March 31, 2014
BioAlliance Pharma SA , an innovative company specialized in the development of drugs in orphan oncology diseases, announced today 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.
About Penn Pharma
Penn Pharma is a privately owned provider of services to the pharmaceutical and biotech industry. Penn Pharma’s services include Formulation Development and Analytical Services, support for clinical trial studies by manufacturing and labelling investigational products for distribution to clinical sites worldwide. Penn also offers support for the importation and release of non-EU products. The Company has specialist facilities for the supply of commercial licensed products including those requiring contained operations, protecting both operators and the environment.
Penn Pharma is inspected by many authorities allowing supply of services and products to the international market (e.g. MHRA, FDA and ANVISA) for both human and veterinary medicines.
For more information about Penn Pharma, visit the Penn Pharma website at www.pennpharm.com
About BioAlliance Pharma
Dedicated to cancer treatments with a focus on resistance targeting and orphan products, BioAlliance Pharma conceives and develops innovative products for orphan or rare diseases.
Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA.
BioAlliance Pharma has developed an advanced product portfolio:
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) (primary liver cancer): Phase III on going
Validive® (Clonidine Lauriad®) (mucositis): Phase II on going
AMEP® (invasive melanoma): Phase I on going
For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com
This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the 2012 Reference Document filed with the AMF on April 18, 2013, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA’s website ().