Po­laris cash­es in its chips as Langer-backed Ar­sia is auc­tioned off to Ea­gle for up to $78M

Robert Langer, pho­to cred­it: Chem­i­cal Her­itage Foun­da­tion

Re­cent­ly frus­trat­ed in its at­tempt to win a reg­u­la­to­ry ap­proval at the FDA, Ea­gle Phar­ma­ceu­ti­cals $EGRX has swooped in to buy Po­laris-backed Ar­sia Ther­a­peu­tics for a rel­a­tive­ly mod­est up­front pay­ment. The deal comes with the ser­vices of Ar­sia’s sci­en­tif­ic co-founders, MIT’s high pro­file drug de­liv­ery spe­cial­ist Bob Langer and Alexan­der Klibanov, who are sign­ing on as ad­vis­ers to the new own­ers.

Ar­sia is go­ing for $30 mil­lion up front; $27.3 mil­lion in cash and an­oth­er $2.7 mil­lion in stock. And Wood­cliff Lake, NJ-based Ea­gle added $48 mil­lion in po­ten­tial mile­stones.

As part of this deal, Ar­sia’s sci­en­tif­ic team is be­ing trans­ferred to Ea­gle, which is keep­ing the biotech’s pres­ence in the Cam­bridge, MA hub.

Ea­gle has a mar­ket cap of $1.3 bil­lion.

Scott Tar­riff, Ea­gle CEO

Langer has long spe­cial­ized in ad­vanc­ing new tech­nolo­gies de­signed to im­prove ther­a­pies through re­for­mu­la­tion. In this case, Ar­sia— helmed by Pfiz­er vet and Po­laris part­ner Amy Schul­man — dealt with the vis­cos­i­ty of bi­o­log­ics; cre­at­ing con­densed ther­a­pies that are eas­i­er to ad­min­is­ter. By re­for­mu­lat­ing these drugs Ar­sia — now Ea­gle — ex­pects to make it pos­si­ble to de­liv­er them through sub­cu­ta­neous in­jec­tion rather than more dif­fi­cult IV ap­proach­es.

That tech drew the at­ten­tion of Bio­gen $BI­IB, which part­nered with Ar­sia on its he­mo­phil­ia drugs, which are be­ing spun out in­to a new com­pa­ny.

That tech al­so fits well in­to Ea­gle’s plans to come up with so-called bio­bet­ters, new and im­proved ver­sions of some high earn­ers in the field. Last spring the FDA re­ject­ed Ea­gle’s ap­pli­ca­tion for a quick-use ver­sion of the an­ti­co­ag­u­lant An­giomax.

Im­por­tant­ly, Ar­sia cur­rent­ly has sev­er­al ear­ly-stage part­ner­ships with phar­ma­ceu­ti­cal com­pa­nies. “We plan to part­ner with key biosim­i­lar com­pa­nies to help al­ter their ex­ist­ing pipelines in­to bio­bet­ters. This is a nat­ur­al ex­ten­sion of Ea­gle’s busi­ness mod­el, ap­plied to the bi­o­log­ics space,” stat­ed Scott Tar­riff, Pres­i­dent and Chief Ex­ec­u­tive Of­fi­cer of Ea­gle.

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.

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.

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.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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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.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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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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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

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.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

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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