Newly Approved Administration of Cephalosporin Antibiotic Rocephin^® for Injection: Once Daily Administration in Children

November 19, 2007 (Tokyo) - Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo. President: Osamu Nagayama (hereafter, "Chugai")] announced that "once daily administration in children" was approved on November 13 for an additional administration of ceftriaxone sodium for injection (product names: Rocephin^® Intravenous 0.5g, Rocephin^® Intravenous 1g, Rocephin^® Intravenous Drip 1g Bag: hereafter, "Rocephin^®").

"Rocephin^®" is a cephalosporin antibiotic for injection which was synthesized by F. Hoffmann-La Roche [Head Office: Basel, Switzerland. Chairman and CEO: Franz B. Humer] in 1978 and launched in Japan in 1986. With its strong antibacterial activity and a broad antibacterial spectrum, the clinical efficacy of "Rocephin^®" against various bacterial infectious diseases is highly valued.

"Rocephin^®" is now recommended as first-line therapy for infectious diseases, such as community-acquired pneumonia, meningitis, biliary tract infection and gonococcal infection, in various treatment guidelines in and outside Japan. In recent years, the emergence of drug-resistant bacteria including Streptococcus pneumoniae and Haemophilus influenzae has been a problem especially in pediatric infectious diseases, resulting in many reported cases of acute otitis media and community-acquired pneumonia which fail to respond to oral antimicrobials. "RocephinR" is also expected to produce a therapeutic effect on these cases.

"Rocephin^®" has been the only cephalosporin injection drug available for once daily administration in adults. However, this newly approved dosage, once daily administration in children, will make possible the reduction in dosing frequency during hospital stay, thereby avoiding patients' burden of late-night administration as well as reducing healthcare workers'  burden. Moreover, now that Outpatient Parenteral Antimicrobial Therapy (OPAT) will be available for children as well as adults, it is expected that this therapy will enhance the satisfaction with care of patients who want outpatient therapy, maintain the quality of life of patients and their family members, reduce medical costs (hospital expenses), as well as facilitate treatment of infectious diseases at medical institutions with no bed capacity.

In response to the submission of requests concerning once daily administration of "Rocephin^®" in children by the Japanese Society of Chemotherapy (July 2005 and May 2006), this additional dosage has been approved as a common knowledge in the medical field, following application based on "Handling of Ethical Drugs concerning Off-Label Use" (Notification No.4 of the Research and Development Division, No.104 of the Evaluation and Licensing Division, MHLW, dated February 1, 1999).

Chugai places infectious diseases field as one of its key areas of focus. It is our belief that this new administration, once daily administration in children, in addition to the already approved adult dosage for "Rocephin^®" will allow us not only to provide its clinical effects but also to meet a variety of medical needs in infectious disease therapies.