news

Penn Pharma Enter into manufacturing agreement with BioAlliance

Posted: 3 April 2014 | | No comments yet

Pharmaceutical manufacturer Penn Pharma has announced an agreement with BioAlliance Pharma to manufacture one of their leading development products in Penn’s new contained manufacturing facility…

Penn Pharma logo

Pharmaceutical manufacturer Penn Pharma has announced an agreement with BioAlliance Pharma to manufacture one of their leading development products in Penn’s new contained manufacturing facility which opened last year.

Penn Pharma has been chosen by BioAlliance, an international specialist based in France, for the development and manufacture of Validive®.

The product, which is developed for the prevention and treatment of oral mucositis induced by radiotherapy and/or chemotherapy in cancer patients, received Fast Track status this month from the U.S. Food and Drug Administration (FDA). Penn Pharma, based in South Wales, will be involved in the development of the final dosage form, Phase lll clinical supplies and future commercial supply needs.

Chief Executive at BioAlliance Pharma, Judith Greciet said: “We have chosen to continue the development of this leading product with Penn Pharma due to their expertise and capability in solid dose contained manufacturing.

Validive® is a mucoadhesive tablet based on our Lauriad® technology that delivers the anti-inflammatory active clonidine, directly onto the site of inflammation in the oral cavity.

The FDA’s decision to grant Fast Track approval to Validive® reflects how serious oral mucositis is, the vital need for an effective treatment, and the potential Validive® has to address an unmet clinical need.”

Penn Pharma’s Chief Executive, Richard Yarwood, added: “We are privileged to have been chosen by BioAlliance Pharma to manufacture one their most advanced pipeline products. Our expertise in contained manufacturing allied with our proven ability to support products through to commercialisation will ensure we will meet the customer’s needs.

We hope to continue our partnership with BioAlliance Pharma for many years to come.

Penn Pharma, based in Tredegar in Blaenau Gwent, South Wales, delivers integrated drug development, clinical trial supply and manufacturing services to the international healthcare industry.