ITMN:
Shionogi received marketing approval! I think the review took much longer then expected and Shionogi (and Intermune) had noted the Japanese minister came back to them with at least one set of questions (maybe two going by memory). Also the data presented at ATS left some people with as many questions so I think there were begining to be some doubters. There was no information on pricing (PR text is below)
As an aside last time Shionogi announced Pirfenidone news Intermune stock did not react till late in the day. A few astute investors were able to capitalize before the about 30% move.
Shionogi Receives Marketing and Manufacturing Approval
for Pirespa® 200mg Tablet
Idiopathic Pulmonary Fibrosis Treatment
Osaka, October 16, 2008 -- Shionogi & Co., Ltd. (Head Office: Osaka;
President: Isao Teshirogi) today announced that it received marketing and
manufacturing approval for Pirespa® 200mg Tablet (generic name:
Pirfenidone), an Idiopathic Pulmonary Fibrosis treatment, on October 16. It
is scheduled to launch pending its National Health Insurance (NHI) price
listing.
Pirespa® was licensed from U.S.-based Marnac, Inc. and KDL, Inc., Tokyo,
and Shionogi has developed it in Japan. The Phase III clinical trials showed
it significantly preserved vital capacity as a primary endpoint for Idiopathic
Pulmonary Fibrosis compared to placebo, and it received marketing and
manufacturing approval for the first time in the world.
Shionogi will prioritize securing the safety of patients who receive Pirespa®
for launch ahead, and will make every effort to collect and provide
information on the proper use, while following launch, we plan to conduct
all-case surveillance on the patients who receive the drug.
Shionogi will do its utmost to make a larger contribution to the treatment for
Idiopathic Pulmonary Fibrosis by getting Pirespa® properly prescribed.
2
For Reference:
About Idiopathic Pulmonary Fibrosis
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).
＊Honeycomb lung: A high-resolution CT scan of the lung yields a honeycomb pattern.
Product Overview
Product Name:
Generic Name:
Effect:
Form and Content:
Dosage and
Administration:
Pirespa® 200mg Tablet
Pirfenidone
Idiopathic Pulmonary Fibrosis
Film-coated tablet containing 200mg of Pirfenidone in one tablet
Generally in adults, one 200mg tablet as a primary dosage is
administered orally three times daily (600mg in a day) after
meal. The dosage is increased by 200mg increments per admin
up to 600mg per admin (1800mg in a day), examining condition
of the patient. The dosage should be adjusted according to the
patient’s condition.
For further information:
Shionogi & Co., Ltd. Corporate Communications Department
Osaka Tel: +81-6-6209-7885 Fax: +81-6-6229-9596
Tokyo Tel: +81-3-3406-8164 Fax: +81-3-3406-8099
