Date: 2014-03-31
Type of information: Production agreement
Compound: Validive® (clonidine Lauriad®)
Company: BioAlliance Pharma (France) Penn Pharma (UK)
Therapeutic area: Cancer - Oncology
Type agreement: production
Action mechanism:
Disease: severe oral mucositis induced by radiotherapy and/or chemotherapy in head and neck cancer patients
Details: * On March 31, 2014, BioAlliance Pharma, an innovative Company specialized in the development of drugs in orphan oncology diseases, 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.
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