EMA Accepts MAA Submission of Shionogi’s Ospemifene for the Treatment of VVA

  EMA Accepts MAA Submission of Shionogi’s Ospemifene for the Treatment of VVA

Business Wire

LONDON -- March 27, 2013

Shionogi Limited, the London-based European subsidiary of Shionogi & Co., Ltd
announced today that on 26^th March 2013 the European Medicines Agency (EMA)
accepted its Marketing Authorisation Application (MAA) submission for
ospemifene for the treatment of vulvar and vaginal atrophy (VVA) in
post-menopausal women.

“We are pleased to announce the MAA submission for ospemifene to the EMA
following the US Food and Drug Administration (FDA) approval last month. The
acceptance of the MAA submission for ospemifene not only represents an
important step forward in expanding the treatment options for women living in
Europe with this condition, but it is also an important milestone for Shionogi
as it continues to build its business in Europe” said Takashi Takenoshita, CEO
of Shionogi Limited.

About Shionogi

Shionogi Limited is the London-based, European subsidiary of Shionogi &
Co.,Ltd, headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a major
research-driven pharmaceutical company dedicated to placing the highest value
on patients. Shionogi’s Research and Development currently targets three
therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. In
addition, Shionogi is engaged in new research areas such as allergy and
cancer. Contributing to the health of patients around the world through
development in these therapeutic areas is Shionogi’s primary goal. For more
details, please visit www.shionogi.co.jp. For more information on Shionogi
Limited, headquartered in London, United Kingdom, please contact +44 203 609
8660.

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.

Contact:

Shionogi Limited
Media Relations
+44 203 609 8628
info@shionogi.co.uk
 
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