01-17-2013

Pierre Fabre and Maruho sign a licensing agreement in the treatment of severe infantile haemangioma

Laboratoires Pierre Fabre Dermatologie (PFD), a subsidiary of Laboratoires Pierre Fabre and Maruho Co., Ltd. (Maruho), today announced that an exclusive licensing agreement has been reached to develop and market in Japan, an oral formulation of paediatric beta-blocker for the treatment of infantile haemangioma requiring a systematic therapy.

Laboratoires Pierre Fabre Dermatologie recently completed a worldwide Phase III study with this oral formulation of beta-blocker which resulted in complete or nearly complete resolution of the haemangioma for a large majority of the infants treated, compared to an almost complete lack of effect for the placebo.

Under the terms of this agreement, Maruho will be responsible for developing and registering this oral formulation in Japan. Maruho has been granted an exclusive licence to import, distribute and promote the product in the country. Pierre Fabre Dermatologie will manufacture and supply the drug.

Asked about this agreement, Eric Ducournau, C.E.O. Pierre Fabre Dermo-Cosmetics, said: "we are excited about this partnership with Maruho, Japan’s leading dermatological company. It’s the best guarantee of success for our oral formulation of paediatric beta-blocker, the first effective and safe treatment for infantile haemangioma, in the world’s second biggest pharmaceutical market. Our determination to make dermatology one of our priority growth franchises can only benefit from this agreement".

Koichi Takagi, President and Chief Executive Officer of Maruho, said: “We are very glad to be able to make this agreement with Pierre Fabre Dermatologie. In Japan, there are currently no therapies available with an indication for infantile haemangioma. This agreement meets an unmet medical need for infantile haemangioma patients in Japan, and will contribute to the progress of the field of dermatology”.
As a reminder, the oral formulation of paediatric beta-blocker was developed by Pierre Fabre Dermatologie in compliance with the European Paediatric Regulations, which promotes the development of drugs specially designed for children.

About beta-blockers

The beta-blocker family, a well known molecule, has been used in the past for several infantile heart indications. The 2007 discovery by Dr Christine Léauté-Labrèze (paediatric dermatology team at the Bordeaux University Hospital) of its efficacy in the treatment of infantile haemangioma provides a powerful alternative to the reference treatments, corticotherapy and interferon.
In 2008, Pierre Fabre Dermatologie signed an exclusive worldwide licence agreement with the University of Bordeaux to develop, produce and market a paediatric beta-blocker for the treatment of severe infantile haemangioma with the aim of obtaining marketing authorisation (MA / NDA) both in Europe and the USA.
On October 10th 2012, Pierre Fabre Dermatologie announced positive results in a Phase III clinical trial and expects to shortly file an application for marketing authorisation specific to children (PUMA, Paediatric Use Marketing Authorisation) with the European Medicines Agency (EMA). In the United States, where this treatment benefits from orphan drug status, an application will be similarly filed with the Food and Drug Administration (FDA).