On December 3, 2019 Piramal Enterprises Limited’s Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), reported that the company will be partnering with BerGenBio ASA (OSE: BGBIO) on the development of bemcentinib for the treatment of elderly patients with relapsed Acute Myeloid Leukemia (AML) (Press release, Piramal, DEC 3, 2019, View Source [SID1234551896]). Bemcentinib was recently designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA), as there are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need.
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Peter DeYoung, CEO, Piramal Pharma Solutions, stated, "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, stated that "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."
To accelerate the timelines required for Fast Track development, PPS will be developing the drug leveraging its Xcelerate Integrated Solutions platform that delivers speed, flexibility and versatility to the drug development process. The Xcelerate platform, which addresses the industry’s growing need for preferred partner relationships, has been successfully applied to more than eighty programs.
Xcelerate Integrated Solutions takes advantage of the extensive PPS network of drug discovery and development capabilities located across its sites in North America, Europe and India. Customers benefit from streamlined and fully integrated services, all managed by a single point of contact who expedites the exchange of information and accelerates timelines.
The bemcentinib development program encompasses a fully integrated program of PPS resources that 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.