Copenhagen, Denmark – The FDA rejected Zealand Pharma’s glucagon receptor agonist in congenital hyperinsulinism (CHI) after identifying problems at a third-party manufacturing site.
The company said it remains confident that it can resubmit in the first half of 2024.
Zealand revealed last week that the regulator issued a complete response letter in response to part one of the NDA for dasiglucagon to prevent and treat hypoglycemia in newborns seven days old or older for up to three weeks of dosing.
Dasiglucagon won FDA approval under the brand name Zegalogue in 2021 as a treatment for severe hypoglycemia in adults and children with diabetes, but it has since struggled to meet revenue expectations.
The agency’s thumbs-down was due to “deficiencies identified following an inspection at a third-party contract manufacturing facility,” Zealand said in a company release. The biotech did not detail these deficiencies, though it noted they were not specific to dasiglucagon. The CRL did not highlight any problems with the data package for the drug or any safety concerns.
Zealand plans to resubmit part one of the NDA in the first half of 2024 assuming a successful reinspection of the site in question. The company also expects to provide additional analyses of continuous glucose monitoring datasets requested by the FDA for part two of its NDA in CHI, pertaining to the use of dasiglucagon for more than three weeks.
A week before the CRL was announced, Zealand inked a €90 million ($99 million) loan facility agreement with the European Investment Bank. The funds are expected to be spread across three tranches with the first tranche of €50 million ($55.5 million) on track to be disbursed to the company in early 2024.
“Whilst the CRL is disappointing, we do not view it as material,” Jefferies analysts said Tuesday.
The analysts said that CHI is a “minor contribution” to the bank’s valuation of Zealand, with the peak sales projection for the indication sitting at $900 million. Besides, chronic use of dasiglucagon for longer than three weeks is “likely to drive the bulk of commercial opportunity” in CHI, they noted.
The Jefferies analysts instead put more stock in the rest of Zealand’s pipeline, with particular enthusiasm for its amylin-based approach to obesity, which could present a $10 billion peak sales opportunity. Survodutide, the amylin candidate, is currently in Phase III trials as part of a partnership with Boehringer Ingelheim. The company also has a wholly-owned long-acting amylin asset called petrelintide that’s currently in Phase Ib development.
CHI is an ultra-rare disease that develops when pancreatic beta cells don’t function as they should and release too much insulin. The condition affects between 180 and 300 newborns in the US and Europe each year, according to Zealand.
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Anna Krassowska
Vice President, Investor Relations & Corporate Communications
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