VIENNA, Austria, July 19 /PRNewswire/ -- AOP Orphan Pharmaceuticals, manufacturer and product developer of Thromboreductin(R), announces that it has achieved its intermediate goal to make Thromboreductin(R) available in the European Union by means of an ambitious GCP compliant clinical trial programme. Thromboreductin is the first Anagrelide containing medicinal product approved within the EU and thus available for treatment of patients with essential thrombocythaemia (ET), a rare myeloproliferative disorder which can cause life threatening complications. Until recently Hydroxyurea was the only drug approved for treatment of ET in some EU countries. However, Hydroxurea has a potential risk of inducing leukaemia during long term treatment, whereas Thromboreductin is devoid of any leukaemogenic risk.
The granting of the marketing authorizations strongly supports AOP Orphans concept of maintaining the GCP standard in the development of orphan drugs as requested by EU regulatory authorities. In case of Thromboreductin(R) this means that the developmental work will be finalized by completion of the currently ongoing AOP Orphan phase III ANAHYDRET study.
"ANAHYDRET poses an extremely high challenge in the development plan of a drug for a rare disease, because it requires the recruitment of 220 treatment naive high risk ET patients in 30 centers. This obligatory study will answer questions asked for by EU regulatory authorities with respect to the relative safety and efficacy of Anagrelide and Hydroxyurea. Moreover, as recently confirmed at a meeting of the European Working Party for Myeloproliferative Disorders in Rotterdam, ANAHYDRET is regarded as a study, major opinion leaders have been waiting for for a long time. Recruitment for the interim analysis will be completed shortly, and this will additionally improve the quality of our dossier for further regulatory submissions", says Dr. Rudolf S. Widmann, CEO of AOP Orphan. "Our development programme for Thromboreductin(R) proves, that the conduct of GCP compliant studies in a total of more than 350 patients is feasable also in rare myeloproliverative diseases".
AOP Orphan Pharmaceuticals AG is a pharmaceutical company based in Vienna, Austria, specialized in the development, production and marketing of medicines for rare diseases. AOP Orphan is strongly committed to meet the challenges inherent in bringing new products to the market for patients with rare and debilitating diseases. This has just recently been reinforced by entering into a development cooperation for Duramycin in the indication cystic fibrosis with Lantibio Inc.
AOP Orphan Pharmaceuticals AG
CONTACT: For Information contact: Birgit Gumpinger, E-Mail:email@example.com, AOP Orphan Pharmaceuticals AG,Wilhelminenstr. 91/IIf/B4, 1160 Vienna, Austria, T:+43-1-5037244 F: +43-1-5037244-5