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Technology

Momenta's Proven Scientific Approach

Innovative Technology to Unlock the Structure and Biology of Complex Molecules

Momenta is an innovator in the analysis, characterization, and design of complex molecules. We have developed finely tuned high-resolution analytics that resolve structural components of complex molecules and allow us to unravel structure-process relationships. We have also created novel methods to combine multiple data sets, taking advantage of orthogonal approaches to yield solutions that no one data set can provide. This highly detailed understanding of complex molecules then allows us to reverse-engineer a manufacturing process with control over the highly nuanced manufacturing process parameters. The ability to engineer the correct manufacturing process in turn results in the ability to replicate the complex structural signatures of the molecule.

Our integrated scientific platform also opens up the potential for a broad new level of understanding that guides our product development in many areas of biology and disease. By understanding the link between a compound’s chemical structure, its manufacturing process, and its biological function, we have created a diversified pipeline consisting of complex generics, biosimilars and potentially interchangeable biologics and novel drugs.

Our scientific approach has been commercially validated by the first-ever FDA approval of two complex generic products thought to be impossible to replicate without conducting clinical trials, including:

  • In 2010, the enoxaparin sodium injection application filed by our collaborator Sandoz was approved by the U.S. Food and Drug Administration (FDA) as the first generic version of LOVENOX®. LOVENOX is used to prevent and treat deep vein thrombosis. To learn more about the development of our generic enoxaparin sodium injection product please view our Case Study.
  • In 2015, the FDA approved Glatopa® (glatiramer acetate injection), our generic version of daily COPAXONE® 20 mg/mL, also developed in collaboration with Sandoz. Glatopa is the first and only AP-rated substitutable generic indicated for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS), a devastating chronic disease of the central nervous system characterized by inflammation and neurodegeneration.


Today, we are developing biosimilars and potentially interchangeable biologics, as well as novel drug candidates based on the structural and process insights gained through our work in complex generics. Our commitment to consistently follow the most rigorous scientific path is the foundation of Momenta’s past and future success. Over the coming years, Momenta is dedicated to replicating our success in complex generics and creating biosimilar and novel drug candidates that have the potential to help reduce healthcare costs and improve care for patients.

 

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 Updated 1/4/2016