CV Therapeutics Announces $185 Million Transaction with TPG-Axon Capital for Half of Royalty for Lexiscan(TM) (regadenoson) Inje
April 15 2008 - 5:01PM
PR Newswire (US)
PALO ALTO, Calif., April 15 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that TPG-Axon
Capital has agreed to pay CV Therapeutics up to $185 million in
exchange for rights to 50 percent of CV Therapeutics' royalty on
North American sales of Lexiscan(TM) (regadenoson) injection. CV
Therapeutics received $175 million on closing of the transaction
and could receive a potential future milestone payment of $10
million. 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. 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 Pharma US, Inc. "With the
funds from this non-dilutive financing and multiple product-related
revenue streams, we believe CV Therapeutics now has the funds to
become cash flow positive and meet the debt obligation which is
putable in 2010, both without requiring capital market financing or
partnership dollars," said Louis G. Lange, M.D., Ph.D., chairman
and chief executive officer of CV Therapeutics. "We are
aggressively pursuing a partner to support Ranexa commercialization
and this additional financial independence provides important
leverage for managing both the balance sheet and our discussions
with potential partners." 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 manages 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 CVT is entitled to a $12 million milestone from
Astellas upon FDA approval of the new drug application. 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) (regadenoson) injection is the first A2A
adenosine receptor agonist approved by the FDA for use as a
pharmacologic stress agent in radionuclide MPI studies. The product
has been designed to target the A2A adenosine receptor, which is
the adenosine receptor subtype responsible for coronary
vasodilation. Lexiscan(TM) (regadenoson) injection is administered
as a rapid intravenous bolus injection, with no dose adjustment
required for body weight. 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 $15 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. 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 Annual
Report on Form 10-K for the year ended December 31, 2007. 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/
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