Sanofi, Zealand hit by U.S. setback for diabetes drug

Reuters News
Posted: Sep 12, 2013 1:12 AM
Sanofi, Zealand hit by U.S. setback for diabetes drug

PARIS (Reuters) - French drugmaker Sanofi said on Thursday it would withdraw its U.S. application for diabetes treatment lixisenatide in order to wait for results from an ongoing cardiovascular patient study.

The decision, which will delay the drug's launch in the world's biggest market, sent shares in Sanofi down 1.6 percent by 0720 GMT, while its smaller Danish partner Zealand Pharma dropped 20 percent.

Sanofi said it would resubmit its application in 2015, after the completion of the cardiovascular test, and said the decision was "not related to safety issues or deficiencies in the new drug application."

Lixisenatide, which has already been approved for sale in Europe under the brand name Lyxumia, is one of the new products Sanofi is betting on to restore growth after losing several blockbusters to generic competition.

Sanofi expects to have the full results of its evaluation of lixisenatide in acute coronary syndrome, which is focused on patients with high cardiovascular risk, in approximately 15 months.

Lyxumia is part of a new class of diabetes treatments called GLP-1 analogues that prompt the body to release insulin when a diabetic's blood sugar level climbs too high.

It competes with other GLP-1 drugs as Victoza, from Novo Nordisk, and Byetta and Bydureon, from Bristol-Myers Squibb and AstraZeneca.

Sanofi added that a combination of lixisenatide and its existing insulin drug Lantus remains on schedule to enter into final Phase III clinical testing in the first half of 2014. The combination is known as LixiLan.

(Reporting by Lionel Laurent and Ben Hirschler; editing by Blaise Robinson and Jane Merriman)