BioAlliance Pharma SA has entered an agreement with Penn Pharma for the manufacture of Validive, currently in a Phase II trials for the prevention and treatment of severe oral mucositis induced by radiotherapy and/or chemotherapy in head and neck cancer patients. Penn will provide pharmaceutical development of Validive, including the production of Phase III clinical batches and commercial production. Validive has been granted Fast Track designation by the FDA enabling an accelerated data review.
“The decision to collaborate with Penn Pharma is based on their commitment to quality and on their expertise, compliance to quality being recognized through inspections from main worldwide health authorities. With this industrial collaboration, we have implemented the key elements to optimize the development program of Validive, a key asset that should be a strong value creator on the short term for BioAlliance,” said Judith Greciet, BioAlliance Pharma’s chief executive officer.
“We are very pleased with this partnership with BioAlliance Pharma to manufacture one their most advanced orphan oncology products. We are determined to do our best to fully meet their requirements thanks to our expertise in contained manufacturing allied with our proven ability to conduct the formulation development of a drug through to its commercialization,” added Richard Yarwood, Penn Pharma’s chief executive officer.