Experienced Cardiovascular Team to Commercialize First Genetically-Targeted
Heart Failure Treatment and Develop Short-Acting Anticoagulant
Webcast Conference Call Scheduled for Thursday, September 25, 2008 at 8:30
a.m. EDT
SAN CARLOS, Calif. and BROOMFIELD, Colo., Sept. 25
/PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO) and ARCA biopharma,
Inc., a privately-held biopharmaceutical company developing
genetically-targeted therapies for heart failure and other cardiovascular
diseases, announced that they have entered into a definitive merger
agreement, expected to create a biotechnology company with a near-term
commercial opportunity Gencaro (bucindolol hydrochloride), as well as a
mid-stage pipeline asset, novel short-acting anticoagulant NU172, to drive
long-term growth.
"We believe this combination brings both immediate and longer-term
value to our stockholders," said Dr. Ted W. Love, chairman and chief
executive officer of Nuvelo. "After thorough review of numerous options, we
chose to merge with ARCA because it enables us to transform ourselves into
a late-stage company with multiple significant milestones and a near-term
commercialization opportunity, backed by a promising cardiovascular
pipeline.
"This unique transaction offers us the financial resources, people, and
pipeline as we continue to build our company," said Richard B. Brewer,
president and chief executive officer of ARCA. "We believe this merger
brings together known industry leaders with significant cardiovascular drug
development and commercialization expertise, forming an ideal team to lead
the development of the first personalized heart failure medicine, Gencaro,
and short-acting anticoagulant NU172, which is being tested as a potential
new therapy in indications where heparin and protamine are the current
standard of care."
Overview of Combined Company
Cardiovascular Product Portfolio
-- Gencaro(TM), (trade name pending FDA approval), a Near-term
Commercial Product Opportunity: Gencaro is a genetically-targeted
beta-blocker with unique vasodilating properties for the treatment of heart
failure. Phase 3 data showed statistically significant results for major
clinical endpoints including combined heart failure hospitalization and
all-cause mortality in the entire patient population studied, and even
greater efficacy in a genetically targeted subpopulation, highlighting its
differentiated profile and efficacy in heart failure patients. The New Drug
Application (NDA) for Gencaro has been accepted for review by the U.S. Food
and Drug Administration (FDA) with a PDUFA date of May 31, 2009. Pending a
positive regulatory decision, ARCA expects to commercialize Gencaro in the
first half of 2010.
-- NU172, a Catalyst for Long-term Growth: NU172 is a short-acting
anticoagulant that is being tested as a potential new therapy in
indications where heparin and protamine are the current standard of care,
such as coronary artery bypass graft (CABG) surgery, kidney dialysis and a
variety of vascular surgical and coronary interventions. A Phase 2 trial
evaluating NU172 in CABG patients is expected to begin in the fourth
quarter of 2008 or the first quarter of 2009.
Resources to Provide Solid Foundation
-- The cash position of the combined company at the close of the
transaction is expected to fund operations at least through 2009, including
the potential FDA advisory meeting in the first half of 2009, and
anticipated regulatory approval for Gencaro in mid 2009.
Experienced Leadership Capable of Driving Value
-- Chief Executive Officer: Richard B. Brewer, current president and
CEO of ARCA, former president and CEO of Scios and senior vice president of
sales and marketing of Genentech;
-- Chief Science and Medical Officer: Michael R. Bristow, MD, PhD,
current chairman and CSMO at ARCA and former CSMO at Myogen;
-- Executive Vice President of Commercial Operations: Randall St.
Laurent, current EVP of commercial operations at ARCA and former vice
president of commercial development at Scios;
-- Vice President of Marketing: James Carr, current VP of marketing at
ARCA who was instrumental in the successful commercialization of Coreg, a
leading beta-blocker treatment for heart failure; and
-- The combined company's board of directors will include Dr. Bristow,
Mr. Brewer, Dr. J. William Freytag, Dr. Jean-Francois Formela and John
Zabriskie from ARCA's current board, and Dr. Ted W. Love, Dr. Burton E.
Sobel, and Mary K. Pendergast from Nuvelo's current board. Dr. Bristow will
serve as chairman of the board.
Terms of the Proposed Transaction
Under the terms of the definitive merger agreement between Nuvelo, ARCA
and Dawn Acquisition Sub, Inc., a wholly owned subsidiary of Nuvelo, Dawn
Acquisition Sub will be merged with and into ARCA and ARCA will become a
wholly owned subsidiary of Nuvelo. Under the agreement, Nuvelo will issue
new shares of its common stock to ARCA common and preferred stockholders
and assume outstanding options and warrants to acquire capital stock of
ARCA such that these stockholders, option holders and warrant holders are
expected to own or have the right to acquire approximately 67 percent of
the common stock of the combined company on a fully-diluted basis, using
the treasury stock method. Current Nuvelo stockholders are expected to own
approximately 33 percent of the common stock of the combined company on a
fully-diluted basis, using the treasury stock method.
The boards of directors of both Nuvelo and ARCA have approved the
definitive merger agreement. The transaction is structured as a tax-free
reorganization for federal income tax purposes. Consummation of the
transaction is subject to closing conditions, including among other things:
-- the filing by Nuvelo of a registration statement on Form S-4 with
the Securities and Exchange Commission (the "SEC") with respect to the
registration of the shares of Nuvelo common stock to be issued in the
merger, and a declaration of its effectiveness by the SEC;
-- approval and adoption of the merger agreement and merger by the
requisite vote of the stockholders of ARCA;
-- approval of the issuance of shares of Nuvelo common stock in
connection with the merger by the requisite vote of Nuvelo stockholders;
and
-- conditional approval for the listing of Nuvelo common stock to be
issued in the Merger on any of the Nasdaq Global Select Market, Nasdaq
Global Market or Nasdaq Capital Market.
Subject to these and other customary closing conditions, the
transaction is expected to close by the end of this year or early 2009. The
merger agreement contains certain termination rights for both Nuvelo and
ARCA, and further provides that, upon termination of the merger agreement
under specified circumstances, ARCA may be required to pay Nuvelo a
termination fee of approximately $1.9 million and Nuvelo may be required to
pay ARCA a termination fee of approximately $0.9 million, both based on
their relative enterprise values. The officers and directors of ARCA, as
well as certain of its significant stockholders and certain Nuvelo
stockholders have executed voting agreements in favor of the transaction.
Nuvelo expects to file a Form S-4 and related proxy statement/prospectus
with the SEC in the coming weeks. If the merger is consummated, the
combined company is expected to be renamed ARCA biopharma, Inc., and to
apply to change its ticker symbol on the Nasdaq exchange. In order to
comply with Nasdaq listing requirements, Nuvelo intends to seek stockholder
approval to effect a reverse stock split of its common stock in conjunction
with the closing of this transaction.
Nuvelo was advised in the transaction by Jefferies & Company and ARCA
was advised by J.P. Morgan.
Conference Call Information
Nuvelo and ARCA will hold a conference call today at 8:30 a.m. Eastern
Time (5:30 a.m. Pacific Time) to discuss this announcement. To participate
in the conference call, please dial 866-854-8095 for domestic callers and
706-634-8567 for international callers and reference conference passcode,
66253667. A telephone replay of the conference call will be available
through October 2, 2008. To access the replay, please dial 800-642-1687 for
domestic callers and 706-645-9291 for international callers and reference
conference passcode, 66253667.
In addition, this call is being webcast Thomson/CCBN and can be
accessed at Nuvelo's website at http://www.nuvelo.com or ARCA's website at
http://www.arcabiopharma.com. The webcast is also being distributed through the
Thomson StreetEvents Network. Individual investors can listen to the call
at http://www.earnings.com, Thomson's individual investor portal, powered
by StreetEvents. Institutional investors can access the call via Thomson
StreetEvents (http://www.streetevents.com), a password-protected event
management site.
About Nuvelo
Nuvelo, Inc. is dedicated to improving the lives of patients through
the discovery, development and commercialization of novel drugs for acute
cardiovascular disease, cancer and other debilitating medical conditions.
Nuvelo's development pipeline includes NU172, a direct thrombin inhibitor
which has completed Phase 1 development for use as a potential short-acting
anticoagulant during medical or surgical procedures; and NU206, a Wnt
pathway modulator in Phase 1 development for the potential treatment of
chemotherapy/radiation therapy-induced mucositis and inflammatory bowel
disease. In addition, Nuvelo is pursuing research programs in leukemia and
lymphoma therapeutic antibodies and Wnt signaling pathway therapeutics to
further expand its pipeline and create additional partnering and licensing
opportunities.
Information about Nuvelo is available at our website at
http://www.nuvelo.com or by phoning 650-517-8000.
About ARCA biopharma
ARCA biopharma, Inc. is a privately held company focused on developing
and commercializing genetically targeted therapies for heart failure and
other cardiovascular diseases. The Company's lead product candidate,
Gencaro(TM) (bucindolol hydrochloride), is an investigational
pharmacologically unique beta-blocker and mild vasodilator being developed
for heart failure and other indications. ARCA has identified common genetic
variations that predict individual patient response to Gencaro. The
companion genetic test for Gencaro is in development by ARCA's partner,
Laboratory Corporation of America. For more information please visit
http://www.arcabiopharma.com.
Forward-looking statements
This press release contains "forward-looking statements" which include,
without limitation, statements regarding the completion of the proposed
merger transaction between Nuvelo, ARCA and Dawn Acquisition Sub, Inc., the
transaction's anticipated benefits, timing, progress and anticipated
completion of the combined company's clinical stage and research programs,
including possible regulatory approval, the potential benefits that
patients may experience from the use of the combined company's clinical
stage compounds, and the cash position of the combined company, which
statements are hereby identified as "forward-looking statements" for
purposes of the safe harbor provided by the Private Securities Litigation
Reform Act of 1995. Such statements are based on our management's current
expectations and involve risks and uncertainties. Actual results and
performance could differ materially from those projected in the
forward-looking statements as a result of many factors, including, without
limitation, failure of Nuvelo or ARCA's stockholders to approve the merger,
the ability to complete the transaction contemplated by this communication
in a timely fashion, the risk that Nuvelo's and ARCA's business operations
will not be integrated successfully; the combined company's inability to
further identify, develop and achieve commercial success for products and
technologies; the risk that the combined company's financial resources will
be insufficient to meet the combined company's business objectives;
uncertainties relating to drug discovery and the regulatory approval
process; clinical development processes; enrollment rates for patients in
our clinical trials; changes in relationships with strategic partners and
dependence upon strategic partners for the performance of critical
activities under collaborative agreements; and the impact of competitive
products and technological changes. These and other factors are identified
and described in more detail in Nuvelo's filings with the SEC, including
without limitation Nuvelo's quarterly report on Form 10-Q for the quarter
ended June 30, 2008 and subsequent filings. We disclaim any intent or
obligation to update these forward-looking statements.
Additional Information and Where to Find It
Nuvelo intends to file a registration statement on Form S-4, and a
related proxy statement/prospectus, in connection with the merger.
Investors and security holders are urged to read the registration statement
on Form S-4 and the related proxy statement/prospectus when they become
available because they will contain important information about the merger
transaction. Investors and security holders may obtain free copies of these
documents (when they are available) and other documents filed with the SEC
at the SEC's website at http://www.sec.gov. In addition, investors and security
holders may obtain free copies of the documents filed with the SEC by
contacting Nuvelo Investor Relations at the email address: ir@nuvelo.com or
by phone at 650-517-8000.
In addition to the registration statement and related proxy
statement/prospectus, Nuvelo files annual, quarterly and special reports,
proxy statements and other information with the SEC. You may read and copy
any reports, statements or other information filed by Nuvelo, Inc. at the
SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549.
Please call the SEC at 1-800-SEC-0330 for more information. Please call the
SEC at 1-800-SEC-0330 for further information on the public reference room.
Nuvelo, Inc.'s filings with the SEC are also available to the public from
commercial document-retrieval services and at SEC's website at http://www.sec.gov,
and from Investor Relations at Nuvelo as described above.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to buy any
securities, nor shall there be any sale of securities in any jurisdiction
in which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
jurisdiction. No offering of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities Act of
1933, as amended.
Nuvelo, ARCA and their respective directors and executive officers may
be deemed to be participants in the solicitation of proxies from the
stockholders of Nuvelo in connection with the merger transaction.
Information regarding the special interests of these directors and
executive officers in the merger transaction will be included in the proxy
statement/prospectus of described above. Additional information regarding
the directors and executive officers of Nuvelo is also included in Nuvelo's
proxy statement for its 2008 Annual Meeting of Stockholders which was filed
with the SEC on April 23, 2008 and its Annual Report on Form 10-K for the
year ended December 31, 2007, which was filed with the SEC on March 12,
2008. These documents are available as described above.
SOURCE Nuvelo, Inc.
 back to top
Related links:
http://www.nuvelo.com
http://www.arcabiopharma.com
CONTACT:
Nicole Foderaro, +1-415-215-5643,
nfoderaro@wcpglobal.com, or Danielle Bertrand, +1-415-577-8258,
dbertrand@wcpglobal.com, both of WeissComm Partners, for Nuvelo,
Inc.
|
