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Perampanel

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  1. Perampanel (E2007)
  2. Summary: Perampanel is a first-in-class AMPA-type glutamate receptor antagonist being developed by Eisai for partial onset seizures. Three global Phase III studies have been completed including 1490 patients, and Eisai indicated on Jan. 25, 2011 that it intends to file for approval in the US and EU duing the first quarter of 2011.
  3. Community Ranking:
  4. Patient Impact
  5. Probability of Success
  6. Time to Market
  7. Overall Assessment
  8. Therapy Description: A first-in-class AMPA-type glutamate receptor antagonist.
  9. Sponsor
    • Eisai Co., Ltd is a global pharmaceutical company headquartered in Tokyo Japan.  US Subsidiary Eisai Inc.is based in Woodcliff Lake, New Jersey.
    • Web Address: http://www.eisai.com/
  10. Status:3 Phase III trials completed.  Reg submission US And EU Q1 2011.  Japan PII
  11. Pharmacokinetics
  12. Dosing
  13. Formulations Under Development
  14. Indications
    • Epilepsy: submitting for adjunctive treatment of Partial Onset Seizures in patients with epilepsy
    • Other:in development (P2) for neuropathic pain, migraines and multiple sclerosis.
  15. Estimated Arrival In Market: Assuming 15 months from regulatory submission in March 2011, could be on market in June 2012
  16. Trial Data
    • Patients Exposed and Timeframe
    • Phase 3
    • Phase 2 Trials
    • Phase 1 Summary (footnote)
  17. Adverse Events
  18. Animal Data
  19. Additional Sponsor Detail 
    • Eisai Co. Ltd.
      • Public, TYO:4523
      • Market Capitalization: Approx. $10 bil US at 2/1/11
      • Revenues: On Feb 1, 2011, Eisai reported 9 months results and forecast full year sales for the fiscal year ending March 2011 of Yen 770 bil, down 4.1%.
      • Profits: Forecast at $70 bil Yen for March/11 Fiscal Year.
      • Employees at 9/30/10: 11,653
      • Other CNS Products Marketed by Sponsor: Aricept for Alzheimers; Banzel (BANZEL® is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults.); Zonegran for epilepsy
      • Other CNS Products in Sponsor Pipeline:
      • Partnership status, Commercial Strategy 
      • Development History of Compound 
  20. Publications (from PubMed)
  21. Commentary (ETP Scientific and Business Advisory Boards, Community)
  22. Wiki Tags
    • Use “pipelinedrug” to feature therapy under the “Drugs” section
    • Use “pipelinedevice” to feature therapy under the “Devices” section
    • Use “pipelineother” to feature it under the “Other” section

warren7
warren7
Created by warren7 02/1/2011 at 01:31am

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