June 26 (Bloomberg) -- Sanofi-Aventis SA’s Lantus diabetes drug was linked to an increased risk of cancer in studies in Germany and Sweden, according to the European Association for the Study of Diabetes, which issued an “urgent” call for further research into the connection.
While patients should continue to take Lantus, they may want to consider alternatives, the group said in an e-mailed statement. The studies are published in the group’s journal, Diabetologia. Paris-based Sanofi said the research wasn’t conclusive and it stood behind the safety of Lantus.
A German study of about 127,000 insulin-treated patients in an insurance database showed a “statistically significant link between patients who had used Lantus insulin and those who had been diagnosed with cancer,” according to the statement. The study didn’t consider Levemir, an insulin produced by Novo Nordisk A/S, the group said.
Sanofi shares slumped 12 percent over the past two days, knocking 7.7 billion euros ($10.8 billion) off its market value, on concern that a study would show increased cancer risks. Lantus is Sanofi’s third-biggest-selling drug and helped first- quarter earnings beat analyst estimates.
After the German study, research was done using patient databases in Sweden, Scotland and the U.K., the association said. The Swedish study found that patients on Lantus alone had twice the risk of breast cancer than patients on insulins other than Lantus, the group said. The Scottish study showed a non- significant increased risk of breast cancer, while the U.K. study found no link between Lantus and cancer, the group said.
Edwin Gale, a professor of diabetic medicine at the University of Bristol and editor of Diabetologia, and Ulf Smith, president of the diabetes group, said in the statement that the studies had limitations, so further research is needed. Smith is a researcher at the Lundberg Laboratory for Diabetes Research at Göteborg University in Sweden.
“We believe people are entitled to know that use of Lantus insulin might be associated with greater risk, but this must also be balanced against the possibility that we might be causing unnecessary alarm by raising these concerns,” they said.
The diabetes research group has given its findings to the European Medicines Agency, the European Union’s drug regulator, and to Sanofi. While a clinical trial would be the best way to confirm the existence of a link to cancer, “such a trial would be slow, unfeasible and unethical,” Smith and Gale said.
“A large combined analysis of the best available databases worldwide is the best way forward, and EASD and Sanofi-Aventis are pledged to carry this investigation forward until we have either confirmed these preliminary observations or, more hopefully, finally put them to rest,” the researchers said in the statement.
“Given the extensive clinical evidence covering over 70,000 patients and the results of post-marketing surveillance arising from 24 million patient-years of experience, Sanofi- Aventis stands behind the safety of Lantus,” Jean-Pierre Lehner, the Paris-based company’s chief medical officer, said in an e-mailed statement. “We consider that the results of these patient registries are not conclusive.”
Concern over Lantus was stoked by Ralph DeFronzo, a diabetes researcher at the University of Texas Health Science Center, on a June 11 conference call sponsored by Credit Suisse, UBS analysts said yesterday. He predicted an “earthquake” event that might prompt doctors to not “feel so comfortable with glargine” insulin, according to a transcript of the call. Glargine is a chemical name for Lantus. He didn’t provide details.
The stock dropped this week as word of the call spread among investors. Analysts at Morgan Stanley and JPMorgan Chase & Co. cut their rating on Sanofi today because of the talk of a study that highlighted the cancer risk.
Lantus is a long-acting, injectable form of insulin that is used to control the blood sugar level in diabetics, who have difficulty producing insulin naturally. The drug, approved for sale in the U.S. in 2000, was the first once-a-day form of insulin. An injection steadily releases insulin into the blood over 24 hours.
Diabetes affects 23.6 million people in the U.S., according to the American Diabetes Association.
Competing diabetes treatments include Byetta, marketed by Eli Lilly & Co. of Indianapolis and San Diego-based Amylin Pharmaceuticals Inc. DeFronzo was an investigator on a company- sponsored study of Byetta, also known as exenatide, which stimulates the body to produce more insulin. Amylin shares surged $1.10, or 8.7 percent, to $13.69 at 4 p.m. New York time in Nasdaq Stock Market trading.
‘Negative Headlines’
“Negative headlines from a publication in a major medical journal could substantially damage the Lantus franchise,” JPMorgan’s Hauber wrote in her report today before the European diabetes group’s announcement. “A worst-case scenario is difficult to quantify before seeing the data.”
Lantus was Sanofi’s fastest-growing drug last year, with sales up 28 percent from the previous year, the company said on Feb. 11. Lantus sales reached 2.45 billion euros ($3.45 billion) in 2008, or 9.9 percent of the company’s net pharmaceutical revenue.
The French drugmaker said in February 2008 it aimed to make the medicine the world’s top diabetes treatment by 2015, overtaking Takeda Pharmaceutical Co.’s Actos. Lantus, the world’s No. 1 insulin, takes second place to Actos in the $23 billion diabetes market.
Chief Executive Officer Chris Viehbacher, who joined Sanofi in December, has handled controversy over a diabetes treatment before. He was the public face of his former employer, GlaxoSmithKline Plc, in the debate over the Avandia diabetes drug, doing media interviews and speaking at regulatory hearings. Avandia lost sales after a report of heart risks in 2007.
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