Chugai Pharmaceutical : Approval of an Orphan Drug, “Pulmozyme®,” a Recombinant Human Deoxyribonuclease I (rhDNase)

March 30, 2012 (Tokyo) - Chugai Pharmaceutical Co., Ltd. [Main Office: Chuo-ku, Tokyo. Chairman & CEO: Osamu Nagayama (hereafter, “Chugai”)] announced that it has obtained approval on March 30, 2012, from the Ministry of Health, Labour and Welfare (MHLW), for Pulmozyme® Inhalation Solution 2.5mg (hereafter, “Pulmozyme®”)[recombinant human deoxyribonuclease I (rhDNase), generic name: dornase alfa] for the indication of “improvement of pulmonary function in patients with cystic fibrosis.” Pulmozyme® is designated as an orphan drug for this indication by the MHLW.

As a result of the evaluation by the “Review Committee on Unapproved Drugs and Indications with High Medical Needs*” held on April 18, 2011, it was concluded that it is reasonable that dornase alfa be filed for approval in this indication based on available data, and on July 15, 2011, the filing was made using overseas data. In overseas clinical studies, administration of dornase alfa by inhalation is confirmed to be effective for the improvement of pulmonary function and reduction of the risk of serious infection of the respiratory tract in cystic fibrosis patients, compared to placebo... Chugai Pharmaceutical's Press Release -