Recordati announced the submission to the U.S. FDA by Orphan Europe (a Recordati group company) of an Original New Drug Application (NDA) for Carbaglu® (carglumic acid). The NDA provides for the safe and effective use of Carbaglu® in the treatment of hyperammonaemia due to an autosomal genetic disorder resulting in the deficiency of the liver enzyme N-acetylglutamate synthase (NAGS deficiency).

The prestigious French review Prescrire rewarded the most important medicines in 2007 and awarded the “Pilule d’Or” (the golden pill), its highest distinction, to Carbaglu® (carglumic acid), an Orphan Europe product.

It will take place in Dublin, Ireland on 27th and 28th June, 2008.

The application covers the indications Vitamin E-deficiency in children diagnosed with chronic cholestasis or cystic fibrosis.

Orphan Europe has signed an agreement with Teva Pharmaceutical Industries Ltd. regarding the distribution rights to Wilzin® in the Nordic (Sweden, Denmark, Norway, Finland and Iceland) as well as the Baltic countries (Estonia,Latvia, Lithuania).

Riyadh and Beirut, February 15, 2007 – Middle East Metabolic Group (MEMG), an interest group of physicians, laboratory scientists and nutritionists largely experienced in investigation, management and diagnosis of metabolic disorders in the Middle East region is now developing into Middle East Society for Inborn Errors of Metabolism.

Cystadane® has marketing approval in the US, Canada, Australia and Israel. On the 15th of February 2007, Orphan Europe received marketing authorization for Cystadane® in Europe. 

Orphan Europe was present at the 6th Conference on Homocysteine Metabolism -World Congress on Hyperhomocysteinemia at the Saarbruecken Congress Hall (Germany), from June 5th-9th, 2007. Orpahn Europe presented a recently approved treatment for homocystinuria.