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19-Oct-2009

Novartis receives Complete Response letter from FDA for QAB149, an investigational bronchodilator for COPD

• US Food and Drug Administration (FDA) has requested additional information on dosing proposed for QAB149
• Novartis will continue to work with the FDA to gain US approval for QAB149

East Hanover, NJ, October 19, 2009 - Novartis has received a Complete Response letter from the US Food and Drug Administration (FDA) as part of the US regulatory review for QAB149 (indacaterol), an investigational bronchodilator given once daily for the treatment of adult patients with chronic obstructive pulmonary disease (COPD).

The FDA has requested additional information on the dosing proposed for QAB149. Novartis will work with the FDA to review already submitted data for QAB149 as well as recently available data to determine what, if any, further clinical trials would be required.

"We will continue to work closely with the FDA to gain US regulatory approval for QAB149, which we believe could offer an important new treatment option for patients with COPD," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG.

QAB149 was submitted for US regulatory approval in December 2008 as a new investigational bronchodilator given once daily for maintenance treatment of airflow obstruction in patients with COPD. The original submission was based on a Phase III clinical trial program with three pivotal studies and enrolled 4,400 patients with moderate-to-severe COPD.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "would," "believe," "could," or similar expressions, or by express or implied discussions regarding potential marketing approvals for QAB149 (indacaterol) or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may 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 QAB149 will be approved for sale in any market. Nor can there be any guarantee that QAB149 will achieve any particular levels of revenue in the future. In particular, management's expectations regarding QAB149 could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; 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 Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, preventive vaccines, diagnostic tools, cost-saving generic pharmaceuticals, and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

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