| May 10th, 1999 |
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Launch of "Navelbine", an anticancer agent to be used in the treatment of non-small cell lung cancer |
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Kyowa Hakko Kogyo Co., Ltd. (President: Tadashi Hirata) is pleased to announce that "Navelbine" (generic name: vinorelbine ditartrate), an anticancer agent to be used in the treatment of non-small cell lung cancer, is launched on May 24th, 1999, whose National Health Insurance (NHI) drug price was listed on May 7th. "Navelbine" is a vinca alkaloid anticancer agent for which the company has obtained a license from Pierre Fabre Médicament S.A. in France. In the late phase II studies in patients with non-small cell lung cancer, Navelbine achieved much more favorable results than other vinca alkaloids, with the response rate being 30.7% in monotherapy and 57.4% in 3-drug combination use (Navelbine, cisplatin and mitomycin). In addition, foreign data give evidence that Navelbine prolongs the patient's survival time, and we therefore expect that the drug can greatly contribute to the treatment of non-small cell lung cancer which is known to be relatively less sensitive to anticancer agents. Navelbine is an injectable preparation, which is intravenously administered at a dose of 20 to 25 mg/m2 of vinorelbine at one week intervals. The main adverse reaction is bone marrow depression, and monotherapy in particular was associated with a high incidence of leukopenia (91.0%). However, peripheral neuropathy (numbness of extremities, etc.), an adverse reaction which is specific to vinca alkaloid anticancer agents and may interfere with treatment, is less frequent, which we believe contributes to the improvement of patient's QOL. Navelbine has already been marketed in 70 countries with its high efficacy established. Kyowa Hakko has acquired an exclusive license to market Navelbine in Japan, and launches it following the said NHI drug price listing. Kyowa Hakko has a long history in the cancer field, and has marketed 8 different anticancer agents since the launch of Mitomycin C in the 1960s. Navelbine, which has just joined in our anticancer lineup, is under continued development for not only lung cancer having increasing incidence in Japan but also additional indications of breast cancer and others. The sales at peak is estimated at ¥5 billion. We are continuing research and development activities in this field, and intend to make our best collective efforts to further develop excellent anticancer agents.
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