(AOF) – Erytech Pharma gains more than 5% to 1.26 euros. The clinical-stage biopharmaceutical company that develops innovative therapies by encapsulating drugs in red blood cells, today announced the sale of its U.S. manufacturing site to Catalent, a contract development and manufacturing (CDMO) company, leader in the field of innovative therapies.
Under the terms of the asset purchase agreement between Erytech and Catalent, Catalent is acquiring Erytech’s commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, United States for a total consideration of $44, $5 million. Catalent proposes to take over the current staff of the Erytech site, approximately 40 people.
The parties will also enter into a long-term supply agreement, under which Catalent will manufacture Erytech’s lead product candidate, eryaspase (GRASPA), for clinical and commercial supply in the United States.
Erytech is currently conducting a Phase 1 clinical study in the first-line treatment of pancreatic cancer in the United States and maintains an ongoing dialogue with the Food and Drugs Administration (FDA) regarding the potential submission of a Biologics License Application – BLA) for GRASPA in the treatment of Hypersensitive Acute Lymphoblastic Leukemia, now scheduled for release in the third quarter of 2022, subject to resolution of outstanding issues and questions posed by the FDA.
Catalent will also make its expertise in the manufacture of innovative therapeutic products at late stage and commercial use available, including product characterization, commercial production, inspections and regulatory approvals.
The Erytech site in Princeton is a state-of-the-art manufacturing unit of approximately 3000 m², designed to be able to meet a variety of cell therapy production needs and capacities. Catalent plans to expand the Princeton site and leverage Erytech’s skilled personnel to manufacture an expanded portfolio of cell therapy products. Erytech retains its French manufacturing site in Lyon, as well as its know-how and skills in production processes to pursue innovation in the manufacture of cell therapies.
LEXICON
Clinical trials (Phases I, II, III)
Phase I: small-scale testing of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: evaluation of tolerance and efficacy on several hundred patients to identify side effects. Phase III: assessment of the overall benefit/risk ratio with several thousand patients.
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Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an amount of credits (7 billion euros) never reached: 1.5 billion for university hospital research, 2 billion for investment in health via bpi france , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenditure reimbursed by Medicare will be 2.4%, which should generate growth of at least 0.5% in the turnover of laboratories,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the medical benefit rendered is sufficient.