28 May 2013

A discovery of the Bordeaux University Hospital and the Bordeaux Segalen University confirmed by clinical trials results

The Pierre Fabre Dermatology Laboratories, subsidiary of the Pierre Fabre group, in collaboration with the Bordeaux University Hospital and the Bordeaux Segalen University, announced favorable outcomes of a phase III clinical trial concerning the use of propranolol as a drinkable solution in the infantile hemangiomas. This pediatric oral formulation of propranolol was co-developed by Pierre Fabre Dermatology, Bordeaux University Hospital and the Bordeaux Segalen University in compliance with the European pediatric regulation.

“HEMANGIOL” Clinical study outcomes

All over the trial, the propranolol medication has permitted a complete or quasi-complete hemangioma cure for a large majority of the medicated infants, unlike the placebo total effect absence. This randomized study, placebo controlled, allowed to evaluate the effectiveness, the harmlessness and the tolerance of the new pediatric propranolol administration. It was dispensed to around 460 patients from 65 investigation centers in Europe, North America, South America, and Oceania.

“This success of the first effective medication development focusing infant hemangioma complies with our volition to make the dermatology one of our priority growth axes. This HEMANGIOL project managed in close collaboration with the Bordeaux University Hospital and the University Bordeaux Segalen is emblematic in our partnership approach which lead our R&D efforts”, Jaques Fabre, Managing Director of Pierre Fabre company.

Marketing Request

Following such results, Pierre Fabre Dermatology will submit a marketing approval specific to infants (PUMA, Pediatric Use Marketing Authorization) to the European Medicine Agency (EMA). In United-States, where the medication takes benefit of the orphaned medicine status, a request will be submitted in parallel to the American Agency (FDA, Food and Drug Administration).

Discovery record

After the recognition in 2007 of the propranolol benefit in the infant’s hemangiomas medication by Dr.Christine Léauté-Labrèze, an exclusive and global license was signed in 2008 by Pierre Fabre Dermatology to develop, to produce and to market the pediatric solution. US and European patents request were deposited and enlarged to 34 countries. Currently, the patent is delivered in Europe, USA and nine other countries. The results were published in 2008 after the patent submission. Under the joint development program of the Pierre Fabre Dermatology Laboratories, the Bordeaux Segalen University and the Bordeaux University Hospital, the HEMANGIOL project emerges to evaluate the efficiency of an adapted pediatric solution of the medicine for the infantile hemangioma medication.