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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Holdco Nuvo Group DG Ltd | NASDAQ:NUVO | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.20 | -11.30% | 1.57 | 1.57 | 1.67 | 1.77 | 1.50 | 1.75 | 76,275 | 23:43:46 |
Filed by Nuvelo, Inc. Pursuant to Rule 425
Under the Securities Act of 1933
And Deemed Filed Pursuant to Rule 14a-12
Under the Securities Exchange Act of 1934
Subject Company: ARCA biopharma, Inc.
Commission File No. 333-154839
The following is a presentation made by ARCA biopharma, Inc. and Nuvelo, Inc. beginning on January 12, 2009.
J.P. Morgan
27
th
Annual Healthcare
Conference
January 12
15, 2009
|
Safe Harbor
Statement
2
This presentation contains forward-looking statements which include, without
limitation,
statements regarding the completion of the proposed merger transaction
between Nuvelo, Inc.,
ARCA biopharma, Inc. and Dawn Acquisition Sub, Inc. the proposed
mergers anticipated
benefits, timing, progress and anticipated completion of the
companies clinical stage and
research programs, the timing of regulatory
approval, the potential benefits that patients may
experience from the use of the
companies clinical stage compounds, and the cash position of
the companies
following the merger, 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 the companies managements
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 to
complete the proposed merger in a timely fashion, the risk that Nuvelos and
ARCAs business operations will not be integrated successfully; the companies
inabilities to
further identify, develop and achieve commercial success for products
and technologies; the risk
that the companies financial resources will be
insufficient to meet their business objectives;
uncertainties relating to drug
discovery and the regulatory approval process; clinical
development processes;
enrollment rates for patients in the companies 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 Nuvelos filings with the SEC, including without
limitation Nuvelos quarterly report
on Form 10-Q for the quarter ended
September 30, 2008 and subsequent filings. Nuvelo and
ARCA disclaim any intent or
obligation to update these forward-looking statements.
|
Introducing: ARCA
biopharma*
3
Pioneering Genetically-Targeted
Cardiovascular Therapies
*ARCA, Nuvelo merger is expected to be
completed in 1/2009
|
Multiple Near &
Long Term Value
Creating Aspects
4
|
Value-Driving
Near-Term Milestones
Milestone
Expected Timing
NDA acceptance by FDA
H2:08
Completion of merger
1/2009
LabCorp PMA submission to FDA for Gencaro genetic test
Q1:09
Anticipated FDA CRAC meeting
H1:09
FDA decision on Gencaro
PDUFA Date: 5/31/09
Anticipated launch of genetic registry post approval
Q3:09
Potential launch of Gencaro
Q1:10 or Q4:09
5
|
Introducing
Gencaro*
(bucindolol hydrochloride)
Investigational drug currently under FDA
review
Next-generation beta-blocker with
unique pharmacology
Potentially first genetically-targeted
heart failure drug
Companion genetic test being developed
by LabCorp
Potential to target ~50% of heart failure
(HF) patients
Very Favorable
genotype is target
patient population for treatment
Potential follow-on indications
Potential prevention of atrial fibrillation
and/or ventricular tachycardia/ventricular
fibrillation being explored
* Trade name pending FDA approval
6
|
Genetic Basis of
Gencaro
Response
Mediated Through Individual Genetic Variation
7
Cardiac myocyte
Arg/Arg
1
389
AR
Better
bucindolol
antagonism
increased survival
reduced hospitalization
Very
favorable
receptor
type
Gly
Variant
1
389
AR
Standard
bucindolol
antagonism
Adverse when combined with
2c
Del genotypes
WT
2c
AR
Mild,
ideal NE lowering with
bucindolol
Favorable
receptor type when
combined with
1
389 Gly
genotypes
Deletion Variant
2c
AR
Marked
NE
lowering
with
bucindolol
Adverse
receptor
type
when
combined with
1
389 Gly
genotypes
|
BEST: Clinical
Responses by Genotypes
*p<0.05; **p<0.007
Endpoint
Very Favorable
Genotype (47%)
{
ß
1
389 Arg/Arg
+ any a
2C
}
Favorable
Genotype (40%)
{
ß
1
389 Gly
carrier
+ a
2C
Wt/Wt}
Unfavorable
Genotype (13%)
{
ß
1
389 Gly
carrier
+ a
2C
Del carrier}
AC Mortality (ACM),
Time-to-Event (TTE)
38% *
25%
4%
CV Mortality, (CVM),
TTE
48% *
40%*
11%
HF Progression, TTE
34% **
20%
1%
HF Hosp/pt
43% *
16%
26%
HF Hosp days/pt
48% **
17%
19%
Composite endpoint consisting of: HF mortality, cardiac transplant, HF hospitalizations, and
HF emergency room visits
8
|
Bucindolol
n = 2708
Metoprolol
n = 1071
Carvedilol
n = 482
Bucindolol
(VF
Genotype)
n = 493
Metoprolol
n = 3991
Carvedilol
n = 2289
Trial Name
BEST
MERIT
COPERNICUS
BEST
MERIT
COPERNICUS
Trial Location
US
US
US
US
WW
WW
All-cause Mortality
-13%
+5%
-20%
-38%
-34%
-35%
CV Mortality
-16%
-4%
-48%
-38%
No Data
Mortality + Cardiac Transplant
-14%
-43%
-32%
No Data
Mortality & HF Hospitalizations
-21%
-16%
-35%
-31%
-33%
HF Hospitalizations, TTE
-23%
No Data
-36%
NA
No Data
HF hospitalization days
-24%
No Data
-48%
-36%
-41%
Total MI in HF Patients
-45-47%
No Data
-48%
No Data
No Data
Comparison of Betablocker Studies*:
US & ROW
9
* Not head-to-head studies
|
Marketing
Research:
Gencaro
Demand
> 600 cardiologists with established HF practices interviewed
or surveyed to date
Demand for Gencaro
is anticipated to be strong
Peak genetic test ordering opportunity for targeted patient
population segments
>60% of beta-blocker naïve HF patients
>60% of HF patients that are difficult to titrate or have been deemed
non-responsive to existing beta-blocking agents
Cardiologists expected to value Gencaros:
Improvement in clinical outcomes
Ability to predict response
10
ARCA Primary Market Research; 11/2008
|
LabCorp
Relationship
Easy-to-administer genetic
test
Quick turnaround time for
results expected
Test results will identify
genetic markers that
predict clinical response
510K/PMA track within FDA
Coordinated with Gencaro
NDA
11
|
Established, Large
Market Opportunity
Beta-blockers = current standard of
care in chronic heart failure
Beta-blockers should be prescribed
to all patients with stable HF due to
reduced LVEF
(ACC/AHA Guidelines
2005)
~6 million US HF patients
~550K newly diagnosed
patients annually
12
|
Commercial
Strategy
Cardiologists initiate and influence beta-blocker
prescriptions
Penetrate U.S. market with specialized sales force
Unique and desirable offering in large market
Expected to be only drug with companion test to predict
response
Defend market exclusivity
Hatch-Waxman protection until 2017
Potential patent protection until 2025
13
|
Competitive
Environment
Limited Competitive Threats
Current beta blockers have
generic equivalents on the
market
Promotion is very limited
Known future competitors
do not have a companion
genetic test or any known
PGt interactions
14
|
Pricing and
Reimbursement
While majority of HF patients are Part D eligible, most opt for
supplemental commercial prescription coverage
Current branded beta-blocker products range from $2.54 -
$4.74 /day (AWP)
Gencaro expected to be on formulary with reasonable pricing
Test anticipated to be covered via medical benefit; Part B for
Medicare patients
15
|
Gencaro US
Approval Process
FDA filed New Drug Application
9/28/08
Clinical site inspections proceeding
FDA Pre-Approval Inspection of manufacturer
scheduled
Regulatory department actively communicating
with the agency
FDAs 2009 performance goal: Review and act on
90% of NDAs by PDUFA date
16
|
NDA submission to
the FDA: 7/31/08
Potential FDA
Cardio-Renal
Advisory
Committee
(CRAC) meeting
Potential
commercial
launch
PDUFA
Date:
5/31/09
FDA NDA filing:
9/28/08
2008
2009
2010
Gencaro Pathway to Market
17
LabCorp PMA
submission to the
FDA for
complementary
genetic test
|
Value-Driving
Near-Term Milestones
Milestone
Expected Timing
NDA acceptance by FDA
H2:08
Completion of merger
1/2009
LabCorp PMA submission to FDA for Gencaro genetic test
Q1:09
Anticipated FDA CRAC meeting
H1:09
FDA decision on Gencaro
PDUFA Date: 5/31/09
Anticipated launch of genetic registry post approval
Q3:09
Potential launch of Gencaro
Q1:10 or Q4:09
18
|
Personalized
Medicine:
Recently in the News
19
|
THANK YOU
|
Additional
Information and Where to
Find It
Nuvelo
has filed a registration statement on Form S-4, and a related proxy
statement/prospectus/consent
solicitation, 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/consent solicitation which contain important
information
about
the
merger
transaction.
Investors
and
security
holders
may
obtain
free
copies
of
these
documents
and
other
documents
filed
with
the
SEC
at
the
SECs
website
at
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/consent
solicitation, 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
SECs
website
at
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
is
included
in
the proxy statement/prospectus/consent solicitation described above. Additional information
regarding the
directors
and
executive
officers
of
Nuvelo
is
also
included
in
Nuvelos
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.
21
|
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