Our Legacy

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Momenta was founded in 2001 based on technology discovered and developed at the Massachusetts Institute of Technology (MIT) for the precise sequencing of complex sugar molecules. Early efforts to explore the biological role of sugars were constrained by the absence of tools to fully analyze complex sugars. The initial methods to characterize these molecules were discovered by two of our founders, Ram Sasisekharan, Ph.D., Professor of Biological Engineering, MIT, and Ganesh V. Kaundinya, Ph.D. Early work by Dr. Sasisekharan, a molecular biologist, in collaboration with Dr. Robert Langer, a world-renowned professor at MIT, overcame many technical obstacles to clone the first heparinase, an enzyme that cuts sugar sequences into smaller components. Shortly thereafter, Dr. Kaundinya and Dr. Sasisekharan began collaborating to create a collection of enzymes and chemicals to cut sugar sequences at precise locations and then to address quantitative approaches for capturing the diversity of complex sugars. They developed improvements to conventional analytical methodologies and created a novel numerical system to describe the myriad permutations of building blocks contained in complex sugars. This early work laid the scientific foundation for our innovative characterization technology.

Complex Generics

Momenta initially developed generic versions of complex drugs that were approved by the United States Food and Drug Administration (FDA), under New Drug Applications (NDAs). The limited availability of complex generics has presented a broad set of challenges in healthcare based on the rising cost of these of types of drugs.

Momenta set out to meet this challenge by employing its complex analytics platform to define the detailed structures present in these complex drugs. Once the precise structures were characterized, this structural characterization of the brand product was used to guide the development of a precise manufacturing process to produce a generic version. Finally, to demonstrate that the biological function of our generic replicated that of the brand, we utilized our complex systems analysis platform to evaluate and compare multiple orthogonal sets of biologic data from in-vitro, in-vivo and ex-vivo models.

We validated our approach to the development of highly complex generic molecules by becoming the first company to achieve FDA regulatory approval of fully substitutable generic versions of LOVENOX (enoxaparin sodium injection) and daily COPAXONE 20 mg (glatiramer acetate injection) trade name Glatopa. Glatopa 40 mg/mL, a three times weekly product, was approved and launched in the U.S. in February 2018. These products were developed in collaboration with and are marketed by Sandoz.

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.

Enoxaparin Sodium Injection

Enoxaparin Sodium Injection is a generic version of LOVENOX® (enoxaparin sodium injection), a low-molecular-weight heparin product widely used for the prevention and treatment of deep vein thrombosis (DVT).

Enoxaparin is a heterogeneous mixture of complex polysaccharide chains. The length and sequence of the polysaccharide chains that comprise enoxaparin vary in length and form, resulting in a diverse mixture of chemical structures and making it difficult to decipher. Our technology and analytical approach allowed us to characterize LOVENOX and successfully develop the first FDA approved generic version, which was approved in July 2010.

Glatopa® (glatiramer acetate injection)

Glatopa® (glatiramer acetate injection) is a once daily and fully substitutable generic equivalent of COPAXONE®, available in both a once daily 20 mg/mL product and a three-times-a-week 40 mg/mL product. Glatopa 20 mg/mL, which was launched in the U.S. in June 2015, was the first AP-rated substitutable generic indicated for the treatment of patients with relapsing-forms of multiple sclerosis (MS), a devastating chronic disease of the central nervous system characterized by inflammation and neurodegeneration. Glatopa 40 mg/mL was approved and launched in the U.S. in February 2018.

Glatopa® was developed by way of a collaboration between Momenta and Sandoz and is commercialized under the Sandoz brand. Characterizing COPAXONE represents another significant technical challenge for generic manufacturers given its complex mixture of polypeptide chains of various lengths and sequences. Momenta addressed this challenge with our core characterization and process engineering capabilities to successfully develop and manufacture Glatopa.

To learn more about Glatopa, please visit: http://www.glatopa.com/