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| February 1, 2001 |
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| Development for
Acute Ischemic Stroke on Argatroban in North America |
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| Mitsubishi-Tokyo Pharmaceuticals, Inc. |
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Mitsubishi-Tokyo Pharmaceuticals, Inc. (head office: Chuo-ku, Tokyo; President:
Ryuichi Tomizawa) today announced to cooperate with the partner, Texas Biotechnology
Corporation (TBC, head office: Texas) on the development of argatroban for acute
ischemic stroke as the second indication in the U.S. and Canada. Argatroban (brand
name in Japan: Novastan ), a selective
anti-thrombotic product, was received an approval from the U.S. FDA as an anticoagulant
for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia
(HIT), on June 30, 2000 and was begun marketing in November 2000 in the U.S..
Under the collaboration with TBC, Mitsubishi-Tokyo expects the Phase II acute
ischemic stroke trial in the U.S. and Canada to begin in the first quarter. The
trial protocol has been approved by the U.S. FDA and the Investigator Meeting
will be held in the beginning of February.
Each year, more than 1,000,000 cases of acute ischemic stroke are reported in
North America. Currently, thrombolytic agent, tPA is the only drug approved for
treatment of acute ischemic stroke, but only within the first 3 hours after the
onset.
Argatroban has been on the Japanese market since 1990. The first indication was
chronic arterial occlusion (Buerger's disease, arteriosclerosis obliterans). Argatroban
was also approved an additional indication for acute cerebral thrombosis in 1996,
with highly evaluated efficacy and safety.
In the U.S., GlaxoSmithKline (GSK, head office: Middlesex, U.K.) began marketing
of the product under its generic name, "Argatroban Injection" for the indication
of HIT. GSK has begun educating the medical community through publications and
seminars as well as hosting numerous symposia. Mitsubishi-Tokyo has sent an expert
to work with GSK on the promotion activities. Over approximately 360,000 patients
will develop HIT in the U.S. and Argatroban Injection will be available not only
to treat, but also to prevent, thrombosis for these patients.
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