October 4, 2007
Astellas Pharma Inc. ("Astellas"; Headquarters: Tokyo; President and CEO: Masafumi Nogimori), Taisho Toyama Pharmaceutical Co., Ltd. ("Taisho Toyama"; Headquarters: Tokyo; President: Akira Ohira) and Toyama Chemical Co., Ltd. ("Toyama"; Headquarters: Tokyo; President: Masuji Sugata) today announced that an oral formulation of new-type quinolone antibacterial agent, Geninax(R) (generic name: garenoxacin mesilate hydrate, a development number: T-3811), will become available in Japan on October 5, 2007.
Garenoxacin, a new type of quinolone discovered by Toyama, has strong activity against respiratory tract infection pathogens and otorhinolaryngological infection pathogens including multi-drug resistant S.pneumoniae. It exhibits good oral absorption and tissue distribution, which allows once-daily oral administration. Geninax(R) is the first synthetic antibacterial which has the indication for penicillin resistant S. pneumoniae, the premium for usefulness was approved, and higher NHI price was obtained as compared with existing antibacterial agents. Toyama and Taisho Pharmaceutical Co., Ltd. (Headquarters: Tokyo; President: Akira Uehara) have jointly developed Geninax(R) for the treatment of respiratory infections and otolaryngologic infections in Japan.
Toyama and Astellas have concluded a basic licensing agreement for the sales & marketing and joint development for Geninax(R) within Japan in March 2006. According to the agreement for Geninax(R), Toyama will manufacture the products, and Astellas will distribute the products, which will be co-promoted by Astellas and Taisho Toyama.
Details of Geninax(R) are as follows:
|Date of marketing approval:||July 31, 2007|
|Brand name:||Geninax(R) Tablets 200mg|
|Generic name:||Garenoxacin mesilate hydrate(JAN)|
|Classification:||Synthetic antibacterial agent|
|Garenoxacin-susceptible bacteria: Staphylococcus sp., Streptococcus sp., Streptococcus pneumoniae (including penicillin resistant Streptococcus pneumoniae), Moraxella (Branhamella) catarrhalis, Escherichia coli, Klebsiella sp., Enterobacter sp., Haemophilus influenzae, Legionella pneumophila, Chlamydia pneumoniae and Mycoplasma pneumoniae.|
|Pharyngitis, Laryngitis, Tonsillitis (including peritonsillitis and peritonsillar abscess), Acute bronchitis, Pneumonia, Secondary infection in chronic respiratory lesion, Otitis media, Sinusitis|
|Dosage and administration:||The usual adult dosage for oral use is 400mg of garenoxacin once daily.|
|Approval holder:||Toyama Chemical Co., Ltd.|
|Packaging:||Tablets 200mg: 100 tablets (PTP), 500 tablets (PTP, Bottle)|
|NHI reimbursement prices:||296.50 Japanese yen/200mg tablet|
|Date of NHI price listing:||September 21, 2007|
|Date of launch:||October 5, 2007|