Wednesday, August 8, 2012

ILDONG PHARMACEUTICAL Receives a Marketing and Manufacturing Approval for Pirespa® 200mg Tablet (pirfenidone))

ILDONG PHARMACEUTICAL Co., Ltd received a marketing and manufacturing approval for idiopathic pulmonary fibrosis (IPF) treatment of Pirespa® 200mg tablet (generic name: pirfenidone).  Ildong Pharma has inlicensed Pirespa (pirfenidone) from  Shionogi, which in-licensed pirfenidone from the U.S.-based Marnac, Inc. and KDL, Inc., Tokyo. Shionogi has already received a 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 on
May, 2011. Following the execution of agreement, 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.
Shionogi will provide the product to ILDONG and receive the royalty payment based on the net sales
of the drug by ILDONG under the agreement in May, 2011.