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TRPV1 Antagonist Pipeline 80 Compound AZD 1386 MK 2295 JTS 653 Vanilloid receptor antagonists Ion channel modulators Small molecule therapeutics Transient receptor potential vanilloid 1 cation channel antagonists TRPV antagonists TRPV cation channel inhibitors TRPV1 antagonists TRPV1 antagonists TRPV1 cation channel inhibitors TRPV1 receptor antagonists Vanilloid 1 receptor antagonists Vanilloid receptor antagonists Vanilloid receptor antagonists Vanilloid receptor antagonists TRPV1 cation channel inhibitors GRC 6211 SB 705498 AMG 517 TRPV1 cation channel antagonists Developer AstraZeneca Merck/Neurogen Japan Tobacco Renovis/Pfizer Hydra Biosciences Amphora Abbott Laboratories Sanofi-Aventis Purdue Pharma DiverDrugs Preclinical Inflammation, Pain Eli Lilly Preclinical Inflammation, Pain, Urinary incontinence with the antagonist. Johnson & Johnson Preclinical Cough, Pain Traxion Therapeutics AmorePacific/Schwarz Neurogen/Merck Novartis Pharmeste Mochida Pharma/Wyeth Glenmark/Eli Lilly Amgen Amgen Phase Phase-II Gastro-oesophageal reflux, Pain JNJ has used high throughput Phase-II Pain Phase-I Pain, Urinary incontinence cancer Asthma, Hypertension, Inflammation, Kidney disorders, Lung disorders, Preclinicalpain, systemic administration of Osteoporosis, Overactive bladder, Pain Preclinical Preclinical Preclinical Preclinical Preclinical Research Discontinued-II Discontinued-II Discontinued-I Discontinued- Preclinical Adis R&D Insight; Nature Reviews Drug Discovery 6, 357-372 (May 2007) © Defined Health, 2009 Pain Insight Briefing Indications screening Phase-I to Overactive generate bladder, Pain a series of TRPV1 antagonists. In a mouse model of the Preclinical TRPV1 antagonist CNS disorders, Metabolic disorders, JNJ-17203212 Pain results in efficacy according to several Preclinical Pain behavioral measures of pain. TRPV1-/- Preclinical Inflammation, Neuropathic pain mice Preclinical show a Painsimilar extent of efficacy as TRPV1+/+ controls that were treated Pain Pain Pain Neuropathic pain Neuropathic pain, Urinary incontinence Pain Cystitis, Dental pain, Neuropathic pain, Urinary incontinence
TRPV1 Antagonist Pipeline 81 Compound AZD 1386 MK 2295 Merck/Neurogen Phase-II Pain JTS 653 Japan Tobacco Phase-I Overactive bladder, Pain • Amgen stopped development of AMG-517 when patients Vanilloid receptor antagonists Renovis/Pfizer Phase-I Pain, Urinary incontinence experienced long-lasting hyperthermia when treated with AMG- Asthma, Hypertension, Inflammation, Kidney disorders, Lung disorders, Ion channel modulators Hydra Biosciences Preclinical 517 following molar extraction; some patients Osteoporosis, Overactive body bladder, temperature Pain Small molecule therapeutics Amphora Preclinical CNS disorders, Metabolic disorders, Pain surpassed 40°C. It is possible that this problem i s due to off- Transient receptor potential vanilloid 1 cation Abbott Laboratories Preclinical Pain channel target antagonistseffects, as TRPV1 -/- mice do not exhibit hyperthermia. TRPV • antagonists GSK’s SB-705498 Sanofi-Aventis showed promising Preclinical results Inflammation, Neuropathic in a study pain designed TRPV cation channel inhibitors Purdue Pharma Preclinical Pain to measure its ability to inhibit heat-evoked pain (capsaicin) and TRPV1 antagonists DiverDrugs Preclinical Inflammation, Pain skin sensitization (UV B irradiation). In addition, treatment with TRPV1 antagonists Eli Lilly Preclinical Inflammation, Pain, Urinary incontinence TRPV1 cation channel inhibitors Johnson & Johnson Preclinical Cough, Pain TRPV1 abandoned receptor antagonists development Traxion Therapeutics of the Preclinical drug, with Pain no explanation as to Vanilloid 1 receptor antagonists Vanilloid receptor antagonists Neurogen/Merck Preclinical Pain • In October 2008 Eli Lilly chose to suspend their trial for GRC- Vanilloid receptor antagonists Novartis Preclinical Neuropathic pain Vanilloid receptor antagonists TRPV1 cation channel inhibitors GRC 6211 SB 705498 AMG 517 TRPV1 cation channel antagonists Developer AmorePacific/Schwarz Amgen Amgen Phase Preclinical Discontinued-II Discontinued-I Discontinued- Preclinical © Defined Health, 2009 Pain Insight Briefing Indications Three TRPV1 antagonists AstraZeneca which Phase-II had entered Gastro-oesophageal the reflux, clinic Pain have been discontinued: 400 mg of SB-705498 did not induce hyperthermia. GSK has since why. 6211, which they were developing in collaboration with Glenmark, Pharmeste Preclinical Neuropathic pain, Urinary incontinence in OA. The companies Mochida Pharma/Wyeth have yet Research to publicly Pain disclose the reason the trial was ended Glenmark/Eli early. Lilly Discontinued-II Cystitis, Dental pain, Neuropathic pain, Urinary incontinence Adis R&D Insight; Nature Reviews Drug Discovery 8, 55-68 (January 2009) Pain
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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
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
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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
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
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: TRPV1 Antagonist Pipeline Compound
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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