Company News

 

June 13, 2002

Public Relations
Ono Pharmaceutical Co., Ltd.
Tel: +81-6-6222-5551
Fax: +81-6-6222-2875


Announcement of the Launch of Elaspol® 100 for Injection, the World's First Drug for Acute Lung Injury
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka City, President: Kimiichiro Matsumoto) will launch Elaspol® 100 for injection, the world's first drug for acute lung injury associated with systemic inflammatory response syndrome (SIRS), on June 17, 2002.

By selectively inhibiting neutrophil elastase, an enzyme released from neutrophils (specialized white blood cells) and responsible for the onset of acute lung injury, and thereby improving the patient's respiratory function, Elaspol® 100 for injection can shorten the period for which patients with lung injury need mechanical ventilation. This reduces serious stress and decreases the onset of ventilator-associated pneumonia in patients under mechanical ventilation.

In addition, early removal from mechanical ventilation will shorten the period of the patients' stay in the intensive care unit (ICU), resulting in reduction of medical costs. With these features, Elaspol® 100 for injection is attracting worldwide attention as an innovative drug.

Eli Lilly and Company, a US company to which Elaspol was out-licensed, has been conducting a six-country Phase II clinical study with acute lung injury as its indication. This study has been performed mainly in the US and Europe since August 2001 and is scheduled to be completed by the end of this year. We are expecting that the development of Elaspol will continue without any problems, leading to multinational submissions of new drug applications starting around 2005. We anticipate that Elaspol will become known as an innovative drug with novel features that was developed in Japan and will be used worldwide.


      Product Profile of Elaspol® 100 for Injection


     Nonproprietary name : Sivelestat sodium hydrate

     Active ingredient : 100 mg sivelestat sodium hydrate per vial

     Indications : Acute lung injury associated with systemic inflammatory response syndrome (SIRS)

     Dosage and administration : Usually, after being dissolved in physiological saline, a daily dose of 4.8 mg/kg body weight of sivelestat sodium hydrate should be diluted with 250 - 500 mL of fluid infusion for 24-hour continuous intravenous administration (at 0.2 mg/kg/hr). Dosing period should not be more than 14 days.

     Drug price : 6,167 yen/vial

     Package : 10 vials or 30 vials of Elaspol® 100 for injection

     Manufactured and distributed by : Ono Pharmaceutical Co., Ltd.