This award is recognition of both Pierre Fabre's expertise in dermatology, one of its development priorities, and of its ability to form public-private partnerships, such as that established with the University of Bordeaux.
Each year, the Prix Galien award distinguishes recent therapeutic innovations, made available to the public. It is conferred after an evaluation by an independent panel of experts and eminent specialists. Its renown and prestige have made it the highest distinction in the field.
Pierre Fabre Dermatologie, a subsidiary of Pierre Fabre Dermo-Cosmetics, was distinguished today by the Prix Galien award (France) for Hemangiol®, an oral pediatric propranolol solution specifically developed for some severe infantile hemangiomas. Hemangiol® was successively approved by American (FDA) and European health agencies (EMA) in March and April 2014. It’s the only dermatologic drug awarded by the Prix Galien award since 1993.
"This award for Hemangiol® is recognition of the progress made in the treatment of a pediatric dermatological condition for which there was a real therapeutic need. Our public-private partnership which kicked off 7 years ago with the Bordeaux University, the University Hospital with support from the agency "Aquitaine Science Transfer", is thus rewarded. Remember also that we owe this success to the determination of Mr. Pierre Fabre who initiated this project," stated Eric Ducournau, CEO of Pierre Fabre Dermo-Cosmetics.
"This Prix Galien award is a credit to the entire Pierre Fabre company. We receive it as a fantastic encouragement to continue our research efforts in our Group's priority fields of therapeutic innovation, in particular dermatology which is the natural link between our activities in medicines and those in dermocosmetics." commented Bertrand Parmentier, CEO of Pierre Fabre Laboratories.
Treating infantile hemangiomas requiring systemic treatment Infantile hemangioma is the most common tumor in infants (3 to 10% of infants up to one year old and up to 30% of premature babies(2) (3) (4) (5) (6)). 12% of hemangiomas require treatment (4) (5). The treatment of hemangiomas requiring systemic treatment hardly evolved at all for decades (7). It consisted of general corticosteroid therapy.
The effect of propranolol in the treatment of certain infantile hemangiomas was observed for the first time in 2007 by Doctor Christine Léauté-Labrèze, a dermatologist at the Bordeaux University Hospital. This discovery revolutionized the management and treatment of infantile hemangiomas requiring systemic treatment.
The story of exemplary partnership and development
Pierre Fabre Dermatologie, specialized in dermatology for 30 years, partnered with the University of Bordeaux to carry out the scientific, clinical and industrial development of this new drug. Pierre Fabre Dermatologie took on the tasks and responsibilities of the pharmaceutical, preclinical and clinical development, which were essential to rendering the discovery of the effect of propranolol on some forms of infantile hemangioma accessible with the greatest level of safety in pediatric medicine. The development confirmed propranolol's effect and determined its tolerability, defined the dosages and treatment regimen to use, the monitoring to perform, with a formula specifically studied for pediatric use with suitable safety measures. During the pivotal study, treatment with propranolol resulted in a complete or nearly complete cure of hemangiomas for a large majority of the infants treated, compared to nearly no effect with the placebo.
The development program involved practitioners who are specialized in the pathology.
The arrival of this new drug is a shining example of the success of a public-private partnership in promoting public research.