Otsuka To Host Web Briefing on Tolvaptan Phase 3 Trial Results In Polycystic Kidney Disease

(Tokyo, Japan and Princeton, N.J.) – Otsuka Pharmaceutical Co., Ltd. (OPCJ) and its affiliate Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) are pleased to invite investors and media to a November 4 web briefing on in-depth results from the REPRISE phase 3 trial for tolvaptan, a drug candidate for the treatment of patients in the U.S. with autosomal dominant polycystic kidney disease (ADPKD).  Webinar briefing for investors and media on November 4 at 7 PM, US Central Daylight Time Agenda
  • Welcome, introductions and overview (5 min.)
Robert McQuade, Ph.D., executive vice president/chief strategic officer, OPDC
  • About ADPKD and Tolvaptan (15 min.)
Frank Czerwiec, M.D., Ph.D., vice president, Global Clinical Development, OPDC
  • REPRISE phase 3 data (20 min.)
Ronald Perrone, M.D., scientific director, Clinical and Translational Research Center and associate chief, Division of Nephrology, Tufts Medical Center, Boston, MA, and a member of the Phase 3 REPRISE trial Steering Committee
  • Q&A (20 min.)
To participate in the web briefing, kindly pre-register at: http://event.on24.com/wcc/r/1534382-1/77E66445B009CE3491DBB035504DCF69 Confirmation of registration and information on how to access the web briefing on November 4 will be sent to registrants by email. An archived version of the webcast will be accessible on the website of Otsuka Pharmaceutical Company’s parent company, Otsuka Holdings Co., Ltd., within 24 hours after the web briefing. The REPRISE phase 3 trial data will also be presented earlier in the day on November 4 in a late breaking oral abstract session at American Society of Nephrology (ASN) Kidney Week 2017, in New Orleans (Abstract# SA-OR128). Attendees of Kidney Week 2017 are invited to attend the session, between 10:30 AM and 12:30 PM in Hall J. The REPRISE trial was completed to supply confirmatory data to the previous study[i] to address the Complete Response Letter issued by the U.S. FDA in 2013 for a New Drug Application for tolvaptan in the treatment of adults with ADPKD. About Tolvaptan Tolvaptan is a selective vasopressin V2-receptor antagonist. By selectively blocking vasopressin at the V2-receptor, tolvaptan has been shown to decrease cyst-cell proliferation and fluid secretion in subjects with ADPKD, ultimately reducing cyst development.[ii] In a previous Phase 3 clinical trial, tolvaptan was associated with reduced kidney growth and slowed decline of kidney function.[i] About Otsuka Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” All Otsuka stories start by taking the road less travelled. Learn more about Otsuka at www.otsuka.co.jp/en/ and connect with us in the US on LinkedIn and Twitter at @OtsukaUS. Otsuka Contacts:             Media Outside U.S.
Jeffrey Gilbert
Leader, Pharmaceutical PR
Otsuka Pharmaceutical Co, Ltd.
81 3 6361 7379
gilbert.jeffrey@otsuka.co.jp Media in U.S.
Melanie Deck
Corporate Communications
Otsuka America Pharmaceutical, Inc.
1 609 535 9132
melanie.deck-cw@otsuka-us.com Investors
Yoko Ishii
Otsuka Holdings Co., Ltd.
81 3 6361 7411
Ishiiyo@Otsuka.jp Tufts University Medical Center Contact: Jeremy Lechan
Senior Specialist, Media Relations and Communications
1 617 636 0104
jlechan@tuftsmedicalcenter.org October 2017      10US17EBC0018 

References

[i] Torres VE, Harris PC et al. Tolvaptan in patients with autosomal dominant polycystic kidney disease. NEJM. 2012;367 (25): 2407-2418 [ii] Reif, GA, Yamaguchi, T et al. Tolvaptan inhibits ERK-dependent cell proliferation, Cl – secretion, and in vitro cyst growth of human ADPKD cells stimulated by vasopressin. Am J Physiol Renal Physiol; 2011; 301:F1005-F1013