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The collaboration includes an integrated program that encompasses formulation development, drug substances, and drug product manufacturing.
On Aug. 27, 2020, Piramal Pharma Solutions (PPS), a contract development and manufacturing organization (CDMO), announced that it will be partnering with Epirium Bio, a San Diego, CA-based clinical-stage biopharmaceutical company, on an exclusive manufacturing relationship for new orphan drugs targeting rare diseases with high unmet needs.
Under the agreement, the PPS team will provide 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 program will be conducted across three PPS sites in India, and information, technology, and project management will be aligned, which will speed up timelines with the goal of bringing drugs to market faster, PPS stated in a company press release.
The first cycle of progressing drug substance to drug product has been successfully completed through the integrated program, and additional cycles are in progress. The program is also progressing with further evolutions that will benefit future indications and new clinical programs.
“This program with Epirium exemplifies the ways we lead the market in delivering integrated services. We’ve backintegrated 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,” said Peter DeYoung, CEO, Piramal Pharma Solutions, in the press release.
“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,” added Sundeep Dugar, chief technology officer, Epirium, in the press release.