Sandoz launches generic Rebetol for the treatment of hepatitis C

Main Category: Liver Disease / Hepatitis
Article Date: 09 Apr 2004 - 0:00 PDT


PRINCETON, N.J., USA - Sandoz Inc., a Novartis company, announced today it is launching generic Rebetol® (Ribavirin), which used in combination with interferon is indicated for the treatment of hepatitis C.

"As one of the first providers of Ribavirin, we are committed to delivering value to patients and to our customers by offering a lower-cost alternative for the treatment of hepatitis C," said John Sedor, President and Chief Executive Officer of Sandoz in North America. "People with hepatitis C who need this drug therapy will now be able to obtain it more readily and receive excellent patient support."

The U.S. Food and Drug Administration (FDA) awarded Sandoz shared exclusivity for Ribavirin in approving its Abbreviated New Drug Application (ANDA) to manufacture and market the product. Sandoz will market Ribavirin in 200 mg capsules in multiple-count bottles. The product will be manufactured at a Sandoz facility in Colorado using state-of-the-art isolation suite technology.

Hepatitis C virus is one of the leading causes of chronic liver disease in the U.S., according to the National Institutes of Health. Hepatitis C affects more than four million Americans, the majority of whom are still undiagnosed and untreated.

According to IMS data, 2003 sales for Rebetol® reached $645 million. Rebetol® is a registered trademark of Schering-Plough.

Sandoz, a Novartis company, is a world leader in generic pharmaceuticals and develops, manufactures and markets these medicines as well as pharmaceutical and biotechnological active ingredients. In the U.S., Sandoz Inc., is one of the largest prescription generic pharmaceutical companies. The company produces more than 200 products each year. Sandoz products range across many therapeutic drug categories including anti-infectives, anti-arthritics, cardiovasculars, gastrointestinal agents and psychotherapeutics. More information about Sandoz U.S. operations can be found at http://www.us.sandoz.com.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD $24.9 billion and a net income of USD $5.0 billion. The Group invested approximately USD $3.8 billion in research and development. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78 500 people and operate in over 140 countries around the world. For further information, please consult http://www.novartis.com.

This release contains certain "forward-looking statements" relating to the Group's business, which can be identified by the use of forward-looking terminology such as "coming on stream", "will be", "to become", or similar expressions, or by express or implied discussions regarding strategies, plans and expectations. Such statements reflect the current plans or views of the Group with respect to future events and are subject to certain risks, uncertainties and assumptions. Management's expectations could be affected by, among other things, competition in general, and other risks referred to in Novartis AG's 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 described herein as anticipated, believed, estimated or expected.

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