Mayne Pharma Group Ltd. · ASX:MYX
Mayne Pharma — Nomura Biotech Conference 2011
17 slides from Mayne Pharma's conference presentation, Jul 26, 2011
Slide 1: Company Presentation - Nomura Biotech Conference
For personal use only Mayne Pharma Group Limited Company Presentation Nomura Biotech Conference 26th July 2011 Dr Roger Aston Chief Executive Officer www.maynepharma.com 26 July 2011 1
Slide 2: Summary
Mayne Pharma Group Limited For personal use only Summary Leading Australian specialty pharmaceutical company – acquired F. H. Faulding oral-dose facility in 2009 – ASX listing in 2007 (previously known as Halcygen Pharmaceuticals Ltd) Successful history in the drug delivery market Proven track
Slide 3: Established product portfolio & partnerships
Established product portfolio & partnerships For personal use only Product Portfolio (core products) In-market global sales of developed products ~ US$ 500M p.a. Pharmaceutical Partners (marketing partners, contract clients) www.maynepharma.com 3
Slide 4: Drug development - SuperGenerics
Drug development - SuperGenerics For personal use only Extended IP Protection Controlled Release New Markets Simplified Regulatory Path Taste Masked Proven Drugs SuperGeneric Drugs Improved Bioavailibility Reduced Safety/ Development Efficacy Time, Cost, Proprietary Drug Delivery Technologies Improv
Slide 5: Proprietary delivery technologies
Proprietary delivery technologies For personal use only Controlled Release Delivery Systems Steady levels of drug concentrations over 12-24 hrs following a single Sustained Release dose Immediate release of a small portion of drug followed by the delayed Modified Release release of the balance Pulse
Slide 6: Product pipeline
Product pipeline For personal use only Filing for Therapeutic Area Formulation Phase 1 Phase 2 Phase 3 Registration Marketing Approval Infection Doryx® Warner Chilcott (US) Available for licensing (ex-US) Pfizer (Canada), Boryung Infection Eryc® (Korea), Meda (Sweden, Norway), Cephalon (UK) Infectio
Slide 7: Doryx Summary
Doryx® For personal use only Summary The only doxycycline formulation containing enteric-coated delayed release pellets designed to minimise nausea whilst still providing therapeutic blood levels of doxycycline Leading branded oral tetracycline in the US - Warner Chilcott #1 market share by valu
Slide 8: Doryx US update
Doryx® For personal use only US update FY11 has been a challenging year for Doryx® with sales down 47% as a result of FX and a reduction in pipeline inventories by Warner Chilcott Vigorously defending patent which underpins marketing exclusivity for Doryx® in the US — Subject to Paragraph IV cha
Slide 9: Astrix Summary
Astrix® For personal use only Summary Astrix® number 1 prescribed low dose aspirin in Australia Delayed release, low dose aspirin indicated for chronic use in the treatment of cardiovascular or cerebrovascular disease Astrix® capsules are the only enteric coated pelletised form of low dose asp
Slide 10: Kadian / Kapanol Summary
Kadian® / Kapanol® For personal use only Summary Sustained release morphine used in the management of chronic pain Kadian® / Kapanol® is sold in Australia, Canada, Japan and various European countries In the US, Kadian® is sold by Actavis (Market value $200m) – patent expired Exploring partn
Slide 11: SUBACAP Summary
SUBACAP® For personal use only Summary Super-bioavailable itraconazole Reliable, effective broad spectrum anti-fungal drug Near market in-licensing opportunity Active program to secure marketing partners in all territories www.maynepharma.com 11
Slide 12: SUBACAP Product
SUBACAP® For personal use only Product Significant improved formulation of itraconazole (J&J - Sporanox®) based on SUBA® technology Sporanox® hampered by erratic/unpredictable clinical response (poorly controlled absorption) and safety issues SUBACAP® formulation provides for significantly les
Slide 13: SUBACAP Market potential
SUBACAP® For personal use only Market potential Targeting the global itraconazole market (US$ 0.6 billion, 2010) Potential for reach through into terbinafine (Lamisal®) market (currently $700M) Initial target indication Onychomycosis (US$ 3.6 billion, 2010) Broad label claim strategy – Candi
Slide 14: Comparison of SUBACAP and Sporanox
Comparison of SUBACAP® and Sporonox® For personal use only Attribute SUBACAP® Sporanox® Percent absorbed 95% 55% Dose 100 mg 200 mg Capsule strength 50 mg 100 mg Capsule size Medium Large Take without regard Take with food to Food effect to meals increase absorption Absorption in Absorption reduced
Slide 15: Effective – Multi-centre US Phase II Onychomycosis study
Effective – Multi-centre US Phase II Onychomycosis study For personal use only 18% 16% p=0.0009 100 mg SUBACAP® before food vs 200 mg SPORANOX® after 14% food; 12 weeks % of patients 12% p=0.0135 Results at study completion 10% (week 24) Number of patients = 175 8% SUBACAP® significantly 6%
Slide 16: SUBACAP Development and regulatory status
SUBACAP® For personal use only Development and regulatory status Six post-IND PK studies completed (AU, US, EU) Positive 175 patient US multi-centre Phase II trial (Onychomycosis) Commercial manufacturing established (FDA-audited facility) Europe - MAA filed Nov 2010 (UK ref state) US – 50
Slide 17: Business strategy for growth
Business strategy for growth For personal use only Optimising current business Product development Expansion into new territories/markets Life cycle management - new dose Vigorous defense against generic strengths, formulations competition New drug development (ICEs) Improved manufacturing