Piramal Pharma Solutions (PPS) is providing Epirium with integrated services encompassing formulation development, supply of APIs and intermediates, chemistry development and manufacturing, and solid oral dosage form drug product. The work is being completed across three PPS sites in India, with the seamless alignment of information, technology, and project management that aims to speed timelines.

The first cycle of drug substance to drug product has been successfully completed through the integrated program. Additional cycles are in progress, as are further evolutions that will benefit future indications and new clinical programs.

Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, said, “This program with Epirium exemplifies the ways we lead the market in delivering integrated services. We’ve back-integrated our supply of intermediates to ensure supply chain security and quality, we’ve invested more than $1 million to add a dedicated area to our plant with the specialized technologies required to produce Epirium’s product, and we’ve developed a fully integrated process that utilizes the expertise of our teams at three sites.”

Dr. Sundeep Dugar, Chief Technology Officer for Epirium, added, “Our scientific insights have led to the discovery of a novel pharmacological approach for the treatment of diseases characterized by mitochondrial depletion and dysfunction. Proof of concept has been established in early human studies and we intend to advance our clinical candidate as a potential treatment for certain relevant rare diseases with high unmet need. We expect our partnership with PPS to expedite these efforts and help us bring high-quality orphan drugs to market.”