BY BEN HIRSCHLER
(Reuters) - Sanofi's new Toujeo diabetes drug is on track to receive a potential green light from European regulators this week, building on a U.S. regulatory approval awarded on Wednesday.
Toujeo is a more potent follow-up to the French drugmaker's top-selling Lantus insulin product, which accounts for a fifth of group sales, and the new drug is pivotal to Sanofi's diabetes business as Lantus faces loss of patent protection.
A committee of experts at the European Medicines Agency is considering whether to recommend Toujeo at a regular monthly meeting in London, according to the agency's website. Decisions from such meetings are normally announced around midday on Fridays.
Assuming Toujeo gets a positive opinion, it is likely to be formally approved by the European Commission a couple of months later, allowing Sanofi to launch in its chosen first European markets of Germany and Britain.
The U.S. approval for Toujeo disappointed some Sanofi investors because the wording on the drug's label failed to spell out the benefits of Toujeo over Lantus.
In Europe, however, the labeling rules are different and Sanofi may be able to make more claims for Toujeo.
Pascale Witz, Sanofi's executive vice president of global divisions, said she was confident doctors would recognize the benefits of using Toujeo, even if this was not spelt out on the U.S. label, because clinical studies about the drug had been published in major journals.
Toujeo has the same active ingredient as Lantus, called insulin glargine, but at three times the concentration and with a design to release the insulin more gradually.
The medicine provides similar blood glucose control as Lantus with lower rates of hypoglycemia, a potentially dangerous drop in blood sugar.
Witz declined to comment on the price of Toujeo but said "pricing will not be a barrier to access".
Even with a competitive price, investors fear Sanofi may struggle to switch sufficient patients from Lantus to Toujeo. Many analysts see a modest switch rate of only around 20 percent, although Witz said that figure was too low.
"That's a pessimistic view. We think it's going to be more than that," she said on the sidelines of an Economist pharmaceuticals conference in London.
(Reporting by Ben Hirschler)