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The U.S. Food and Drug Administration (FDA) approved Lexiscan(TM)(regadenoson) injection, an A2A adenosine receptor agonist, for use as apharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI)in patients unable to undergo adequate exercise stress, on April 10, 2008.
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On April 15, 2008, CV Therapeutics announced the completion of anon-dilutive financing transaction with TPG-Axon in which TPG-Axon agreed topay up to $185 million in exchange for rights to 50 percent of its royalty onNorth American sales of Lexiscan(TM). CV Therapeutics received $175 million onclosing of the transaction and has now earned an additional $10 millionmilestone associated with the commercial launch of the product, which Astellasannounced today.
CV Therapeutics retains rights to the other 50 percent of royalty revenuefrom North American sales of the product, and also may receive a royalty onanother Astellas product under the terms of the company's collaborationagreement with Astellas.
"The commercial launch of Lexiscan(TM) marks the culmination of a decadeof work at CV Therapeutics where we discovered regadenoson and did theclinical, manufacturing and regulatory work needed to bring this importantinnovation to physicians and patients," said Louis G. Lange, CV Therapeuticschairman and chief executive officer. "Our partners at Astellas are the marketleaders in the MPI market and are very well positioned for commercialsuccess."
CV Therapeutics owns the rights for regadenoson outside of North Americaand currently expects to submit a marketing authorization application for theproduct 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 withexclusive North American rights to Lexiscan(TM) (regadenoson) injection,CV Therapeutics completed the development program and Astellas is responsiblefor all commercial activities for the product in North America. Under thearrangement, Astellas paid CV Therapeutics a $7 million milestone uponsubmission of the new drug application to the FDA, and a $12 million milestonein April 2008. Astellas also reimburses CV Therapeutics for 75 percent ofdevelopment costs. CV Therapeutics will receive a royalty on product sales ofLexiscan(TM) (regadenoson) injection, and may receive a royalty on anotherAstellas product.
About Lexiscan(TM) (regadenoson) injection
Lexiscan(TM) is an A2A adenosine receptor agonist approved for use as apharmacologic stress agent in radionuclide MPI studies in patients unable toundergo adequate exercise stress. Lexiscan(TM) was designed to producecoronary vasodilation and increase coronary blood flow by activation of theA2A 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- orthird-degree AV block or sinus node dysfunction who do not have a functioningartificial pacemaker. Adenosine receptor agonists, including Lexiscan(TM),induce arterial vasodilation and hypotension. The risk of serious hypotensionmay be higher in patients with cardiac or cerebrovascular insufficiency.Complete prescribing information for Lexiscan(TM) is available atwww.Lexiscan.com.
About Myocardial Perfusion Imaging Studies
MPI studies help detect and characterize coronary artery disease byidentifying areas of
