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Novartis Animal Health

2. Novartis Animal Health part of the Novartis healthcare portfolio. . Sales by division 2008. . . . . 4%. 64%. 14%. 18%. Consumer Health. Sandoz. Pharmaceuticals. V

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Novartis Animal Health

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    1. Novartis Animal Health Dedication to Innovation FolkertFolkert

    2. 2 Novartis Animal Health – part of the Novartis healthcare portfolio Folkert Folkert

    3. 3 Novartis Animal Health portfolio 2008 Folkert Folkert

    4. 4 R&D at the core of the company Leading position in parasiticides Leveraging R&D achievement from the Novartis group as much as possible Expanding the therapeutic segment and demonstrating leadership Deramaxx – first COXIB in veterinary medicine in the US Onsior – first COXIB for cat Focusing on offering our customers comprehensive animal health solutions Folkert Folkert

    5. 5 Novartis Animal Health Global R&D Sites Folkert To develop products successfully, it takes a large number of people (within Novartis Animal Health over 400 associates) in several sites around the world - Six major R&D sites - Three smaller R&D sites Sites are located geographically disperse - Longitudinal – some projects are literally worked on for 24 hours a day as data and information is moved from one site to another - Latitudinal: Having sites in the Northern and Southern hemisphere allows us to conduct studies that require a season (for example specific parasites, tick attachment) twice a year – it is spring in the Southern hemisphere when it is fall in the Northern hemisphere. Folkert To develop products successfully, it takes a large number of people (within Novartis Animal Health over 400 associates) in several sites around the world - Six major R&D sites - Three smaller R&D sites Sites are located geographically disperse - Longitudinal – some projects are literally worked on for 24 hours a day as data and information is moved from one site to another - Latitudinal: Having sites in the Northern and Southern hemisphere allows us to conduct studies that require a season (for example specific parasites, tick attachment) twice a year – it is spring in the Southern hemisphere when it is fall in the Northern hemisphere.

    6. 6 R&D stages Folkert There are uncertainty & risks when running R&D projects such as: a chance to end up taking detour(s) temptation to look into every ‚nook and cranny‘ Have to make multiple, interlinked decisions and you may take a wrong turn never find the exit and have to give up come out the wrong end But also opportunities ... to overcome hurdles and find the shortest possible way to the target to take good decisions based on a systematic review of facts and potential outcomes to learn from mistakes Research and development of pharmaceutical products is a long term and complex process that is broken down in several consecutive steps. The following slides provide some background information on how this is done. This slide shows the individual stages of the R&D process and what happens at each stage. Folkert There are uncertainty & risks when running R&D projects such as: a chance to end up taking detour(s) temptation to look into every ‚nook and cranny‘ Have to make multiple, interlinked decisions and you may take a wrong turn never find the exit and have to give up come out the wrong end But also opportunities ... to overcome hurdles and find the shortest possible way to the target to take good decisions based on a systematic review of facts and potential outcomes to learn from mistakes Research and development of pharmaceutical products is a long term and complex process that is broken down in several consecutive steps. The following slides provide some background information on how this is done. This slide shows the individual stages of the R&D process and what happens at each stage.

    7. 7 Attrition per stage and average duration Folkert This slide shows how many projects fail at each stage and the time line for each of the steps is shown – these are averages, remember that many projects take longer for one or the other step. ATTRITION STAGE What I want to show is that product development is a complex process, takes a long time and involves significant risk at each stage. Project terminations are due to many different reasons, from lack of efficacy, unacceptable safety issues (i.e. side effects), to often cost of the active compound that exceed what is acceptable for a food or companion animal market. DURATION All steps together take 9 years on average. That is nine years from research to product on the market, requiring companies to invest, plan and make decisions with a very long term horizon. This is especially important when looking at the attrition rates, the rates of projects failing at each stage which can be seen in the following slide. Folkert This slide shows how many projects fail at each stage and the time line for each of the steps is shown – these are averages, remember that many projects take longer for one or the other step. ATTRITION STAGE What I want to show is that product development is a complex process, takes a long time and involves significant risk at each stage.

    8. 8 R&D Spend Folkert To allow for the duration, uncertainty and risks involved with product development, companies invest strategically While the development stage is most expensive and, therefore, has the highest part of the R&D budget, it is important to continue investment in the discovery and proof of concept stages to keep the pipeline filled. Investment doesn’t stop once products are approved and on the market. Regulatory agencies around the world require ongoing investment in regulatory support and studies that continue to prove the stability, efficacy and safety of approved products. To balance the portfolio further, most companies divide their investment between different species – investing in both farm and companion animals. Folkert To allow for the duration, uncertainty and risks involved with product development, companies invest strategically While the development stage is most expensive and, therefore, has the highest part of the R&D budget, it is important to continue investment in the discovery and proof of concept stages to keep the pipeline filled. Investment doesn’t stop once products are approved and on the market. Regulatory agencies around the world require ongoing investment in regulatory support and studies that continue to prove the stability, efficacy and safety of approved products. To balance the portfolio further, most companies divide their investment between different species – investing in both farm and companion animals.

    9. 9 Global challenges and changing environment High development costs Folkert The environment in the R&D arena has been changing drastically over the last ten years. The time to develop pharmaceutical products essentially doubled in all markets, and the cost increased by more than 100% in major markets. Note the average time and cost (as reported in an industry survey from 2005) that it takes to develop a product for veterinary medicine. Folkert The environment in the R&D arena has been changing drastically over the last ten years. The time to develop pharmaceutical products essentially doubled in all markets, and the cost increased by more than 100% in major markets.

    10. 10 What it takes to develop a veterinary medicine Good people - motivation, experience, expertise Lots of investment at high risk More than US $100 million per successful project A long term view Often more than 10 years A good screening process to identify candidates early Determined focus on outcome Folkert So, to summarize – it takes a large number of outstanding scientists and support staff, preferably working across time zones and geographically different research sites, a large and long-term investment taking the development timelines and high-risk into account and a a good screening process and determined focus that allows us to continue to find and bring to market new compounds like the one we are launching today. Folkert So, to summarize – it takes a large number of outstanding scientists and support staff, preferably working across time zones and geographically different research sites, a large and long-term investment taking the development timelines and high-risk into account and a a good screening process and determined focus that allows us to continue to find and bring to market new compounds like the one we are launching today.

    11. Rachel Rachel

    12. Onsior Essence of relief Rachel Novartis Animal Health received regulatory approval by the EMEA for Onsior®, the first and only coxib NSAID (non-steroidal anti-inflammatory drug) for the relief of pain and inflammation in both cats and dogs, and is now introducing the product to the market all over Europe.Rachel Novartis Animal Health received regulatory approval by the EMEA for Onsior®, the first and only coxib NSAID (non-steroidal anti-inflammatory drug) for the relief of pain and inflammation in both cats and dogs, and is now introducing the product to the market all over Europe.

    13. Rachel Introduction of speakers Agenda of session: Introduction to NAH and its R&D activities was given by Folkert Kamphuis, COO NAH Next 30-40 minutes, presentation of Onsior, the product benefits and the science behind the product, presented by NAH experts Q&A Functionality: During and after the presentations you can send through your questions, click “Ask question”, enter your name and email address and write us your questions. We will answer them following the presentations. The webcast will be live for three months. Questions can be send through anytime after the launch as well. Rachel Introduction of speakers Agenda of session: Introduction to NAH and its R&D activities was given by Folkert Kamphuis, COO NAH Next 30-40 minutes, presentation of Onsior, the product benefits and the science behind the product, presented by NAH experts Q&A Functionality: During and after the presentations you can send through your questions, click “Ask question”, enter your name and email address and write us your questions. We will answer them following the presentations. The webcast will be live for three months. Questions can be send through anytime after the launch as well.

    14. 14 Companion animal pain market Pet pain control medication market one of the fastest growing1 Strong growth in recent years driven by introduction of new products e.g. Deramaxx (deracoxib) and increased focus on educational and market development initiatives Primary growth driver: nonsteroidal anti-inflammatory drugs (NSAID) Estimated at 113 million USD2 Existing unmet needs for both dogs and cats Increased drug safety and reduction of frequency of NSAID side-effects Improved palatability Rachel Rachel

    15. Rachel Powerful and gentle, Onsior® helps both cats and dogs get back to their old tricks – and maybe even some new ones. Onsior moves through the blood quickly, concentrating at the inflamed site and staying there to target the pain and inflammation. It inhibits pain-causing COX-2 and spares beneficial COX-1 to help protect gastrointestinal and platelet functions. With a complete range of formulations for cats and dogs, Onsior provides relief for their pain and for a vet’s concerns. Now that is truly amazing. Rachel Powerful and gentle, Onsior® helps both cats and dogs get back to their old tricks – and maybe even some new ones. Onsior moves through the blood quickly, concentrating at the inflamed site and staying there to target the pain and inflammation. It inhibits pain-causing COX-2 and spares beneficial COX-1 to help protect gastrointestinal and platelet functions. With a complete range of formulations for cats and dogs, Onsior provides relief for their pain and for a vet’s concerns. Now that is truly amazing.

    16. 16 Onsior firsts Rapid pain relief Convenience of an oral and injectable range Simplicity of dosing High safety index Excellent palatability Onsior. New, effective pain-relief Rachel A new fast-acting pain reliever which concentrates its action at the site of inflammation.Rachel A new fast-acting pain reliever which concentrates its action at the site of inflammation.

    17. 17 Onsior firsts First COXIB licensed for cats for both dogs and cats First injectable COXIB licensed for either dogs or cats Kelly Onsior will provide veterinarians with an effective pain-relief option for both cats and dogs. As the first coxib NSAID to be approved for cats, Onsior is an excellent new option available for veterinarians providing pain-control management for cats and dogs. Kelly Onsior will provide veterinarians with an effective pain-relief option for both cats and dogs. As the first coxib NSAID to be approved for cats, Onsior is an excellent new option available for veterinarians providing pain-control management for cats and dogs.

    18. 18 Rapid pain relief Fast peak blood concentrations for rapid relief Kelly Kelly

    19. 19 Convenience of an oral and injectable range Kelly The drug fits different administration routes with pain and inflammatory indications: flavored tablets and injectable solution for surgery. With this complete range, Onsior will offer to veterinarians a convenient solution addressing all different needs. Onsior is formulated to fit in with an effective pain management protocol. Kelly The drug fits different administration routes with pain and inflammatory indications: flavored tablets and injectable solution for surgery. With this complete range, Onsior will offer to veterinarians a convenient solution addressing all different needs. Onsior is formulated to fit in with an effective pain management protocol.

    20. 20 Tablets for dogs and cats Flavored, palatable tablets Convenient once-daily dosing Well accepted by most dogs and cats Range of tablet sizes that allows most cats and dogs to take only one tablet per day Kelly Kelly

    21. 21 Tablets for dogs and cats Tablets for Dogs Treatment of pain and inflammation associated with chronic osteoarthritis No time limit to treatment 4 different tablet sizes Tablets for Cats Treatment of acute pain and inflammation associated with musculo-skeletal disorders Treatment up to 6 days 1 tablet size suitable for all cats Kelly Onsior tablets are available for dogs and cats. The tablets for dogs are beef-flavored and indicated to relieve pain and inflammation associated with chronic osteoarthritis. For cats they are small and flavored to be accepted easily by the majority of cats suffering from acute pain and inflammation due to musculo-skeletal disorders. Kelly Onsior tablets are available for dogs and cats. The tablets for dogs are beef-flavored and indicated to relieve pain and inflammation associated with chronic osteoarthritis. For cats they are small and flavored to be accepted easily by the majority of cats suffering from acute pain and inflammation due to musculo-skeletal disorders.

    22. 22 Solution for injection for dogs and cats Dog Treatment of pain and inflammation associated with orthopedic or soft tissue surgery Cat Treatment of pain and inflammation associated with soft tissue surgery Kelly For surgery, Onsior injectable can be used in cats as one single injection for soft tissue surgery and in dogs as one single injection for orthopedic or soft tissue surgery.Kelly For surgery, Onsior injectable can be used in cats as one single injection for soft tissue surgery and in dogs as one single injection for orthopedic or soft tissue surgery.

    23. 23 Simplicity of dosing Kelly Kelly

    24. 24 High safety index Onsior is well tolerated by dogs and cats: Kelly Dosed once daily, Onsior has an excellent safety profile. The drug fits different administration routes with pain and inflammatory indications: injectable solution for surgery and flavored tablets for pain and inflammation related to osteoarthritis in dogs or musculoskeletal disorders in cats, providing relief for pets as well as for pet owners. Onsior is dosed once daily and has an excellent safety profile. Kelly Dosed once daily, Onsior has an excellent safety profile. The drug fits different administration routes with pain and inflammatory indications: injectable solution for surgery and flavored tablets for pain and inflammation related to osteoarthritis in dogs or musculoskeletal disorders in cats, providing relief for pets as well as for pet owners. Onsior is dosed once daily and has an excellent safety profile.

    25. 25 Onsior. Technical features Kelly With the benefits of being tissue selective, sparing COX-1, and having a short blood half-life – as well as being approved for both cats and dogs – Onsior will stand out as the new pain reliever of choice for veterinarians.Kelly With the benefits of being tissue selective, sparing COX-1, and having a short blood half-life – as well as being approved for both cats and dogs – Onsior will stand out as the new pain reliever of choice for veterinarians.

    26. 26 New chemical entity in veterinary medicine Onsior® – robenacoxib Derived from diclofenac (Voltaren®) Jon Jon

    27. 27 Key characteristics of robenacoxib Analgesic, anti-inflammatory, anti-fever activity COXIB class of NSAID Potent and selective inhibitor of COX-2 COX-1 sparing at recommended dosages Jon Jon

    28. 28 What is a COXIB class drug ? JonJon

    29. 29 Why does COX-2 selectivity matter? Jon Traditional NSAIDs inhibit both COX-2 and COX-1 enzymes which can result in common side effects involving the gastrointestinal tract and the kidneys. Onsior, however, targets the pain-causing COX-2 enzymes while sparing the protective actions of COX-1 and is the only coxib licensed for cats as well as dogs. Jon Traditional NSAIDs inhibit both COX-2 and COX-1 enzymes which can result in common side effects involving the gastrointestinal tract and the kidneys. Onsior, however, targets the pain-causing COX-2 enzymes while sparing the protective actions of COX-1 and is the only coxib licensed for cats as well as dogs.

    30. 30 Onsior is COX-2 selective A potent and selective inhibitor of COX-2 COX-1 sparing at recommended dosages of injection and tablets in dogs and cats Jon Dosed once daily, Onsior has an excellent safety profile. The drug fits different administration routes with pain and inflammatory indications: injectable solution for surgery and flavored tablets for pain and inflammation related to osteoarthritis in dogs or musculoskeletal disorders in cats, providing relief for pets as well as for pet owners. Onsior is dosed once daily and has an excellent safety profile. Jon Dosed once daily, Onsior has an excellent safety profile. The drug fits different administration routes with pain and inflammatory indications: injectable solution for surgery and flavored tablets for pain and inflammation related to osteoarthritis in dogs or musculoskeletal disorders in cats, providing relief for pets as well as for pet owners. Onsior is dosed once daily and has an excellent safety profile.

    31. 31 Jon Jon

    32. 32 Jon Jon

    33. 33 Onsior is tissue selective Onsior rapidly reaches peak blood and tissue concentrations Onsior persists for longer and at higher concentrations at sites of inflammation versus blood Onsior is rapidly eliminated from non-inflamed tissues reducing their exposure Jon Another benefit of Onsior is its tissue selectivity. The drug travels rapidly through the bloodstream to the site of injury or irritation. It then concentrates at the point of inflammation, while exiting the bloodstream very quickly. Jon Another benefit of Onsior is its tissue selectivity. The drug travels rapidly through the bloodstream to the site of injury or irritation. It then concentrates at the point of inflammation, while exiting the bloodstream very quickly.

    34. 34 Rapid efficay and tissue selectivity in cats Jon Jon

    35. 35 Rapid efficay and tissue selectivity in dogs Jon Jon

    36. 36 Excellent safety profile due to tissue selectivity Jon Dosed once daily, Onsior has an excellent safety profile. The drug fits different administration routes with pain and inflammatory indications: injectable solution for surgery and flavored tablets for pain and inflammation related to osteoarthritis in dogs or musculoskeletal disorders in cats, providing relief for pets as well as for pet owners. Jon Dosed once daily, Onsior has an excellent safety profile. The drug fits different administration routes with pain and inflammatory indications: injectable solution for surgery and flavored tablets for pain and inflammation related to osteoarthritis in dogs or musculoskeletal disorders in cats, providing relief for pets as well as for pet owners.

    37. 37 Efficacy with a high safety index Drugs combining tissue selectivity and high COX-2 selectivity represent a new generation of NSAIDs which maintain efficacy of older NSAIDs but have improved safety profiles1 Onsior is the only veterinary approved NSAID which combines high COX-2 selectivity and tissue selectivity thus showing a high safety index Jon Jon

    38. 38 Potent inhibitor of COX-2 COX-1 sparing at recommended dosages Tissue selective Excellent efficacy High safety index Fast peak blood concentrations Onsior technical summary Rachel A new fast-acting pain reliever which concentrates its action at the site of inflammation.Rachel A new fast-acting pain reliever which concentrates its action at the site of inflammation.

    39. 39 Rapid and effective pain relief Convenience of an oral and injectable range Simplicity of dosing High safety index Powerful enough for dogs, gentle enough for cats Onsior. Essence of relief Rachel A new fast-acting pain reliever which concentrates its action at the site of inflammation.Rachel A new fast-acting pain reliever which concentrates its action at the site of inflammation.

    40. 40 Onsior. Essence of relief Rachel Rachel

    41. 41 Onsior. Essence of relief Powerful and gentle, Onsior® helps both cats and dogs get back to their old tricks – and maybe even some new ones. Onsior moves through the blood quickly, concentrating at the inflamed site and staying there to target the pain and inflammation. It inhibits pain-causing COX-2 and spares beneficial COX-1 to help protect gastrointestinal and platelet functions. With a complete range of formulations for cats and dogs, Onsior provides relief for their pain and for a vet’s concerns. Now that is truly amazing. Rachel Rachel

    42. 42 Rachel Rachel

    43. 43 Your time to ask us questions Use the online Q&A functionality and send us through your questions Further information on Onsior and Novartis Animal Health is available for you: Onsior Press Kit: www.ah.novartis.com (>About us >Contact us >Media) Onsior website: www.onsior.com Rachel Q&A: ask your questions now, the webcast will be available for three more months, you can send us through your questions now or at a later stage Press Kit: contains a press release, background information on pain management and on Onsior, audio statements on Onsior, pictures, pack shots, logos, CVs of today’s speakers and some key facts about NAH Rachel Q&A: ask your questions now, the webcast will be available for three more months, you can send us through your questions now or at a later stage Press Kit: contains a press release, background information on pain management and on Onsior, audio statements on Onsior, pictures, pack shots, logos, CVs of today’s speakers and some key facts about NAH

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