News Release

October 20, 2017
Taiho Pharmaceutical Co., Ltd.

Health Canada Grants Priority Review Status to TAS-102 (brand name in Japan: "LONSURF") for Refractory Metastatic Colorectal Cancer

New Drug Submission for a new important treatment option for patients with refractory metastatic colorectal cancer formally accepted for review

Taiho Pharmaceutical Co., Ltd. today announced that Health Canada, a Canadian healthcare authority, accepted for review the Taiho’s New Drug Submission (NDS) for TAS-102 (nonproprietary names: trifluridine and tipiracil), and that the NDS has been granted Priority Review status. Health Canada’s review of the NDS under Priority Review is expected to be completed in early 2018.

Priority Review status applies to a NDS or Supplemental New Drug Submission (S/NDS) for a serious, life-threatening or severely debilitating disease or condition, for which there is substantial evidence of clinical effectiveness for the drug described in the submission. Priority Review for TAS-102 was granted for the indication of refractory metastatic colorectal cancer (mCRC).

If approved by Health Canada, Taiho Pharma Canada, Inc., a Canadian subsidiary, will commercialize TAS-102. Through the drug, the company could provide an important new treatment option for adult patients in Canada with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

Results from the Phase III RECOURSE trial of TAS-102 in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies, were published in The New England Journal of Medicine and form the foundation for the NDS to Health Canada. In patients with refractory colorectal cancer, TAS-102 plus Best Supportive Care (BSC), as compared with placebo plus BSC, was associated with a significant and clinically meaningful improvement in overall survival and demonstrated a safety profile consistent with that observed in earlier clinical trials.i

Taiho Pharmaceutical anticipates that TAS-102, as a new treatment option, will make a great contribution to cancer patients in Canada.

About Metastatic Colorectal Cancer in Canadaii

Colorectal cancer is the second most commonly diagnosed cancer in Canada (excluding non-melanoma skin cancers), and is the second leading cause of death from cancer in men and the third leading cause of death from cancer in women. It is estimated that in 2017, 26,800 patients in Canada will be diagnosed with colorectal cancer (this represents 13% of all new cancer cases in 2017), and 9,400 Canadians will die from colorectal cancer (this represents 12% of all cancer deaths in 2017). On average, 73 Canadians will be diagnosed with colorectal cancer every day, and 26 Canadians will die from colorectal cancer every day. There are no definitive data on the number of patients who are refractory to standard mCRC treatments.

About TAS-102 (LONSURF)

LONSURF is an oral anticancer drug, comprising the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines.

FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the 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.

In Japan, Taiho Pharmaceutical markets LONSURF for the treatment of unresectable advanced or recurrent colorectal cancer. In the United States, Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, markets the drug for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF. Under the terms of the agreement, Servier has the rights to co-develop and commercialize LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. In parts of Asia outside Japan, Jeil Pharmaceutical and TTY Biopharm, which are Taiho Pharmaceutical’s business partners in South Korea and Taiwan, respectively, are preparing to bring the drug to market.

As of October 2017, the drug has been approved as a treatment for advanced mCRC in 39 countries and regions worldwide.

i Robert J. Mayer, M.D., et al for the RECOURSE Study Group. Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer. N Engl J Med 2015;372:1909-19. Accessed on July 25, 2017 at http://www.nejm.org/doi/pdf/10.1056/NEJMoa1414325.

ii Canadian Cancer Society. Colorectal cancer statistics. Accessed on July 20, 2017 at http://www.cancer.ca/en/cancer-information/cancer-type/colorectal/statistics/?region=on.

Information in this news release was current as of the original release date.

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