Pharmaceutical Business review

D-Pharm gets KFDA approval for Phase III Macsi study in Korea

The IND was filed by D-Pharm’s co-development partner in South Korea, Yungjin Pharmaceutical (YJP).

YJP gets license to develop, register and market DP-b99 from D-Pharm in South Korea to treat patients with acute ischemic stroke.

The IND was submitted on the basis of a study evaluating DP-b99 completed in early 2011 and demonstrated no safety issues.

D-Pharm CEO Alex Kozak said success of the study in Asian volunteers and extension of Macsi to South Korea is of strategic value, paving the way for DP-b99 to reach vast Asian markets.