Tag Archives: ZEAL

Zealand Initiates Ph3 Dasiglucagon Pediatric Hypoglycemia Study

Zealand announced it has initiated a Ph3 pediatric dasiglucagon hypoglycemia study, which is consistent with timing previously provided by Zealand (September 2018). Recall, Zealand recently released positive topline results for its Ph3 pivotal study in adults. Below, FENIX provides an overview the of pediatric dasiglucagon study as well as thoughts on the pediatric glucagon rescue market.

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Dasiglucagon Ph3 Meets Primary and Secondary Endpoints

Zealand Pharma announced positive topline results and held a subsequent investor call to discuss data from its Ph3 pivotal dasiglucagon hypoglycemia rescue trial. Below, FENIX provides an overview of the results and potential impact on the glucagon rescue market.

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Zealand Lixi Royalty Sale May Indicate BD Challenges

Last week, Zealand sold its rights to Soliqua and Lyxumia future revenue streams to Royalty Pharma for $205M. While Zealand said it will use the funding to continue its pipeline progression, the sale could also indicate Zealand is having difficulty in some of its near-term business development initiatives, including finding a global commercialization partner for dasiglucagon in hypo rescue. Although speculative, it was likely easier for Zealand to sell its future Soliqua/Lyxumia royalty streams than to raise operational proceeds from the public markets. Below, FENIX provides thoughts on the sale and potential read-through to a dasiglucagon partnership.

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Zealand Q2 ’18 earnings summary

Zealand hosted its Q2 ’18 earnings call (press release) and provided updates on its diabetes portfolio including dasiglucagon, which is being studied for three distinct indications (hypoglycemia rescue, use in a dual-hormone pump, and congenital hyperinsulinism).

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Glucagon: Thoughts on Mylan Generic and Novel Launch Timings

The glucagon market for severe hypoglycemia rescue will be evolving in the near future with the anticipated filings of new ready-to-use products from Lilly and Xeris. However, the upcoming Mylan rescue product announced a few months ago will play a significant role in the rescue market ahead of the novel product launches. Below, FENIX provides a rich analysis on the potential timing of the upcoming glucagon rescue entrants from Lilly and Xeris, including also what Mylan’s product may or may not be.

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Thoughts on Beta Bionics and Implications to Stable Glucagon, Senseonics, and Fiasp

Beta Bionics has initiated (press release) their home-use clinical trial (CT.gov record)of an insulin-only iLet AP system. Additionally, Ed Damiano, Beta Bionic’s CEO, presented at the Friends For Life conference and provided an update on the iLet commercial device. Below, FENIX provides analysis of the iLet study as well as implications to the glucagon market.

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Drug ADA ‘18 Key Data Press Releases (June 23)

21 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs, devices, and apps, a major increase from 9 on the first day of ADA ‘17. Below, FENIX has provided context and analysis for 14 drug-related announcements, with analysis of device and app-related announcements to follow in a separate alert.

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Zealand completes 2nd Ph3 pivotal rescue trial for dasiglucagon

Zealand reported completion of the second Ph3 dasiglucagon pivotal trial for the treatment of severe hypoglycemia, slightly ahead of previous guidance. Results of the trial, which included 156 T1DM subjects, are now anticipated in Q3 2018.

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Zealand Q1 ‘18 Earnings Update

Zealand hosted its Q1 ‘18 earnings call and provided updates on its diabetes portfolio including dasiglucagon. Additionally, Zealand discussed the potential of a priority review voucher (PRV) for dasiglucagon in congenital hyperinsulinism (CHI).

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