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.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Bluebird bio had expected to submit a BLA for its sickle cell disease gene therapy lovotibeglogene autotemcel, or lovo-cel, by Friday. Now, that deadline is getting punted for at least a couple of weeks.

CEO Andrew Obenshain detailed the update during the company’s full-year earnings call Wednesday morning after the gene therapy specialist reported the development in its Q4 and 2022 report.

“We will likely miss the Q1 2023 submission goal,” Obenshain said, noting the application is fully written and ready to go. But bluebird is still waiting on FDA feedback for the company’s CMC module submitted in early March.