Date: 2013-01-17
Type of information: Development agreement
Compound: oral formulation of an undisclosed paediatric beta-blocker
Company: Laboratoires Pierre Fabre (France) Maruho (Japan)
Therapeutic area: Dermatological diseases
Type agreement: development
licensing
commercialisation
Action mechanism:
Disease: severe infantile haemangioma
Details: Laboratoires Pierre Fabre Dermatologie (PFD), a subsidiary of Laboratoires Pierre Fabre and Maruho have concluded an exclusive licensing agreement 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. The oral formulation of paediatric beta-blocker was developed by Pierre Fabre Dermatologie in compliance with the European Paediatric Regulations.
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 FDA.
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