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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)
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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.
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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
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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
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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
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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
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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.
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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
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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."
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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
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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
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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
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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!
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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$600M +
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HalcyGen Ltd - Hospira Inc.
Halcygen$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
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“Roger’s favourite”
NIRO Mobile Minor SprayDryer
SUBA Itraconozole development &clinical trial supplies manufacture
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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.
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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
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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
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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
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