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

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

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.