Taiho Oncology's TAS-102 Meets Primary Endpoint of Improving Overall Survival in Global Phase III RECOURSE Trial in Refractory Metastatic Colorectal Cancer

- Company Plans to Pursue Regulatory Submissions -

TOKYO, May 12, 2014 /PRNewswire/ -- Taiho Pharmaceutical Co., Ltd. (Tokyo, Japan) and its division Taiho Oncology, Inc. (Princeton, N.J.) announced on May 12 results from its global Phase III RECOURSE trial on its oral combination anticancer drug TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride) in refractory metastatic colorectal cancer (mCRC). The RECOURSE trial met its primary endpoint of demonstrating improvement in overall survival (OS) in patients with refractory mCRC whose disease had progressed after approved standard therapies.

"We are very pleased by the results from the Phase III RECOURSE trial in refractory mCRC, which support TAS-102 as a potential new treatment option for this patient population," said Fabio M. Benedetti, M.D., Senior Vice President and Chief Medical Officer at Taiho Oncology. "The Taiho Oncology team is preparing for the submission of the NDA and MAA of TAS-102 in the United States and the European Union, respectively. We would like to thank our clinical investigators and healthcare professionals, as well as the patients and caregivers, for their participation in this important trial."

In this trial, TAS-102 appeared to be generally well tolerated and the toxicities were consistent with what was previously reported.

More detailed results from the global Phase III RECOURSE trial will be presented on June 28 in the oral presentation session during the ESMO 16th World Congress on Gastrointestinal Cancer 2014 that will be held in Barcelona, Spain (Speaker: Dr. Takayuki Yoshino, the National Cancer Center Hospital East, Japan).

About RECOURSE

The RECOURSE trial is a global, randomized, double-blind, placebo-controlled Phase III comparison trial evaluating the efficacy and safety of orally administered TAS-102 in patients with refractory mCRC. The trial enrolled 800 patients who received at least two prior regimens of standard chemotherapies for mCRC and were refractory to, or failed, those chemotherapies. The trial was conducted in North America, Europe, Japan and Australia. Patients were randomly assigned to receive either TAS-102 or placebo in order to investigate the efficacy of TAS-102. The primary objective of the RECOURSE trial was improvement in overall survival (OS) versus placebo. The principal researchers are Dr. Robert J. Mayer of the Dana-Farber Cancer Institute (USA), Dr. Eric Van Cutsem of the University Hospital Gasthuisberg (Belgium) and Dr. Atsushi Ohtsu, Director of the Exploratory Oncology Research & Clinical Trial Center of the National Cancer Center Hospital East (Japan).

About Metastatic Colorectal Cancer

Colorectal cancer is the third most common cancer worldwide. In 2014, it is estimated that 136,830 patients (71,830 men and 65,000 women) will be diagnosed with, and 50,310 patients will die from, cancer of the colon or rectum in the United States (*1). Colorectal cancer was the second most common cancer in Europe in 2012. In addition, it was estimated that 447,000 patients (242,000 men and 205,000 women) were diagnosed with and 215,000 patients died of colorectal cancer in Europe during 2012 (*2).

About TAS-102

TAS-102 is an oral combination anticancer drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase.

About Taiho Oncology, Inc.

Taiho Oncology, Inc., a division of Taiho Pharmaceutical Co., Ltd. and Otsuka Holdings Co., Ltd., has built a world class clinical development organization that works urgently to develop innovative cancer treatments. Taiho has an oral oncology pipeline consisting of both novel antimetabolic agents and selectively targeted agents. Advanced technology, dedicated researchers, and state of the art facilities are helping us to define the way the world treats cancer. It's our work; it's our passion; it's our legacy.

For more information about Taiho Oncology, please visit: www.taihooncology.com

About Taiho Pharmaceutical Co., Ltd.

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergies and immunology, and urology. Its corporate philosophy takes the form of a pledge: "We strive to improve human health and contribute to a society enriched by smiles." In the field of oncology in particular, Taiho Pharmaceutical is known as a leading company in Japan and around the world for developing innovative medicines for the treatment of cancer. In areas other than oncology, as well, the company creates quality products that effectively treat medical conditions and can help improve people's quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer over-the-counter medicinal products that support people's efforts to lead fulfilling and rewarding lives.

For more information about Taiho Pharmaceutical, please visit http://www.taiho.co.jp/english/.

About Otsuka Holdings Co., Ltd.

The Otsuka Group is a global organization of 158 healthcare companies with nearly 42,000 employees. Otsuka Holdings Co., Ltd. is the Group's holding company. The Group operates in 26 countries and regions, conducting diversified businesses in four segments all connected by a focus on health: pharmaceuticals, nutraceuticals, consumer products, and others.

The Group's corporate philosophy of "Otsuka-people creating new products for better health worldwide," is supported by the corporate ethic of "JISSHO (Proof through Execution) and SOZOSEI (Creativity)." The Otsuka Group thus seeks to foster a culture and vitality appropriate to an enterprise involved with human health and to create innovative products that contribute to the health and wellness of people worldwide.

For more information, please visit the company's website at http://www.otsuka.com/en/.

(*1) Cancer facts & figures 2014. American Cancer Society.
(*2) Ferlay, J. et. al. Cancer incidence and mortality patterns in Europe:

Estimates for 40 countries in 2012. European Journal of Cancer. 49; 1374-1403.