AOP Orphan Pharmaceuticals AG

AOP Orphan Pharmaceuticals AG obtains Thromboreductin® registrations in Central Europe

    Vienna, Austria (ots) - AOP Orphan Pharmaceuticals, manufacturer
and product developer of Thromboreductin®, announces that it has
achieved its intermediate goal to make Thromboreductin® 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® this means that the developmental work will be
finalized by completion of the currently ongoing AOP Orphan phase III
    "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 naïve 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® 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.
ots Originaltext: AOP Orphan Pharmaceuticals AG

Birgit Gumpinger
AOP Orphan Pharmaceuticals AG
Wilhelminenstr. 91/IIf/B4
1160 Vienna
Phone:  +43/1/5037244
Fax:      +43/1/5037244

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