Lilly Prepares to Launch Bydureon in US

Lilly Chief Executive John Lechleiter, in an interview, stated that, "We intend to file by the end of September. We are assuming it's going to be a six-month type review. If everything goes according to schedule we hope to gain approval for Bydureon in the first half of next year."

A trial of Bydureon, co-developed with Amylin Pharmaceuticals and Alkermes, this month found no link between the drug and changes in heart rhythms, allaying U.S. regulators' concerns.

While offering a more convenient treatment regime than Novo's Victoza, Bydureon's effectiveness failed to match that of once-daily Victoza, trial results published in March showed.

Still, Lechleiter remains upbeat about Bydureon's prospects.

"There aren't many new drugs that are breakthroughs but this is certainly a step forward in terms of convenience."

Both drugs belong to a new class of therapies that not only control blood sugar levels but can prompt weight loss, while some older medicines can spur weight gain.

Lechleiter added that several trials have established Bydureon's effectiveness compared with a number of other treatments. "With respect to Victoza, physicians will have to decide, weighing once a day (injections) versus once a week," the CEO said.

Lechleiter said Bydureon, approved by European health regulators last month, is now being launched in that region.

The company's move to pool much of its diabetes-drug development program with Boehringer Ingelheim could be a model for other disease types, Lechleiter said. "I think if we could replicate that in other therapeutic areas it would be very interesting. Having said that each of the areas is a little bit different."

Eli Lilly News Release, July 2011