NEW DELHI, Aug 27: Contract development and manufacturing organisation Piramal Pharma Solutions on Thursday said it will partner with Epirium Bio on an exclusive manufacturing relationship for new orphan drugs targeting rare diseases with high unmet needs.
According to the US health regulator, USFDA, ‘orphan drug’ is a drug or biologic that is used for the prevention, diagnosis, or treatment of diseases or conditions affecting fewer than 2 lakh people.
It is also defined as a drug or biologic that is intended for diseases or conditions affecting 2 lakh or more people, or for a vaccine, diagnostic drug, or preventive drug to be administered to 2 lakh or more people per year, where the drug will not be profitable within 7 years following the FDA approval.
Piramal Pharma Solutions (PPS) is providing Epirium with an integrated program that encompasses formulation development, supply of active pharmaceutical ingredients (APIs) and intermediates, chemistry development and manufacturing, and solid oral dosage form drug product, it said in a statement.
The work is being completed across three PPS sites in India, it added.
“We’ve back-integrated our supply of intermediates to ensure supply chain security and quality, we’ve invested more than USD 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,” PPS CEO Peter DeYoung said.
The first cycle of drug substance to drug product has been successfully completed through the integrated program, the statement said. Additional cycles are in progress, as are further evolutions that will benefit future indications and new clinical programs, it 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,” Epirium Chief Technology Officer Sundeep Dugar said.
Proof of concept has been established in early human studies and the company intends to advance its clinical candidate as a potential treatment for certain relevant rare diseases with high unmet needs, he added.
“We expect our partnership with PPS to expedite these efforts and help us bring high-quality orphan drugs to market,” Dugar said. (PTI)
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