Piramal Pharma Solutions has formalised an exclusive manufacturing alliance with Epirium Bio, a clinical stage biopharmaceutical company, for new orphan drugs targeting rare diseases.
A contract development and manufacturing organisation, Piramal Pharma Solutions (PPS) will provide Epirium an integrated programme that encompasses formulation development, supply of APIs (active pharmaceutical ingredients) and intermediates, chemistry development and manufacturing, and solid oral dosage form drug product, a note from the Mumbai-based PPS said.
The work is being completed across three PPS sites in India, with the alignment of information, technology and project management to speed up timelines and bring the drugs to market faster.
Peter DeYoung, PPS Chief Executive Officer, said in a statement: “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 the market.”
The first cycle of drug substance to drug product has been successfully completed through the integrated programme, the note said.