Piramal Pharma & Epirium Bio Join Hands to Manufacture Orphan Drugs
Thursday, 27 August 2020, 14:52 IST
The contract development and manufacturing organization (CDMO), Piramal Pharma Solutions announces its collaboration with Epirium Bio. These companies partners to build an exclusive manufacturing relationship for new orphan drugs that target rare diseases with unmet needs.
Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions says, "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."
The Piramal Pharma Solutions (PPS) team would provide Epirium with an integrated program that encompasses formulation development, the supply of APIs and intermediates, chemistry development and manufacturing, and solid oral dosage form drug products. Across the three PPS sites in India, the work has been completed. It has provided seamless alignment of information, technology, and project management that would increase the timelines and bring the drugs to market at a fast-pace.
Through the integrated program, the first cycle of drug substance to drug product has been successfully completed. The Next cycles are in progress as a further evolution that is expected to benefit the future indications and new clinical programs.
Dr. Sundeep Dugar, Chief Technology Officer for Epirium, states, "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."
Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions says, "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."
The Piramal Pharma Solutions (PPS) team would provide Epirium with an integrated program that encompasses formulation development, the supply of APIs and intermediates, chemistry development and manufacturing, and solid oral dosage form drug products. Across the three PPS sites in India, the work has been completed. It has provided seamless alignment of information, technology, and project management that would increase the timelines and bring the drugs to market at a fast-pace.
Through the integrated program, the first cycle of drug substance to drug product has been successfully completed. The Next cycles are in progress as a further evolution that is expected to benefit the future indications and new clinical programs.
Dr. Sundeep Dugar, Chief Technology Officer for Epirium, states, "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."
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