Deer­field com­mits $50M-plus to trans­la­tion­al drug R&D at the Broad

Er­ic Lan­der

Deer­field Man­age­ment and the fa­mous Broad In­sti­tute of MIT and Har­vard have come up with a nov­el plan for pur­su­ing trans­la­tion­al drug re­search work.

In the deal an­nounced this morn­ing, Deer­field will in­vest more than $50 mil­lion in­to projects at the Broad over the next five years. And the biotech in­vestor plans to fol­low up with sup­port to cre­ate new biotechs out of the re­search, with “sig­nif­i­cant ad­di­tion­al re­sources” avail­able for de­vel­op­ment work.

“Over the last decade, sci­en­tif­ic ad­vances have made it pos­si­ble to rapid­ly un­der­stand the bi­o­log­i­cal ba­sis of dis­ease at un­prece­dent­ed res­o­lu­tion,” said Er­ic Lan­der, pres­i­dent and found­ing di­rec­tor of the Broad In­sti­tute. “The chal­lenge now is to de­vel­op ways to speed the process of turn­ing these sci­en­tif­ic in­sights in­to ther­a­pies that ben­e­fit pa­tients.”

Deer­field isn’t stop­ping there. It plans to trans­fer any prof­its for its Health­care In­no­va­tions Fund over to its phil­an­thropic arm, which will be used to sup­port its non­prof­it work.

James Fly­nn

“Over the last few years, Broad In­sti­tute re­searchers have de­vel­oped a num­ber of un­prece­dent­ed bi­o­log­i­cal in­sights and ther­a­peu­tic hy­pothe­ses that are ear­ly-stage but po­ten­tial­ly trans­for­ma­tive,” said James Fly­nn, Man­ag­ing Part­ner of Deer­field. “Mov­ing these hy­pothe­ses from the lab to­ward the clin­ic re­quires sig­nif­i­cant fi­nan­cial re­sources to build on work launched by phil­an­thropy and grants, and are not yet far enough along to at­tract tra­di­tion­al ven­ture fund­ing or phar­ma­ceu­ti­cal col­lab­o­ra­tions. We are pre­pared to fund and de­vel­op these projects so Broad re­searchers can im­me­di­ate­ly pur­sue bold ideas, and have con­fi­dence that re­al break­throughs will have ad­di­tion­al sup­port to move to­ward clin­i­cal suc­cess.”

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.

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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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.

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.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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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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