Shionogi partner Ildong gains South Korean approval for Pirespa

14 August 2012

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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical