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Piramal Pharma Solutions to join hands with Epirium Bio to develop and manufacture orphan drugs

The integrated programme, involving three Piramal Pharma Solutions sites, encompasses formulation development, supply of APIs and intermediates, chemistry development and manufacturing, and solid oral dosage form drug product

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Piramal Pharma Solutions, a contract development and manufacturing organisation (CDMO), announced that the company will be partnering with Epirium Bio on an exclusive manufacturing relationship for new orphan drugs targeting rare diseases with high unmet needs.

“The Piramal Pharma Solutions (PPS) team is providing Epirium with an integrated programme 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,” informed the company through a statement.

According to Peter DeYoung, CEO, Piramal Pharma Solutions, “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 specialised technologies required to produce Epirium’s product, and we’ve developed a fully integrated process that utilises 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 characterised 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 to benefit future indications and new clinical programs.

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