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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 the status is unknown). Other 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
- 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
Will NGF for Pain Be Like TNF is for RA?<br />
Products/<br />
Indication<br />
Clinical Data<br />
Economics/<br />
Providers<br />
91<br />
Enbrel, 1 st<br />
Biologic<br />
Rheumatoid<br />
Arthritis, selfinjectedsubcutaneous<br />
Defined Health analysis<br />
1998 1999 2002 2003 2005-06 2007<br />
Remicade, 1 st<br />
Biologic Crohn’s<br />
Disease, IV-<br />
Infusion<br />
Medicare<br />
Part B covers<br />
Remicade but<br />
not Enbrel<br />
Enbrel<br />
approved for<br />
Juvenile RA<br />
Remicade<br />
approved<br />
for RA<br />
ATTRACT Trial<br />
supports launch of<br />
Remicade into RA<br />
Out-patient infusion<br />
becomes available<br />
© Defined Health, 2009<br />
Pain Insight Briefing<br />
Amgen acquires<br />
Immunex (Enbrel)<br />
Enbrel<br />
approved for<br />
Psoriatic<br />
Arthritis and<br />
Psoriasis<br />
Humira<br />
Launched for<br />
RA, selfinjectedsubcutaneous<br />
Orencia<br />
approved<br />
for RA<br />
Remicade<br />
approved for<br />
Psoriatic<br />
Arthritis and<br />
Psoriasis<br />
ASPIRE Trial shows<br />
positive results of<br />
Remicade for early RA<br />
Rituxan<br />
approved<br />
for RA<br />
Medicare<br />
Part D covers<br />
Enbrel & Humira<br />
Remicade continues<br />
coverage under<br />
Medicare Part B<br />
2008<br />
Humira<br />
launched for<br />
Crohn’s<br />
Disease<br />
Cimzia (SC<br />
injection)<br />
launched for<br />
Crohn’s
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