Orphan Europe has been developing, co-developing and distributing orphan drugs since 1990, well before the orphan drug legislation was introduced in Europe. Thanks to a complete dedication to and understanding of this market, Orphan Europe is experiencing a 20-30% annual growth in sales.

Today Orphan Europe maintains a good balance between in-house developed drugs, co-development and distribution agreements. It is a highly qualified organisation with expertise in medical, regulatory, marketing and distribution issues for orphan drugs, providing 10+ medicinal products to patients all over the world.

 

Synergies

Orphan Europe cooperates with a number of well-established pharmaceutical and biotechnology companies as well as research institutes. These partnerships have involved co-development, clinical studies, regulatory applications, production, marketing and worldwide distribution.

For example Orphan Europe and Peptimmune Inc. are collaborating in the development of a peptide immunotherapy for the treatment of pemphigus vulgaris. The common goal is to bring to market a new specific disease-modifying drug to treat this rare, life-threatening, autoimmune skin disease.

Peptimmune has conducted a phase 1 trial establishing the safety of the treatment and an orphan drug designation has been obtained in the USA. Orphan Europe will continue the clinical development of this peptide in Europe. Orphan Europe intends to take this product through the regulatory process in Europe until market authorization for future commercialisation in Europe, the Middle East, and Africa.

Another example of a fruitful cooperation is the licensing of a drug for the treatment of acute attacks of porphyria from the Finnish company Leiras (today belonging to Bayer GmbH). The drug was only approved in Finland but Orphan Europe submitted the regulatory dossier. In 1995 Orphan Europe obtained the Marketing Authorization in France and in successive waves of Mutual Recognition Procedure Orphan Europe extended the approval to the rest of Europe.

Looking for a partner?

Are you a company working with orphan drugs? Do you need a co-development partner? Are you looking for expertise in developing your European regulatory dossier? Do you need access to the European or Middle East market?

Please contact our business development department at: