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Pain Historically: Drug Delivery has “Delivered” 12 Drug Delivery-Based Pain Products Have Greatly Surpassed Expectations • The epidemiology of pain is uncertain at best • Off-label use is always greater than anticipated • Nature of a symptom-driven market welcomes the next new thing • Healthy price hikes Development Risk Regulatory Risk THE BAR © Defined Health, 2009 Pain Insight Briefing Market Risk
It’s Getting Tougher Labopharm LabopharmGets Gets FDA FDA Okay Okay For For Once-Daily Tramadol (Ryzolt) --Finally Finally December December 31, 31, 2008: 2008: 12:03 12:03 PM PM ET ET To To say say Labopharm Labopharm Inc.'s Inc.'s (DDSS) (DDSS) first first U.S. U.S. drug drug approval approval followed followed a a long long and and winding winding road road would would be be an an understatement, understatement, but but the the tramadol tramadol saga saga with with the the U.S. U.S. FDA FDA is is finally finally over over and and investors investors aren't aren't dwelling dwelling on on the the past. past. Earlier Earlier Wednesday, Wednesday, the the Canadian Canadian specialty-pharma specialty-pharma company company announced announced that that the the FDA FDA approved approved its its once-daily once-daily formulation formulation of of painkiller painkiller tramadol, tramadol, named named Ryzolt. Ryzolt. Labopharm, Labopharm, which which has has been been public public for for 12 12 years, years, went went through through hoops hoops to to get get the the drug drug approved, approved, having having to to redo redo trials, trials, construct construct new new statistical statistical analyses, analyses, and and even even engage engage the the U.S. U.S. regulator's regulator's formal formal dispute-resolution dispute-resolution process. process. It It expects expects marketing marketing partner partner Purdue Purdue Pharma Pharma to to launch launch the the product product in in the the second second quarter. quarter. "This "This is is a a great great milestone milestone for for the the company company and and fantastic fantastic news news for for investors, investors, but but this this approval approval has has been been a a long long time time coming," coming," said said a a biotech biotech observer observer familiar familiar with with the the company. company. "I "I can't can't help help but but believe believe the the opportunity opportunity today today is is much much smaller smaller than than it it was was a a few few years years ago. ago. The The results results will will be be apparent apparent enough enough once once the the company company launches launches the the drug." drug." … In In the the U.S., U.S., Ryzolt Ryzolt will will face face competition competition from from Biovail Biovail Corp.'s Corp.'s Ultram Ultram ER, ER, which which has has a a three-year three-year head head start start and and is is backed backed by by marketing marketing juggernaut juggernaut Johnson Johnson & Johnson. Johnson. Despite Despite the the lead lead and and having having the the market market to to itself, itself, the the drug's drug's sales sales have have been been a a disappointment disappointment to to investors. investors. In In 2007, 2007, Biovail's Biovail's revenue revenue from from Ultram Ultram ER ER was was $86.7 $86.7 million; million; through through the the third third quarter quarter of of 2008, 2008, revenue revenue was was $ $ 64.1 64.1 million. million. 13 CNNMoney.com © Defined Health, 2009 Pain Insight Briefing
Page 1 and 2: Game Changing Plays in the Pain Mar
Page 3 and 4: Our Disclaimer 3 The information in
Page 5 and 6: Everyone Hurts “Pain is whatever
Page 7 and 8: It’s A Big Market with a Few Domi
Page 9 and 10: $ Millions But Few “Big Pharma-Si
Page 11: Pain Historically: Drug Delivery ha
Page 15 and 16: The Risk : Reward Profile for Novel
Page 17 and 18: Current Standard of Care for Pain
Page 19 and 20: Leaving Plenty of Unmet Need to Be
Page 21 and 22: In the Meantime, Let’s Teach Old
Page 23 and 24: A Better NSAID: NicOx • Naproxcin
Page 25 and 26: A Better NSAID: NicOx 25 Company pr
Page 27 and 28: A Better NSAID: Pozen / AstraZeneca
Page 29 and 30: The First-to-Market Topical NSAIDs
Page 31 and 32: Even So, Flector is Expected To Be
Page 33 and 34: Now We Have a Patch and a Gel Volta
Page 35 and 36: The Need is Clear 35 © Defined Hea
Page 37 and 38: Progenics / Wyeth: Making Opioids M
Page 39 and 40: Adolor / Pfizer: Making Opioids Mor
Page 41 and 42: Like All Things CNS, It’s Not So
Page 43 and 44: A New, and Better Opioid from J&J /
Page 45 and 46: A New, and Better Opioid from J&J /
Page 47 and 48: Opioid Abuse Deterrence 47 © Defin
Page 49 and 50: King Pharmaceuticals: Making Big Be
Page 51 and 52: But Also Significant Hurdles • Te
Page 53 and 54: The Technologies are Not the Proble
Page 55 and 56: The Real Issue is Risk Management
Page 57 and 58: Fentanyl: Again, REMS is the Big Re
Page 59 and 60: Lessons from Fentora 59 What the FD
Page 61 and 62: For Some Mechanisms, the US Regulat
Page 63 and 64:
FAAH Pipeline 63 Compound SSR 10101
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FAAH Pipeline KDS-4103, acquired by
Page 67 and 68:
Addressing the Big Problem 67 >50%
Page 69 and 70:
New MOA Challenges 69 NeuroDiscover
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New MOA Challenges 71 The identific
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TRPV1 • The transient receptor po
Page 75 and 76:
TRPV1: Target for Novel Analgesics
Page 77 and 78:
TRPV1 Antagonists: Hot … Too Hot
Page 79 and 80:
TRPV1 Antagonist Pipeline Compound
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TRPV1 Antagonist Pipeline 81 Compou
Page 83 and 84:
TRPV3: Hopeful, But Too Early to Te
Page 85 and 86:
Good Phase III Data, An Accepted ND
Page 87 and 88:
Pfizer Pursuing Multiple Chronic Pa
Page 89 and 90:
Concerning, but Transient Adverse E
Page 91 and 92:
Will NGF for Pain Be Like TNF is fo
Page 93 and 94:
Repurposed anti-TNF Antibodies for
Page 95 and 96:
What’s Next for Pain? • Continu
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