momenta pharmaceuticals inc (MNTA) Key Developments
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 Announces Publication Revealing Development of a Novel Process to Generate High-Quality Hyper-Sialylated Ivig Drug Candidate in PNAS
Mar 2 15
Momenta Pharmaceuticals Inc. announced that results from preclinical studies on its hyper-sialylated IVIg (hsIVIg) program. The article summarizes Momenta's progress in creating a hsIVIg drug candidate with the potential for more consistent and enhanced anti-inflammatory activity compared to the current IVIg therapy used to treat inflammatory and autoimmune diseases. IVIg therapy has demonstrated beneficial therapeutic effects and is often used as a last line of defense in many severe inflammatory diseases. Although efficacious in these diseases, inconsistent efficacy and potency remain as major limitations for patients and physicians using IVIg. The identification of the important anti-inflammatory role of Fc-sialylation has presented the opportunity to develop a more potent alternative therapy to IVIg; however, translating this finding into a more potent anti-inflammatory product has been hampered by the difficulty of generating sialylated products suitable for clinical use. Momenta utilized its expertise in the characterization and engineering of complex biologics to develop a robust and scalable process to generate a hyper-sialylated IVIg drug candidate for potential clinical development.
Momenta Pharmaceuticals Inc. Reports Unaudited Earnings Results for the Fourth Quarter and Year Ended December 31, 2014
Feb 17 15
Momenta Pharmaceuticals Inc. reported unaudited earnings results for the fourth quarter and year ended December 31, 2014. For the quarter, the company's total collaboration revenue was $21.2 million compared with $12.8 million a year ago. Operating loss was $16.1 million compared with $30.3 million a year ago. Net loss was $15.98 million or $0.31 per basic and diluted share compared with $30.1 million or $0.59 per basic and diluted share a year ago.
For the year, the company's total collaboration revenue was $52.3 million compared with $35.5 million a year ago. Operating loss was $99.4 million compared with $109.6 million a year ago. Net loss was $98.6 million or $1.91 per basic and diluted share compared with $108.4 million or $2.13 per basic and diluted share a year ago.