Olu­mi­ant from Lil­ly, In­cyte clears third eczema study, but who will use it?

Months ago In­cyte $IN­CY elect­ed to stop fund­ing the de­vel­op­ment of Olu­mi­ant (baric­i­tinib) — com­ing up with those funds be­came part­ner Eli Lil­ly’s prob­lem. The JAK in­hibitor, which has been dogged by safe­ty con­cerns, has now cleared an­oth­er late-stage atopic der­mati­tis (AD) study.

In June 2018, the FDA ap­proved on­ly the small 2 mg dose of the drug for rheuma­toid arthri­tis, with a black box warn­ing high­light­ing the ther­a­py’s side ef­fects, in­clud­ing a star­tling throm­boem­bolism sig­nal, quash­ing Lil­ly’s $LLY block­buster dreams. The agency had ini­tial­ly re­ject­ed the drug, de­mand­ing a new study, but un­der the lead­er­ship of (now for­mer) FDA com­mis­sion­er Scott Got­tlieb, the FDA had an in­ex­plic­a­ble change of heart, and al­lowed the mar­ket­ing ap­pli­ca­tion to pro­ceed.

The eczema study, BREEZE-AD7, eval­u­at­ed the im­pact of adding baric­i­tinib (ei­ther 2 mg or 4 mg) to stan­dard-of-care top­i­cal cor­ti­cos­teroids in mod­er­ate-se­vere dis­ease pa­tients, ver­sus those who were just giv­en cor­ti­cos­teroids. The ad­di­tion of baric­i­tinib sig­nif­i­cant­ly im­proved dis­ease sever­i­ty — meet­ing the pri­ma­ry end­point of the study at 16 weeks.

Da­ta from the study showed 30.6% (34/111) AD pa­tients treat­ed with 4 mg baric­i­tinib achieved in­ves­ti­ga­tor’s glob­al as­sess­ment for atopic der­mati­tis score of “clear or al­most clear” ver­sus 14.7% (16/109) in place­bo group at Week 16. The study al­so met the sec­ondary end­points mea­sured by Eczema Area and Sever­i­ty In­dex 75 (EASI75) and 4-Point im­prove­ment on the Itch Num­ber Rat­ing Sale (NRS). This is the third pos­i­tive AD tri­al of baric­i­tinib; da­ta from the first two pos­i­tive tri­als were dis­closed in Feb­ru­ary.

“(B)ari will like­ly play a mi­nor role in AD, which may have con­tributed to In­cyte’s pri­or de­ci­sion to no longer co-fund the de­vel­op­ment of the baric­i­tinib pro­gram with LLY, re­sult­ing in roy­al­ties based on glob­al net sales,” SVB Leerink’s An­drew Berens wrote in a note.

Giv­en the dom­i­nance of (Re­gen­eron’s) Dupix­ent in the mod­er­ate and se­vere AD mar­ket and known safe­ty risks of in­fec­tions, ma­lig­nan­cies, and throm­bo­sis with oral JAK in­hibitors, we be­lieve oral, sys­temic JAK in­hibitors may not cap­ture a mean­ing­ful por­tion of the AD mar­ket. While this pro­file rep­re­sents lim­i­ta­tions of the JAK class for sys­temic ther­a­py, we be­lieve this could open the door for a greater role for top­i­cal JAK us­age, which could be pre­scribed in con­junc­tion with non-JAK sys­temic treat­ment.

In­cyte, as part of its quar­ter­ly re­sults in April, in­di­cat­ed it would in­stead fo­cus on shep­herd­ing its in­ter­nal pipeline through clin­i­cal stud­ies, but con­tin­ue to re­ceive roy­al­ties on glob­al net sales of baric­i­tinib, in ac­cor­dance with its deal with Lil­ly. In the first half of 2019, In­cyte earned about $35 mil­lion in baric­i­tinib roy­al­ties.

One of In­cyte’s in­ter­nal as­sets is its ex­per­i­men­tal rux­oli­tinib cream, which is be­ing eval­u­at­ed for use in atopic der­mati­tis and vi­tili­go.

“If top­i­cal rux­oli­tinib can suc­ceed in the two on­go­ing Phase 3 tri­als (da­ta ex­pect­ed in 2020), we be­lieve the drug could be used across the spec­trum of dis­ease and in con­junc­tion with sys­temic, non-JAK ther­a­py. There­fore, while the pro­file of bari and the JAK class sug­gests lim­it­ed sys­temic us­age in AD, it could al­low greater us­age of top­i­cal rux in this dis­ease. We as­sume a 2021 U.S. launch for top­i­cal rux­oli­tinib, with peak rev­enue of ~$1.1bn,” Berens said.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

Bio­phar­ma ramps up lob­by­ing spend as drug pric­ing leg­is­la­tion nears

The top biopharma companies in the world collectively spent more than $40 million in just the first quarter of 2021 on lobbying Congress as part of preparations to stave off major drug pricing legislation that’s expected later this year.

Although the numbers are not dramatically higher than what the companies collectively spent in the first quarter of 2020, some like GlaxoSmithKline, Teva, Merck and Johnson & Johnson have already increased their quarterly lobbying spend in 2021 by about $1 million more each when compared to recent quarters in 2020.

House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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