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| 8-K - 8-K - SEELOS THERAPEUTICS, INC. | d482905d8k.htm |
 Apricus
Biosciences, Inc. (NASDAQ:APRI) Corporate Presentation
BIO
CEO
&
Investor
Conference
–
New
York
City
Tuesday February 12, 2013
1
Exhibit 99.1 |
 Safe-Harbor
Statement 2
Statements
under
the
Private
Securities
Litigation
Reform
Act,
as
amended:
With
the
exception
of
the
historical
information
contained
in
this
presentation,
the
matters
described
herein
contain
forward-looking
statements
that
involve
risks
and
uncertainties
that
may
individually,
mutually,
or
materially
impact
the
matters
herein
described.
These
forward-looking
statements
include,
but
are
not
limited
to:
the
ability
to
obtain
regulatory
approval
for
Vitaros
in
Europe
and
other
markets
in
the
time
frames
estimated,
if
at
all;
the
ability
to
successfully
develop
other
products in
clinical
development,
including
a
room-temperature
formulation
of
Vitaros
and
Femprox;
our
ability
to
enter
into
new
licenses
and
partnering
agreements;
our
ability
to
realize
revenue
under
existing
license
agreements;
and
our
ability
to
successfully
commercialize
Vitaros.
Attendees
and
readers
of
these
materials
are
cautioned
not
to
place
undue
reliance
on
these
forward-looking
statements
as
actual
results
could
differ
materially
from
the
forward-looking
statements
contained
herein.
Attendees
and
readers
of
these
materials
are
urged
to
read
the
risk
factors
set
forth
in
the
Company’s
most
recent
annual
report
on
Form
10-K,
subsequent
quarterly
reports
filed
on
Form
10-Q
and
its
most
recent
SEC
filings
for
additional
risks
and
considerations
that
could
cause
actual
results
to
differ
materially
from
expected
results.
Company
disclaims
any
intention
to
update
this
presentation
to
reflect
actual
subsequent
events. |
 Company
Highlights - NASDAQ (APRI)
•
Apricus Bio (Nasdaq: APRI) is a pharmaceutical company that develops and
markets pharmaceutical products that help large patient populations primarily in
the area of sexual health
•
Lead Products / Product Candidates:
•
Vitaros ®
-
Topical Treatment for Erectile Dysfunction
–
Approved in Canada for entire ED patient population & awaiting approval
decision in Europe
•
Femprox®
-
Topical Treatment for Female Sexual Arousal Disorder
–
Completed one successful Phase III trial in China and moving towards
additional late-stage trials
•
The Company has commercial partnerships with multiple large pharmas (Abbott,
Takeda, Sandoz, Warner Chilcott and Bracco)
•
The
Company
is
focused
on
(1)
establishing
new
Vitaros®
partnerships
in
the
territories available for licensing and (2) developing and licensing Femprox®
throughout the world
3 |
 Upcoming
Expected Milestones Commence sales of Vitaros®
in Canada by Abbott (H1 2013)
Vitaros®
approval decision in Europe (H1 2013)
Approval decision in Switzerland, other territories (2013)
Additional Vitaros partnerships for the emerging markets
(H1 2013)
Femprox®
regulatory and clinical design plan
communicated (H1 2013)
4 |
 Leading
Commercial & Development Partners
5
Partnerships throughout the world for Vitaros® |
 Vitaros®
6
•
Vitaros®
(alprostadil/DDAIP.HCl) for the treatment of erectile dysfunction
•
Significant efficacy, including difficult to treat populations
•
Approved in Canada (H1 2013 launch)
•
Filed
in
Europe
using
DCP
–
potential
approval
expected
H1
2013
•
Potential CRL response to US FDA (via Warner Chilcott)
•
Patent coverage thru 2031
•
Seeking commercial partners: Latin America, select EU countries,
Russia, Japan
Second
Generation
RT Available
in 2014
•
Cold
Chain
(2
C
-
8
C)
•
7 Days Room Temp
•
Room Temperature
•
Expected 24-36 month shelf life
–
Rapid onset (generally 5-15 minutes)
–
Studied in over 3,300 patients
–
Diabetics, hypertensives, patients with cardiac issues or on nitrates/alpha
blockers, prostatectomy patients, Sildenafil (Viagra®) failures
|
 Vitaros®
-
Target Patient Population
Want a faster acting and on-demand
treatment
Patients who prefer a locally acting treatment
instead of an oral treatment
Are contraindicated due to medications or
concurrent diseases (18%¹)
Are healthy enough to take the PDE5 inhibitors
but quit taking them because they are non-
responders (20%
1,3
) and
Drop out after initial prescription (31%²) or
drop out after 3 years from start (48%²)
7
(Present Existing Market)
$2.6B Ex-US
1.
D2 Market Research, June 2007
2.
Sato Y et al, How long do patients with erectile dysfunction continue to use sildenafil
citrate? International Journal of Urology. (2007) 14, 339-342
3.
Carvalheira AA, Pereira NM, Maroco J, and Forjaz V. Dropout in the treatment of erectile
dysfunction with PDE5: A study on predictors and a qualitative analysis of reasons for
discontinuation. J Sex Med 2012;9:2361–2369
ED Market Segmentation
51%
18%
20%
11%
PDE5 Market
Contraindicated Patients
Non-Responders
Other Dropouts
Vitaros is a non-PDE-5 treatment for patients
who: |
 Femprox
•
Femprox
®
(alprostadil/DDAIP.HCl) intended for the treatment of female
sexual arousal disorder (FSAD)
•
FSAD affects as many as 10M women in the US and is different than
Female Sexual Dysfunction
•
Achieved statistically significant efficacy in primary and secondary
endpoints with favorable safety and tolerability
•
No product currently approved in the US for FSAD
•
Regulatory guidance meetings (US FDA, Europe, Canada) on-going
•
Apricus to provide planned regulatory and clinical path for US, Canada, and
European markets in H1 2013
•
Patent coverage through 2031
•
Seeking global commercial partner
8
•
Seven clinical studies completed to date, including one, 98-patient
Phase II study in the U.S. and a 400-patient Phase III study in China
|
 Femprox®
Phase III Study
•
A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Study
of
the
Efficacy
and
Safety
of
Alprostadil
Cream
in
Patients
with
Female
Sexual Arousal Disorder (FSAD) in China
o
n=
400
patients
placebo,
500,
700
or
900
mcg
alprostadil
cream
groups,
Application sites: clitoris and the distal anterior vaginal wall
o
Five (5) month study
9 |
 Market Potential
of Top Pipeline Products •
Vitaros®
–
Ex-US market potential for ED: $2.5-3.0B
•
Europe: $1B+
•
Canada: $180M
–
First-line treatment for entire patient population
including non-PDE5 patients
•
Femprox®
–
Worldwide market potential: $2-4B
–
Potential to be the first drug approved for FSAD
10 |
 Financial
Snapshot 11
•
NASDAQ:
APRI
•
Operations
in:
San
Diego,
California
Montigny,
France
(near
Paris)
•
Employees
:
~120
•
Shares
outstanding
:
29.9M*
•
Shares
fully
-diluted:
35.7M*
•
Cash
position
:
$15.0M*
•
Share-price:
$3.34
†
•
Market
Cap:
$99.9M
†
†
As of February 8, 2013
*As of December 31, 2012 |
 Summary
•
Apricus Bio (Nasdaq: APRI) is a pharmaceutical company that develops and
markets pharmaceutical products that help large patient populations primarily in
the area of sexual health
•
Lead Products / Product Candidates:
•
Vitaros
®
-
Topical
Treatment
for
Erectile
Dysfunction
–
Approved in Canada for entire ED patient population & awaiting approval
decision in Europe
•
Femprox®
-
Topical
Treatment
for
Female
Sexual
Arousal
Disorder
–
Completed one successful Phase III trial & planning for second Phase III trial
•
The Company has commercial partnerships with multiple large pharmas
(Novartis, Abbott, Sandoz, Takeda, Warner Chilcott and Bracco)
•
The
Company
is
focused
on
(1)
establishing
new
Vitaros®
partnerships
in
the
territories available for licensing and (2) developing and licensing Femprox®
throughout the world
12 |
 Apricus
Biosciences, Inc. 11975 El Camino Real, Suite 300 –
San Diego, CA 92130
Phone: (858)-222-8041
13
For further information, please contact:
Mr. Edward Cox
Vice President, Corporate Development & Investor Relations
Email: ECox@ApricusBio.com |