BioAlliance Pharma SA has announced an agreement with Penn Pharma to manufacture Validive®, currently in a late phase II trial for the prevention and treatment of severe oral mucositis induced by radiotherapy and/or chemotherapy in head and neck cancer patients.
Penn Pharma is a company based in South Wales, specialized in the industrial development and manufacturing of highly potent drugs.
Under this agreement, BioAlliance Pharma entrusts the pharmaceutical development of Validive® to Penn Pharma, including the production of phase III clinical batches and the commercial production.
This new step of industrialization fits with the overall development program of Validive®. With Fast Track designation obtained from the FDA enabling an accelerated data review, completion of the phase II clinical trial and preliminary results are expected by the end of this year.
“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,” commented Judith Greciet, BioAlliance Pharma’s CEO.
“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 CEO.