Pharma Case Closing Argument

A sample slide deck based off of an actual closing argument by plaintiff's in a pharmaceutical case.

Transcript

1. What do we expect and what do we deserve from drug companies?
2. A drug company should identify the safest dose that works. 2
3. A drug company should not instruct or tell doctors and patients to use a higher dose than they need. 3
4. A drug company should not recommend a treatment dose to doctors and patients, if a lower dose can be safely used for prevention. 4
5. When a drug company doesn’t follow these simple rules, it puts patients in unnecessary danger. 5
6. 6 Phase II Studies: Finding the Right Dose
7. We expect drug companies to find the safest effective dose. 7
8. Do the test. Get the data. Protect patients. 8
9. Drug Development Dose- Finding Prove Safety & Efficacy FDA Approval Market
10. Early Dose Finding Studies 10
11. Drug Development Dose Finding Prove Safety & Efficacy FDA Approval Market
12. Doses Evaluated in “Phase II” Studies 12 Dec 2003 Sept 2004 Nov 2004 July 2005 Oct 2005 Dec 2005 Prevention Treatment 5 mg 10 mg 20 mg 30 mg 40 mg 60 mg 20 mg 30 mg 40 mg 60 mg
13. Doses Evaluated in “Phase II” Studies 13 Dec 2003 Sept 2004 Nov 2004 July 2005 Oct 2005 Dec 2005 Prevention Treatment 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 60 mg 20 mg, 30 mg, 40 mg, 60 mg Recurrence Prevention ???
14. Pharma Corp did not do any dose finding studies for recurrence prevention. 14
15. 15 Dec 2003 Sept 2004 Nov 2004 July 2005 Oct 2005 Dec 2005 Prevention Treatment 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 60 mg 20 mg, 30 mg, 40 mg, 60 mg Recurrence Prevention ??? Doses Evaluated in “Phase II” Studies
16. 16 Phase III: Proving Safety and Effectiveness
17. Drug Development Dose- Finding Prove Safety & Efficacy FDA Approval Market
18. Pharma Corp needs to choose which doses to study for recurrence prevention in Phase III.
19. Which dose for Recurrence Prevention? PREVENTION ? 30 mg 10 mg 20 mg 5 mg 40 mg 60 mg 40 mg 30 mg 20 mg 60 mg TREATMENT RECURRENCE PREVENTION 19
20. Pharma Corp knows from the dose finding studies that higher doses do not work better than lower doses. 20
22. But higher doses may increase the risk of danger. 22
24. Pharma Corp’s own scientists want to study both 10 mg and 20 mg.
25. Pharma Corp Scientists Want 10mg and 20mg PREVENTION ? 30 mg 10 mg 20 mg 5 mg 40 mg 60 mg 40 mg 30 mg 20 mg 60 mg TREATMENT RECURRENCE PREVENTION 25
26. 3231930 Email from Frank Misselwitz, “Antwort: message from Harry Buller” April 11, 2005 2003 2005 2007 2009 2011 2013 2015 2017
27. 647037 Email from Jesse Berlin, “BO” April 27, 2006 2003 2005 2007 2009 2011 2013 2015 2017
28. 647037 Email from Jesse Berlin, “BO” April 27, 2006 2003 2005 2007 2009 2011 2013 2015 2017
29. Pharma Corp meets with the FDA.
30. FDA also wants Pharma Corp to study 10 mg and 20 mg.
31. FDA Wants 10mg and 20mg PREVENTION ? 30 mg 10 mg 20 mg 5 mg 40 mg 60 mg 40 mg 30 mg 20 mg 60 mg TREATMENT RECURRENCE PREVENTION 31
32. 245248 End of Phase II FDA Meeting Minutes August 23, 2006 2003 2005 2007 2009 2011 2013 2015 2017
33. 874343 Pharma Corp Internal End of Phase II Meeting Minutes August 23, 2006 2003 2005 2007 2009 2011 2013 2015 2017
34. 227439 Email from Robert Kale, “FW: Rivaroxaban FDA EoPII Meeting – VTE Treatment – Executive Summary” August 24, 2006 2003 2005 2007 2009 2011 2013 2015 2017
35. Pharma Corp scientists discuss adding 10 mg to the study.
36. 699844 Email from Gary Peters, “recent health authority meetings and way forward VTE” August 26, 2006 2003 2005 2007 2009 2011 2013 2015 2017
37. 699844 Email from Gary Peters, “RE: recent health authority meetings and way forward VTE” August 30, 2006 2003 2005 2007 2009 2011 2013 2015 2017
38. But ultimately Pharma Corp decides to study only the 20 mg dose.
39. Company Studies Only 20 mg PREVENTION ? 30 mg 10 mg 20 mg 5 mg 40 mg 60 mg 40 mg 30 mg 20 mg 60 mg TREATMENT RECURRENCE PREVENTION 39
40. Same 20 mg dose for prevention as for treatment. No 10 mg study. 40
41. Why don’t they study 10 mg? 41
42. The market for this drug is lucrative and profitable. 42
43. 948640 Email from Kemal Malik, “Rivaroxaban DP3 Decisions 2006” May 31, 2006 2003 2005 2007 2009 2011 2013 2015 2017
44. 948640 Email from Kemal Malik, “Rivaroxaban DP3 Decisions 2006” May 31, 2006 2003 2005 2007 2009 2011 2013 2015 2017 “IR” = Investor Relations
45. 948640 Email from Kemal Malik, “Rivaroxaban DP3 Decisions 2006” May 31, 2006 2003 2005 2007 2009 2011 2013 2015 2017
46. “Our goal is to improve the lives of patients and create a multi-billion dollar antithrombotic franchise.” Dr. Glombitza Pharma Corp 46
47. “we have continued to seize all opportunities to maximize the values of this asset.” 47 Dr. Glombitza Pharma Corp
48. Pharma Corp thinks this drug could be a blockbuster.
49. 3041252 “Xarelto Rivaroxaban.ppt”
50. But they know competition is coming. 50
51. 3228103 ODIXa Bay 59-7939 Planning Group Meeting Minutes July 17, 2004, Amsterdam 2003 2005 2007 2009 2011 2013 2015 2017
52. Development must be fast! 52
53. 3228103 ODIXa Bay 59-7939 Planning Group Meeting Minutes July 17, 2004, Amsterdam 2003 2005 2007 2009 2011 2013 2015 2017
54. Adding an additional dose to the study would slow it down. 54
55. 989059 Email from Robert Mackey, “RE: Quick Commercial Question” September 1, 2006 2003 2005 2007 2009 2011 2013 2015 2017
57. Any delay would put them behind in the race to market. 57
58. Investors weigh in... 58
59. 5194092 Email from Alex Evans to Dr. Berkowitz August 16, 2006 2003 2005 2007 2009 2011 2013 2015 2017
60. 5194092 Email from Alex Evans to Dr. Berkowitz August 16, 2006 2003 2005 2007 2009 2011 2013 2015 2017
61. “safe enough” 61
62. 5194092 Email from Alex Evans to Dr. Berkowitz August 16, 2006 2003 2005 2007 2009 2011 2013 2015 2017
63. “push on” 63
64. 5194092 Email from Alex Evans to Dr. Berkowitz August 16, 2006 2003 2005 2007 2009 2011 2013 2015 2017
65. Delay would cost time and money. 65
66. A one year delay in the EINSTEIN Treatment and Secondary Prevention studies would cost between $1.9 and $4 billion. Dr. Kessler Former FDA Chair 66
67. To beat the competition, Pharma Corp rushed a 20 mg dose to market. 67
69. Pharma Corp ignored the science, the FDA, and their own experts – and didn’t study a lower dose for prevention. 69
70. Pharma Corp delayed testing a lower dose for economic reasons. 70
71. They promoted the 20 mg treatment dose for prevention. 71
72. Pharma Corp failed to find the lowest effective dose. 72
73. Pharma Corp’s failures caused patients to take more drug than they needed. 73
74. Pharma Corp’s failures put patients in unnecessary danger. 74