Zealand ac­quires a strug­gling di­a­betes med-tech in push in­to US mar­ket

Zealand Phar­ma is ex­pand­ing again.

Four months af­ter buy­ing out Cana­da’s En­cy­cle Ther­a­peu­tics and their li­brary of GI-drug­ging pep­tides, Zealand has agreed to pur­chase Va­ler­i­tas, a strug­gling med­ical tech­nol­o­gy com­pa­ny fo­cused on di­a­betes. It will cost them $23 mil­lion.

The deal pri­mar­i­ly serves as an­oth­er on­ramp for the biotech to en­ter the US mar­ket. Copen­hagen-based Zealand has pre­vi­ous­ly part­nered with large phar­ma com­pa­nies, most no­tably join­ing with Sanofi on a pair of di­a­betes drugs that in­clud­ed the biotech’s GLP-1 ana­log: Soli­qua and Lyx­u­mia.

But Soli­qua was a huge com­mer­cial dis­ap­point­ment. Pegged as a fu­ture block­buster, it sold just €26 mil­lion in its first full year be­fore Zealand sold off its fu­ture roy­al­ties to Roy­al­ty Phar­ma. Zealand, pin­ning the drug’s fail­ure on Sanofi, said they were go­ing to do fu­ture com­mer­cial launch­es in-house.

Em­manuel Du­lac

No easy feat for a small biotech, the com­mer­cial piv­ot al­so re­quired re­ori­ent­ing their R&D to fo­cus on rar­er in­di­ca­tions, where small pa­tient pop­u­la­tions make mar­ket­ing eas­i­er. They al­so ful­ly reshuf­fled their C–Suite. Last year, they brought in a new CSO and a new CFO and hired for­mer Al­ny­lam ex­ec­u­tive Em­manuel Du­lac as CEO.

Zealand said this ac­qui­si­tion will help them as they look to “be­come a ful­ly in­te­grat­ed biotech­nol­o­gy com­pa­ny with com­mer­cial op­er­a­tions in the U.S” and specif­i­cal­ly as they try to launch dasiglucagon in 2021. An ana­log to glucagon, the drug is be­ing de­vel­oped first for di­a­betes with se­vere hy­po­glycemia. Af­ter a pos­i­tive Phase III, the biotech has said they will file an NDA ear­ly this year.

Va­ler­i­tas si­mul­ta­ne­ous­ly filed for Chap­ter 11 bank­rupt­cy, in or­der “to ac­com­plish the sale in the most ef­fi­cient man­ner.” Zealand will con­tin­ue all of Va­ler­i­tas’s com­mer­cial op­er­a­tion and re­tain “near­ly all” em­ploy­ees, Va­ler­i­tas said in their press re­lease.

So­cial im­age: Zealand Phar­ma

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

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Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

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Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.