Transcription of BAN2401 18 856 - eisai.co.jp
1 1 2018 7 6 BAN2401 18 856 II 18 CEO (Nasdaq: BIIB CEO ) A BAN2401 856 II 201 18 ADCOMS Alzheimer s Disease Composite Score PET 201 identifier NCT01767311 856 II 18 ADAS-cog CDR-SB MMSE 3 ADCOMS mg/kg
2 2 1 5 mg/kg 1 5 mg/kg 10 mg/kg 10 mg/kg 5 5 18 ADCOMS BAN2401 10 / 18 PET BAN2401 PET PET PET BAN2401 ADCOMS 6 12 2 BAN2401 18 ARIA ARIA-E 10 APOE4 15 Lou Ruvo Center for Brain Health Dr.
3 BAN2401 18 Dr. BAN2401 1 Dr. BAN2401 18 2017 12 BAN2401 12 III 18 ADCOMS 12 PR TEL 03-3817-5120 TEL: +1-781-464-3260 3 1.
4 BAN2401 BAN2401 A 2007 12 2014 3 2017 10 2. ADCOMS ADCOMS (Alzheimer s Disease Composite Score) 3 ADAS-cog Alzheimer's Disease Assessment Scale-cognitive subscale CDR-SB Clinical Dementia Rating Sum of Boxes MMSE Mini-Mental State Examination 201 FDA ADCOMS 3 PET PET Positron Emission Tomography PET 4
5 A BAN2401 BACE elenbecestat A aducanumab EU BAN2401 elenbecestat 5. hhc 1 1 6.
6 Biogen Inc. 1978 4 SNS Twitter LinkedIn Facebook YouTube 7. BioArctic AB. 2003 AbbVie Nasdaq Stockholm Mid Cap(STO.)
7 BIOA B) Biogen Safe Harbor Statement This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 about results from the Phase 2 study of BAN2401 , the potential clinical effects of BAN2401 , risks and uncertainties associated with drug development and commercialization, the potential benefits, safety and efficacy of BAN2401 , the timing and status of current and future regulatory filings, the anticipated benefits and potential of Biogen s collaboration arrangements with Eisai and the potential of Biogen s commercial business and pipeline programs, including BAN2401 , elenbecestat and aducanumab.
8 These forward-looking statements may be accompanied by words such as aim, anticipate, believe, could, estimate, expect, forecast, intend, may, plan, potential, possible, will and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval.
9 You should not place undue reliance on these statements or scientific data presented. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen s drug candidates, including BAN2401 , elenbecestat and/or aducanumab; the occurrence of adverse safety events.
10 Risks of unexpected costs or delays; uncertainty of success in the development and potential commercialization of BAN2401 , elenbecestat and/or aducanumab, which may be impacted by, among other things, failure to protect and enforce Biogen s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; uncertainty as to whether the anticipated benefits and potential of Biogen s collaboration arrangement with Eisai can be achieved; and third party collaboration risks.
