Piramal Pharma Solutions on Tuesday said it will be partnering with Norway-based firm BerGenBio ASA on the development of bemcentinib for the treatment of elderly patients with relapsed Acute Myeloid Leukemia (AML).
Bemcentinib, an AXL protein inhibitor for oncology, was recently designated as a Fast Track drug by the US Food and Drug Administration (USFDA), as there are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need, Piramal Pharma Solutions said in a statement.
"BerGenBio's decision to partner with us is a validation of our integrated business model. The breadth and scale of our assets and our expertise as a leading contract development and manufacturing organisation (CDMO) allow us to customise services according to their needs and deliver solutions that benefit the patients," Piramal Pharma Solutions CEO Peter DeYoung said.
The bemcentinib development programme encompasses a fully integrated programme of Piramal Pharma Solutions resources that includes intermediates sourced from India, pilot process development and API validation in North America and formulation development in Europe, the statement said.
As part of the partnership agreement, Piramal Pharma Solutions is also expected to provide commercial manufacturing of the final drug product, it added.
"Outsourcing of development and manufacturing services is a requirement for us, and we were rigorous in our due diligence of potential partners. Piramal Pharma Solutions' capabilities especially the Xcelerate Integrated Solutions platform represent an ideal solution for BerGenBio," BerGenBio CEO Richard Godfrey said.
As per the US health regulator, Fast track approach is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.