April 16, 2010
Shionogi & Co., Ltd.
Eli Lilly Japan K.K.
Launch of an Antidepressant Drug, “Cymbalta
®
Capsules
20mg and 30mg”
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President: Isao Teshirogi; hereafter “Shionogi”)
and Eli Lilly Japan K.K. (Head Office: Kobe, Japan; President and General Manager: Alfonso G.
Zulueta; hereafter “Eli Lilly Japan”) today announced that
it is scheduled to launch
a serotonin
noradrenalin reuptake inhibitor, “Cymbalta
®
Capsules
20mg and 30mg” (generic name: duloxetine
hydrochloride) for depression and depressive symptoms treatment on April 19, 2010.
Cymbalta
®
, a serotonin noradrenalin reuptake inhibitor (SNRI), originally discovered by Eli Lilly
and Company, the U.S., and it has been approved in 99 countries and prescribed to 18 million
patients since its launch in the U.S. in August, 2004. Shionogi has received its marketing and
manufacturing approval on January, 2010 and both companies are scheduled to start co-marketing
in Japan. Because Cymbalta
®
is expected to have the efficacy and the good remission rate against
broad range of depressive symptoms including core emotional symptoms as well as painful physical
symptoms by once-daily oral dosing, this drug will help patients to recover from depression and
rehabilitate into society.
Shionogi and Eli Lilly Japan will dedicate to the treatment for depression and depressive symptoms
treatment by the provision of high–quality information through the co-marketing Cymbalta
®
and
make efforts to improve patients’ QOL.
Cymbalta
®
Product Overview
Product Name:
Cymbalta
®
Capsules 20 and 30mg
Generic Name:
Duloxetine Hydrochloride
Indication:
Depression and depressive symptoms
Dosage and
Administration:
In general, a single dose of 40mg of duloxetine is to be administrated orally to
adult patients after breakfast. Dosage is initiated from a dose of 20mg per day,
and increased by 20mg at more than a week intervals.
If the effect is insufficient, dosage can increase up to 60mg per day.
Approval Date:
January 20, 2010
NHI Drug Price
Listing:
April 16, 2010
Launch Date:
April 19, 2010
NHI Drug Price:
169.3 yen for 20mg capsule (Daily drug cost of 338.6 yen)
230.5 yen for 30mg capsule
Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
For further information, contact:
Corporate Communications Department
Shionogi & Co., Ltd.
Telephone: +81-6-6209-7885
Fax: +81-6-6229-9596
Access & Marketing Communications
Eli Lilly Japan K.K.
Telephone: +81-78-242-9192
Fax: +81-78-242-9169
