Geoffrey Porges, SVB Leerink

Se­ries of JAK in­hibitor de­lays may sig­nal an up­com­ing FDA ad­comm

Three-month re­view de­lays from the FDA have be­come the norm in re­cent days for JAK in­hibitors, some of which are seek­ing la­bel ex­pan­sions.

But the push­back of these ac­tion dates for Ab­b­Vie’s Rin­voq, Pfiz­er’s Xel­janz and abroc­i­tinib, and Eli Lil­ly’s Olu­mi­ant may be a sign that the FDA is prepar­ing to hold an ad­vi­so­ry com­mit­tee of out­side ex­perts to re­view the risk/ben­e­fit pro­files of JAK in­hibitors for atopic der­mati­tis, ac­cord­ing to SVB Leerink an­a­lyst Ge­of­frey Porges. This wouldn’t be the first time this year that the FDA wants to re­view a se­ries of drugs be­fore an ad­comm as the agency is hold­ing such a re­view lat­er this month for can­cer drugs that have pre­vi­ous­ly won ac­cel­er­at­ed ap­provals.

“This is not a com­plete sur­prise giv­en the FDA’s cau­tious stance on JAK in­hibitors gen­er­al­ly, their re­luc­tance to ap­prove the high­er dos­es most­ly re­quired for ef­fi­ca­cy in atopic der­mati­tis, and their re­cent ac­tions on ap­pli­ca­tions from all the JAK de­vel­op­ers,” Porges writes. “While the FDA’s more strin­gent ap­proach to JAKs as a drug class in­creas­es the per­ceived lev­el of risk to the cat­e­go­ry’s out­look, we be­lieve that ul­ti­mate­ly Pfiz­er’s abroc­i­tinib should get ap­proved in this in­di­ca­tion giv­en its rel­a­tive­ly clean pro­file (vs. Xel­janz).”

Any fail­ures for these JAK in­hibitors in atopic der­mati­tis will fur­ther firm up Re­gen­eron and Sanofi’s top po­si­tion with Dupix­ent, “giv­en its ex­cel­lent safe­ty track record in this in­di­ca­tion,” Porges writes.

He al­so says Ab­b­Vie in­di­cat­ed that FDA’s re­quest for more in­for­ma­tion on Rin­voq was dri­ven by Pfiz­er’s an­nounce­ment in late Jan­u­ary that Xel­janz failed a six-year safe­ty study man­dat­ed by the FDA.

“While we do not ex­pect any JAKs to be used ahead of Dupix­ent in AD, the strong re­sults from the 30mg dose in the head-to-head study make Rin­voq a con­tender for sec­ond line treat­ment,” he adds. “Giv­en the mixed his­to­ry of JAKs and hes­i­tan­cy from der­ma­tol­o­gists to uti­lize JAKs in AD, an Ad­Comm may be an ef­fec­tive plat­form to dif­fer­en­ti­ate be­tween JAK can­di­dates in AD, which could ben­e­fit Rin­voq.”

Over­all, Porges thinks the JAK in­hibitor de­lays once again show an FDA that’s hard­en­ing its stance against the in­dus­try, par­tic­u­lar­ly with re­spect to safe­ty is­sues.

“There is a per­cep­tion among in­vestors that the FDA has be­come more ac­tive and de­mand­ing un­der new act­ing com­mis­sion­er Janet Wood­cock,” Porges adds in an­oth­er in­vestor note this week. “If this is a sea change (rather than a co­in­ci­dence of tim­ing), then it seems sen­si­ble to as­sume that reg­u­la­to­ry ap­pli­ca­tions with any un­cer­tain­ties or ques­tions have a high­er-than-ex­pect­ed risk of be­ing de­layed and will be sub­ject to fur­ther in­for­ma­tion re­quests and ad­vi­so­ry com­mit­tee re­views. This is con­sis­tent with most of the era of mod­ern reg­u­la­tion of the bio­phar­ma in­dus­try, but not so much with the last 4-5 years.”

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.

J&J’s Rem­i­cade — the poster child for how to block biosim­i­lars — fi­nal­ly set­tles Pfiz­er suit

Biosimilars have proven time and again (although mostly in Europe) that competition works to bring down the cost of a once-pricey biologic, and can even expand its use.

J&J’s Remicade, however, has always proven to be an outlier.

Back in 2016, Pfizer won FDA approval for its infliximab biosimilar, known as Inflectra, but when the launch foundered, the company sued J&J, claiming that the company’s plan to block biosimilar competition worked incredibly well. Pfizer even went on to win FDA approval for a second infliximab biosimilar in 2017, known as Ixifi, but decided to never launch it.

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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