TTY Biopharm (4105.TWO) continues its commitment to strengthening oncology business with continued investment in developing new drugs and in completing product portfolio for decades. TTY Biopharm has signed an agreement with Taiho Pharmaceutical Co., Ltd. and received an exclusive license to present registration dossier, to develop new indications and to sell trifluridine/tipiracil (development code: TAS-102, brand name in Japan, the US, and Europe: Lonsurf®) in Taiwan.
Trifluridine/tipiracil is an oral combination anticancer drug of trifluridine (FTD, a nucleoside metabolic inhibitor) and tipiracil hydrochloride (TPI, a thymidine phosphorylase inhibitor). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, interfering with DNA synthesis and prohibiting cell from proliferating. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme. TPI enhances FTD’s effect of antitumor and achieves an effect of anti-angiogenesis. Trifluridine/tipiracil is approved in Japan, the U.S. and Europe, and is indicated in the U.S. for the treatment of patients with metastatic colorectal cancer 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 the Phase III study (RECOURSE), the result of trifluridine/tipiracil versus placebo group in patient with previously treated metastatic colorectal cancer (mCRC), has showed a statistically significant 32% reduction in the risk of death and 52% reduction in the risk of progression. Due to its efficacy and safety, trifluridine/tipiracil has already been approved on Japan market in 2014, on the U.S. in 2015 and on EU this year, 2016.
TTY Biopharm plans to submit registration dossier in early 2017. According to Taiwan Cancer Registry, 15,140 new cases were diagnosed with colorectal cancers. Among these new cases, around 18% of them are diagnosed in late stage (Stage IV) and the 5-year survival rate is merely 12%.
TTY Biopharm endeavors to specialize in the anticancer area and to develop special drug formulations, especially well-known liposomal products and other special delivery systems. Through building global partners and collaboration agreements, this new collaboration of licensing in new oral anticancer drug accelerates the completion of TTY Biopharm’s product portfolio, strengthens its technology to cure cancer related diseases, and brings more benefits for patients.