Pierre Fabre Dermatologie Starts Clinical Trials on a Beta-Blocker to Treat Severe Infantile Haemangioma

CASTRES, France - Pierre Fabre Dermatologie, specialised department of Pierre Fabre Laboratories, is proud to announce the launch of a set of clinical trials following the signature of an exclusive and worldwide licence agreement on July 10th 2008 with the University of Bordeaux. The contract covers the development, production and marketing of a paediatric beta-blocker for the treatment of severe infantile haemangioma with the intention of obtaining NDA-approval (New Drug Application) both for Europe and the USA. Patents were also applied for in this indication.

The efficacy of beta-blockers on haemangioma was discovered by Dr. Christine Leaute- Labreze, dermatologist in Pr. Alain Taieb’s department in Bordeaux. “Effectiveness of this treatment has been demonstrated in several hundred children throughout the world. Rigorous clinical trials are, however, yet to be conducted to ascertain the efficacy and tolerance of this new therapeutic strategy, hence this agreement with Pierre Fabre Dermatologie, which would ensure safety and availability of the treatment.”

This therapeutic breakthrough has been widely talked about, not only during scientific conferences but also through professional and general-interest press.

“This is a major discovery that will bring true therapeutic advance to patients affected by this highly apparent disease, which can be very severe and can have a strong impact on their quality of life and that of their parents. For this reason, we are highly honoured to have signed this agreement with the University of Bordeaux on severe haemangioma,” specifies Jacques Fabre, General Manager of Pierre Fabre Dermocosmetique.

About haemangioma:

Infantile haemangioma refers to a vascular tumour highly prevalent in infants, with a 10% concurrency rate. Haemangioma occurs in the first months of life and is located on the face in 60% of cases. The lesion is bright red and commonly referred to as a “strawberry mark”.

Local complications may occur in the form of ulceration and critical localisations such as the eye area or the upper respiratory tract. These complications are the serious forms of the disease and represent 10% of total haemangioma occurrence, or 1% of births. First intention treatment is usually long-term systemic corticotherapy. The trouble with this kind of treatment is that it involves numerous and sometimes serious side-effects that are well known in infants.

About Pierre Fabre:

Pierre Fabre Laboratories, France’s second biggest independent pharmaceutical laboratory, achieved a turnover of 1.75 billion euros in 2008. It employs nearly 10,000 people including 1,400 in the research sector. Its business sectors are ethical drugs, healthcare products and dermocosmetics with the brands Avene, Ducray/A Derma, Galenic/Elancyl, Klorane and Rene Furterer. Pierre Fabre Dermatologie, as part of Pierre Fabre Dermocosmetique, is specialised in prescription drugs.

In 2008, Pierre Fabre Medicament dedicated 33% of its annual turnover to R&D in five main therapeutic areas: oncology (priority sector with 50% of the overall R&D budget), Central Nervous System, cardiology, internal medicine/urology and dermatology. To find out more about Pierre Fabre Laboratories: www.pierre-fabre.com

Source: Pierre Fabre SA

Press contacts:, Laboratoires Pierre Fabre, Caroline Perdrix-Thomas, Tel.: +33(0)1-49-10-81-12 - +33(0)6-09-22-29-67, Email: caroline.perdrix at pierre-fabre.com; Catherine de Rohan Chabot,, Communication officer, Tel. : + 33(0)1-53-53-20-50-51 - +33(0)6-89-45-87-95, Email: catherine.de.rohan.chabot at pierre-fabre.com, Universite de Bordeaux, Pascal Barthoumieux, Tel: +33(0)5-57-57-92-08