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Press release

Sandoz Inc. 506 Carnegie Center Drive Suite 400 Princeton, NJ 08540 Phone +1 609 627 8500 Fax +1 609 627 8682 Sandoz launches first generic version of DUETACT®
Princeton, New Jersey, January 11, 2013 – Sandoz today announced the US market introduction of its
first-to-file pioglitazone hydrochloride and glimepiride tablets, the first generic version of Takeda
Pharmaceuticals’ DUETACT®.
Pioglitazone hydrochloride and glimepiride tablets is a combination product. It is indicated as an adjunct to
diet and exercise to improve the control of blood sugar in adults with type 2 diabetes mellitus who are
already treated with certain diabetes medications or who have inadequate glycemic control when using
certain diabetes medications alone.1
Diabetes affects nearly 26 million people in the US, or 8.3 percent of the population. Type 2 diabetes
accounts for more than 90 percent of diabetes cases.2
"Sandoz is proud to be both the first to file for and the first to launch a generic version of this important
therapy for US diabetes patients,” said Don DeGolyer, President of Sandoz US. “This launch represents
another important step in our mission to provide high-quality generic options for Americans.”
According to IMS Health, US sales for the branded version of pioglitazone hydrochloride and glimepiride
tablets were approximately USD 29 million for the 12 months ending in November 2012. Sandoz is
marketing pioglitazone hydrochloride and glimepiride tablets in the 30 mg/2 mg and 30 mg/4 mg dosage
strengths, the same strengths that are marketed as DUETACT®.
The foregoing release contains forward-looking statements that can be identified by terminology such as
“launches,” “introduction,” “launch,” “mission,” or similar expressions, or by express or implied discussions
regarding potential future product approvals, or regarding potential revenues from pioglitazone
hydrochloride and glimepiride tablets or any potential future products. You should not place undue
reliance on these statements. Such forward-looking statements reflect the current views of the Company
regarding future events, and involve known and unknown risks, uncertainties and other factors that may
1 For full safety information, please see the pioglitazone hydrochloride and glimepiride tablets prescribing information, available in the Product Catalog a2 Centers for Disease Control and Prevention. “National Diabetes Fact Sheet, 2011.” Available from: Accessed December 4, 2012. cause actual results to be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that either pioglitazone
hydrochloride and glimepiride tablets or any potential new products will achieve any particular levels of
revenue in the future. In particular, management’s expectations could be affected by, among other things,
unexpected regulatory actions or delays or government regulation generally, including potential FDA
approval of additional versions of pioglitazone hydrochloride and glimepiride tablets; competition in
general; government, industry and general public pricing pressures; unexpected patent litigation
outcomes; unexpected manufacturing issues; the impact that the foregoing factors could have on the
values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated
balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the
US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize,
or should underlying assumptions prove incorrect, actual results may vary materially from those
anticipated, believed, estimated or expected. Novartis is providing the information in this press release as
of this date and does not undertake any obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or otherwise.

About Sandoz
Sandoz, a Division of the Novartis group, is the second-largest generic pharmaceuticals company globally,
offering a broad range of about 1,000 high-quality, affordable products that are no longer protected by
patents. With approximately 25,000 employees in 140 countries, Sandoz holds the #1 position globally in
biosimilars as well as generic injectables, ophthalmics, dermatology, and antibiotics. Key product groups
include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines,
cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these
medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In
addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek
(Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel
Therapeutics (US), and Fougera Pharmaceuticals (US). In 2011, Sandoz posted sales of USD 9.5 billion.

For further information:
Sandoz US Communications
Chris Lewis
+1 609 627 5287; [email protected]
Sandoz Global Communications
Neil Moorhouse
+49 8024 476 2597; [email protected]
DUETACT® is a registered trademark of Takeda Pharmaceuticals North America, Inc.

Source: http://www.lekpharma.ru/assets/media/shared/documents/2013_01_11_pioglitazone.pdf

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