Hovione Product Development & Licensing Courtney R Smith Bio Europe Conference: Delivery Track Wednesday, November 5, 2014
Agenda
Hovione overview Product Development & Licensing Integrated approach to pulmonary delivery Dry powder inhalation devices
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A leader in Active Pharmaceutical Development and Manufacturing since 1959…
New Jersey, USA Technology transfer center. R&D Labs,Kilo and pilot plant. Sales and marketing for North America
Cork, Ireland 427 m3 manufacturing facilities
Macau, China 100 m3 manufacturing facilities
Loures, Portugal 430 m3 manufacturing facilities including R&D Labs, kilo and pilot plants
Taizhou, China 350 m3 manufacturing facilities BIO Europe 2014 Frankfurt, Germany
Shanghai, China Process chemistry R&D Center November 5, 2014
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Overview of Hovione • Privately-held; stable management • 1200 Team members world-wide • Our customers: • Biotech • Medium, specialty and large pharma • 50% innovators, 50% generics • Revenues (2013) USD 201 m • Sales: World-wide reach • 40% USA, 25% EU, 25% Japan
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Growth fueled by particle technology platforms
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Particle Engineering Technologies
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** New offer/ coming soon BIO Europe 2014 Frankfurt, Germany
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Agenda
Hovione then and now Product Development & Licensing Integrated approach to pulmonary delivery Dry powder inhalation devices
BIO Europe 2014 Frankfurt, Germany
November 5, 2014
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Product Development and Licensing Build a balanced drug product portfolio • Reformulated products from known APIs (505b2) • High value Generics (DPI)
Leverage on our technology strengths • Particle Engineering expertise • Inhalation know-how • Dry Powder Inhalation Devices Design
Develop partnering opportunities • Licensees • Co-development with synergetic technologies • Investors to pay for clinical development BIO Europe 2014 Frankfurt, Germany
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PDL Product Pipeline
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Agenda
Hovione then and now Product Development & Licensing Integrated approach to pulmonary delivery Dry powder inhalation devices
BIO Europe 2014 Frankfurt, Germany
November 5, 2014
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Integrated Approach to Inhalation API synthesis
Particle Engineering
Particles
Formulation
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Device
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Product Performance
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Agenda
Hovione then and now Product Development & Licensing Integrated approach to pulmonary delivery Dry powder inhalation devices
BIO Europe 2014 Frankfurt, Germany
November 5, 2014
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Dry Powder Device Portfolio
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Hovione Dry Powder Inhalers Key Advantages
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TwinCaps® • Cavity-based, high efficiency single-use, disposable inhaler
XCaps
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Market-leader in Japan– combination product regulatory path Acute diseases Patent life until 2027
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Partnering opportunities – vaccines, antibiotics, anti-viral, others
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Capsule based high efficiency re-usable inhaler Generic or NCE delivered as a stable powder Patent life until 2033
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Partnering opportunities – asthma, COPD, CF, others
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Benefits of Hovione inhalers Dose Loading
Efficient delivery
Easy to use
Patent protected devices
Global reach
• Large doses for mAbs. Antibiotics • Small doses for asthma, COPD (corticosteroids)
• More accessible to patients with reduced lung function
• Designed from human use factor feedback
• Extended patent life and protected product sales
• Cost conscious on a global scale
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November 5, 2014
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Thank you for your attention.
Courtney R Smith
[email protected] hovione.com