January 13, 2009
To Whom It May Concern
Company: Taisho Pharmaceutical Co., Ltd.
Representative: Akira Uehara, President
(TSE First Section: Code 4535)
Contact: Masaki Tsuboi, General Manager,
Public Relations Section
(Tel: +81-3-3985-1115)
Taisho Reaches Agreement on
the Development and Sale of Anti-obesity Drug orlistat, in Japan
Taisho Pharmaceutical Co., Ltd. [Headquarters: Toshima-ku, Tokyo;
President: Akira Uehara] (Taisho) has reached an agreement with
Glaxo Group Limited, a subsidiary of GlaxoSmithKline (GSK) plc
[Headquarters: U.K.; CEO: Andrew Witty] to grant Taisho the rights
for the development and marketing of the anti-obesity drug orlistat, in
Japan.
Orlistat, an anti-obesity drug developed by Roche [Headquarters:
Switzerland; CEO: Severin Schwan], is designed to prevent the
absorption of fat by inhibiting lipases, which are enzymes that break
down fat. Orlistat has yet to be approved in Japan, but is sold overseas
as a prescription product under the product name XENICAL
®
(orlistat
120mg) in more than 149 markets around the world.
Orlistat is sold as the only Federal Drug Administration
(FDA)-approved Over the Counter (OTC) product in the US, under the
trade mark
alli
®
(orlistat 60mg), with its sales of $298.5 Million for the
first six months after the launch of
alli
®
in July 2007. As a global OTC
brand,
alli
®
is accompanied by a behavioral support program to help
overweight and obese people achieve meaningful weight loss.
XENICAL
®
(orlistat 120mg) is also available OTC in a number of
countries in the Asia Pacific region including Australia.
GSK has the rights to develop orlistat 60mg for non-prescription use
worldwide. In the U.S., orlistat 60mg was approved as an OTC weight
loss aid, in February 2007. In October 2008, the European Medicines
Agency’s (EMEA) Committee for Medicinal Products for Human Use
(CHMP) issued a positive opinion supporting the approval of orlistat
60mg to be marketed as an OTC product in the European Union.
Orlistat is supported by more than 100 clinical studies conducted in
more than 30 countries, including the four-year landmark XENDOS
trial, the longest study ever for a weight loss medicine. More than 30
million patient treatments attest to orlistat’s safety and efficacy.
Obesity is a global public health problem. Japan is estimated to have
around 16 million overweight people. Of that number, roughly 12.8
million, or about 80%, are estimated to be obese. Obesity is associated
with a variety of health problems, including diabetes, dyslipidemia and
hypertension.
Leveraging GSK’s global knowledge and expertise with
alli
®
, Taisho
and GSK will work together to provide Japanese consumers who need
it - an effective, safe and readily available obesity treatment option.