Piramal Pharma Solutions (PPS) has partnered with BerGenBio ASA on the development of bemcentinib for the treatment of elderly patients with relapsed Acute Myeloid Leukemia (AML). Bemcentinib was recently granted Fast Track designation by the U.S. FDA, as there are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need.
 
Peter DeYoung, chief executive officer, Piramal Pharma Solutions, said, “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 CDMO allow us to customize services according to their needs and deliver solutions that benefit the patients.”
 
Richard Godfrey, chief executive officer of BerGenBio, said, “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.”
 
PPS will be developing the drug leveraging its Xcelerate Integrated Solutions platform designed to deliver speed, flexibility and versatility to the drug development process. The Xcelerate platform has been successfully applied to more than eighty programs.
 
Xcelerate Integrated Solutions leverages PPS network of drug discovery and development capabilities across its sites in North America, Europe and India. The streamlined and integrated services are managed by a single point of contact to expedite the exchange of information.
 
The bemcentinib development program includes intermediates sourced from India, pilot process development and API validation in North America and formulation development in Europe. As part of the partnership agreement, PPS is also expected to provide commercial manufacturing of the final drug product.