Positive results of a study involving Amylin’s long-acting release (LAR) version of Byetta (exenatide) were the highlight of the company’s R&D day in New York yesterday.
A new datapoint from a Phase III study showed that 50% of patients treated with exenatide LAR had an A1C (glycated hemoglobin or HbA1c level) of 6.5%. after 30 weeks. Amylin also stated that the filing timetable could have upside if a planned bioequivalence study is waived by the FDA.
“LAR continues to look like a $3 billion-plus seller in our minds as no other diabetes medication — now or on the horizon — comes close to lowering A1c as effectively combined with the weight loss profile, which likely gets better in longer-term studies,” said Jim Reddoch, an analyst with Friedman, Billings, Ramsey & Co., in a note to investors.
Of all the data presented so far, this may be the most powerful result in terms of positioning the drug, according to Reddoch.
For example, Novo Nordisk’s Phase III pipeline diabetes treatment liraglutide barely gets patients to the 7% A1c average level. In two of the trials involving liraglutide, well less than 50% made it to 7%. In the exenatide LAR trial, roughly 75% made it to 7%.
“The (exenatide) LAR data should blow away data from the LEAD (liraglutide) trials at the American Diabetes Assoication (ADA),” Reddoch said. “Timetable-wise, a scenario for an upside was presented. Amylin says it is possible that a bioequivalence trial it is planning could be waived.”
Phase III trials testing exentide LAR versus other diabetes medications will begin in 2008 and should position it as a more efficacious drug, Reddoch said. Manufacturing and regulatory updates could move the stock up, as could data at ADA, allowing comparative analyses between LAR and competitors, he added.
Exenatide LAR is expected to eventually replace the immediate-release formulation of Byetta, developed by Amylin and Eli Lilly, has been on the market since April 2005 and the treatment has been used by over 700,000 patients. The first patent for Byetta is set to expire in 2013. Byetta requires twice daily administration by injection, so a once-weekly formulation could be a more attractive option for patients.
An NDA for exenatide LAR is expected to be submitted in 2009.