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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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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.
DURATIONAll 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 doesnt 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 doesnt 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 vets 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 vets 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 andinflammation 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 vets 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 todays 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 todays speakers and some key facts about NAH