September 30, 2008
Whom It May Concern
KYORIN Co., Ltd.
Dainippon Sumitomo Pharma Co., Ltd.

Discontinuation of Commercialization of Gatiflo® (gatifloxacin) Tablets,
a broad-spectrum antibacterial agent, in Japan
Kyorin Pharmaceutical Co., Ltd. (Tokyo, President: Itaru Kojo), a wholly owned
subsidiary of Kyorin Co., Ltd., and Dainippon Sumitomo Pharma Co., Ltd. (Osaka,President: Masayo Tada) announce that they have decided to voluntarily discontinuecommercialization of Gatiflo® (gatifloxacin) Tablets, a broad-spectrum antibacterial agent,in Japan as of September 30, 2008.
[Profile of Gatiflo® Tablets]
Generic Name:
gatifloxacin hydrate
Brand Name:
Gatiflo® Tablets (Approved on April 11, 2002, Launched in June2002)
Therapeutic Category: Synthetic antimicrobial
Marketing Companies: Manufactured by Kyorin Pharmaceutical Co., Ltd.
Marketed by Kyorin and Dainippon Sumitomo Pharma Co., Ltd.
Sales Performance:
About 3.5 billion yen (Fiscal year ending in March 2008, NHI
price basis)
Indications:
Respiratory tract infection, urologic tract infection, otologic tract
infection etc.
[Background behind Discontinuation]
Gatiflo® Tablets was launched in June 2002 as a broad-spectrum antibacterialagent, having a high degree of usefulness for various infection diseases, such as
respiratory tract and urologic tract infections. After the launch, serious hyperglycemia
and hypoglycemia of which the relationship with the product could not be denied werereported.
In response to such reports, we warned of possible serious hyper/
hypoglycemia and changed the product label to contraindicate use in patients withdiabetic mellitus in addition to the issuance of “Dear Dr. Letter” in March 2003. As theresult of such our efforts, incidence of dysglycemia has been decreased.
On the other hand, Kyorin’s licensee in the US, Bristol-Myers Squibb Company(New York) has discontinued commercialization of Tequin® (gatifloxacin tablets, injection
and oral suspension) for commercial reason in June 2006. The Food and Drug
Administration (FDA) recently announced on the Federal Register its decision thatTequin® was delisted from the Orange Book for the reason of safety, etc. This was themeasure not to accept any abbreviated new drug application (ANDA) for Tequin®.
Under the circumstances, we have discussed the handling of Gatiflo® Tablets inJapan seeking opinions from various sectors. As the result of such discussion andinvestigation, while the necessity of Gatiflo® Tablets is recognized by a number of expert
physicians even now when new drugs having similar antibacterial spectrum are available,
taking into the consideration future risk-benefit of patients for the use of Gatiflo® Tablets,
which includes the difficulty in eradicating administration to diabetic patients, only byfamiliarizing physicians with the contraindication of the product in diabetic patients, wehave decided to voluntarily discontinue commercialization of Gatiflo® Tablets.
We will carefully investigate how the discontinuation impacts on the forecast of
our financial performance of this fiscal year. If the revision of the current forecast isnecessary after our investigation, we will disclose immediately.
###Contacts:
Management Planning Department
K Y O R I N
C o . ,
L t d .
T E L :
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R e l a t i o n s
Dainippon Sumitomo Pharma Co., Ltd.
T E L :
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