Commercial Launch of Lexiscan(TM) (Regadenoson) Injection Triggers $10 Million Milestone Payment from TPG-Axon Capital to CV The
June 24 2008 - 9:40AM
PR Newswire (US)
PALO ALTO, Calif., June 24 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that in
conjunction with the commercial launch of Lexiscan(TM) by Astellas
Pharma US, Inc., CV Therapeutics has earned a milestone payment of
$10 million from TPG-Axon Capital, through an affiliated entity
(TPG-Axon). CV Therapeutics will recognize the milestone as revenue
earned in the second quarter of 2008. The U.S. Food and Drug
Administration (FDA) approved Lexiscan(TM) (regadenoson) injection,
an A2A adenosine receptor agonist, for use as a pharmacologic
stress agent in radionuclide myocardial perfusion imaging (MPI) in
patients unable to undergo adequate exercise stress, on April 10,
2008. On April 15, 2008, CV Therapeutics announced the completion
of a non-dilutive financing transaction with TPG-Axon in which
TPG-Axon agreed to pay up to $185 million in exchange for rights to
50 percent of its royalty on North American sales of Lexiscan(TM).
CV Therapeutics received $175 million on closing of the transaction
and has now earned an additional $10 million milestone associated
with the commercial launch of the product, which Astellas announced
today. CV Therapeutics retains rights to the other 50 percent of
royalty revenue from North American sales of the product, and also
may receive a royalty on another Astellas product under the terms
of the company's collaboration agreement with Astellas. "The
commercial launch of Lexiscan(TM) marks the culmination of a decade
of work at CV Therapeutics where we discovered regadenoson and did
the clinical, manufacturing and regulatory work needed to bring
this important innovation to physicians and patients," said Louis
G. Lange, CV Therapeutics chairman and chief executive officer.
"Our partners at Astellas are the market leaders in the MPI market
and are very well positioned for commercial success." 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. Complete prescribing information for
Lexiscan(TM) is available at http://www.lexiscan.com/. About
Myocardial Perfusion Imaging Studies MPI studies help detect and
characterize coronary artery disease by identifying areas of poor
blood flow in the heart. Every year, between 7.5 and 9.3 million
MPI studies are performed in the United States. Almost half of
these studies utilized a pharmacologic stress agent. About TPG-Axon
Capital TPG-Axon Capital is a leading global investment firm, with
over $16 billion of capital invested in both public and private
markets around the world. Through offices in New York, London, Hong
Kong and Tokyo, the firm makes focused, long-term investments in
companies, industries and assets across geographies. About CV
Therapeutics CV Therapeutics, Inc., headquartered in Palo Alto,
California, is a biopharmaceutical company primarily focused on
applying molecular cardiology to the discovery, development and
commercialization of novel, small molecule drugs for the treatment
of cardiovascular diseases. CV Therapeutics' approved products
include Ranexa(R) (ranolazine extended-release tablets), indicated
for the treatment of chronic angina in patients who have not
achieved an adequate response with other antianginal drugs, and
Lexiscan(TM) (regadenoson) injection for use as a pharmacologic
stress agent in radionuclide myocardial perfusion imaging in
patients unable to undergo adequate exercise stress. CV
Therapeutics also has other clinical and preclinical drug
development candidates and programs that have not been determined
to be safe or effective in humans for any uses. Except for the
historical information contained herein, the matters set forth in
this press release are forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially, including: upside potential for Lexiscan(TM)
North American sales; ability of CV Therapeutics to achieve
profitability; operating losses and fluctuations in operating
results; capital requirements; regulatory review and approval of
our products; special protocol assessment agreement; the conduct
and timing of clinical trials; commercialization of products;
market acceptance of products; product labeling; reliance on
strategic collaborative partners; reliance on contract
manufacturers; intellectual property; and other risks detailed from
time to time in CV Therapeutics' SEC reports, including its
Quarterly Report on Form 10-Q for the year ended March 31, 2008. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements. DATASOURCE: CV Therapeutics, Inc.
CONTACT: John Bluth, Executive Director, Corporate Communications
& Investor Relations of CV Therapeutics, Inc., +1-650-384-8850
Web site: http://www.cvt.com/ http://www.lexiscan.com/
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