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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®. Disclaimer 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.