CV Therapeutics owns the rights for regadenoson outside of North America and currently expects to submit a marketing authorization application for the product to the European Medicines Agency by the end of 2008.
Astellas Pharma US, Inc. / CV Therapeutics Inc. Collaboration
Under a license and collaboration agreement providing Astellas with exclusive North American rights to Lexiscan(TM) (regadenoson) injection, CV Therapeutics completed the development program and Astellas is responsible for all commercial activities for the product in North America. Under the arrangement, Astellas paid CV Therapeutics a $7 million milestone upon submission of the new drug application to the FDA, and a $12 million milestone in April 2008. Astellas also reimburses CV Therapeutics for 75 percent of development costs. CV Therapeutics will receive a royalty on product sales of Lexiscan(TM) (regadenoson) injection, and may receive a royalty on another Astellas product.
About Lexiscan(TM) (regadenoson) injection
Lexiscan(TM) is an A2A adenosine receptor agonist approved for use as a
pharmacologic stress agent in radionuclide MPI studies in patients unable
to undergo adequate exercise stress. Lexiscan(TM) was designed to produce
coronary vasodilation and increase coronary blood flow by activation of the
A2A adenosine receptor. Lexiscan(TM) is administered as a rapid bolus
(approximately 10 seconds) with no dose adjustment required for body
weight. Lexiscan(TM) should not be administered to patients with second- or
third-degree AV block or sinus node dysfunction who do not have a
functioning artificial pacemaker. Adenosine receptor agonists, including
Lexiscan(TM), induce arterial vasodilation and hypotension. The risk of
serious hypotension may be higher in patients with cardiac or
cerebrovascular insufficiency. Comple
|SOURCE CV Therapeutics, Inc.|
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