Momenta Pharmaceuticals, Inc. (MNTA)

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Momenta Pharmaceuticals Announces FDA Approval and Launch of Glatopa® (glatiramer acetate injection) 40 mg/mL

--Glatopa 40 mg/mL is a fully substitutable, AP-rated generic version of three times-a-week COPAXONE® (glatiramer acetate injection) 40 mg/mL for the treatment of patients with relapsing forms of multiple sclerosis (MS)--

--Glatopa 40 mg/mL joins the Sandoz glatiramer acetate injection portfolio along with Glatopa 20 mg/mL, which was launched in the US in June 2015--

CAMBRIDGE, Mass., Feb. 13, 2018 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that the U.S. Food and Drug Administration (FDA) has approved Sandoz’s Abbreviated New Drug Application for Glatopa (glatiramer acetate injection) 40 mg/mL and that Sandoz has initiated the launch of this product in the US. Glatopa was developed under a collaboration agreement between Momenta and Sandoz and is produced in the US.

Glatopa 40 mg/mL is FDA-approved as a fully substitutable, AP-rated generic version of three times-a-week COPAXONE 40 mg/mL therapy for patients with relapsing forms of multiple sclerosis (MS). In April 2015, the collaboration’s Glatopa 20 mg/mL product received FDA approval and remained the only generic glatiramer acetate product on the market for over two years.

“This approval further validates the strength of our physicochemical and biological characterization capabilities,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “We are very proud to once again be able to provide patients with relapsing-forms of MS with a cost effective, high-quality generic alternative treatment option.”

Momenta will provide a corporate update, including an update on the approval and launch of Glatopa 40 mg, at the Leerink Partners 7th Annual Global Healthcare Conference on Thursday, February 15, 2018 at 10:00 a.m. ET and as part of the Company’s fourth quarter and year end 2017 financial results conference call on Wednesday, February 21, 2018 at 10:00 a.m. ET. A live webcast of both events will be available on the "Investors" section of the company's website, www.momentapharma.com.

http://ir.momentapharma.com/news-releases/news-release-details/momenta-pharmaceuticals-announces-fda-approval-and-launch