PIERRE-FABRE

Pierre Fabre Dermatologie Laboratories have obtained European Commission authorization to market Hemangiol® (propranolol), the first and only drug to be approved for the treatment of “proliferating infantile hemangioma requiring systemic treatment”. Hemangiol® is an oral solution specially developed for pediatric use. It will be launched firstly in France and Germany, and gradually throughout other European markets.

This European agreement follows the FDA* approval obtained on March 14th for Hemangeol^TM , the trade name of the identical drug to be launched on in the US in June.

This PUMA (Paediatric Use Marketing Authorization ) is only the second of its type, for all pathologies, that the European Medicines Agency (EMA) has issued since the system was established in 2007.

From a discovery to a trusted drug
The efficacy of propranolol for the treatment of infantile hemangioma was first discovered in 2007 by Christine Léauté-Labreze MD, a dermatologist at Bordeaux University Hospital Center. “12% of hemangiomas are severe forms that can lead to complications such as airway obstruction, vision problems or irreversible disfigurement. Yet there was no treatment available for this pathology that offered adequate efficacy and tolerance. The marketing authorization provides a legal framework that protects the child, family members and the prescribing practitioner, ” explained Christine Léauté-Labreze MD, a dermatologist at Bordeaux University Hospital Center.

In 2009, Pierre Fabre Dermatologie and the University of Bordeaux had formed a partnership to make this discovery available to infants with infantile hemangioma (IT) under conditions specifically adapted to pediatric use. Within this framework, Pierre Fabre Dermatologie took charge of the pharmaceutical, toxicological, clinical and industrial development aspects, including:

• Developing a formula for infants - containing no excipients known to have a recognized effect (such as alcohol and sugar), and flavored to allow for better acceptability of the treatment;
• Setting up three clinical trials, including a Phase II / III trial, conducted on 460 babies between five weeks and five months of age, to confirm the appropriate treatment regimen, and the efficacy and tolerance of the formula;
• Designing a product presentation aimed at safe and easy use, thanks notably to a graduated (in mg) oral syringe and a non-movable adaptor on the bottle,
• The industrial adaptation and manufacturing in accordance with pharmaceutical standards in order to ensure the quality and reproducibility of the drug.

“Every year, thousands of children will be able to benefit from this new pediatric dermatology treatment specially formulated, developed, tested and produced for safe pediatric use,” stated Jean-Jacques Voisard MD, Dermatologist, General Manager of Pierre Fabre Dermatologie.

“The approvals obtained from the American and now the European agency are testimony to the capacity for innovation in French research and reward a public-private partnership formed six years ago between the University, the Bordeaux University Hospital Center and Pierre Fabre Laboratories, with support from the innovation agency, Aquitaine Science Transfert,” commented Eric Ducournau, CEO of Pierre Fabre Dermo-Cosmétique. “This achievement is a source of great encouragement to maintain the focus of on R&D efforts on oncology, dermatology and neuropsychiatry, our three priority therapeutic franchises” stated Bertrand Parmentier, Group CEO of Pierre Fabre Laboratories.

About infantile hemangiomas : www.infantilehemangiomas.com

About Pierre Fabre and Pierre Fabre Dermatologie : www.pierre-fabre.com

Contact:

Press contacts
Pierre Fabre Médicament
Valérie Roucoules, +33 (0)1 49 10 83 84
Deputy Director Media Relations
valerie.roucoules@pierre-fabre.com
or
Agence PRPA
Juliette Billaroch, +33 (0)1 77 35 60 94
juliette.billaroch@prpa.fr

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