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An archived version of the webcast will be accessible on the website of Otsuka Pharmaceutical Company’s parent company, Otsuka Holdings Co., Ltd., within 24 hours after the web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 studyi 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 TolvaptanTolvaptan 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 OtsukaOtsuka 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.

 

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  

Otsuka Contacts:Media Outside U.S.Otsuka Pharmaceutical Co, Ltd.Jeffrey Gilbert, 81 3-6361-7379Leader, Pharmaceutical PRgilbert.jeffrey@otsuka.co.jporMedia in U.S.Otsuka America Pharmaceutical, Inc.Melanie Deck, 1 609-535-9132Corporate Communicationsmelanie.deck-cw@otsuka-us.comorInvestorsOtsuka Holdings Co., Ltd.Yoko Ishii, 81 3-6361-7411Ishiiyo@Otsuka.jporTufts University Medical Center Contact:Jeremy Lechan, 1 617-636-0104Senior Specialist, Media Relations and Communicationsjlechan@tuftsmedicalcenter.org