Princeton, New Jersey; April 30, 2008 – Sandoz, the generics division of Novartis AG, today announced that the Food and Drug Administration (FDA) has provided guidance regarding its abbreviated new drug application (ANDA)  for enoxaparin.  Sandoz is developing enoxaparin, a technology-enabled generic version of Lovenox®, in collaboration with Momenta.

Earlier this year, after constructive dialog with the FDA, Sandoz in collaboration with Momenta submitted a proposal to the agency for addressing the potential immunogenicity of enoxaparin, in response to the FDA’s letter of November 2007.  On April 28, 2008, the FDA responded to the proposal and provided additional guidance which indicated their general concurrence with the companies’ approach and proposal.   The FDA also requested additional data from in vitro and in vivo animal tests, the testing of additional samples for tests previously proposed, and additional information regarding certain of the methods proposed. The agency has not requested human clinical trials at this time. 

“This latest communication further clarifies our approach in addressing the original FDA deficiency letter and we are hopeful to submit the requested additional data in the third quarter of 2008,” said Dr. Bernhard Hampl, chief executive officer of Sandoz Inc., the US subsidiary of Sandoz.

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 more than 950 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) and Eon Labs (US) In 2007, Sandoz employed around 23,000 people worldwide and posted sales of USD 7.2  billion

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "expects", "expectations", "would", "hope", "hopeful", or similar expressions, or by express or implied discussions regarding potential future regulatory filings or marketing approvals for enoxaparin or regarding potential future revenues from enoxaparin. 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 with enoxaparin to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that enoxaparin will be submitted to regulatory authorities for approval, or will be approved for sale in any market. Nor can there be any guarantee that enoxaparin will achieve any particular levels of revenue in the future. In particular, management's expectations regarding enoxaparin could be affected by, among other things, unexpected test results, including unexpected test data and unexpected additional analysis of existing test data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, 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.

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For further information

Sandoz US Communications:
Charles A. Bruns
609.627.8881

Lovenox® is a registered trademark of Sanofi-Aventis.