Novo Nordisk A/S (NOVOB) is likely to proceed with development of a once-weekly version of its daily diabetes shot Victoza or a medicine from the same class to fend off competition from Amylin Pharmaceuticals Inc. (AMLN)’s Bydureon.
Chief Executive Officer Lars Soerensen is “starting to open up” to the idea, Mads Krogsgaard Thomsen, chief science officer, said in a March 30 interview at Novo’s headquarters in Bagsvaerd, a town outside Copenhagen.
A long-acting version of Victoza or the experimental semaglutide, a compound that also mimics the hormone GLP-1 to prompt the pancreas to produce insulin, would allow some diabetics to cut back on injections and would challenge Bydureon, the once-weekly version of the older medicine Byetta that Amylin introduced this year.
Novo will announce which product it has picked when it releases second-quarter results in August, according to Thomsen. For now it awaits data on the long-acting version of Victoza.
“Semaglutide is actually looking quite good but what if once-weekly Victoza looks even better,” he said. “That we still don’t know.”
Novo pushed back its deadline last year for picking a compound after rival products, including Bydureon, suffered setbacks.
The company, the world’s largest maker of insulin, also said it doesn’t expect last week’s Food and Drug Administration advisory panel recommendation on weight-loss treatments to delay approval of Victoza as a weapon against obesity.
An FDA panel voted 17-6 on March 29 to recommend that companies developing weight-loss therapies for the U.S. market conduct tests to assess heart risks.
Novo began selling Victoza in 2009 to expand its offering for blood sugar-lowering medicines. The drug is now in advanced clinical tests for obesity and the Danish company aims to submit it for approval as a weight-loss treatment by the end of next year, according to Thomsen.
“We are not expecting a delay,” Thomsen said. The FDA panel discussions “pertained to new obesity molecules. We already agreed with the FDA that as part of our post-marketing requirements for Victoza we will do a cardiovascular outcome trial.”
There are indications that GLP-1 medicines may be beneficial to the heart, Thomsen said.
“As it looks now GLP-1s, not only ours, seem to be, if anything, cardio-protective,” he said. Even so “that’s never been proven statistically.”
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