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TNF Inhibitors: A $13+ Billion Market & Growing 92 SG Cowen Therapeutic Categories Outlook Sept 2008 Note: Arcoxia and Prexige received “non-approvable” letters in the US. © Defined Health, 2009 Pain Insight Briefing
Repurposed anti-TNF Antibodies for Pain? • When tissue injury and skin inflammation ensue, chronic inflammatory signals are released from surrounding cells at the peripheral nerve terminal and lead to the sensitization of the nociceptors. • Such factors include, but are not limited to, adenosine and its related mono- or polyphosphorylated compounds (AMP, ADP and ATP), bradykinin, glutamate, histamine, interleukin 1, interleukin 6, nerve growth factor, platelet-activating factor, prostaglandin E2, substance P and tumor-necrosis factor-α. 93 Nature Reviews Neuroscience, Vol 10, Jan 2009 Inflammation © Defined Health, 2009 Pain Insight Briefing TNF IL-1 NGF TRPV-1 Potential to repurpose TNF inhibitors for the treatment and/or modulation of pain?
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Game Changing Plays in the Pain Mar
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Our Disclaimer 3 The information in
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Everyone Hurts “Pain is whatever
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It’s A Big Market with a Few Domi
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$ 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
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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
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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 and 90: Concerning, but Transient Adverse E
Page 91: Will NGF for Pain Be Like TNF is fo
Page 95 and 96: What’s Next for Pain? • Continu
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