Castres, France, December 5, 2014 / B3C newswire / - Recognition for major progress
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.
About the Prix Galien
The Prix Galien France Award is the highest distinction conferred each year on pharmaceutical research. It rewards recent therapeutic innovations made available to health care professionals and patients as well as pharmaceutical research. The members of the panel not only include Nobel laureates, but also the most eminent experts and specialists in pharmacology, treatment, pharmacy, medicine, clinical practice, biochemistry and toxicology. The renown of the members of the panel, their pharmaceutical meticulousness and their independence have made the Prix Galien an institutional gold standard among the pharmaceutical industry and public authorities, and is often considered to be the highest distinction on the field of drugs.
About Pierre Fabre and Pierre Fabre Dermatologie
Pierre Fabre is the third largest pharmaceutical laboratory in France and the second largest dermo-cosmetics laboratory in the world. In 2013, its revenue represented €2 billion, 56% of which came from international business. Pierre Fabre, which has always been based in the Midi-Pyrénées in southern France, has subsidiaries in 44 countries and distribution agreements in over 130 countries.
Present in all health care segments; from ethical pharmaceuticals to dermocosmetic products and health (OTC, Oral Care), Pierre Fabre employs some 10,000 staff worldwide. In 2013, the group devoted over 17% of its revenue from pharmaceuticals to R&D, based on three research priorities: oncology, dermatology and neuropsychiatry.
Through the holding company Pierre Fabre Participations, 86% of Pierre Fabre Laboratories are held by the Pierre Fabre Foundation, recognized as a public-interest foundation since 1999. The remainder of the shares is held by the company’s employees (7%) and as treasury shares (7%).
Created in 1983 and present in 84 countries, Pierre Fabre Dermatologie has become a major player in dermatology over the last 30 years. It is the medical essence of the Dermo-Cosmetics branch, also consisting of the brands Avène, A-Derma, Darrow, Ducray, Elancyl, Galénic, Glytone, Klorane and René Furterer. The portfolio of Pierre Fabre Dermatologie specialty products covers the treatment of major dermatological conditions: acne, psoriasis, inflammatory dermatoses, mycoses, alopecia, etc. Drawing on the Group’s pharmaceutical expertise, Pierre Fabre Dermatologie combines the absolute demand for pharmaceutical rigor with the search for the pharmaceutical forms which are most appropriate to dermatological treatments and supporting dermatologists.
About Aquitaine Science Transfert® (SATT Aquitaine)
Aquitaine Science Transfert® is the Technology Transfer Office for the Aquitaine area. Aquitaine Science Transfert® aims the enhancement of academic research and the improvement of the technology transfer process to companies. The company is driven by its founding shareholders that are the “Communauté d’Universités” and “Etablissements d’Aquitaine”, the University of Pau and Pays de l’Adour, CNRS, Inserm and the “Caisse des Dépôts et Consignations” on behalf of the state.
The skills of Aquitaine Science Transfert® cover all stages of technology transfer: detection of inventions and market needs, maturation (investment in the technical, economical and legal proof of concept), management and transfer of Intellectual Properties and negotiation with the socio-economic contractors (license agreements, cooperation agreements, start-up creation).
With a significant investment capacity for technology, IP, legal and business studies, Aquitaine Science Transfert® will have invested between July 2012 and July 2015, around € 10 million over 80 projects.
From its creation to December 2013 Aquitaine Science Transfert® has invested in 26 projects for a total amount of 3.6 million euros.
Contact
Pierre Fabre
Valérie Roucoules
Tel: +33 1 49 10 83 84
valerie.roucoules@pierre-fabre.com
References:
(1) Summary of Product Characteristics for Hemangiol®
(2) Leauté-Labrèze C et al. Propranolol for severe hemangiomas of infancy. N Engl J Med 2008 ;358(24) :264
(3) Frieden IJ et al. Guidelines of Care for Hemangiomas of Infancy. American Academy of Dermatology Guidelines /Outcomes Committee. Journal of the American Academy of Dermatology. 1997 oct ; 37 (4) :631-537
(4) Kilcline C., Frieden IJ. Infantile hemangiomas: how common are they? A systematic review of the medical literature. PediatrDermatol. 2008;25: 168-73
(5) Hoornweg MJ., Smeudlers MJ., Van der Horst CM. Prevalence and characteristics of hemangiomas in young children. Ned TujdschrGeneeskd. 2005;149: 2455-8
(6) Hartzell Larry D., Buckmiller Lisa M. Current management of infantile hemangiomas and their common associated conditions. OtolaryngolClin N Am 45. 2012;545–56
(7) Enjolras O et al. Betabloquants et hémangiome infantile nécessitant un traitement systémique : une révolution thérapeutique ? http://www.jppediatrie.com/pdf/livre-2009/Article34_Enjolras.pdf
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