BioAlliance Pharma collaborates with Penn Pharma on development of Validive
BioAlliance Pharma entrusts the pharmaceutical development of Validive to Penn Pharma, including the production of phase III clinical batches and the commercial production
BioAlliance Pharma, which specialises in the development of drugs in orphan oncology diseases, has entered into 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.
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 industrialisation fits with the overall development programme 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 recognised through inspections from main worldwide health authorities,' said Judith Greciet, BioAlliance Pharma’s CEO. 'With this industrial collaboration, we have implemented the key elements to optimise the development program of Validive, a key asset that should be a strong value creator in the short term for BioAlliance.'
'We are very pleased with this partnership with BioAlliance Pharma to manufacture one their most advanced orphan oncology products,' added Richard Yarwood, Penn Pharma’s CEO. '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 commercialisation.'
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