Sandoz announces launch of first generic version of leading muscle relaxant Skelaxin®, with ANDA exclusivity

Sandoz announces launch of first generic version of leading muscle relaxant Skelaxin®, with ANDA exclusivity
Princeton, NJ, May 20, 2010 - Sandoz today announced the launch in the US of the first generic version of metaxalone tablets, a generic equivalent of Skelaxin®, enjoying 180-day ANDA exclusivity. Metaxalone is a leading muscle relaxant used to treat acute skeletal muscle conditions, such as lower back spasms caused by injury, in combination with rest and physical therapy.

"An important element of our strategy is to be first-to-market with key products and the approval of metaxalone demonstrates the success of this approach," said Don DeGolyer, President of Sandoz US. "Metaxalone is a key new product for Sandoz, and further strengthens our broad and diverse portfolio of high-quality, affordable medicines in the US market. We are pleased to be able to offer a new costeffective treatment to this sizeable patient population."

According to IMS Health, Skelaxin had US sales of approximately USD 476 million for the 12 months ending in December 2009. Sandoz is marketing metaxalone in 800mg strength tablets, the same as Skelaxin®.

Acute back pain is one of the most common medical problems in America; research suggests that, in a three-month period, about one-fourth of US adults experience at least one day of back pain [1]. In addition, lower back pain is the second most common neurological ailment in the US, and is the most common cause of job-related disability as well as a leading contributor to missed work [2, 3].

The launch of metaxalone adds another key product to the global Sandoz portfolio of pain management medications. Furthermore, the launch demonstrates Sandoz's focus on advancing the pipeline through challenging patents where appropriate to bring high-quality, affordable medicines to market as quickly as possible.

Sandoz was the first to launch generic metaxalone tablets following FDA approval on March 31, 2010. Following a temporary restraining order (TRO) issued by the US District Court, District of New Jersey, Sandoz ceased further shipments until the TRO was lifted on April 9, 2010. King Pharmaceuticals, Inc, and Pharmaceutical IP Holding also filed a motion with the Court for a preliminary injunction to prevent Sandoz from selling metaxalone. On May 17, 2010, the Court denied this motion.

Disclaimer The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "strategy," "pipeline," or similar expressions, or by express or implied discussions regarding potential future revenues from metaxalone tablets. 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 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 metaxalone tablets will achieve any particular levels of revenue in the future. In particular, management's expectations could be affected by, among other things, unexpected inabilities to maintain exclusivity periods for our product; FDA approval of additional versions of generic metaxalone tablets; competition in general; government, industry and general public pricing pressures; unexpected regulatory actions or delays or government regulation generally; patent litigation outcomes; 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 a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents. Sandoz has a portfolio of about 1000 compounds and sells its products in more than 130 countries. 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) and EBEWE Pharma (Austria). In 2009, Sandoz employed around 23,000 people worldwide and posted sales of USD 7.5 billion. References [1] National Institute of Arthritis and Musculoskeletal and Skin Diseases. Handout on Health: Back Pain. 2009. [2] National Institute of Neurological Disorders and Stroke. Low back pain fact sheet. Available from: http://www.ninds.nih.gov/disorders/backpain/detail_backpain.htm#119423102. [3] Hemp P. Presenteeism: at work - but out of it. Harvard Business Review 2004; 82(10): 49-58.

For further information Sandoz US Communications: Ted Deutsch +1 609 627 5287 Sandoz Global Communications: Chris Lewis +49 8024 476 2550 Novartis Investor Relations (North America) Richard Jarvis +1 212 830 2433 Skelaxin® is a registered trademark of King Pharmaceuticals, Inc.

Sandoz announces launch of first generic version of leading muscle relaxant Skelaxin®, with ANDA exclusivity Princeton, NJ, May 20, 2010 - Sandoz today announced the launch in the US of the first generic version of metaxalone tablets, a generic equivalent of Skelaxin®, enjoying 180-day ANDA exclusivity. Metaxalone is a leading muscle relaxant used to treat acute skeletal muscle conditions, such as lower back spasms caused by injury, in combination with rest and physical therapy.

"An important element of our strategy is to be first-to-market with key products and the approval of metaxalone demonstrates the success of this approach," said Don DeGolyer, President of Sandoz US. "Metaxalone is a key new product for Sandoz, and further strengthens our broad and diverse portfolio of high-quality, affordable medicines in the US market. We are pleased to be able to offer a new costeffective treatment to this sizeable patient population."

According to IMS Health, Skelaxin had US sales of approximately USD 476 million for the 12 months ending in December 2009. Sandoz is marketing metaxalone in 800mg strength tablets, the same as Skelaxin®.

Acute back pain is one of the most common medical problems in America; research suggests that, in a three-month period, about one-fourth of US adults experience at least one day of back pain [1]. In addition, lower back pain is the second most common neurological ailment in the US, and is the most common cause of job-related disability as well as a leading contributor to missed work [2, 3].

The launch of metaxalone adds another key product to the global Sandoz portfolio of pain management medications. Furthermore, the launch demonstrates Sandoz's focus on advancing the pipeline through challenging patents where appropriate to bring high-quality, affordable medicines to market as quickly as possible.

Sandoz was the first to launch generic metaxalone tablets following FDA approval on March 31, 2010. Following a temporary restraining order (TRO) issued by the US District Court, District of New Jersey, Sandoz ceased further shipments until the TRO was lifted on April 9, 2010. King Pharmaceuticals, Inc, and Pharmaceutical IP Holding also filed a motion with the Court for a preliminary injunction to prevent Sandoz from selling metaxalone. On May 17, 2010, the Court denied this motion.

Disclaimer The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "strategy," "pipeline," or similar expressions, or by express or implied discussions regarding potential future revenues from metaxalone tablets. 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 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 metaxalone tablets will achieve any particular levels of revenue in the future. In particular, management's expectations could be affected by, among other things, unexpected inabilities to maintain exclusivity periods for our product; FDA approval of additional versions of generic metaxalone tablets; competition in general; government, industry and general public pricing pressures; unexpected regulatory actions or delays or government regulation generally; patent litigation outcomes; 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 a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents. Sandoz has a portfolio of about 1000 compounds and sells its products in more than 130 countries. 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) and EBEWE Pharma (Austria). In 2009, Sandoz employed around 23,000 people worldwide and posted sales of USD 7.5 billion. References [1] National Institute of Arthritis and Musculoskeletal and Skin Diseases. Handout on Health: Back Pain. 2009. [2] National Institute of Neurological Disorders and Stroke. Low back pain fact sheet. Available from: http://www.ninds.nih.gov/disorders/backpain/detail_backpain.htm#119423102. [3] Hemp P. Presenteeism: at work - but out of it. Harvard Business Review 2004; 82(10): 49-58.

For further information Sandoz US Communications: Ted Deutsch +1 609 627 5287 Sandoz Global Communications: Chris Lewis +49 8024 476 2550 Novartis Investor Relations (North America) Richard Jarvis +1 212 830 2433 Skelaxin® is a registered trademark of King Pharmaceuticals, Inc.

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