Sanofi (SAN) withdrew the application for U.S. approval of an experimental drug called lixisenatide, delaying the company’s effort to bolster sales of diabetes medicines in the world’s biggest pharmaceutical market.
Giving regulators access to data from an existing trial, known as Elixa, to study the treatment’s cardiovascular effects could affect the integrity of the test, the Paris-based company said in a statement today. The drugmaker will resubmit the application in 2015, after completion of the study, Sanofi said. The withdrawal isn’t related to safety issues or deficiencies in the application, Sanofi said.
The delay benefits Novo Nordisk A/S (NOVOB), Bristol-Myers Squibb Co. (BMY) and AstraZeneca Plc, which make competing treatments. The U.S. Food and Drug Administration had been expected to rule by mid-December on lixisenatide, according to data compiled by Bloomberg. The drug is marketed elsewhere under the brand name Lyxumia. Earlier approval would have let it benefit from joint promotion with Sanofi’s Lantus, the world’s best-selling insulin, said Eric Le Berrigaud of Bryan Garnier & Co.
“This is a setback for a franchise that would have benefited from Lyxumia in the U.S. starting in 2014,” the Paris-based analyst said in a report to clients today. He recommends buying Sanofi shares.
Zealand Pharma A/S (ZEAL), the Glostrup, Denmark-based company that licensed the drug to Sanofi, fell the most since its initial public offering in 2010.
A late-stage clinical trial of lixisenatide combined with Lantus is on schedule to begin in the first half of 2014, Sanofi said. Lantus loses U.S. patent protection in 2015.
The FDA introduced tougher standards for the cardiovascular safety of diabetes medicines in 2008, after GlaxoSmithKline Plc’s Avandia diabetes pill was linked to heart attacks.
The Elixa trial is comparing lixisenatide with a placebo in about 6,000 patients with Type 2 diabetes who recently experienced an acute coronary event such as a heart attack. The goal is to see whether the drug affects cardiovascular outcomes for patients.
Elixa is a so-called double-blind study, where neither patients nor their doctors know who is receiving the drug and who’s getting a dummy. The design helps ensure an objective result, since the expectations of the patient and doctor about the drug’s efficacy can’t affect the outcome.
“Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing Elixa study,” the company said in the statement.
Sales of lixisenatide continue in the European Union, Japan, Mexico and Australia, Zealand said in a separate statement. Analysts predict revenue of 481.2 million euros ($639.7 million) for the drug by 2018, based on the average of five estimates compiled by Bloomberg.
Zealand plunged 15 percent to close at 66 kroner at 5:30 p.m. in Copenhagen. The stock declined as much as 23 percent, the biggest intraday drop since the company’s Nov. 24, 2010, initial share sale. Sanofi sank 2.6 percent to close at 72.32 euros.
“Zealand has a solid cash position and we foresee continued commercial roll-out of Lyxumia in 2013 and 2014 in Europe, Japan and elsewhere, where approval has been granted,” Zealand Chief Executive Officer David Solomon said. “We support Sanofi’s view that the integrity of the ongoing full Elixa study should not be put at risk by making interim results publicly available.”
The European Commission approved lixisenatide for sale in February under the brand name Lyxumia, and the FDA accepted the company’s application the same month.
Lixisenatide belongs to a class of drugs known as GLP-1 analogues, which mimic the function of a digestive hormone that stimulates the pancreas to produce insulin after meals. Diabetics lack the insulin needed to convert blood sugar into energy. Novo’s GLP-1 is called Victoza, while Bristol-Myers and AstraZeneca jointly market Byetta and Bydureon.