UPDATE 1-Novartis, Sun Pharma settle dispute over generic Gleevec

Thu May 15, 2014 3:49am EDT

* Generic launch delayed to Feb 2016 vs July 2015

* Novartis shares down 2 pct (Adds analyst comment, edits)

ZURICH/MUMBAI May 15 (Reuters) - Novartis won a seven-month reprieve from generic competition to its blockbuster leukemia drug Gleevec after reaching a settlement on Thursday with Indian firm Sun Pharmaceutical Industries Ltd.

Competition from copycat drugs is a major worry for the Basel-based drugmaker, which unveiled a series of deals worth over $25 billion aimed at strengthening its cancer business and exiting underperforming operations last month.

Novartis is looking to plug the hole left by the upcoming expiration of its patent for Gleevec with other treatments, as well as stave off generic competition to the lucrative drug for as long as possible.

Sun, which has tentative approval from the U.S. Food and Drug Administration for a generic version of Gleevec, is the most tangible threat to Novartis' drug.

The drugmaker missed first-quarter sales forecasts last month, blaming a slowdown in sales of the leukemia drug as well as generic competition for Zometa, a bone repair drug.

Under the settlement with Sun, that firm will be allowed to launch a generic version of Gleevec in the United States on Feb. 1, 2016, which gives Novartis seven extra months without the competition from the Indian firm.

"This settlement validates the Novartis patents while allowing Sun Pharma's subsidiary to enter the market with its generic product," Novartis said.

The settlement is mildly positive for Novartis, according to analysts, although investors may have been hoping for a longer delay to Sun's product reaching the market.

"Whilst this settlement might not be as long a delay as some might have hoped for, it nonetheless should provide upside to current expectations," Jefferies analyst Jeffrey Holford said in a note to investors.

Novartis shares traded 0.2 percent lower at 79.90 Swiss francs following the ruling, compared to a 0.3 percent rise in a European index of drug stocks. (Reporting by Katharina Bart and Aradhana Aravindan; editing by Anupama Dwivedi and Tom Pfeiffer)

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