For Immediate Release

Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, President and CEO
(Code no.: 4568, First Section of Tokyo, Osaka and Nagoya Stock Exchanges)
Please address inquiries to Toshiaki Sai, Corporate Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126 (Public Relations)
+81-3-6225-1125 (Investor Relations)
http://www.daiichisankyo.com/

Daiichi Sankyo receives approval in Japan to manufacture and market Cravit(R) intravenous injections

Tokyo, Japan (October 27, 2010) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced that it has received approval in Japan to manufacture and market new formulations of Cravit® (generic name: levofloxacin hydrate). The fluoroquinolone intravenous anti-bacterial agent comes in 500mg/100ml IV bags and 500mg/20ml injections (hereafter, Cravit® IV).

 

Cravit® IV is administered once daily according to PK-PD theory (see Note 1 below). It is highly efficacious against major pathogens and atypical bacteria that are not indicated for treatment with penicillin-, cephem- and carbapenem-based preparations. It is classified as a respiratory quinolone (see Note 2 below) suited to treat respiratory tract infections. The treatment has already been approved in 120 different countries and territories, and has been very well received.

 

In Japan, orally administered 100mg Cravit® tablets were approved for sale in December of 1993, and in July of 2009, the once-daily administration with 500mg Cravit® was approved in line with the world standard dosage regimen. Now, Daiichi Sankyo has further expanded treatment options with the addition of Cravit® IV, and it will continue to contribute to the development of improved treatments for infectious diseases by promoting the adoption of this new formulation.

 

Note 1: PK-PD theory

This is a scientifically proven concept for designing the optimal administration of anti-bacterial agents. This anti-bacterial efficacy and safety assessment concept combines pharmacokinetics (PK), which shows how anti-bacterial agent concentration changes within the human body, and pharmacodynamics (PD), which considers the actions of anti-bacterial agents within organisms.

 

Note 2: Respiratory quinolone

Respiratory quinolones are fluoroquinolones which have a high degree of efficacy against many bacterial pathogens including S. pneumoniae, the major cause of bacterial respiratory infections. They also have been shown to be effective against many atypical bacteria (such as Mycoplasma pneumoniae and Chlamydia pneumoniae) that are not susceptible to cephems, carbapenems and penicillins.