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NGF Antagonists: A Growing Pipeline • Including tanezumab, at least 10 compounds (monoclonal antibodies and small molecules) have been generated to inhibit NGF signaling. Currently only two drugs are reportedly in clinical trials, Pfizer’s tanezumab and OrthoMcNeil/Janssen Pharmaceuticals’ AMG 403 (although <strong>the</strong> status is unknown). O<strong>the</strong>r pharma companies likely have early stage programs. Drug Tanezumab AMG 403 PG110 PPC-1807 VMD-902 BXL1H5 Anti-NGF ALE 0540 ReN 1820 ReN 1826 ??? 90 Company Pfizer Amgen/OMJP/Takeda PainCeptor VM Discovery BioXell Yonsei University College of Medicine NPS Pharmaceuticals ReNeuron ReNeuron Big Pharma A,B & C Adis R&D Insight; IDdb3; Company websites Lay Line Genomics/PanGenetics Class mAB - NGF mAB/peptibody - NGF mAB - NGF Small molecule Small molecule mAB – TrkA mAB - NGF Small molecule Soluble TrkA Modified ReN 1820 mAB - NGF © Defined Health, 2009 Pain Insight Briefing Status Phase II - Pain Phase I - Pain PC - Pain PC - Pain PC - Pain PC - Pain No development reported(PC) Discontinued (PC) - Neuropathic pain Discontinued (PC) - Inflammation Discontinued (PC) - cancer ???
Will NGF for Pain Be Like TNF is for RA? Products/ Indication Clinical Data Economics/ Providers 91 Enbrel, 1 st Biologic Rheumatoid Arthritis, selfinjectedsubcutaneous Defined Health analysis 1998 1999 2002 2003 2005-06 2007 Remicade, 1 st Biologic Crohn’s Disease, IV- Infusion Medicare Part B covers Remicade but not Enbrel Enbrel approved for Juvenile RA Remicade approved for RA ATTRACT Trial supports launch of Remicade into RA Out-patient infusion becomes available © Defined Health, 2009 Pain Insight Briefing Amgen acquires Immunex (Enbrel) Enbrel approved for Psoriatic Arthritis and Psoriasis Humira Launched for RA, selfinjectedsubcutaneous Orencia approved for RA Remicade approved for Psoriatic Arthritis and Psoriasis ASPIRE Trial shows positive results of Remicade for early RA Rituxan approved for RA Medicare Part D covers Enbrel & Humira Remicade continues coverage under Medicare Part B 2008 Humira launched for Crohn’s Disease Cimzia (SC injection) launched for Crohn’s
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Game Changing Plays in the Pain Mar
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Our Disclaimer 3 The information in
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Everyone Hurts “Pain is whatever
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It’s A Big Market with a Few Domi
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$ Millions But Few “Big Pharma-Si
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Pain Historically: Drug Delivery ha
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It’s Getting Tougher Labopharm La
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The Risk : Reward Profile for Novel
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Current Standard of Care for Pain
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Leaving Plenty of Unmet Need to Be
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In the Meantime, Let’s Teach Old
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A Better NSAID: NicOx • Naproxcin
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A Better NSAID: NicOx 25 Company pr
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A Better NSAID: Pozen / AstraZeneca
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The First-to-Market Topical NSAIDs
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Even So, Flector is Expected To Be
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Now We Have a Patch and a Gel Volta
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The Need is Clear 35 © Defined Hea
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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
Page 65 and 66: 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
Page 71 and 72: New MOA Challenges 71 The identific
Page 73 and 74: 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
Page 81 and 82: 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: Concerning, but Transient Adverse E
Page 93 and 94: Repurposed anti-TNF Antibodies for
Page 95 and 96: What’s Next for Pain? • Continu
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