Novartis Pharma AG NVS.
Per the collaboration agreement, Sandoz is responsible for commercialization of Glatopa 20 mg/mL, and Momenta earns 50% of contractually-defined profits on the drug’s sales.
Sandoz’s abbreviated New Drug Application ("ANDA") for the 40-mg thrice-weekly formulation of Copaxone (Glatopa 40mg) was under the FDA review. However, Momenta suffered a setback with the FDA issuing a warning letter to Pfizer in February 2017, which is Sandoz’s contracted fill/finish manufacturing partner for Glatopa.
While the ANDA for Glatopa remains under regulatory review, Momenta believes that the application review could be completed at any time in connection with the change to the VAI status.
The news brought a breath of fresh air to investors and the company’s shares went up 5.2%. Momenta’s stock has lost 10.9% over a year, underperforming the industry’s rally of 10.5%.
Nevertheless, with the announced change in compliance status for McPherson, Kansas facility amended to VAI, Momenta expects to gain marketing approval and subsequently launch Glatopa 40 mg in the first half of 2018.
Momenta has had a rough time in 2017. Mylan NV MYL obtained FDA approval for a generic version of Copaxone 40 mg making it the first generic to be approved. This was a huge setback for Momenta. With Mylan launching both Copaxone 20mg and Copaxone 40mg product, the company expects revenues from Glatopa to be adversely impacted due to declines in both price and volume. Moreover, there will be additional pressure in the market for customers to switch from the 20mg product to the 40mg product.
The company also suffered a blow in regard to the development of its biosimilar candidate, M834. The candidate did not meet its primary pharmacokinetic end points in a phase I study to compare the pharmacokinetics, safety and immunogenicity of M834 to reference drug Orencia in normal healthy volunteers. Hence, Momenta and partner Mylan will evaluate the next course of action.
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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