Oncology Focused Specialty Pharmaceutical Company
Rich Product Pipeline
–
Active Partnering Strategy
This
presentation
contains
certain
statements
that
may
be
forward
-
looking
within
the
meaning
of
Section
27
a
of
the
Securities
Act
of
1933
,
as
amended,
including
statements
relating
to
the
product
portfolio
and
pipeline
and
clinical
programs
of
the
combined
company,
the
market
opportunities
for
MuGard™,
the
sales
of,
market
opportunities
for
and
planned
studies
of
ProLindac™,
the
market
opportunities
for
Thiarabine
and
the
Cobalamin
programs,
and
the
combined
company’s
goals
and
objectives
.
These
statements
are
subject
to
numerous
risks
and
uncertainties,
including
but
not
limited
to
the
risks
detailed
in
Access's
Annual
Report
on
Form
10
-
KSB
for
the
year
ended
December
31
,
2008
,
and
other
reports
filed
by
the
companies
with
the
Securities
and
Exchange
Commission
.
These
materials
are
not
an
offer
to
sell
securities
and
are
not
soliciting
an
offer
to
buy
securities
.
2
Safe Harbor Statement
Pipeline & Platforms:
Deep pipeline of late stage products
(including FDA approved
MuGard, for the treatment of oral mucositis)
mitigates single product/technology exposure.
Partnering Strategy:
Access has completed six partnerships in the past
18
months:
upfront payments, royalties, clinical costs.
Experienced Team:
Experienced chemists, pre
-
clinical and manufacturing experts, clinical
development personnel, and business development and finance personnel.
Focus on Shareholder Value
:
Management and board members are significant
shareholders, focused on increasing shareholder value.
3
Corporate Strategy & Highlights
Late Stage Oncology Pipeline; Emphasis on Strategic
Partnering; Focus on Building Shareholder Value
4
Product
Oncology Pipeline
Pre
-
clinical
IND
Phase 1
Phase 2
Phase 3
Potential
MuGard ™
FDA Approved
and Launched !
>$1B
ProLindac™
~ $3 B
Thiarabine
>$600 M
Drug Delivery Platform Technologies
VB
-
12
Oral Delivery
Developing under partnership arrangements (insulin, HGH)
Polymer Conjugates
Drug
-
polymer conjugate platform (ProLindac, ProLindaun)
Late Stage Oncology Pipeline
>$
1
Billion Addressable Market:
Target all cancer
patients;
1
,
500
,
000
US cancer patients annually
(incidence). Roughly
90
% of patients on radiation (
43
%
severe); and
40
% of patients receiving chemotherapy
MuGard Stands Alone:
Only FDA approved product that
instructs pre
-
treatment and treatment; Safe to swallow
Multiple Marketing Partners:
Partners signed for EU,
Switzerland, Norway, Iceland, China, Korea; US
–
contract salesforce
1
Q
2010
; partners to come
Royalties:
20
%, scaling to
25
%
5
MuGard
™
-
Oral Mucositis (OM)
US Launch 1Q 2010; European Launch Underway
Royalties Start This Year
Signs & Symptons:
Redness or rash, ulceration,
pain (sometimes severe), inability to chew, speak or
swallow
Patient Risk Affected By:
Area, dose and timing of
radiation treatment; type, intensity and combinations
of chemotherapy; prior therapies and prior episodes
of OM; incidence/severity unpredictable
6
MuGard
™
-
OM As Significant Health Issue
Significant Medical Issue
–
Often Unrecognized,
Undiagnosed and Undertreated
1.
Schattner MD. Oral mucositis is often underrecognized and undertreated. Highlights
of the
13
th Annual Conference National Comprehensive Cancer Network. March
2008
.
Elsevier.
7
MuGard
™
-
Preventing OM
Oral Mucositis Has Profound Impact on Patient Health
“
…
patients
with
OM
[oral
mucositis]
are
fourfold
more
likely
to
have
unplanned
breaks
in
radiation
therapy
and
more
than
three
times
as
likely
to
be
hospitalized
…
”
1
“Use
of
a
preventive
oral
care
regimen
should
be
part
of
routine
supportive
care
along
with
a
therapeutic
oral
care
regimen
if
mucositis
develops”
2
International guidelines recommend
preventive strategies
2
1.
Vera
-
Llonch
, M., G.
Oster
,
et al.
(
2006
). "Oral mucositis in patients undergoing radiation treatment for head and neck carcinoma." Cancer
106
(
2
):
329
-
36
2.
Keefe, D. M., M. M. Schubert,
et al.
(
2007
). "Updated clinical practice guidelines for the prevention and treatment of mucositis." Cancer
109
(
5
):
820
-
31
.
Well being
Pain
Problems with eating, drinking,
speaking and swallowing
Weight loss
Impairment of quality of life
e.g. mood
Infection
Reduces infection barrier
Compromised
treatment
Reduced dosage
Breaks or delays in therapy
affecting treatment outcomes
Economic
impact
Prolonged hospital stays
Increased use of resources e.g.
feeding tube placement
UK, Germany, Italy Seeding Studies:
Providing over 1200 patients with MuGard;
clinicians provide feedback and assessments
Prophylactic Use:
Used prior to radiation
and/or chemotherapy treatment
Early results
: Very positive feedback from
clinicians, nurses, patients and SpePharm; data
to be collected, analyzed, presented in 2010
Roll Out:
Launched in UK, Germany, Italy,
Greece and Norway; France, Benelux and Spain
throughout 2009/2010
8
MuGard
™
-
Early Results Very Positive
Post Approval Marketing Assessment Studies
Showing Significant Efficacy
9
Indications:
dryness or
dry mouth associated
with various conditions
Directions for use:
swish and spit out.
Indications:
indicated
for the management of
pain and relief of
pain…
Directions for use:
Gargle and spit out.
Indications:
Magic
mouthwash" prepared
by pharmacists and
used to treat mouth
sores (oral mucositis)
Directions for use:
Gargle and spit out
Indications:
MuGard
is indicated for the
management of oral
mucositis/ stomatitis
Directions for use:
… rinse may be
expelled or swallowed
… safe to swallow …
…recommended that
patients purchase
MuGardTM
prior to
the commencement
of cancer therapy ..
MuGard is recommended for preventative use
MuGard can be swallowed to coat lesions in throat
Market / Patient Dynamics
Few good treatment options and no prophylactic; OM underdiagnosed (unlike emesis)
Incidence / Severity is unpredictable among patients; should treat all (larger market)
Interruption of chemo or radiation treatment affects patient care and doctor revenue
US Market Launch
Launch product being manufactured
–
Accupac
Hybrid direct / contract sales force
Target key opinion leaders
–
radiation (H/N); large oncology networks
Secure 3
rd
party payor/Medicare reimbursement
Seeking co
-
promotion arrangements with oncology/onc. supportive care companies
Leverage ongoing market assessment data from European partner, SpePharm
10
MuGard
™
-
Market Dynamics / US Launch
Access Preparing for 1Q 2010 US MuGard Launch
Eloxatin
®
•
FDA approved (2001) for front
-
line
metastatic colorectal cancer
•
2008 $2.5+ billion projected sales globally
•
Significant cumulative neurotoxicity
•
Losing patent protection globally
ProLindac
TM
–
Access designed a second
generation DACH platinum using our
proprietary nano
-
polymer expertise.
Partnering On
-
going
:
Partnered with
Aosaikang Med Group (ASK) in China and
JCOM in Korea. Partners paid upfronts,
committed to run 3 clinical trials that ACCP
controls, and royalties.
11
ProLindac
™
Market Opportunity
Positioning ProLindac as a Replacement for Sanofi
-
Aventis’ Eloxatin
Represents a $3+ Billion Market Opportunity
Tumor Model
Efficacy vs. Eloxatin
M5076 sarcoma (Pt
-
resistant)
Markedly Superior
B16 melanoma
Markedly Superior
2008 ovarian xenograft
Markedly Superior
Colo
-
26 colon
Superior
HT
-
29 colon xenograft
Superior
HCT
-
116 colon xenograft
Superior
L1210 leukemia
Superior
0157 Hybridoma
Superior
M5076 sarcoma
Similar
Lewis lung
Similar
P815 Mastocytoma
Similar
12
0
400
800
1200
1600
2000
0
2
4
6
8
10
12
14
16
18
20
22
24
26
28
30
Day
Tumor Mass (mg)
Vehicle
Oxaliplatin 5 mg Pt/kg q1w x 3
ProLindac 75 mg Pt/kg q1w x 3
ProLindac
™
-
More Platinum, More Safely
Unique Design Enables Delivery of More Platinum,
with Fewer Side Effects;
Represents “equi
-
toxic” doses
of ProLindac and Eloxatin
DACH Platinum (same active in
Eloxatin) is inactive while attached
to polymer background
Chelator releases platinum
compound in low pH
environment; e.g. tumor
New PK/PD studies shows ProLindac simulates “4
-
day continuous infusion”,
contributing to increased activity and enhanced safety profile
All Late
-
Stage Solid Tumors
–
dose ranging (60 mg Pt/m
2
to 1240 mg Pt/m
2
) once
weekly for 3 weeks
Primary Endpoints
–
maximum tolerated dose and safety
Safety (n=26)
Dose limiting toxicity: neutropenia
No unanticipated AEs (adverse events)
No acute neurotoxicity (important as compared to Eloxatin)
Efficacy (n=16 evaluable patients)
2 PR (melanoma, ovarian)
1 PR biomarker (ovarian)
4 SD (esophageal, melanoma, thyroid, cervical)
13
ProLindac
™
-
Phase 1/2 Trial
Initial European Phase 1/2 Clinical Trial Suggests Efficacy
With Improved Safety Profile
Significant Drug Activity and Benign Toxicity Profile
Warrants Further Development
Monotherapy in relapsed, platinum
-
sensitive patients
•
28 patients enrolled in six centers in France; final follow
-
up ongoing
•
Heavily treated patients (at least 3, up to 6, previous regimens)
•
Exploring two dosing schedules (once/two weeks and once/three weeks)
Safety
–
ProLindac Exhibited Very Benign Safety Profile
•
Patients tolerating drug well through multiple cycles (up to 9 or more)
•
No Eloxatin
-
like neurotox; no nephrotox; no hematotoxicity; no worse emesis
Efficacy and Activity
–
ProLindac “Outperforms” Current Best Care
•
At highest doses, 66.7% ProLindac patients responded; Activity levels superior to
oxali or carbo in monotherapy in similar but healthier patient populations (approx 20%)
Next Steps
•
Combination trials
: Partners ASK and JCOM paying for three Access
-
designed and
managed Phase 2/3 trials: ProLindac plus taxol in recurrent ovarian and ProLindac
plus Lilly’s Gemzar in liver and pancreatic cancer; additional combination studies
possible in other tumor types
•
Partnering discussions ongoing
14
ProLindac
™
Phase 2 Trial
–
Relapsed Ovarian
Final Study Results
–
Safe and Active DACH Platinum Drug
New Nucleoside Analogue
–
Same class as other clinically successful FDA approved
nucleoside analogues such as fludarabine and cladrabine;
Clofarabine was approved after
a single 44 patient study.
Significant Data/Information Known
–
Drug was well tolerated and active in two Phase 2
clinical trials in advanced solid tumors. Significant clinical pharmacology and dose scheduling
information known.
MD Anderson Cancer Center
–
Principal investigator is Hagop Kantarjian, M.D., Head of
Leukemia Dept. at
MD Anderson
(same team of experts that have successfully led to
approved nucleoside analogues in leukemias and lymphomas).
Clinical Plan
–
Pre
-
clinical and clinical studies indicate strong potential in leukemia or
lymphoma. Based upon clinical data, ACCP is finalizing trial designs and protocols in AML,
ALL, and B
-
cell lymphomas.
15
Thiarabine
–
A Novel Nucleoside Analogue
Significant Clinical Data Available
–
Ready for Phase 2 Trials
16
Cobalamin
-
coated Nanopolymer Platform
1
2
3
4
The nanoparticle coated
with Cobalamin (red)
binds to intrinsic factor (1),
which in turn binds to its
cell surface receptor (2).
The nanoparticle is
transported across the
cell (3), crosses the gut
wall and enters the
bloodstream (4).
Using The Body’s Own Vitamin B
-
12 Absorption System
To Enable and Enhance Delivery of Drugs Through Gut Wall
The “Trojan Horse” Delivery Vehicle
Nanopolymer “payload” can be
Insulin, growth hormone, EPO, etc.
17
Uses Cobalamin (VB12 analogs) to take
advantage of the body’s natural receptor
-
based transport system
Recently announced two MTA
collaborative agreements
Studies conducted on numerous
products including Insulin, LHRH, EPO,
Interferon, G
-
CSF
Achieved significant levels of oral
bioavailability with insulin and HGH
Potential for use in wide variety of
disease states where vitamin intake is up
regulated, including cancer, rheumatoid
arthritis, Crohn’s, autoimmune disorders
Cobalamin
-
coated Nanopolymer Platform
Cobalamin Enhanced Nanopolymers
–
Enabling Oral Insulin
Sponsored Research Partnerships Ongoing
Clinically Relevant Glucose Lowering
Effect in Diabetic Rat Model
Jeffrey B. Davis, Chief Executive Officer
President, SCO Financial Group LLC; Senior Vice President and Chief Financial Officer of a healthcare technology company; Vic
e P
resident, Corporate Finance, at
Deutsche Morgan Grenfell; Senior marketing and product management positions at AT&T Bell Laboratories; Marketing and Product
Man
ager at Philips Medical Systems
North America. MBA, The Wharton School, University of Pennsylvania; BS Biomedical Engineering, Boston University.
Esteban Cvitkovic, M.D., Vice Chairman, Senior Director, Clinical Oncology R&D
Dr. Cvitkovic is a board
-
certified oncologist with more than 30 years experience in oncology therapeutics, including clinical re
search, clinical pharmacology, design of
single
-
agent and combination regimens, and optimization of clinical efficacy. Dr. Cvitkovic played a fundamental role in the re
gistration strategy and post
-
registration
development of cisplatin and oxaliplatin. Dr. Cvitkovic has held staff and academic appointments at Memorial Sloan Kettering
Ca
ncer Center (NY), Columbia
Presbyterian (NY), Hospital St. Louis (Paris), Instituto Mario Negri (Milan) and Institut Gustave Roussy (Villejuif).
Frank Jacobucci, Vice President Sales & Marketing
Mr. Jacobucci has over 20 years experience in sales management, including senior sales executive positions at oncology
focused companies including MGI Pharma,
Genetics Institute, Wyeth Oncology, Aventis, Precision Therapeutics and CRC Oncology Services.
David P. Nowotnik, Ph.D., Senior Vice President Research and Development
Senior Director, Product Development, Guilford Pharmaceuticals, Inc.; Group Leader, Bristol
-
Myers Squibb. Section Leader, Amers
ham International. Research
Chemist, Tate and Lyle and Aspro
-
Nicholas. PhD, Organic Chemistry, University of London.
Stephen B. Thompson, Vice President and CFO
Controller and Administration Manager, API; Controller, Robert E. Woolley, Inc., a hotel real estate company; Controller, OKC
Li
mited Partnership, an oil and gas
company. Accounting and finance, Santa Fe International Corporation.
Phillip Wise, Vice President Business Development and Strategy
VP, Commercial and Business Development and Chief Financial Officer, Enhance Pharmaceuticals; VP, Commercial and Business Dev
elo
pment, Ardent
Pharmaceuticals; Director of Managed Care Marketing & Director of New Product Planning, Glaxo Wellcome; MBA, University of Vi
rgi
nia; BS, Industrial and Systems
Engineering, Georgia Institute of Technology.
18
Management
Experienced Management Team
Steven H. Rouhandeh, Chairman
Steve Rouhandeh is a Chief Investment Officer of SCO Capital Partners, L.P., a New York based life sciences fund.
Steve also i
s a founder of SCO Financial
Group LLC, a highly successful value
-
oriented healthcare group with 11
-
year track record in sector (advisory, research, banking
and investing).
Steve
possesses a diverse background in financial services that includes experience in asset management, corporate finance, investm
ent
banking and law.
Mark Ahn, Ph.D.
Dr. Ahn is currently Professor and Chair of the Science & Technology Entrepreneurship Faculties of Commerce & Administration
an
d Science at the Victoria
University of Wellington, in Wellington, New Zealand. Previously, Dr. Ahn was President and CEO of Hana Biosciences, Inc., a
nd
earlier, Vice President
Hematology at Genentech, Inc. where he was responsible for Rituxan. Prior to that, Dr. Ahn held senior positions at Bristol
-
Mye
rs Squibb, Amgen and FMC
Corporation.
Mark Alvino
Mark Alvino is a Managing Director at Griffin Securities, a leading provider of corporate finance advisory and brokerage serv
ice
s to the life sciences industry.
Prior to that, Mark was a Managing Director for SCO Securities, and additionally held several senior management positions wit
hin
the investment banking and
investor relations industries
Stephen B. Howell, M.D.
Dr. Howell is Professor of Medicine, University of California at San Diego, and has extensive experience in platinum therapeu
tic
s. Dr. Howell is also a Director
of Clinical Investigation and Development TherapeuticsProgram, UCSD Cancer Center, and has previously received the Milken Fou
nda
tion prize for
contributions to cancer chemotherapy.
David Luci, CPA, Esq.
David Luci has extensive experience in accounting and legal in the biotechnology sector, and previously held the position of
Exe
cutive Vice President, Chief
Financial Officer and General Counsel of Bioenvision, Inc. David Luci is currently General Counsel and Director of Investor
Rel
ations for MacroChem
Corporation.
19
Board of Directors
Strong Board of Directors with Relevant Experience
Ticker: ACCP (OTCBB)
Applying to Nasdaq and NYSE
-
AMEX exchanges
Capital Structure
Common shares outstanding
13.1 million shares
Common under preferred shares
9.9 million shares
Total common shares
23.0 million shares
Debt:
$5.5 million note due end 2011, convertible at $27.50 per share.
Cash Burn:
Roughly $3 million annually. With current cash on balance sheet and expected
upfront and milestone payments, Access has sufficient cash into 2010.
High Quality Institutional Investors:
Includes SCO Capital Partners, Oracle Partners, CSFB,
UBS, Schroeder’s Bank
20
Financial Overview
Secure MuGard partnership in Europe (SpePharm BV) and China (RHEI Pharma)
Secured ProLindac & MuGard Partnership in Korea (JCOM)
Secured ProLindac Partnership in China (ASK
–
Aosaikang Med Group)
Signed 2 Cobalamin collaborative agreements
Issued Final Study Report on Phase 2 Recurrent Ovarian Cancer Trial
Achieved GMP manufacturing scale
-
up of ProLindac
European commercial launch of MuGard (UK, Germany, Italy, Norway, Sweden)
US launch of MuGard; Asian launch of MuGard
Ongoing data from European Marketing Assessment Study (UK, Germany, Italy).
Seek global or regional partnerships for ProLindac (discussions ongoing)
Initiate additional ProLindac Phase 2 combination trials globally
Re
-
List Access on a national exchange
Secure additional investment banking research analyst coverage
21
Milestones / News Flow
–
2010
and forward
Significant News Flow Anticipated in 2009 and 2010
Late Stage Oncology Pipeline:
Proprietary technology has created portfolio of new
products for large markets
•
One FDA
-
Approved product, MuGard
–
US launch in early 2010; intro in Europe
underway; Asia next; >$1 billion opportunity
•
One Phase 2/3
-
ready cancer drug, ProLindac
–
New form of proven drug, takes direct
aim at Sanofi’s $2.5 billion Eloxatin franchise
•
One Phase 2
-
ready cancer drug, Thiarabine
–
superior version of clinically and
commercially successful nucleoside analogue
•
Vitamin B
-
12 oral delivery platform
–
multiple long term opportunities (oral insulin, oral
HGH, etc.); multiple collaborations ongoing
Commercial Strategy:
Multi
-
local development and marketing partners to shift risk
and share costs, while retaining very attractive revenue/royalty rights.
Value Visibility
: Seek “re
-
listing” on national exchange; actively present company to
the investment community.
22
Conclusions
–
Investment Highlights
ACCP
–
An Undervalued Investment Opportunity
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