Pierre Fabre Dermatologie Laboratories has received paediatric use marketing authorisation from the European Commission for Hemangiol (propranolol), indicated for treatment of proliferating infantile hemangioma.
An oral solution specially developed for paediatric use, Hemangiol is the first and only drug to be approved for treatment of proliferating infantile hemangioma requiring systemic treatment.
Hemangiol will be initially launched in France and Germany, and gradually throughout other European markets.
In March, Hemangeol received approval from the US Food and Drug Administration and is expected to be launched in the US in June.
In 2007, Bordeaux University Hospital Center dermatologist Dr Christine Léauté-Labreze first discovered the efficacy of propranolol for treatment of infantile hemangioma.
Pierre Fabre and the University of Bordeaux formed a partnership in 2009 to make this discovery available to infants with infantile hemangioma under conditions specifically adapted to paediatric use.
Within this framework, Pierre Fabre took charge of the pharmaceutical, toxicological, clinical and industrial development aspects.
The aspects included developing a formula for infants, setting up three clinical trials, including a Phase II/III trial, designing a product presentation aimed at safe and easy use, and the industrial adaptation and manufacturing in accordance with pharmaceutical standards in order to ensure the quality and reproducibility of the drug.
Pierre Fabre Dermo-Cosmétique CEO Eric Ducournau said: "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."
Pierre Fabre Laboratories Group CEO Bertrand Parmentier said: "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."