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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

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.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

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.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

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 re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

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.”

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Blue­bird to miss Q1 dead­line for lo­vo-cel fil­ing, shares sliced

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.