EISAI Launches Anticancer Agent Halaven® in Japan Tokyo, Japan, Eisai Co. today announced the market launch of its novel anticancer agent Halaven® in Japan for the treatment of inoperable or recurrent breast cancer. The intravenous Halaven® is the first novel anticancer agent to be discovered and developed by Eisai. Halaven® is the first single-agent chemotherapy to demonstrate a statistically significant overall survival (OS) benefit in pretreated metastatic breast cancer patients. In a Phase III study (EMBRACE study) conducted overseas in pretreated patients with advanced or recurrent breast cancer, Halaven® extended overall survival by 2.7 months compared to Treatment of Physician's Choice (TPC) (OS: 13.2 months vs. 10.5 months; Hazard Ratio[HR] 0.81; p=0.014). Additionally, a Phase II study (Study 221) conducted in Japan in patients with advanced or recurrent breast cancer patients previously treated with an anthracycline and a taxane showed that Halaven® monotherapy demonstrated an excellent antitumor effect as well as a favorable tolerability profile. Breast cancer remains one of the leading causes of cancer death among women. Approximately 60,000 patients in Japan are affected by the disease each year. Although advances are being made in the treatment of breast cancer, there are still relatively few options available for patients with inoperable or recurrent disease. The launch of Halaven® in Japan means that it will be possible for inoperable or recurrent breast cancer patients across country to have access to the agent. Eisai plans to develop Halaven® as a treatment for other types of cancer such as non-small cell lung cancer, sarcoma, and prostate cancer, which along with the development of its existing pipeline products including MORAb-003 (farletuzumab), a monoclonal antibody targeting ovarian cancer, and E7080 (lenvatinib), a potential treatment for thyroid or endometrial cancer, will enhance the company's portfolio of Women's Oncology products. Having simultaneously submitted marketing authorization applications to the regulatory authorities in Japan, the United States and the European Union (EU) in March 2010, the company first launched Halaven® in the United States in November of the same year, and began marketing the agent in the United Kingdom, Germany and other European countries in April 2011. Product Outline 1) Product Name: Halaven® Injection 1mg 2) Generic Name: Eribulin mesylate 3) Indications and Usage: Treatment of inoperable or recurrent breast cancer 4) Administration and Dosage: The recommended adult daily dose of eribulin mesylate is 1.4 mg/m2 (body surface area). This dose should be administered intravenously over 2 to 5 minutes once a week for two consecutive weeks of a repeated three-week cycle. Dosage may be reduced according to the patients' condition. 5) Listed Price Halaven® Injection 1 mg 64,070 yen (per 2 ml vial) 6) Packaging Halaven® Injection 1mg: 1 vial (Ⓒ NPJ News) First Fixed Dose Drugs For Diabetes 2 Launched in Japan OSAKA, Japan, First fixed dose drug combination for treatment of type 2 diabetes
hit the market in Japan
on July 6. This happens almost three months after drug approval on Actos OD tablets swiftly disintegrate in the oral cavity and can be taken easily without water, the manufacturer Takeda Pharmaceutical explains in its press release. It is excepted that these products will enable the patients to avoid missing a dose due to the greater ease of administration. This allows patients with type 2 diabetes to better control their blood glucose levels. These new additions to Takeda product lineup will strengthen company’s presence in the life style-related disease area. ”Regarding diabetes, we expect that the addition of METACT and Actos OD tablets to our large line of products for treatment of diabetes will allow us to provide patients and healthcare professionals with better-tailored treatment options”, said Yasuhiko Yamanaka, a vice-president at Takeda’s Pharmaceutical Marketing Division. Product details: METACT®” (generic name: Pioglitazone HCL / Metformin HCL) Actos® Orally Disintegrating Tablets (generic name: Pioglitazone HCL; Actos OD tablets). (Ⓒ NPJ News) Insomnia Drug Rozerem® Launched
OSAKA, Japan, Takeda Pharmaceutical Company Limited today announced the market launch of “ROZEREM®” (generic name: Ramelteon) for treatment of insomnia. According to company’s press release, Rozerem works by selectively targeting two melatonin receptors in the brain, MT1 and MT2. These receptors are located in the suprachiasmatic nucleus, the body’s ‘master clock’ that regulates circadian (24-hour) rhythms, including the sleep-wake cycle. By acting on these receptors, the body’s sleep-wake cycle is regulated and physiological sleep is promoted. In Japan, Rozerem was approved on Drug Candidate T-1106 May Stop Foot-And-Mouth Disease
(Tokyo) A candidate drug codenamed T-1106 is the only hope that may thwart foot-and-mouth disease outbreak raging currently in Japan and decimating hundreds of thousands of life stock animals. The new medicinal formulation developed by Toyama Chemical Co. inhibits virus propagation and is said to be very effective. The company will file for drug approval with Japanese Ministry of Agriculture as soon as the current animal tasting stage is complete. However it may take up to five years before the drug could reach the market if conventional procedures are to be followed. The only way to speed up the process is if Agriculture Ministry implements emergency measures to stop the outbreak. In a smart move Toyama Chemical has already performed so called “pilot manufacturing” of the antiviral remedy and is ready to supply the powdered version of this pharmaceutical formulation. T-1105 is similar to human anti influenza drug candidate T-705 developed by the same company. Foot-and-mouth disease does not affect humans but they transmit the virus that causes it. (Ⓒ NPJ News) Copyright Ⓒ 2010-2013 NewProductsJapan.com All Rights Reserved. |
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