New Quinolone Oral Antibiotic Avelox®: Sales Rights Transfer
Bayer Yakuhin, Ltd. (Bayer) - headquarters: Osaka; President and Representative Director: Jean-Luc Lowinski - and Shionogi & Co., Ltd. (Shionogi) - headquarters: Osaka; President and Representative Director: Isao Teshirogi – announced today their agreement to transfer to Bayer the sales rights of the New Quinolone oral antibiotic Avelox® tablets 400 mg (generic name: Moxifloxacin HCL) currently sold by Shionogi. The transfer will take effect on 1 July 2010. Avelox® tablets is a respiratory quinolone formulation with excellent antibacterial effect against major pathogenic bacteria causing respiratory infections. It was researched and developed by Bayer HealthCare AG of Germany. In Japan, Bayer Yakuhin obtained marketing approval from the Ministry of Health, Labour and Welfare in October 2005. Under the agreement of both companies, Shionogi started exclusive sales from December 2005. From 1 July 2010, however, Bayer will solely undertake the sales activities. Bayer HealthCare designates three key strategic domains in primary healthcare: cardiovascular/metabolic, urological, and pulmonary/infectious disease domains. To substantiate this global strategy in Japan, Bayer regards Avelox® tablets as the core product in the medium to long-term pulmonary/infection strategy. Accordingly, with agreement from Shionogi, marketing rights were transferred.
Shionogi will concentrate the sales and marketing activities to the targeted and newly launched
products and try to further enhance adequate provision of medical information of these products. In
addition, Shionogi will continue to provide patients with medicines to treat metabolic syndrome,
infectious disease, and pain. Shionogi will also develop products in new therapeutic areas of
obesity/diabetes and viral infection to meet unmet medical needs.
【Avelox® Tablets: Product Summary】
Avelox® Tablets 400 mg (generic name: Moxifloxacin hydrochloride)
< Strains> Moxifloxacin-susceptible strains of Staphylococcus sp., Streptococcus sp., Streptococcus pneumoniae, M.catarrhalis, Escherichia coli, Klebsiella sp., Enterobacter sp., Proteus sp.,
Haemophilus influenzae, L.pneumophila, P.acne, C.pneumoniae and M.pneumoniae
<Indications> ─ Superficial skin infection, deep skin infection ─ secondary infection in trauma, burn or surgical wound ─ pharyngitis, laryngitis, tonsillitis, acute bronchitis, pneumonia, secondary infection of chronic respiratory diseases ─ sinusitis
For oral use, the usual adult dosage is 400mg of moxifloxacin once daily. For further information, please contact: BHC Communications Japan, Bayer Yakuhin, Ltd. FTA: Motokui (Tel) +81-6-6133-7245 FTA: Shimazaki (Tel) +81-6-6133-7243 BHC Communications Japan main line: (Tel) +81-6-6133-7333 (Fax) +81-6-6344-2179 Corporate Communications Department, Shionogi & Co., Ltd. (Tel) +81-6-6209-7885 (Fax) +81-6-6229-9596
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NitroMist safely and effectively. • Increased intracranial pressure (4.3) See full prescribing information for NitroMist. • History of hypersensitivity to NitroMist or to other nitrates or nitrites (4.4) NitroMist® (nitroglycerin) lingual aerosol WARNINGS AND PRECAUTIONS
Flexible Spending Accounts: What’s Eligible? The IRS defines eligible health care expenses as amounts paid for the diagnosis, cure, mitigation or treatment of a disease, and for treatments affecting any part or function of the body. The expenses must be primarily to alleviate a physical or mental condition or illness. This list is not meant to be all-inclusive. Eligible Expenses DE