Biotech Values

[ghmm]

Shionogi Top Line Results of Pirfenidone Trial -- Relevance to InterMune

Don't know if anyone posted this yet (am traveling and have a slow dial-up connection when have access). Happy holidays to everyone (I am much happier with this news), really a great board and best wishes for a better 2007 (2006 was so-so for me) UTHR offset BMRN and ITMN gains!
This is bigger news then any 191 progress (to date anyway). Lets see what InterMune does (not just stock price but as far as plans for Pirfenidone).

http://www.shionogi.co.jp/ir_en/news/detail/e_061222.pdf


December 22, 2006
Shionogi & Co., Ltd.
Results of Phase III Clinical Trials of the Idiopathic Pulmonary Fibrosis
Treatment S-7701
Osaka, December 22, 2006 — Shionogi & Co., Ltd. (Head Office: Osaka; President:
Motozo Shiono) today 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., Tokyo.
Idiopathic pulmonary fibrosis (IPF) is a medical condition of unknown etiology with
poor prognosis in which progressive fibrosis of the alveolar walls produces irreversible
“honeycomb lung”*. In general, restrictive impairment (reduction of vital capacity (VC)
and total lung capacity (TLC)) is evident. As the symptom (fibrosis of the alveolar
walls) progresses, gas exchange in the lungs (exchange of oxygen and carbon dioxide)
becomes difficult. In some cases, oxygen therapy becomes necessary. 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.
*Honeycomb lung: A high-resolution CT scan of the lung yields a honeycomb pattern.
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.