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发表于 2003-10-13 16:09
DGNews
Europe Grants Orphan Drug Designation to Thymitaq (Nolatrexed) for Treatment
of Primary Liver Cancer
BERWYN, PA -- October 9, 2003 -- EXIMIAS Pharmaceutical Corporation
announced today that it has received Orphan Medicinal Product designation
from the Commission of the European Communities, based on the favorable
opinion of the European Agency for the Evaluation of Medicinal Products
(EMEA), for Thymitaq® (nolatrexed) in the treatment of hepatocellular
carcinoma (primary liver cancer or HCC). A similar designation has already
been granted to Thymitaq in the United States by the US Food and Drug
Administration (FDA).
Orphan Medicinal Product designation in Europe provides for a ten-year
exclusive marketing period in all European Union member countries; full or
partial exemption from product registration fees; and protocol and
regulatory assistance from the EMEA. The designation is intended for
products that treat life-threatening, debilitating or serious and chronic
diseases, where the patient population is less than 185,000 and where a
satisfactory method of diagnosis, prevention, or treatment does not
currently exist.
"The granting of Orphan Medicinal Product designation to Thymitaq is another
element in our overall regulatory strategy for marketing approval within the
European Community where the incidence of HCC is over 50,000 new cases
annually. HCC is the fifth most common cancer in the world, causing the
deaths of almost all affected patients within one year," said Elizabeth
Corsi, EXIMIAS' President and Chief Executive Officer. "This designation
reinforces the completion of our pivotal study with the continued support of
our clinical study sites in Europe, as well as our sites in eastern Europe,
North America and South Africa."
About Thymitaq®
Thymitaq is a unique potent direct thymidylate synthase inhibitor with broad
anticancer activity in solid tumors. The product was designed with
sophisticated computer modeling to overcome the drawbacks of existing
therapies. Thymitaq is currently being tested in an international pivotal
Phase III registration trial called ETHECC(C) (Evaluation of Thymitaq in
Hepatocellular Carcinoma). The study is 70% enrolled, and a New Drug
Application is targeted for 2004 filing.
SOURCE: EXIMIAS Pharmaceutical Corporation
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