12/22/06 Osaka, Japan — Shionogi & Co., Ltd. announced that it has achieved the primary objectives of Phase III clinical trials for the idiopathic pulmonary fibrosis treatment S-7701 (generic name: pirfenidone), which the Company is developing in Japan under a license from U.S.-based Marnac, Inc. and KDL, Inc., of Tokyo.

Because of its severity, IPF is designated as a “specified disease” (in other words, an intractable disorder). Under development as a treatment for IPF, S-7701 has been designated as an orphan drug (a drug used to treat a rare disease) by the Pharmaceuticals and Medical Devices Agency.

In the Phase III clinical trials for this drug with VC change (from before commencement of treatment to 52 weeks after commencing treatment) as the primary endpoint, both high and low doses of the drug (600mgl per day, three times a day and 400mgl per day, three times a day, respectively), significantly inhibited worsening of the condition compared with a placebo. While continuing to conduct further analysis and study, Shionogi plans to expedite the application process based on these clinical results, with the intention of submitting a new drug application (NDA) within the current fiscal year.

InterMune (Brisbane, Calif.) is also studying the use of pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis in its Phase III “CAPACITY” clinical trials. InterMune commented on the Shionogi clinical trial in a recent Regulatory filing with the Securities & Exchange Commission (SEC) that “While we are encouraged by Shionogi's announcement, we believe that the Shionogi findings are informative but not necessarily predictive of a potential outcome of InterMune's CAPACITY trials. There are key differences between the Shionogi and InterMune clinical trials, including differing patient populations, dosing regimens and length of treatment. There is no assurance that the results of the Shionogi and InterMune clinical trials will be similar.” InterMune has worldwide rights, excluding Japan, Korea and Taiwan, to develop and commercialize pirfenidone for all fibrotic diseases.

Source: Shionogi Press Release 12/22/06 & InterMune SEC Filing 12/22/06