25
1 Capitalising on Pharmaceutical Opportunity A License-Based Partnership with Hospira Inc. (Mayne Pharma International) ACN 115 832 963 ASX CODE: HGN SuperGenerics – Next generation pharmaceuticals based on proprietary improvements of existing drugs BIOMELBOURNE 19TH JUNE 2008 DR. R. ASTON (HALCYGEN) AND MR. P. SCHEMBRI (HOSPIRA) For personal use only

For personal use only - ASX · For personal use only arising from any use of this presentation ... Extensive Human Clinical Studies (3 yrs) Abbreviated NDA FDA Review (1 to 2½ yrs)

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

1

Capitalising onPharmaceutical OpportunityA License-Based Partnership with Hospira Inc. (Mayne PharmaInternational)

ACN 115 832 963

ASX CODE: HGN

SuperGenerics – Next generation

pharmaceuticals based on proprietary

improvements of existing drugs

BIOMELBOURNE19TH JUNE 2008

DR. R. ASTON (HALCYGEN) AND MR. P. SCHEMBRI (HOSPIRA)

For

per

sona

l use

onl

y

2

Disclaimer

This presentation is not and does not constitute an offer, invitation or recommendation to subscribe for, or purchaseany security and neither this presentation nor anything contained in it shall form the basis of any contract orcommitment.

This presentation does not constitute an offer or invitation in any jurisdiction anywhere, or to any person to whom,such an offer would be unlawful. This presentation is not intended as an offer, invitation, solicitation orrecommendation with respect to the purchase or sale of any security in the United States or to any person to whomit is unlawful to make such an offer or solicitation.

Reliance should not be placed on the information or opinions contained in this presentation. This presentation doesnot take into consideration the investment objectives, financial situation or particular needs of any particularinvestor. Any decision to purchase or subscribe for securities in HalcyGen must be made solely on the basis of theinformation contained in the in the public domain and if necessary, after seeking appropriate financial advice.

No representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctnessof the information, opinions and conclusions contained in this presentation. To the maximum extent permitted bylaw, HalcyGen and its affiliates and related bodies corporate, and their respective officers, directors, employees andagents disclaim any liability (including, without limitation, any liability arising from fault or negligence) for any lossarising from any use of this presentation (or its content) or otherwise arising in connection with it.

For

per

sona

l use

onl

y

3

The Pharmaceutical Playing Field

Global pharmaceutical sales will grow 5-6% to over US$735 billion in 2008Information from IMS HEALTH Global Pharma Forecasts 1998-2002 part of the Pharma Prognosis serieshttp://www.ims-global.com/insight/report/global/report.htm

Pharmaceutical Sales 2002

For

per

sona

l use

onl

y

4

Pharmaceutical Industry Profile

GENERICS PROPRIETARYPHARMACEUTICALSSUPER GENERICS

Identical Drug Copies

2-4 years for registration

Novel Patented Pharmaceuticals

10-12 years for registration

Novel Proprietary Modifications of Generics

3-4 years for registration

$ $ $$5-$50

TypicalProduct Pricing:

$50-$500 $500-$50,000For

per

sona

l use

onl

y

5

The Rules - New Drugs Vs SuperGenerics

2-4 Years12 Years

SUPER GENERICPHARMACEUTICAL

NOVEL PHARMACEUTICAL

Laboratory and Animal Studies (3½yrs)

Clinical Studies – Safety (1 yr)

Safety and EfficacyEstablished by Clinical

Trials of Innovator

Clinical Studies – Effectiveness (2 yrs)

Formulation BioavailabilityStudy (½ to 1½ yrs)

Extensive Human Clinical Studies(3 yrs)

Abbreviated NDA FDAReview (1 to 2½ yrs)

NDA SubmittedFDA Review (2½ yrs)

FDA ApprovalFDA Approval

For

per

sona

l use

onl

y

6

The Pharma Industry Problem:More spending, but fewer newdrugs

10 Year Trends in Number ofApprovals of New Molecular Entities

by US FDA

PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2002/2003

10

15

20

25

30

35

40

45

50

55

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 //2006

For

per

sona

l use

onl

y

7

The Referees - Regulators such as FDA, TGA, EMEAprovide the hurdles: Product Withdrawals in the Industryare increasing “Times have Have Changed”

• 15 product withdrawals between 1997 and 2005 Combined peak sales $13 Bn - In 26 years prior to 1997,there were only 8 product withdrawals - Has FDA Set the Bar Too High?

“The U.S. new pharmaceutical market has entered a new era — one characterized by more modest growth due to the continuing impact of new generics products, fewer and more narrowly indicated novel medications, and closer scrutiny of safety issues,” said Aitken...... IMS Health Reports U.S.

For

per

sona

l use

onl

y

8

The New Rules for Serious Players Where are the experts investing?

Short-Cutting Discovery Is Today’s Dominant SmallCompany Model Favored by the US VC Community

Re-Profiling, Re-Purposing… Re-Discovering

SuperGeneric pharmaceuticals - are "next generation" versions of existing drugs that often benefit from a new patent life Super generics aim to improve the way in which a drug is presented to the patient in terms of dose, treatment regimen, formulation, route (oral injectable)

$1.0 Billion committed - 150 life science companies

For

per

sona

l use

onl

y

9

Why Super Generics - Plenty of Scopefor Improvements

“All drugs known to humansare poisons, only theamount or dose determinethe effects.”

Paracelsus, 1490 - 1541William Osler, M.D. 1849-1919

"The person who takes medicinemust recover twice, once from thedisease and once from the medicine."

For

per

sona

l use

onl

y

10

Key Risk Minimizers - Associatedwith SuperGenerics

• Manufacture of product is compliant with current FDA Guidelines• Scale capability to meet market needs• CMC and Formulation are to Good Manufacturing Practice standards• QA and Stability is to regulatory guidelines• Clarity in potential safety benefits• Clarity in potential patient compliance benefits• Clarity on drug efficacy benefitsF

or p

erso

nal u

se o

nly

11

Advantages of HalcyGen’sLead product - Itraconazole

• The “active” ingredient is already approved– Substantial safety (itraconazole has been in 70million

people plus)– No question about efficacy– Regulators have clear guidelines as to where they

would like to see improvements• Premium pricing due to patentability of improvements• Risk is much lower than for new drugs• PatentsF

or p

erso

nal u

se o

nly

12

SUBA™-Itraconazole Vs thecompetition (Sporanox®)

Stable blood levelsLarge inter and intra patientvariability

Low gastrointestinal side effectsexpected due to higher absorptionthan Sporanox®

High gastrointestinal side effectsdue in part to low absorption

Absorbed in fed and fasted stateMust be taken with full stomach(30-50% by weight fat)

Small Capsule size 1Large Capsule - size 0

Dose for registration - 50mgRegistered dose - 100mg

Therapeutic dose 100mgTherapeutic dose - 200mg

SUBA™-ItraconazoleHalcyGen

Sporanox® Market Leader(J&J)/Janssen

For

per

sona

l use

onl

y

131950 1960 1970 1980 1990 2000...2007

ketoconazolemiconazole

5-flucytosine

voriconazole

fluconazole

caspofungin

lipid AmphB

itraconazole

terbinafine

amphotericin B

Approved Anti-fungal AgentsMARKET EVOLUTION

Sales Global Anti-fungals $2.5 Billion

SUBA™-Itraconazole

HGN

Adapted from: Catherine Knupp.Pfizer Global Research and DevelopmentNystatin

$500M+

$600M+

HIVInfection

ICUCareChemotherapyNailInfections!

For

per

sona

l use

onl

y

14

SUBA™-Itraconazole

• Broad spectrum anti-fungal agent– Reduced dosage formulation identified and patented by

Mayne/Hospira

• Total market size for anti-fungals >US$2.5 Billion

Otheranti-fungalsUS$850 m

Pfizer IncFluconozole/VoricanazoleUS$750 m ++

Other Generic SporanoxManufacturers/Sales

NovartisLamisilUS$650 m

Johnson&Johnson/Janssen -

Sporanoxbeing absorbed by

generics manufacturersSPORANOX MARKET

US$600M +

For

per

sona

l use

onl

y

15

HalcyGen Ltd - Hospira Inc.

Halcygen$Development

Mayne Pharma*Product dev.*Reg & Tech.

*Manufacturing

Licensee*Marketer

Variousmarkets“territories”

IP

Contract product development

$ Royalty$ Upfront

Developedproducts

Contract manufactured product

A$ return for manufacturing

Partnership based on Global Exclusive License with first right to Hospira for manufacturing and marketing in Australia and NZ

For

per

sona

l use

onl

y

16

Mayne Pharma InternationalSalisbury, SA.

For

per

sona

l use

onl

y

17

Key Plant & Equipment

FluidBeds

SpherioniserFor

per

sona

l use

onl

y

18

“Roger’s favourite”

NIRO Mobile Minor SprayDryer

SUBA Itraconozole development &clinical trial supplies manufacture

For

per

sona

l use

onl

y

19

Tablet & Capsule BlisterPacking Line

IMA C62For

per

sona

l use

onl

y

20

Hospira Inc. – Mayne Pharma

To appreciate why a relationship like this would be considered we need to understand what Hospira(Mayne Pharma – Salisbury) is about.

For

per

sona

l use

onl

y

21

Hospira Inc. – Mayne Pharma“Salisbury Site strategy”

For

per

sona

l use

onl

y

22

Company Highlights

Cash $12.5 million raised in an oversubscribed offering June 2007 –cash in bank as 31st March 2008 $12.7M

Two global exclusive license agreements with Hospira Inc providingrights to two proprietary SuperGeneric drugs (SUBA-Itraconazole andMinocycline)

Successful completion of five pharmacokinetic studies in man fordetermining drug doses of SUBA-Itraconazole for registrationpurposes

Approval of IND submission to US FDA

Negotiating a third licensing agreement with Mayne Pharma International

Licensing interest from third party marketing and distribution companies

For

per

sona

l use

onl

y

23

Capital Structure

6,250,000Total Options on issue post IPONilOptions offered pursuant to IPO

6,250,000Options currently on issue

Options

76,099,000Total Shares on issue post IPO

25,000,000Shares offered pursuant to IPO @50¢51,099,000Shares currently on issue

NumberShares

Cash at Bank: $12.7 million Mar 31st 2008

For

per

sona

l use

onl

y

24

Board and Management

• Company secretary for pSivida Ltd• Former CFO of INVESCO Australia• Formerly with PwC in London and Perth

Mr Aaron FinlayCompany Secretary & CFO

• Board member Victorian Health Promotion Foundation and National Party Spokesperson on Health• Former member of the Victorian Parliament from 1988-2002• Consultant for PFD Food Services Pty Ltd

Hon. Ron BestNon-executive Director

• Director and CEO of Australian Leisure and Hospitality Group Ltd (joint venture with WoolworthsLtd)

• ALH Group: 260 hotels, 450 retail outlets, turnover $1.6 billion; 14,000 staff• Management and transactional experience across many industries

Mr Bruce MathiesonNon-executive Director

• 20 years’ experience in establishing and developing commercial ventures.• Regions of activity included; United States of America, United Kingdom, Hong Kong, Singapore,

Australia and New Zealand

Mr Craig BottomleyChief Operating Officer

• 20 years’ experience in pharmaceutical and biotechnology industries• Previously with Welcome plc (now GSK), Peptech Ltd (former CEO), Cambridge Antibody

Technology, Cambridge Drug Discovery, QinetiQ and pSivida Ltd (co-founder)• Chairman of Clinuvel Pharmaceuticals Ltd

Dr Roger AstonChairman & CEO

For

per

sona

l use

onl

y

25

THANK YOU

“If opportunity doesn’t knock, build a door” - Milton Berle

For

per

sona

l use

onl

y