News Releases

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced today that the novel antitumor agent Yondelis_® (nonproprietary name: trabectedin, development code: ET-743) 0.25 mg and 1 mg IV infusion has been listed on the National Health Insurance (NHI) reimbursement price list. Taiho Pharmaceutical plans to launch the drug on December 7, 2015 in Japan.

Yondelis is an antitumor agent developed by the Spanish company PharmaMar, S.A. After entering into a license agreement with PharmaMar in 2009 to develop and market the drug in Japan, Taiho Pharmaceutical developed the drug and in September 2015 it received approval to manufacture and market the drug for the indication of soft tissue sarcoma.

Yondelis was originally isolated from the Caribbean tunicate (Ecteinascidia turbinata) and is now produced synthetically. It is an antitumor agent that binds to DNA, where it interferes with cell division, the transcription process, and the DNA repair machinery.

In September 2007, PharmaMar received the first approval for Yondelis in the EU for the treatment of advanced soft tissue sarcoma in adults for whom anthracyclines and ifosfamide were not effective or for whom administration of those drugs is not recommended. It is currently approved in 78 countries and regions^*1 worldwide, including the United States and various countries in Europe, South America and Asia.

Taiho Pharmaceutical believes that Yondelis will contribute to the treatment of patients in Japan, as a new treatment option for soft tissue sarcoma, an area of unmet medical needs.

About soft tissue sarcoma
Soft tissue sarcoma is an intractable malignancy which develops in the soft tissues (muscles, connective tissues, fat, blood and lymph vessels, etc.) of the body. In Japan, the annual incidence rate is about 2～3 cases per 100,000 population, and it is an orphan disease with an estimated patient number of approximately 5,000.^*2

About PharmaMar
Headquartered in Madrid, Spain, PharmaMar is the world-leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived anticancer drugs. The company has a rich pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis in Europe for the treatment of advanced soft-tissue sarcomas and for relapsed platinum-sensitive ovarian cancer, and has three clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM60184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland and the United States.

1. As of October, 2015
2. Calculated by subtracting 1,000 “mesothelioma” patients from the 6,000 “malignance of mesothelioma and soft tissue” patients, referencing the MHLW Patient Survey (2011).

Product Summary

Brand name	Yondelis® 0.25 mg and 1 mg IV Infusion
Nonproprietary name	trabectedin
Indication	Soft tissue sarcoma
Dosage and administration	In adults, trabectedin is normally administered via intravenous infusion in a dose of 1.2 mg/m2 per administration over 24 hours with at least 20 days of rest. This constitutes one repeatable cycle. The dose may be reduced based on the patient's condition.
Date of manufacturing and marketing approval	September 28, 2015
Date listed on the NHI reimbursement price list	November 26, 2015
Date of product launch in Japan	December 7, 2015
Packaging	Yondelis IV Infusion 0.25 mg: 1 vial Yondelis IV Infusion 1 mg: 1 vial
NHI reimbursement price	Yondelis IV Infusion 0.25 mg: 49,307 yen Yondelis IV Infusion 1 mg: 197,698 yen
Manufacturing Distributor	Taiho Pharmaceutical Co., Ltd.