New Zealand? Firm eyes US ops to prep for commercial peptides

Zealand Pharma has taken its first steps to build US commercial operations with an aim to launch four peptides over the next five years.

According to Zealand Pharma CEO Emmanuel Dulac, the Danish biotech has “one of the most predictive and promising platforms” in the therapeutic peptide space, and 20 years of discovery and R&D are rapidly approaching fruition.

“We have proven that we can take multiple programs through the clinics and execute on them according to industry benchmarks. To harvest the benefits of these years of investments and efforts, we are now preparing to take our own products through registration and commercialization,” he told stakeholders during Zealand’s first half 2019 financial results call.

Zealand Pharma hopes to become a commercial peptide firm from 2021. Image: AdobeStock/Olivier Le Moal

“We have retained the full commercial rights for our late-stage programs, and assuming we get approval for glepaglutide and dasiglucagon in all indications, we are contemplating four launches in three years, starting in 2021.”

Glepaglutide, a long-acting GLP-2 analog for the treatment of short bowel syndrome (SBS), is in Phase III studies in the US and elsewhere, as is dasiglucagon, being developed in different formulations for severe hypoglycemia, type 1 diabetes management and congenital hyperinsulinism (CHI).

“After a score assessment of market potential and partnerships we concluded that building our own commercial presence in the US to market all of the products coming from our fully own programs is the best way for Zealand Pharma to maximize the value of our company and grow our assets.”

And to support this strategy, the firm said it is taking its first steps into building out its US operations.

“We are accelerating the buildup of our US operations and preparing for transition into a commercial stage company in 2020,” said Dulac.

“We are recruiting for the top leadership roles and started executing on our medical and commercial launch strategy. I look forward to welcoming new team members into these critical roles and to establishing a footprint in the most important markets for potential products.”

Further details have not been announced, but promises were made to update investors “in the coming quarters on our commercial readiness efforts in much more detail.”

For the first half 2019, Zealand reported sales of DKK 19.9 million ($3 million) from an existing license agreement with Alexion, but reported a net operating loss of DKK 272 million ($40 million).