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Conclusion of the Agreement on Apaziquone for Non-muscle invasive bladder cancer

2009/11/11

(This document is an English translation of the Japanese language original.)

Nippon Kayaku Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo, Japan; President: Koichiro Shimada) concluded the agreement on apaziquone (generic name) for non-muscle invasive bladder cancer (superficial bladder carcinoma and carcinoma in situ of bladder) with Spectrum Pharmaceuticals, Inc. (Irvine, California, USA; CEO: Rajesh C. Shrotriya) which is a commercial-stage biotechnology company with a primary focus in oncology on November 6, 2009. Nippon Kayaku received the exclusive rights to develop and commercialize apaziquone in Asia except South Korea.

Apaziquone is an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, and is specialized in the use of non-muscle invasive bladder cancer. The Phase 2 data held in the US has confirmed anti-tumor activity in patients with multiple, recurrent non-muscle invasive bladder cancer, showing 67% of a complete response after receiving six weekly treatments with 4 mg of apaziquone instilled into the urinary bladder. According to the apaziquone registration plan, which the U.S. Food and Drug Administration (FDA) concurred with under a Special Protocol Assessment, Spectrum and Allergan, Inc. (Irvine, California, USA, Chairman and CEO: David E.I. Pyott) are conducting the Phase 3 clinical studies and planning to complete the enrollment by year-end 2009. The FDA has also granted Fast Track Designation for the investigation of apaziquone for the treatment of non-muscle invasive bladder cancer. Next year Nippon Kayaku starts clinical development in Japan.

Now Nippon Kayaku sells 24 anti-cancer agents and 6 cancer supportive products, and is building a business platform focused on oncology area. Especially, as Nippon Kayaku has several products in urological cancer field, it is aiming at the enhancement of lineup by apaziquone and expects to contribute to the improvement of cancer therapy and happiness of patients, the families and the medical experts by marketing this medicine early.

【Summary of reference materials - Spectrum Pharmaceuticals, Inc.】

Company name	Spectrum Pharmaceuticals, Inc.
Location	Irvine, California, USA
Listed stock	NASDAQ（SPPI）
Business contents	The biotechnology company focused on development of medical products in oncology and urology. The Company has been already selling radioactive antibody (Zevalin) for malignant lymphoma and folate metabolism antagonist (Fusilev) for osteosarcoma.

Reference link: Spectrum Pharmaceuticals, Inc.