Teva Pharmaceutical Industries Ltd. climbed the most in more than two weeks on speculation failure by the company to win U.S. approval for a new formulation of its multiple sclerosis drug Copaxone means it will be more difficult for competitors to enter the market.

Teva received a complete response letter from the Food and Drug Administration saying the company’s application for the new formulation of Copaxone with a higher concentration of medicine can’t be approved as submitted and may require a new study to prove it works, the company said Dec. 23.
“Given that the FDA is requiring clinical trial efficacy data from the originator because of a concentration change, the likelihood of the FDA requiring clinical trials for generics is even higher,” John Boris, an analyst at Citigroup Inc. in New York, wrote in a Dec. 23 report.
About 19 percent of Teva’s sales come from Copaxone, an inject-able drug that faces new competition after the FDA in September approved the first pill for multiple sclerosis, Novartis AG’s Gilenya.
The FDA’s letter “supports Teva’s belief that even slight changes to a glatiramoid like Copaxone can significantly and unpredictably influence the efficacy, toxicity and immunogenicity profile of the compound,” the Petah Tikva, Israel-based company said.
(Source: Bloomberg)