|
WHITEHOUSE STATION, N.J. and SAN DIEGO,
July 25, 2007 - Merck & Co., Inc., one of the world's
leading research-based pharmaceutical companies, and NovaCardia,
Inc., a privately held clinical-stage pharmaceutical company
focused on cardiovascular diseases, today announced that they have
entered into a definitive agreement under which Merck will acquire
NovaCardia.
Under the agreement, Merck will acquire all of the outstanding
equity of NovaCardia for $350 million plus the amount of cash on
hand at the time of closing, all of which will be paid in Merck
stock based on the average closing stock price on the five days
prior to closing of the acquisition.
"This acquisition continues to deliver on our strategy of targeted
acquisitions in areas of unmet medical need in the therapeutic
areas of strategic importance for Merck such as cardiovascular
diseases," said Richard Kender, vice president of business
development and corporate licensing at Merck.
NovaCardia's lead product candidate KW-3902, an adenosine
A1 receptor antagonist, is being studied in Phase 3
clinical trials in patients with acute congestive heart failure
(CHF). KW-3902 is believed to block adenosine-mediated
constriction of blood flow to the kidneys and inhibit reabsorption
of salt and water by the kidney, thereby increasing urine volume
and maintaining renal function in patients with CHF. To date,
no other vasodilator has demonstrated the selective renal
vasodilation attribute of KW-3902 that helps preserve renal
function. As renal function deteriorates in patients with CHF,
higher doses of diuretics are required in order to reduce fluid
overload. Multiple studies have demonstrated that renal
dysfunction is a strong independent predictor of worse short- and
long-term outcomes in patients with CHF.
"We are excited to see our lead product become part of the superb
scientific environment of Merck," said Randall E. Woods, president
and chief executive officer at NovaCardia. "NovaCardia
demonstrated the potential of KW-3902 in clinical trials, and we
believe that Merck can expedite the development of this novel
agent."
"Merck is very excited to have the opportunity to bring forward
potential new treatments for patients with heart failure," said
Richard C. Pasternak, M.D., vice president of clinical research at
Merck Research Laboratories. "Our acquisition of NovaCardia
enhances Merck's considerable internal research efforts committed
to the development of new medicines to treat major cardiovascular
diseases that are underserved by existing therapies."
NovaCardia recently presented preliminary results from a pilot
Phase 3 trial of KW-3902 at a late-breaking session of the European
Society of Cardiology's Heart Failure Congress 2007 that indicated
a strong trend toward efficacy for the 30 milligram dose.
Patients treated with KW-3902 experienced a higher rate of
improvement in dyspnea, or shortness of breath, which is a common
symptom of CHF, compared to the placebo group, and KW-3902 also
enhanced diuresis and mitigated deterioration of renal function
that is often experienced by patients undergoing standard
treatment. Two pivotal Phase 3 trials, PROTECT 1 and PROTECT
2, are currently enrolling participants in the United States,
Canada, Europe, Israel and Russia. NovaCardia in-licensed
KW-3902 from Kyowa Hakko Kogyo Co., Ltd., in 2003.
"NovaCardia's management team has done an exceptional job advancing
KW-3902 into Phase 3 clinical trials, demonstrating the compound's
potential and building NovaCardia into a successful company," said
Eckard Weber, M.D., founder and chairman of NovaCardia and partner
at Domain Associates.
In addition to Domain Associates, NovaCardia's investors include
Forward Ventures, Montreux Equity Partners, Versant Ventures,
Skyline Ventures and InterWest Partners. NovaCardia will
spin-out a new corporate entity to support clinical development of
the company's second compound, K201 (JTV-519) for atrial
fibrillation.
"This acquisition gives Merck the possibility to expand its
cardiovascular product pipeline into congestive heart failure, an
area of important unmet medical need and significant burden to the
healthcare system," said Guy Eiferman, general manager of the
atherosclerosis and cardiovascular franchise at Merck.
The acquisition is subject to clearance under the
Hart-Scott-Rodino Antitrust Improvements Act and other customary
conditions. The two companies expect to close the acquisition
within 45 days.
Merck's 2007 full-year financial guidance, provided on July 23,
2007, did not include the anticipated overall financial impact of
any charges associated with the NovaCardia acquisition. Merck
will provide an update to the full-year 2007 financial guidance
following the closing of the acquisition.
About Congestive Heart Failure
CHF is a widespread and debilitating disease most often caused by a
weakening or stiffening of the heart muscle, which leads to a
progressive loss in the heart's ability to pump blood effectively
throughout the body. There are nearly 5 million people in the
United States with CHF, according to the American Heart Association
(AHA). With the aging population and more patients surviving
the early stages of cardiovascular diseases, the prevalence of CHF
is increasing. Approximately 550,000 new cases of CHF are
reported in the United States each year, according to the AHA.
About NovaCardia
NovaCardia, Inc. is a clinical-stage pharmaceutical company focused
on developing drugs to treat major cardiovascular diseases that are
underserved by existing therapies.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical
company dedicated to putting patients first. Established in
1891, Merck currently discovers, develops, manufactures and markets
vaccines and medicines to address unmet medical needs. The
Company devotes extensive efforts to increase access to medicines
through far-reaching programs that not only donate Merck medicines
but help deliver them to the people who need them. Merck also
publishes unbiased health information as a not-for-profit
service. For more information, visit http://www.merck.com.
Forward-Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995. These statements are based on management's current
expectations and involve risks and uncertainties, which may cause
results to differ materially from those set forth in the
statements. The forward-looking statements may include statements
regarding product development, product potential or financial
performance. No forward-looking statement can be guaranteed, and
actual results may differ materially from those projected. Merck
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events,
or otherwise. Forward-looking statements in this press
release should be evaluated together with the many uncertainties
that affect Merck's business, particularly those mentioned in the
risk factors and cautionary statements in Item 1A of Merck's Form
10-K for the year ended Dec. 31, 2006, and in its periodic reports
on Form 10-Q and Form 8-K, which the Company incorporates by
reference.
|
