Innovative Technology to Unlock the Structure of Complex Generics, Follow-on Biologics and Novel Drugs
Momenta is an innovator in the analysis, characterization, and design of complex molecules. By understanding the link between a compound’s chemical structure, its manufacturing process, and its function, we have created a diversified pipeline consisting of both complex generic and novel complex mixture drugs, as well as an emerging pipeline of biosimilars and potentially interchangeable biologics. We are applying our technology to complex polysaccharides, synthetic polypeptides, and recombinant proteins to understand and better resolve the structural components of these molecules. We then translate this knowledge to the development of therapies for a variety of diseases.
We have developed analytical methods that resolve structural components of complex molecules and allow us to unravel structure-process relationships. This highly detailed understanding of complex molecules 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 approach has been commercially validated with the first-ever FDA approval of a generic low molecular weight heparin, enoxaparin sodium injection. We are currently working to develop a generic version of Copaxone® (glatiramer acetate), a complex polypeptide mixture drug, as well as additional highly similar and potentially interchangeable biologics.
Momenta is also developing a pipeline of novel drug candidates based on these structural and process insights, which illuminate relevant structure-activity relationships in complex molecules. In addition, we are evaluating our sialylation technology to further potentiate the anti-inflammatory activities of these antibodies and to potentially develop drugs with differentiated attributes such as enhanced efficacy and/or a wider therapeutic window to address autoimmune and inflammatory diseases. By systematically investigating known disease-specific interactions of complex molecules, we engineer novel medicines to address unmet medical needs.
Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
Last revised 10/18/2013