CDMO: AGC Biologics will produce for Provention Bio
AGC Biologics has made a commitment to American biotech Provention Bio regarding the commercial production of its new treatment for type 1 diabetes, Tzield (teplizumab-mzwv). The CDMO will manufacture this monoclonal antibody at its Seattle site (United States), which had already contributed to the manufacture of clinical batches of this drug. Financial details were not disclosed. “At AGC Biologics, we are proud to have contributed to the development of this innovative new drug and to manufacture it for commercial distribution. This achievement demonstrates the capabilities of our Seattle facility in commercial manufacturing.”said Kevin Ingham, general manager of the AGC Biologics site in Seattle.
Tzield was approved last November by the FDA to delay the onset of insulin dependence in people with type 1 diabetes. AGC Biologics’ Seattle site has been manufacturing biologics for more than thirty years. In addition to this factory, the CDMO has an extensive production network, with other American sites (Boulder, Longmont), European sites (in Denmark, Germany and Italy) and a site in Japan.
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Evotec will collaborate with Janssen
The German manufacturer has announced the signing of a partnership with Janssenthe subsidiary of J&J for the development of immunotherapy first-in-class in oncology. The American laboratory will rely on the capabilities ofEvotec in terms of discovery and manufacturing during the preclinical R&D phase, while Janssen will assume full responsibility for clinical development and commercialization. Evotec is eligible for an undisclosed upfront payment and milestone payments potentially up to $350 million in addition to royalties on future sales.
Orphan drug designation for Poxel
The European Commission has granted orphan drug designation (ODD) to PXL770 and PXL065 from Lyon biotech Pixel, for the treatment of adrenoleukodystrophy (ALD), an orphan neurometabolic disease. These two compounds are currently being evaluated in phase I for the treatment of this pathology. The FDA had already granted the status Fast Track to these two molecules on this indication.
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