Experienced Cardiovascular Team to Commercialize First
Genetically-Targeted Heart Failure Treatment and Develop
Short-Acting Anticoagulant 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: 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. DATASOURCE: Nuvelo, Inc. CONTACT:
Nicole Foderaro, +1-415-215-5643, , or Danielle Bertrand,
+1-415-577-8258, , both of WeissComm Partners, for Nuvelo, Inc. Web
site: http://www.nuvelo.com/ http://www.arcabiopharma.com/
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