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Mumbai, August 27, 2020
Piramal Pharma Solutions (PPS), a leading contract development and manufacturing organization (CDMO), today announced it will partner Epirium Bio on an exclusive manufacturing relationship for new orphan drugs targeting rare diseases with high unmet needs.
A press release from the company said the PPS team is providing Epirium with an integrated program that encompasses 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 will speed timelines and bring the drugs to market faster," it said
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.”
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.”
"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," the release added.
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government or other assistance. The conditions are referred to as orphan diseases.
PPS is a part of Piramal Enterprises Limited's (PEL) pharmaceuticals business.
Epirium Bio is a clinical-stage biopharmaceutical company that uses unique insights related to the biology of mitochondrial function and tissue regeneration to pursue novel and clinically significant therapeutic approaches for neuromuscular, neurodegenerative and mitochondrial disorders.