momenta pharmaceuticals inc (MNTA) Key Developments
Momenta Pharmaceuticals Inc. Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015; Provides Financial Guidance for the Second Quarter and Full Year 2015
May 1 15
Momenta Pharmaceuticals Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported a net loss of $21.9 million, or $0.40 per share, compared to a net loss of $27.4 million, or $0.53 per share for the same period in 2014. Total revenues were $8.6 million compared to $10.8 million for the same period in 2014. Operating loss was $20.08 million compared to $27.62 million for the same period in 2014.
The company provided guidance that its net cash usage, excluding revenue from the approval and potential launch of Glatopa, and excluding revenue from any potential new collaboration(s), will be approximately $28 to $32 million per quarter for 2015.
The projected cash burn for the second quarter will be offset by a $10.0 million milestone earned for the sole approval of M356 under the Sandoz collaboration. In the quarter that Glatopa is launched, the Company will also earn an additional $10.0 million milestone from Sandoz.
Momenta Pharmaceuticals Inc. Presents Key Glatopa(TM) (Glatiramer Acetate Injection) Data at American Academy of Neurology Annual Meeting
Apr 20 15
Momenta Pharmaceuticals Inc. presented new data from studies conducted as part of the ANDA submission for once daily Glatopa (glatiramer acetate injection) at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington D.C. The posters presented provide examples of a selection of methods the company utilized to show the equivalence of Glatopa and once daily COPAXONE 20 mg. Presentation highlights: Poster #P1.144 – Comparative Gene Expression Profiling between a Generic (Glatopa) and Brand COPAXONE (glatiramer acetate injection): Microarray analysis across the entire genome was performed in murine glatiramer acetate-responsive Th2-polarized T cells, a test system highly relevant to the biology of glatiramer acetate. Multiple statistical methods consistently demonstrated assay sensitivity as well as equivalent gene expression profiles between Glatopa and Copaxone. Poster #P1.145 – Demonstration of Equivalence between a Generic (Glatopa) and Brand COPAXONE (glatiramer acetate injection): This poster summarized company's overall approach of comparison, as well as multiple examples of equivalence of starting materials and basic chemistry; equivalence of structural manufacturing process signatures; equivalence of physicochemical (structural) properties; and equivalence of biological/immunological (functional) properties. The selected assays and data presented at AAN are examples of the physicochemical methods and biological/immunological assays that were submitted to the FDA as part of the recently approved data package for Glatopa.
Momenta Pharmaceuticals Inc. - Special Call
Apr 16 15
To discuss the approval of Glatopa (glatiramer acetate injection, formerly M356) 20mg/mL
Momenta Pharmaceuticals, Inc. Announces FAD Approval of ANDA for Glatopa(TM)
Apr 16 15
Momenta Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has granted marketing approval of Sandoz's Abbreviated New Drug Application for once daily Glatopa™ (glatiramer acetate injection, formerly M356) 20 mg/mL, a generic equivalent of daily COPAXONE® 20 mg. Glatopa is the first substitutable generic indicated for the treatment of patients with relapsing-forms of multiple sclerosis (RRMS), a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. Glatopa was developed under a collaboration agreement between Momenta and Sandoz and is the second complex generic developed by Momenta together with Sandoz to receive FDA approval. Glatopa will be commercialized under the Sandoz brand. Glatopa was determined by the FDA to be therapeutically equivalent to daily COPAXONE 20 mg, with the same active ingredients, route of administration, strength and dosage form. Glatopa's high quality U.S.-based supply chain and manufacturing process meets rigid FDA standards, and Glatopa is fully substitutable at the pharmacy level. Glatopa is expected to offer a more affordable treatment option for people living with RRMS. Under the terms of its collaboration agreement with Sandoz, Momenta is eligible to receive up to $140 million in milestone payments upon the achievement of certain U.S. regulatory, commercial and sales-based milestones for Glatopa, including a $10.0 million payment earned upon sole FDA approval of the ANDA, and another $10.0 million milestone payment upon first commercial sale.
Momenta Pharmaceuticals Inc. to Report Q1, 2015 Results on May 01, 2015
Apr 15 15
Momenta Pharmaceuticals Inc. announced that they will report Q1, 2015 results at 9:00 AM, Eastern Standard Time on May 01, 2015