JP-2022516569-A5 -

Dates

Publication Date

20221219

Application Date

20200103

Description

XIAFLEX® (collagenase derived from Clostridium histolyticum (CCH)) is currently approved for the treatment of Dupuytren's contracture (DC) and Peyronie's disease (PD). The currently approved XIAFLEX® formulation is supplied as a lyophilized cake containing 0.9 mg of CCH in a 3 CC vial with a diluent. The current XIAFLEX® formulation (before lyophilization) has a lyophilization cycle time of approximately 72 hours in the vial. Efficient lyophilization is necessary for shelf life and enzyme stability. The following are prior art documents related to the invention of this application (including documents cited in the international phase after the international filing date and documents cited when the application entered the national phase in other countries): (Prior art document) (Patent Document) (Patent Document 1) International Publication No. 2013/059619 (Patent Document 2) International Publication No. 2007/100675 (Patent Document 3) International Publication No. 2018/160905 (Patent Document 4) U.S. Patent Application Publication No. 2011/033464 (Patent Document 5) U.S. Patent Application Publication No. 2018/099049 (Patent Document 6) U.S. Patent Application Publication No. 2006/263347