Sanofi-Aventis, the French drug major which is in a dilemma over a study which has found a possible link between its blockbuster drug Lantus and cancer, has come out with more clarifications to mitigate public concern.
The $3.45-billion drug, approved for sale in the US in 2000, was the first once-a-day form of insulin. Following the disclosure by the study, shares of Sanofi-Aventis SA slumped the most in seven months in Paris trading. The two-day drop knocked $10.8 billion off Sanofi?s market value.
The company on Tuesday said it will convene a ?roundtable of global experts? for advice on how to proceed with a study to address concern that its Lantus diabetes drug may be tied to an increased risk of cancer.
?We are going to work hard and work with the external medical and scientific communities to decide what are our next steps,? said Chris Viehbacher, chief executive officer during a conference call with analysts and investors. Sanofi?s own data show that Lantus is safe, the company said.
Last week, Diabetologia, the journal of the European Association for the Study of Diabetes (EASD), published online data from four studies relating to a possible link between a long-acting insulin analogue, insulin glargine (Lantus) and cancer following evidence from studies in Germany, Sweden, UK and Scotland covering 3.4 lakh people with diabetes. The disturbing result is that malignancies were found more frequently in patients treated with glargine than in those prescribed a comparable dose of human insulin, the study said.
Lantus was Sanofi?s fastest-growing drug last year, with sales up 28% from the previous year. Lantus has sales of about $3.45 billion in 2008, which is 9.9% of the company?s net pharmaceutical revenue.
In an email statement, Muruga Vadivale, senior director?medical & regulatory affairs, Sanofi-Aventis India, said, ?The results and the way they have been publicised, generating questions and anxiety among patients and Health Care professionals, are the sole responsibility of the study authors. As the company manufacturing and marketing Lantus, our prominent concern is to bring reassurance to physicians who prescribe Lantus and to the patients treated with Lantus.