Lausanne, Switzerland, and Paris, France, November 17, 2008 – Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, and Pharmaleads SAS, a science driven drug discovery and early development company, today announced the signature of an exclusive license agreement for the development, registration and commercialisation of a small molecule called Debio 0827 or PL37, about to enter phase I clinical trials. Debio 0827 is the first in a new class of painkillers that could be used in the treatment of chronic pain conditions, primarily in neuropathic pain. Under the terms of the agreement, Debiopharm will make an up-front payment to Pharmaleads, as well as further payments as Pharmaleads reaches predefined development milestones.
“With this agreement we add the new therapeutic area of chronic pain management to the Debiopharm product portfolio. There is currently an unmet medical need for the treatment of chronic pain, which can often not be treated successfully and can seriously affect patients’ quality of life. For this reason, we have decided to develop this new therapeutic approach,” said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group.
“This exclusive licence agreement is very exciting and promising: it will speed up the development of a totally new class of painkillers, hence confirming the validity of our science and chemistry, as well as our capabilities as a drug discovery and early development company,” added Thierry Bourbié, Chairman and CEO of Pharmaleads.
Following authorisation from the French Medicine Agency (AFSSAPS), Debio 0827 is about to enter a single ascending dose Phase I, randomised, double-blind, placebo controlled single oral dose escalation study in France, to investigate its safety, tolerability and pharmacokinetics in healthy volunteers.
About Neuropathic pain
Neuropathic pain is a major chronic pain condition. According to the most recent surveys, its estimated prevalence in the world’s population is up to 6%, with many causes such as shingles, diabetes, antiviral or antitumor chemotherapy surgery, or low back disorders. Neuropathic pain does not respond well to usual painkillers. Worldwide market for neuropathic pain is estimated to reach 5 billion USD by 2010.
About Debiopharm Group
Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. It develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed three products with global combined sales in excess of $2.65 billion in 2007.
For more information on Debiopharm Group, please visit: www.debiopharm.com.
Pharmaleads is a science driven drug discovery and early development company. Headquartered in Paris, France, Pharmaleads was founded in 2001 by Professors Bernard P. Roques, pharmacist and pharmacologist and PhD in physico-chemistry, Member of the French and European Academies of Sciences, and Marie-Claude Fournié-Zaluski, PhD in chemistry. Professors Roques and Fournié-Zaluski are the inventors of two marketed drugs, and have developed the concept of “physiological” treatment of pain which has led to PL37.
In 2004, Thierry Bourbié, alumnus from Polytechnique and Mines, PhD from Stanford, former Deputy General Manager, Suez Group and Jean-Pierre Rogala, PhD from Agro, MBA from MIT (IBM, Suez Group) brought to Pharmaleads their first rank international business expertise. In 2006, Michel Wurm, M.D. joined and added his extensive experience in both drug and business development.
For more information on Pharmaleads, please visit: www.pharmaleads.com