Shionogi partner Ildong gains South Korean approval for Pirespa

Japanese drug major Shionogi (TYO: 4507) says that its South Korean partner Ildong Pharma has received marketing and manufacturing approval for idiopathic pulmonary fibrosis (IPF) treatment of Pirespa (pirfenidone) 200mg tablets, and Ildong plans to launch the drug as soon as possible.

Shionogi in-licensed pirfenidone from the USA-based Marnac and KDL of Japan and received marketing and manufacturing approval for IPF in October and launched it as Pirespa in December 2008 in Japan for the first time in the world. Pirfenidone is a promising therapeutic agent which is expected to inhibit the progression of IPF through a new mechanism of action inhibiting fibrosis directly and offering a new option for IPF treatment.

Shionogi entered into licensing agreement for the sale of pirfenidone in South Korea with Ildong last year, the financial terms of which were not disclosed (The Pharma Letter July 14, 2011). Following the execution of deal, Ildong has developed it and submitted a New Drug Application of pirfenidone for the treatment of IPF to Ministry of Health and Welfare in April 2012 and received the approval after a fast track procedure as an orphan drug.