Momenta is a leader in the analysis, characterization, and design of complex pharmaceutical products. Our scientific foundation is a set of tools and methods that enable one to develop a deep understanding of the links between a compound’s chemical structure, its manufacturing process and its biological function. We are applying our innovative technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications.
Our success is a result of our committed and talented people. We attract scientists exceptionally skilled in integrating information from diverse technical disciplines and task them with challenging characterization, process, and biology problems. Using this approach, we have designed tools and methods to understand the structure (characterization of chemical components), structure-process (design and control of manufacturing process) and structure-activity (relationships between structure and biological and clinical activity) of complex mixture drugs. From this knowledge comes a diversified product development pipeline consisting of complex generics, biosimilars and novel drugs designed to address a variety of medical needs.
In April 2015, Momenta announced the FDA approval of once daily Glatopa™ (glatiramer acetate injection), a fully substitutable generic version of Copaxone® 20 mg/mL. Glatopa is the first AP-rated substitutable generic indicated for the treatment of patients with relapsing-forms of multiple sclerosis (MS), 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.
In July 2010, Momenta announced the FDA approval of our first drug, Enoxaparin Sodium Injection developed in collaboration with Sandoz. Enoxaparin is a more affordable, generic version of Lovenox® (Enoxaparin Sodium Injection), which is indicated for the prophylaxis of deep vein thrombosis (DVT). Enoxaparin Sodium Injection is a heparin-based complex mixture drug that was developed using our innovative scientific approach.
Following this initial success with Enoxaparin and Glatopa, we are applying a similar approach to developing biosimilars with a goal of achieving a designation of interchangeability.
With the knowledge acquired from our complex generic and biosimilars business, we are using our tools and technology to design and improve the structures of proteins and heparin-derived products to create novel drugs. Our goal is to leverage the multi-targeting nature of complex mixture molecules to develop novel products which could positively modulate multiple pathways in a disease. Our lead novel drug candidate, necuparanib is currently in a Phase 2 study in patients with advanced metastatic pancreatic cancer. Additionally, in December 2011 we acquired selected assets relating to sialylation technology. Sialic acid is a type of sugar modification on selected proteins that is understood to regulate anti-inflammatory and immunomodulatory function. These assets add to our core ability to modify and engineer protein backbones to precisely regulate biological networks and develop novel biologic product candidates. We now have three novel autoimmune drug candidates in the pre-clinical stage of development.
Lovenox® is a registered trademark of Sanofi-Aventis. Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd. Glatopa™ is a trademark of Novartis AG.
Last revised 4/17/2015