Novartis AG (NVS) has reached a tentative agreement to settle 124 lawsuits brought by people who claimed their use of the gastrointestinal drug Zelnorm caused heart-related injuries.
The Swiss drug maker also disclosed Thursday that it settled a patent- infringement lawsuit against Teva Pharmaceutical Industries Ltd. (TEVA), under which Teva won't begin selling generic versions of bone-building drugs Zometa and Reclast in the U.S. until after patent protection for the branded drugs expires in March 2013. Zometa, Reclast and a related drug, Aclasta, had combined first-half 2010 sales of about $1 billion.
Novartis disclosed the legal developments in its second-quarter earnings release Thursday. The company didn't disclose how much it's paying in the Zelnorm settlement, which was reached in May.
Novartis spokesman Eric Althoff said the Zelnorm pact is still tentative and terms haven't yet been disclosed.
Novartis had suspended U.S. sales of Zelnorm in 2007 at the request of the U.S. Food and Drug Administration because a safety analysis found it increased the risk of heart attack, stroke and chest pain, compared with placebo.
Zelnorm, which first went on sale in 2001, was approved to treat irritable bowel syndrome with constipation. It had sales of $561 million in 2006, the last full year before its withdrawal.
The withdrawal sparked a number of lawsuits. Novartis said in its earnings release it's a defendant in about 135 cases brought in U.S. and Canadian courts.
Looking beyond the spin of Big Pharma PR. But encouraging gossip. Come in and confide, you know you want to! “I’ll publish right or wrong. Fools are my theme, let satire be my song.” Email: jackfriday2011(at)hotmail.co.uk
Saturday, July 17, 2010
Novartis In Tentative Pact To Settle Zelnorm Injury Suits
via nasdaq.com
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