TAIHO PHARMA CANADA, INC. ANNOUNCES HEALTH CANADA APPROVAL OF LONSURF® (TRIFLURIDINE AND TIPIRACIL TABLETS) FOR METASTATIC COLORECTAL CANCER

- LONSURF, a new important treatment option for adult patients with metastatic colorectal cancer that has been shown to extend overall survival, represents the first Health Canada-approved product for Taiho Pharma Canada -

TORONTO, ON, March 6, 2018 – Taiho Pharma Canada, Inc., a Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced that Health Canada approved LONSURF® (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.¹

“LONSURF is an important new treatment option for Canadians with metastatic colorectal cancer whose disease has progressed after treatment with standard therapies,” said Dr. Ronald Burkes, a medical oncologist at Mount Sinai Hospital in Toronto, Ontario. “Metastatic colorectal cancer patients often become resistant to previously effective treatment. In a pivotal clinical trial, LONSURF demonstrated that it can extend overall survival, providing patients with a novel therapeutic option.”

“Health Canada’s approval of LONSURF for the treatment of patients with metastatic colorectal cancer is very welcome news for those who are living with the second biggest cancer killer in this country,” said Barry D. Stein, President, Colorectal Cancer Canada. “With the approval by Health Canada, patients with advanced disease have further hope and opportunity to improve and extend their lives. We look forward to a rapid approval of the drug by our regulatory authorities so that all Canadians can have equal access to it as soon as possible.”

Pivotal Phase III Study Demonstrates Improvement in Overall Survival (OS)²
The Health Canada approval of LONSURF is based on results from the global Phase III RECOURSE trial in 800 patients who have been previously treated for mCRC.

The trial met the primary efficacy endpoint of statistically significant improvement in OS compared to placebo (HR = 0.68, CI: 0.58, 0.81, p < 0.001). LONSURF reduced the risk of death by 32 percent when compared to placebo. Median OS was 7.1 months (95 percent CI: 6.5, 7.8) and 5.3 months (95 percent CI: 4.6, 6.0) for LONSURF and placebo, respectively.

The most common adverse drug reactions or laboratory abnormalities were anemia, neutropenia, asthenia/fatigue, nausea, thrombocytopenia, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia. The most common adverse reactions leading to dose reduction were neutropenia, anemia, febrile neutropenia, fatigue, and diarrhea. The full product monograph should be consulted for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The full product monograph for Canada is available here.

“The Health Canada approval of LONSURF and the priority review granted by the pan-Canadian Oncology Drug Review represents a significant milestone for our company, and is further recognition of LONSURF’s potential as a new treatment option for patients challenged by metastatic colorectal cancer,” said Ross Glover, General Manager, Taiho Pharma Canada, Inc. “To date, patients have had limited therapeutic options to treat their disease. LONSURF will help address this unmet medical need by providing patients with a new oral therapy that can help extend their overall survival.”

As of February 2018, LONSURF has been approved as a treatment for advanced metastatic colorectal cancer in 44 countries and regions worldwide.

About Metastatic Colorectal Cancer³
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 were diagnosed with colorectal cancer (this represents 13% of all new cancer cases in 2017), and 9,400 Canadians died from colorectal cancer (this represents 12% of all cancer deaths in 2017). On average, an estimated 73 Canadians were diagnosed with colorectal cancer every day, and an estimated 26 Canadians died from colorectal cancer every day. There are no definitive data on the number of patients who are refractory to standard mCRC treatments.

About LONSURF
LONSURF (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.1

About Taiho Pharma Canada, Inc. (Canada)
Taiho Pharma Canada, Inc., a Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), is located in Oakville, Ontario and managed by Taiho Oncology, Taiho’s U.S. R&D and commercial operations, based in Princeton, New Jersey. Taiho Oncology has established world class clinical development and commercial organizations that work urgently to develop and market innovative cancer treatments in the U.S. and Canada. Taiho Oncology Inc. has an oral oncology pipeline consisting of both novel anti-metabolic agents and selectively targeted agents. Advanced technology, dedicated researchers, and state of the art facilities are helping Taiho define the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy.

For more information about Taiho Pharma Canada, please visit: https://www.taihopharma.ca/en/.

About Taiho Pharmaceutical Co., Ltd. (Japan)
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergy 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 for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts. In areas other than oncology, as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people's quality of life. Always putting customers first, Taiho Pharmaceutical aims to also offer consumer healthcare products that support people's efforts to lead fulfilling and rewarding lives.

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

About Otsuka Holdings Co., Ltd. (Japan)
The Otsuka group of companies is a total-healthcare enterprise that aims to contribute to the health of people around world under the corporate philosophy, “Otsuka-people creating new products for better health worldwide”.

Healthcare is broadly and holistically addressed through the two main pillars – the pharmaceutical business for the diagnosis and treatment of diseases and the nutraceutical⁴ business to support the maintenance and promotion of everyday health. Our 46,000⁵ employees across 183 companies in 28 countries and regions take on challenges across various fields and themes to help fulfill the universal wish of people to be healthy. Our pursuit of these challenges is motivated by the Otsuka’ s corporate culture, articulated as “Ryukan-godo” (by sweat we recognize the way), “Jissho” (actualization) and “Sozosei” (creativity), and fostered by successive generations of Otsuka leaders. By striving to provide unique products and services, we seek to achieve sustainable growth and be an indispensable contributor to the world.

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

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For more information, please contact:
Fiona Cassidy
(416) 662-4783
cassidycomms@gmail.com

^{1 LONSURF Product Monograph. https://pdf.hres.ca/dpd_pm/00043592.PDF. Accessed February 2018.
2 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. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1414325. Accessed February 2018.
3 Canadian Cancer Society. Colorectal cancer statistics. http://www.cancer.ca/en/cancer-information/cancer-type/colorectal/statistics/?region=on. Accessed February 2018.
4 Nutraceuticals: nutrition + pharmaceuticals.
5 As of end of December, 2017.}