Advancing “oral” treatments for bone & joint diseases especially for osteoporosis and arthritis...

Advancing “oral” treatments for

bone & joint diseases especially for

osteoporosis and arthritis

Paul HopperExecutive Chairman

February 2006

2

This presentation contains forward-looking statements that involve

risks and uncertainties. These forward-looking statements are not

guarantees of Bone Medical Limited’s future performance and involve

a number of risks and uncertainties that may cause actual results to

differ materially from the results discussed in these statements.

Factors that might cause the Company’s results to differ materially

from those expressed or implied by such forward-looking statements

include but are not limited to, development and commercialisation of

the Company’s product portfolio; development or acquisition of

additional products; and other risks and uncertainties. Bone Medical

Limited undertakes no duty to update any of these forward-looking

statements to confirm them to actual results.

Safe Harbor Statement

2006 Bone Medical Ltd.CONFIDENTIAL

3

Corporate Overview

2006 Bone Medical Ltd.

• Founded December 2002

• Novel, proprietary oral drug delivery technology for musculoskeletal disease

• Phase I/IIa clinical trial for oral calcitonin- Capsitonin- completed

• Phase I clinical study for oral parathyroid hormone- Perthoxal completed

• Listed Public August 2004

Ticker: (ASX:BNE) (ADR:BMEDY.PK)

Office: Bentley, WA, Australia 6102

Shares Outstanding: 64,291,032 (Ordinary); 9,999,204 (Preferred C)

Market Cap (13-2-06): AU$19.3 million (US$15.2 million)

• Over AU$5.1MM spent to date developing two core compounds

• Approximately AU$1.4 million cash on-hand

CONFIDENTIAL

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Capsitonin Phase I/IIa clinical trial for “osteoporosis” completed

Capsitonin Pre-IND meeting held with FDA in December 2005

Rapid regulatory process / strategy for Capsitonin- bioequivalence & 505(b)(2)

NDA submission

Perthoxal- oral parathyroid hormone for “osteoporosis” Phase I clinical study

completed

New, unique oral formulation technology with robust IP and long patent life

“Multi-billion” dollar market opportunity(s) for both Capsitonin and Perthoxal

Balanced portfolio between lower-risk drug delivery programs and potential

breakthrough future treatments

Experienced management with experience in science, management and capital

markets


Investment Highlights

CONFIDENTIAL

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Sources: International Osteoporosis Foundation, CDC, Mayo Clinic, NIAMS, National Center for Chronic Disease Prevention and Health Promotion

• Osteoporosis

Approximately 200 million women worldwide

Incidence is expected to “double” in the next 50 years

Estimated US$48.0 million spent to treat disease in North America and in Europe

• Osteoarthritis

Over 20 million people in the U.S. alone

Most common form of arthritis, approximately 5-10% of population will develop

• Treatments

Calcitonin (sCT): US$600 million

• Injectable and Nasal forms only (no oral form available)

Parathyroid Hormone (PTH): US$450 million

• Injectable form only (no oral from available)


Market Opportunity

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• Osteoporosis

Painful and debilitating

• Worldwide cost burden to reach US$131.5 billion by 2050

• Only 1 in 2 vertebral fractures diagnosed by a physician

• Less than 20% of Osteoporosis patients receive timely treatment

• Osteoarthritis (and rheumatoid arthritis)

Painful, physically and emotionally debilitating

• 25% of persons “cannot” perform major daily activities (e.g., lifting, climbing stairs)


Market Need

“There are no oral formulations available

for calcitonin or parathyroid hormone

limiting the number of treated patients”

“There are no oral formulations available

for calcitonin or parathyroid hormone

limiting the number of treated patients”

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Capsitonin (“oral” sCT)Therapeutic peptide1° Osteoporosis, 2°Osteoarthritis


Product Pipeline

R&D Pre-clinical Phase I Phase II

Phase III NDA

Perthoxal (“oral” PTH)Therapeutic peptideOsteoporosis

BN007 (collagen tolerance)Oral Immune therapyRheumatoid Arthritis

BN006 (TNF down-regulator)

BN008 (Osteoclast down-reg)

BN005 (Osteoblast up-reg)

Products / Compounds

Novel therapeutic entitiesRheumatoid Arthritis, Osteoarthritis

Studies (trials)designedto support

bioequivalenceand 505(b)(2) FDA

submissions

8 2006 Bone Medical Ltd.

Lead Compound

CONFIDENTIAL

• Mechanism of Action: Calcitonin aids in the “formation

of new bone” by interfering with

osteoclast activity.

• Use/Indication: Osteoporosis, Osteoarthritis

• Side Effects: Mild, some joint ache,

headache

Capsitonin Oral Capsule(synthetic salmon calcitonin peptide)

Synthetic peptideof salmon calcitonin

“Calcitonin has been usedSafely as a treatment

for osteoporosisfor over 30 years!”

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• Recombinant peptides (Capsitonin

and Perthoxal) are protected from

gastric degradation

• Released in the upper intestine in an

area with high peptide absorption

• Utilizes existing approved

substances and/or excipients

• Opportunity for rapid 505(b)(2) FDA

submission

New, proprietary oral drug delivery technology


Novel Oral Formulation

Enteric coating for easy swallowing

Capsule Contents:

Drug, stabilizers, solublizers, protease inhibitors,

various GRAS pharmaceutical excipients

Gastric (stomach) cellular surface●

●●

●

●●

●●●

●●

● ●●

●●●

●●

●● ●●● ●

●

●

●●●

●

Capsulecontents

Improved transcellular

absorption

10 2006 Bone Medical Ltd.CONFIDENTIAL

Capsitonin Oral Capsule

• Background

Existing injectable and nasal formulations of calcitonin are difficult to administer

affecting patient compliance and limiting its use as a treatment option

• To date, an “oral” formulation of calcitonin has been unable to be developed

• Capsitonin Pre-clinical / Proof-of-concept

-1

-0.8

-0.6

-0.4

-0.2

0

0.2

0 60 120 180 240 300 360 420 480

5000iu sCT i.j.

Untreated control

200iu sCT s.c.

Decrease in plasma calcium following oral (tablet) administration of Capsitonin in pigs

compared to subcutaneous (injection)

minutes

0.0

50.0

100.0

150.0

200.0

250.0

300.0

350.0

0 0.5 1 1.5 2 2.5 3 3.5 4

E56

S963

S982

S984

Increase in total plasma Capsitonin followingoral (tablet) administration of to primates

Novartis Study

hours


Capsitonin - Phase I/IIa

• Study Objective

Phase I/IIa open label safety & tolerability and preliminary

efficacy / activity

• Study Design

12 post-menopausal, female volunteers

Sequential, cross-over design

1. Positive control (Miacalcin Nasal) – active comparator

2. 1250iu Capsitonin

3. 2500iu Capsitonin

Measurement of key biomarkers: serum calcitonin, serum CTX,

and blood calcium


Capsitonin - Phase I/IIa

• Study Results / Outcomes

The study showed that Capsitonin can be delivered orally and exert a

statistically significant biological effect

• Measurement of markers of bone breakdown in the blood showed that

Capsitonin reduced bone destruction

• Calcitonin (in a small number of patients) was measured in blood

• Calcium levels in the blood were also reduced as expected

Safe and well tolerated

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Lead Compound

CONFIDENTIAL

Perthoxal Oral Capsule(synthetic parathyroid hormone peptide)

Synthetic peptideof the human hormone

• Mechanism of Action: A controlling agent for

maintaining normal calcium levels in the blood for strong bone formation of new bone.

• Use/Indication: Osteoporosis

• Side Effects: Some leg cramps, mild

headache


“The bone formingeffects of parathyroid hormone have been

known for 70 years!”


Perthoxal Oral Capsule

• Background

Existing injectable and nasal formulations of parathyroid hormone (PTH) are

difficult to administer affecting patient compliance and limiting its use as a

treatment option

• To date, an “oral” formulation of PTH has been unable to be developed

• Perthoxal

Pre-clinical / Proof-of-concept:

Time [hours]

0

2

4

6

8

10

0 1 2 3 4 5 6C

alce

mia

[% c

hang

e]0.0

4.0

8.0

12.0

0 1 2 3 4 5 6

500ug PTH orally

50ug PTH s.c. injection

Increase in total plasma calcium followingoral (tablet) administration of PTH to primates

Increase in plasma calcium following oral (tablet) administration of PTH in primates

compared to subcutaneous (injection)


Perthoxal - Phase I

• Study Objective

Phase I open label safety & tolerability study and preliminary pharmacodynamic effects

• Study Design

18 post-menopausal, female volunteers

Sequential, cross-over design (12 of 18 patients only) of two different formulations of Perthoxal

1. Positive control (s.c. injected PTH) – active comparator

2. Formulation (1) 450ug Perthoxal

3. Formulation (2) 400ug Perthoxal

Measurement of key biomarker: serum calcium concentration


Perthoxal - Phase I

• Study Results / Outcomes

The study showed that Perthoxal was able to be delivered safely

and that measurable amounts of calcium were able to be detected in

serum

• One Perthoxal formulation showed levels of measurable calcium

Both Perthoxal formulations were shown to be safe and well

tolerated


Competition

• Calcitonin Nasal Spray (commercially available)

• Miacalcin® Nasal (Novartis), Fortical Nasal (Unigene Laboratories), Calcitonin-Salmon Nasal Spray (Nastech)

Injectable (commercially available)

• Forcaltonin® (Unigene Laboratories)

Oral

• Emisphere Technologies (w/Novartis), Unigene Laboratories

Nasal Spray


Competition

• Parathyroid Hormone

Injectable (commercially available)

• Forteo (Lilly)

Nasal Spray

• Nastech Pharmaceuticals

Oral

• Zelos Therapeutics, Emisphere

Technologies (w/Novartis),

Unigene Laboratories (w/GSK)

Injectable pen device

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• Bone Medical has been granted exclusive worldwide rights

to oral drug delivery technology in the field of

musculoskeletal disease under three patent pending

applications for each product:

1. the use of aromatic alcohols to enhance the uptake of peptides

across the small intestine;

2. pharmaceutical compositions containing certain proportions of

aromatic alcohols; and

3. methods of solubilisation.


Intellectual Property

20

Corporate Secretary

Gabriel Chiappini


Key Management

Executive Chairman

Paul Hopper

Chief Scientific Officer

Roger New, Ph.D.

VP Clinical & Regulatory

Tony Lockett, Ph.D.

VP Commercial Operations

Patrick J. Mallon

Chief Financial Officer

Ed Daquino

Board of Directors

Operations, commercialization, BD, developmentMitos Pharmaceuticals, Pfizer, Roche

R&D, formulation, developmentProxima

R&D, development, regulatoryCovance, Parke-Davis

Capitalization, governance, BDInnovate Oncology, Evolve Oncology,


Business Strategy

• Minimal infrastructure cost and savings

• Corporate / management focus

• Rapidity to market and market up-take

• Minimize infrastructure build & capital needs

• Broaden drug pipeline and product offerings

• Increase revenues and corporate growth

“Hybrid”

distribution

& promotion22

Partner Capsitonin &

Perthoxal (out-license

and/or co-promotion)

“Hybrid”

distribution

& promotion21

Outsource clinicaldevelopment

& manufacturing

Selectively develop

analogs & acquire

oncology compounds

“Hybrid”

distribution

& promotion23

Selectively developand out-license

compounds in pipeline

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“Two” products in clinical trials:

Capsitonin - Oral calcitonin for “osteoporosis” and “osteoarthritis”

Perthoxal - Oral parathyroid hormone for “osteoporosis”

Rapid regulatory process: potential bioequivalence and/or 505(b)(2)

FDA submissions

Multi-billion dollar market opportunity(s)

New, unique oral formulation technology with robust IP and long patent life

Balanced portfolio between lower-risk drug delivery programs and potential

breakthrough future treatments

Experienced management


Value Proposition

CONFIDENTIAL

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Paul HopperExecutive Chairman

Tel: +1 858 200-5636 (San Diego, CA)

[email protected]

Patrick J. MallonVP Commercial Operations

Tel: +1 858 205-2501 (San Diego, CA)

[email protected]


Contact

24

Leon IvoryDirector

Tel: +61 8 9355 5123 (Western Australia)

[email protected]

Ed DaquinoChief Financial Officer

Tel: +61 8 9355 5123 (Western Australia)

[email protected]


Contact

Advancing “oral” treatments for bone & joint diseases especially for osteoporosis and arthritis...

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