Zealand summons Novo Nordisk to resuscitate floundering diabetes newcomer Zegalogue

If at first you don’t succeed, call Novo Nordisk. That’s the plan at Zealand Pharma, at least, as the Danish drugmaker summons its crosstown rival in diabetes to help salvage the launch of severe hypoglycemia med Zegalogue.

Zealand said Wednesday it has forged a global license and development pact with Novo Nordisk to take the marketing reins on Zegalogue—also Zealand’s first launch. The drug won FDA approval last March for severe low blood sugar in diabetes, but so far, sales of the med and its companion diagnostic V-GO have failed to impress.

With the Zegalogue launch imploding, Zealand in March drafted plans to swap in a new CEO, Adam Steensberg, M.D., and to streamline its commercial operations. Specifically, Zealand planned to cull 90% of its U.S. workforce and scale back annual operating expenses by at least 35% versus 2021.

The new deal with Novo will furnish Zealand with 25 million Danish kroner ($3.3 million) upfront, which could grow to upwards of 45 million kroner (about $6 million) if the companies hit certain near-term development, regulatory and manufacturing milestones on Zegalogue, the partners explained in a release.

While Novo has thrown Zealand a life raft of sorts, the Zegalogue maker doesn’t expect the financial tailwind to boost its earnings forecast for the year. Last month, Zealand said it expected its hypoglycemia injection to bring home 11.5 million kroner ($1.52 million) in 2022, give or take 10%, marking a 7.5 million kroner (roughly $1 million) reduction from the full-year sales augury it issued in May.

Long-term, Zealand is looking at up to 220 million kroner ($29.25 million) in potential sales-based milestones and tiered royalties under the Novo agreement, where it will continue to oversee certain “planned regulatory, development and manufacturing activities to support further [Zegalogue] development and approval outside of the U.S.”

While Novo takes over on the Zegalogue commercial front, Zealand will keep hold of all non-licensed intellectual property rights to its other dasiglucagon development programs. Dasiglucagon is the generic name for Zegalogue. Zealand is also testing the glucagon-analog in kids with congenital hyperinsulinism, where a recent phase 3 win tees up the med for another FDA filing by year-end.

Zealand’s Big Pharma marketing pacts haven’t always turned out well, however. Once aligned with Sanofi on the diabetes drug Soliqua, Zealand parted ways with its commercial partner in early 2018 after the French drugmaker said the product had turned out to be a tough sell to doctors. Burned by the unimpressive Soliqua showing, Zealand at the time said it would tackle future launches solo, with plans then centering on rare disease prospect glepaglutide.

“If we give up control to a pharma company we will be evaluated against their internal portfolio and there is a risk of you getting assigned to a lower priority,” then-CEO at Zealand, Britt Meelby Jensen, told Reuters several years back.

While a partnerless launch in glepaglutide’s target indication of short bowel syndrome may be easier if the drug wins approval, Zepalogue has proven that the jam-packed diabetes market is a much tougher nut to crack.