Sanofi's ($SNY) second pivotal trial for a new diabetes drug combo came through with positive head-to-head results against Lantus, according to its biotech partner. And that clears the last hurdle standing in the way of marketing applications on both sides of the Atlantic as it tries to shore up an eroding blockbuster franchise against heated competition.
LixiLan combines the GLP-1 drug lixisenatide with its franchise insulin Lantus, a megablockbuster which is facing generic competition for the first time this year. Sanofi partner Zealand, which outlicensed lixisenatide, says the combo did significantly better than Lantus alone in reducing HbA1c after investigators tested it among 736 patients with Type 2 diabetes. The actual data, though, won't arrive until later in the year.
Sanofi has been scrambling to staunch the decline in revenue from Lantus, turning to some new arrivals like Toujeo to fill the gap. Its hopes to gain an approval for lixisenatide back in 2013, though, were hobbled by its need to produce more cardio safety data, which arrived in June. Sanofi intends to resubmit lixisenatide in Q3, which should set up its application for the combo followup.
Sanofi needs a win here. Lantus earned $7 billion for the Big Pharma last year, protecting it against a poor in-house R&D record--although its close partner Regeneron ($REGN) pushed ahead to gain a pioneering OK for a new PCSK9 cholesterol drug that many expect will earn billions for both companies.
The competitive Novo Nordisk ($NVO), meanwhile, has been marketing its combination of the GLP-1 drug Victoza with the long-acting insulin Tresiba in Europe. Just before Sanofi pulled back in 2013, the FDA rejected Tresiba in a stunning setback. But Novo says it's now on track to win a badly needed approval in the U.S. after the FDA accepted its new application in April based on interim study data.
"With positive results now demonstrated in two pivotal Phase III trials, the planned regulatory submissions of LixiLan by Sanofi before year-end in the US and next year in Europe remain on track," noted Zealand CEO Britt Meelby Jensen in a statement. "It is our belief that the LixiLan fixed-ratio combination of our invented medicine, lixisenatide, with insulin glargine has the potential to offer patients with Type 2 diabetes a new valuable type of treatment--for use both after failure of oral medication, and when basal insulin alone does not provide sufficient blood sugar control."
- here's the release