Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - SEELOS THERAPEUTICS, INC. | d523335d8k.htm |
 Apricus
Biosciences, Inc. (NASDAQ: APRI)
Corporate Presentation
April 18, 2013
1
Exhibit 99.1 |
 Safe-Harbor
Statement 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;
the
ability
of
our
partners
to
launch
Vitaros®
in
any
market,
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.
2 |
 Our Vision and
Strategy •
Our vision
is to be a leader in the development and
commercialization of innovative products that
improve sexual health
•
Our strategy
is to develop and seek regulatory
approval for our products and commercialize those
products in major global markets by establishing
partnerships with leading pharmaceutical companies
3 |
 Company
Highlights •
Established in 1995 as a pharmaceutical company. Headquartered in San Diego, CA
•
NASDAQ Listed: APRI
•
Proprietary NexACT®
drug delivery technology
•
Lead Products / Product Candidates:
•
Vitaros®
-
Topical Treatment for Erectile Dysfunction
–
Approved in Canada for entire ED patient population & awaiting approval
decision in Europe
–
Existing commercial partnerships with Abbott, Takeda, Sandoz, Warner
Chilcott and Bracco
–
Strategic focus is on establishing new partnerships in the territories available
for licensing
•
Femprox®
-
Topical Treatment for Female Sexual Arousal Disorder (FSAD)
–
Potential best and first-in-class treatment for FSAD
–
Completed one successful Phase III proof-of-concept trial in China and moving
towards additional late-stage trials
–
Strategic focus is on developing and licensing Femprox®
throughout the world
4 |
 Upcoming
Expected Milestones Vitaros®
approval decision:
Europe
Switzerland & other territories
Femprox®
regulatory & clinical design plan
communicated
Commence sales of Vitaros®
in Canada by Abbott
Additional Vitaros partnerships
5 |
 6
•
NASDAQ:
APRI
•
Shares
outstanding:
29.9M
†
•
Shares
fully-diluted:
37.0M
†
•
Cash
position:
$15.1M
†
•
Share-price:
$3.00
‡
•
Market
Cap:
$89.7M
‡
†
As of December 31, 2012
‡
As of April 10, 2013
Financial Snapshot |
 Vitaros®
7 |
 Vitaros®
8
•
Vitaros®
(alprostadil/DDAIP.HCl) for the treatment of erectile dysfunction
•
Significant efficacy, including difficult to treat populations
•
Approved
in
Canada
–
launch
date
pending
•
Filed
in
Europe
using
DCP
–
approval
decision
expected
Q2
2013
•
Patent (issued and pending) coverage thru 2031
•
Seeking commercial partners: Europe, Asia Pacific & Emerging Markets
–
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
Second
Generation
•
Cold Chain (2
C -
8
C)
•
7 Days Room Temp
•
Room Temperature
•
Expected 24-36 month
shelf-life |
 Vitaros®
-
Target Patient Population
9
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 (Present Existing Market)
$2.6B Ex-US
51%
18%
20%
11%
ED Market Segmentation
PDE5 Market
Contraindicated Patients
Non-
Responders
Other Dropouts
Vitaros®
is a non-PDE-5 treatment for patients
who:
•
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
) |
 Leading
Commercial & Development Partners
10
Partnerships throughout the world for Vitaros® |
 Femprox®
11 |
 Femprox® -
Product Overview
•
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, Europe, Canada) have occurred and
are planned
•
Patent (issued and pending) coverage through 2031
12
Seven clinical studies completed to date, including one, ~100-patient
Phase II study in the U.S. and a ~400-patient Phase III study in China
|
 Femprox®
-
Profile
13
•
Indications and Usage
–
First-line topical treatment for Female Sexual Arousal Disorder
•
Mechanism of Action
–
Alprostadil induces vasodilation by means of a direct effect on vascular smooth
muscle, clitoral engorgement
–
DDAIP.HCl as a patented proprietary permeation enhancer opens the cellular tight
junctions, allowing drugs to permeate through epidermal barriers, enabling rapid
absorption of high concentrations of alprostadil cream directly to the target site
•
Proof of Concept Phase III Clinical Trial and Result
–
Phase III study in ~400 patients completed in China
–
Femprox
met all primary and secondary endpoints and resulted in statistically
significant and clinically relevant response compared to placebo
–
Favorable safety and tolerability profile. Only 5 patients (1.2%) withdrawn from the
Phase III study because of local adverse events
–
No drug related serious adverse events were reported |
 Femprox®
-
Safety & Efficacy
•
Safety
–
Both alprostadil (US, CDN) and DDAIP.HCl (CDN) are approved agents
–
Administered
topical
and
locally
–
effects
are
local
only
and
of
short
duration
–
Other than Femprox®, other drug candidates are given systemically
(orally, transdermal, subcutaneous) resulting in an increased likelihood
of adverse events and reduced tolerability (which is being confirmed
clinically).
•
Hormones (testosterone)
•
Anti-depressants (SSRI’s)
•
Efficacy
–
Direct route of administration
–
Increases
blood
flow
to
the
genitals
-
this
is
recognized
as
a
major
component of sexual arousal
14 |
 Development Strategy
•
Completion of Femprox®
Product Plan
–
CMC
–
Non-clinical
–
Clinical
–
Commercial assessment
–
Publication Strategy
–
Life cycle management plan
–
IP strategy
•
Obtain US FDA Regulatory Guidance
–
End-of Phase II meeting with US FDA
•
Key Clinical Development Initiatives
–
Complete Femprox room temperature device design
–
Complete required supportive studies
–
Conduct pivotal Phase III trial(s) in the U.S.
15
APRI-
Confidential |
 Investment
Thesis •
Re-calibrated business model:
–
Focus on sexual medicine
–
Disciplined leadership
–
Complete divesture of non-core assets
–
Strengthen development and partnering core competencies
•
Vitaros®
-
Topical Treatment for Erectile Dysfunction
–
Approval decision in Europe in 2013
–
Additional ex-US partnering opportunities
–
Progress on Vitaros room temperature device
•
Femprox®
-
Topical Treatment for Female Sexual Arousal Disorder (FSAD)
–
Potential first and best-in-class FSAD treatment
–
Completed one successful Phase III trial
–
Obtain FDA regulatory guidance in 2013
16
•
Potential near-term milestones: |
 For further
information, please contact: Steve Martin, SVP & CFO
smartin@apricusbio.com
+1-858-222-8041
Lourdes Catala, Argot Partners
lourdes@argotpartners.com
+1-646-439-0410
Apricus Biosciences
11975 El Camino Real, Suite 300
San Diego, CA 92130
17 |