05 December 2019 | News
This will leverage Piramal Pharma Solutions' (PPS) Xcelerate Integrated Solutions ™ platform at all of its sites in North America, Europe, and India
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The Pharma Solutions business of Piramal Enterprises Limited, a leading development and contract manufacturing company (CDMO), announced that the company is going to Associate with BerGenBio ASA to develop bemcentinib for the treatment of elderly patients with recurrent acute myeloid leukemia (AML). Bemcentinib has recently been designated as a fast track drug by the US Food and Drug Administration (FDA), as for the patients with recurrent AML, there are currently no marketed drugs specifically approved for use in Canada.
Peter DeYoung , CEO of Piramal Pharma Solutions , said, "The fact that BerGenBio decided to partner with us validates our integrated business model. The breadth and depth of our assets and the expertise we have gained as a leading CDMO allow us to tailor our services to their needs and deliver solutions that bring benefits to patients. "
Richard Godfrey , BerGenBio's President and Chief Executive Officer , said, "We urgently need outsourcing of development and manufacturing services and we have been rigorous in our pre-audit with potential partners. The capabilities of Piramal Pharma Solutions, in particular the Xcelerate Integrated Solutions Platform, represent an ideal solution for BerGenBio. "
In order to accelerate the time required to implement the expedited procedure, PPS will develop the drug based on its Xcelerate Integrated Solutions ™ platform that provides speed, flexibility and versatility in the drug development process. The Xcelerate platform, which responds to the sector's growing need for close relationships with partners, has been successfully applied to more than 80 programs.
Xcelerate Integrated Solutions ™ leverages PPS's broad network of drug discovery and development capabilities, which can be found at its sites in North America, Europe and India. Customers benefit from streamlined and fully integrated services, all of which are managed by a single point of contact, speeding up the exchange of information and deadlines.
The bemcentinib development program encompasses a fully integrated program of PPS resources that includes intermediate products from India, development of pilot processes and validation of active ingredients in North America, as well as formulation development in Europe. As part of the partnership agreement, PPS should also ensure the commercial manufacture of the final pharmaceutical product.