Momenta Pharmaceuticals Reports Third Quarter 2016 Financial Results

--Company appoints Scott M. Storer as SVP and CFO--

--Initiates Phase 1 trial for M834, biosimilar ORENCIA ® (abatacept) candidate--

CAMBRIDGE, Mass., Nov. 02, 2016 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today reported its financial results for the third quarter ended September 30, 2016.

For the third quarter of 2016, the Company reported total revenues of $29.1 million, including $23.3 million in product revenues from Sandoz's sale of Glatopa ® (glatiramer acetate injection). For the nine months ended September 30, 2016, the Company reported total revenues of $75.4 million, including $58.8 million of product revenues from Sandoz's sales of Glatopa. Momenta reported a net loss of $(17.5) million, or $(0.26) per share for the third quarter of 2016 compared to a net loss of $(30.1) million, or $(0.44) per share for the same period in 2015. For the nine months ended September 30, 2016, the Company reported a net loss of $(62.5) million, or $(0.91) per share compared to a net loss of $(54.1) million, or $(0.88) per share for the same period in 2015. At September 30, 2016, the Company had cash, cash equivalents, and marketable securities of $309.0 million compared to $336.9 million at June 30, 2016.

"Our biosimilars collaboration with Mylan continues to advance. Today we announced the initiation of a Phase 1 trial for our lead candidate, M834, a biosimilar version of ORENCIA ®. We also recently re-gained the rights to M923, our biosimilar HUMIRA ® candidate, and believe this is a real opportunity for us to generate additional value from this product," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "Glatopa 20 mg sales continued to provide us with a healthy revenue stream, and we remain optimistic for the potential launch of our Glatopa 40 mg product candidate early next year." 

Third Quarter Highlights and Recent Events

Complex Generics:
  • In the third quarter of 2016, Momenta recorded $23.3 million in product revenues from Sandoz's Glatopa sales.
  • The Abbreviated New Drug Application (ANDA) submitted by Sandoz for a three-times-a-week generic COPAXONE ® 40 mg (glatiramer acetate injection) is under U.S. Food and Drug Administration (FDA) review. The Company expects to receive tentative regulatory approval in the next few months.
  • A district court trial challenging four of Teva's five Orange Book-listed patents for COPAXONE 40 mg (glatiramer acetate injection) concluded on October 6, 2016. The Company expects a decision to be issued in the first quarter of 2017.        

Biosimilars:
  • Momenta and its collaboration partner Mylan today announced the initiation of a Phase 1 clinical trial for M834, a biosimilar ORENCIA (abatacept) candidate. Under the Mylan collaboration agreement, Momenta achieved a regulatory milestone thereby earning a $25.0 million payment from Mylan. The companies plan to report top-line data from the trial by the end of 2017.
  • In September, the U.S. Patent and Trademark Office held a hearing in Inter Partes Review (IPR) proceedings for the Company's challenge of the validity of Bristol Myers Squibb's U.S. Patent No. 8,476,239 covering formulations of ORENCIA which is set to expire in 2028. The Patent Office's decision is due by January 15, 2017. 
  • In September, Momenta regained global development and commercialization rights to M923, a biosimilar HUMIRA (adalimumab) candidate. Shire exercised its right to terminate the collaboration agreement for M923 following its combination with Baxalta. Under the terms of the collaboration, the agreement will terminate twelve months following the notice, and Shire is obligated to fund the M923 program until termination. The Company plans to release top-line results from the Phase 3 clinical trial for M923 in late 2016, and the first regulatory submission for marketing approval is planned for mid-2017. Subject to marketing approval and patent considerations, the Company expects first commercial launch of M923 to be as early as 2018.

Novel Drugs for Autoimmune Indications:

Momenta's novel autoimmune portfolio includes two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company has initiated a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281 in healthy subjects and expects to report data in the second half of 2017. M230 is in pre-clinical development, and the Company expects to initiate a clinical trial for M230 in 2017. Momenta is also developing a hyper-sialylated IVIg (M254) as a potential high potency version of IVIg. The Company continues its efforts to identify potential collaboration opportunities for the further development and commercialization of its novel drug candidates for autoimmune indications.

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