MuGard - Access Pharmaceuticals Inc.

crunchkingofprussiaBiotechnology

Dec 6, 2012 (4 years and 6 months ago)

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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