After spurning Sanofi for diabetes disappointment, Zealand nets FDA approval in severe hypoglycemia
About two and a half years after selling off royalties on a disappointing Sanofi-partnered diabetes drug, Zealand Pharma now has its own in-house program to boast about.
Zealand received FDA approval for dasiglucagon to treat severe hypoglycemia in children and adults with diabetes older than 6 years, the Danish biotech announced Monday. The drug will be called Zegalogue and a commercial launch is expected in late June.
News of the approval came before the market closed Monday afternoon, sending Zealand $ZEAL shares up about 13% at the time.
Severe hypoglycemia can occur in diabetic patients following insulin treatment, Zealand says, and results in a potentially life-threatening drop in blood glucose levels. The condition is particularly prevalent in children, who may not always be able to monitor their glucose after taking insulin.
Monday’s approval comes from a slate of three Phase III trials that showed injectable Zegalogue significantly reduced the time to treatment success compared to placebo. Success was defined as plasma glucose recovery, or an increase in blood glucose of at least 20 mg/dL from time of administration, without additional intervention within 45 minutes.
In the studies, both children and adults using Zegalogue saw their glucose levels recover by a median time of only 10 minutes, versus 30 to 45 minutes for the placebo group. Zealand also highlighted that 99% of patients in the main adult trial recovered within 15 minutes. The biotech enrolled 253 adults and children across the three studies.
During a conference call with investors Tuesday morning, Zealand said it’s prepping a commercial launch for late June in order to catch the “back to school” market for children. They’re expecting a 60% increase in sales volume from the expected launch date to mid-August.
Zealand is quite familiar with the diabetes market, having previously secured approval for a wearable insulin delivery product to manage type 2 diabetes. They had also partnered with Sanofi on a pair of diabetes drugs that included the biotech’s GLP-1 analog in Soliqua and Lyxumia.
But Soliqua was a massive commercial disappointment, netting just €26 million in its first full year after being pegged as a potential blockbuster. Zealand sold future royalties for the drugs to Royalty Pharma in late 2018, getting a $205 million cash injection in exchange for $85 million in commercial milestones in addition to the royalty stream.
After blaming the lackluster sales on the French pharma, Zealand said it would plan commercial launches in-house rather than with partners. They also turned their R&D attention to rarer indications and mixed things up at the C-suite level, adding a new CSO, CFO and CEO back in 2019.
Looking forward to 2021, Zealand is still planning additional trials for Zegalogue in other indications. This year, they’re planning to launch a Phase III study for the drug as a dual-hormone artificial pancreas pump and are expecting results from a Phase III in congenital hyperinsulinism, with the goal of submitting an NDA next year.