STOCKLEY PARK, London, March 2, 2015 /PRNewswire/ -- Taiho Pharma Europe Ltd., a subsidiary of Japan based Taiho Pharmaceutical Co., Ltd., announced that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal cancer (mCRC).
Taiho Pharma Europe Ltd.'s TAS-102 MAA submission closely follows the TAS-102 New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which was accepted for review by the FDA on February 17, 2015.
"Submission of the TAS-102 Marketing Authorisation Application to the European Medicines Agency is a significant milestone for the company," said Eric Benn, Director of Taiho Pharma Europe Ltd. "It exemplifies our commitment to delivering novel cancer treatment options to patients and physicians. We look forward to working with the EMA as it conducts its review of TAS-102."
Taiho Pharma Europe Ltd.'s MAA submission is supported by the results of the randomized, double blind, placebo controlled, Phase III RECOURSE trial of TAS-102 in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies. The TAS-102 RECOURSE trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR = 0.68, p < 0.0001) and demonstrated a safety profile consistent with that observed in earlier clinical trials.
"Metastatic colorectal cancer is one of the top causes of morbidity and mortality in European men and women who are suffering with cancer," said Professor Eric Van Cutsem, MD, PhD, Professor of Medicine at the University of Leuven and Head of Digestive Oncology at the University Hospitals of Leuven, Belgium and principal investigator of the RECOURSE study. "If authorised, TAS-102 has the potential to become an important new treatment option for patients within the European Union who are living with refractory metastatic colorectal cancer."
About TAS-102
TAS-102 is an oral combination investigational 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 Refractory Metastatic Colorectal Cancer
There are no definitive data on the number of patients who are refractory to standard metastatic colorectal cancer treatments; however, colorectal cancer is one of the most common cancers in the European Union[i] and the third most common cancer worldwide.[ii] In 2013, a study published in the European Journal of Cancer revealed that an estimated 447,000 patients (242,000 men and 205,000 women) were diagnosed with and 215,000 patients died of colorectal cancer in Europe in 2012.i In addition, the American Cancer Society estimated that 136,830 patients (71,830 men and 65,000 women) were diagnosed with and 50,310 patients died of cancer of the colon and rectum in the U.S. in 2014.[iii]
About Taiho Pharma Europe Ltd.
Taiho Pharma Europe Ltd., a subsidiary of Taiho Pharmaceutical Co., Ltd. works urgently to support the development of innovative cancer treatments coming out of Taiho's in-house cancer research efforts. 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.
About Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Co., Ltd., 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 Co., Ltd. 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 Co., Ltd. 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 Co., Ltd. please visit http://www.taiho.co.jp/english/.
About Otsuka Holdings Co., Ltd.
The Otsuka Group is a global organization of 176 healthcare companies with nearly 43,000 employees (including unconsolidated subsidiaries). Otsuka Holdings Co., Ltd. is the Group's holding company. The Group operates in 27 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/.
Media Contact:
Edie DeVine
GCI Health on behalf of Taiho Pharma Europe Ltd.
edie.devine@gcihealth.com
00-1-415-403-8316
References
i Ferlay, J. et. al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012.European Journal of Cancer. (2013) 49; 1374-1403
ii World Cancer Research Fund International. Worldwide Data. 2013. http://www.wcrf.org/int/cancer-facts-figures/worldwide-data. Accessed February 2015. GLOBOCAN2012 Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012.
iii Cancer facts & figures 2014. American Cancer Society.
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SOURCE Taiho Pharma Europe Ltd.
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