In­cyte pulls away 'dam­aged good­s' baric­i­tinib to fo­cus on in­ter­nal pipeline

Jakafi-mak­er In­cyte has ef­fec­tive­ly made Olu­mi­ant (baric­i­tinib) — the tar­nished JAK in­hibitor dogged by safe­ty con­cerns that bare­ly crossed the FDA fin­ish line with a small­er dose — Eli Lil­ly’s prob­lem.

Last June, the FDA ap­proved on­ly the small 2 mg dose of the drug — which In­cyte part­nered with Lil­ly on — with a black box warn­ing high­light­ing the ther­a­py’s side ef­fects, in­clud­ing a star­tling throm­boem­bolism sig­nal, quash­ing Lil­ly’s 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 un­ex­plained change of heart, and al­lowed the mar­ket­ing ap­pli­ca­tion to pro­ceed.

In the first quar­ter of 2019, In­cyte $IN­CY earned baric­i­tinib roy­al­ty pay­ments of rough­ly $16 mil­lion. The com­pa­ny, as part of its quar­ter­ly re­sults on Tues­day, said it had elect­ed to no longer co-fund the de­vel­op­ment of baric­i­tinib, but will con­tin­ue to re­ceive roy­al­ties on glob­al net sales of the drug, in ac­cor­dance with its deal with Lil­ly $LLY.

Da­ta from two late-stage stud­ies eval­u­at­ing baric­i­tinib in pa­tients with mod­er­ate-to-se­vere atopic der­mati­tis is ex­pect­ed to be pre­sent­ed by Lil­ly lat­er this year, in ad­di­tion to re­sults from oth­er on­go­ing Phase III tri­als in the same in­di­ca­tion. Lil­ly, which is com­bat­ing its own pipeline is­sues, has shelved plans to test the treat­ment for pso­ri­at­ic arthri­tis

The de­ci­sion to pull out of baric­i­tinib is not based on the drug’s fu­ture, but rather on the cu­mu­la­tive in­vest­ment In­cyte has made so far, In­cyte chief Hervé Hop­penot told an­a­lysts in a post-earn­ings con­fer­ence call. “There is a point we reached where we be­lieve we have a bet­ter re­turn-on-in­vest­ment…by re­al­lo­cat­ing our re­sources to oth­er pro­grams.”

Hervé Hop­penot

The move is set to save In­cyte be­tween $40 mil­lion and $60 mil­lion this year, which it can pour in­to oth­er pro­grams such as its ex­per­i­men­tal rux­oli­tinib cream, which is be­ing eval­u­at­ed for use in atopic der­mati­tis and vi­tili­go, com­pa­ny ex­ec­u­tives un­der­scored.

On Tues­day, In­cyte al­so is­sued a spate of pipeline up­dates, in­clud­ing that rux­oli­tinib cream had cleared a mid-stage vi­tili­go study, for which de­tailed da­ta will be dis­closed in the sec­ond quar­ter. Mean­while, an FDA de­ci­sion to ex­pand the use of Jakafi for treat­ment of steroid-re­frac­to­ry acute GvHD is ex­pect­ed by May 24. Sales of its flag­ship drug, Jakafi, con­tin­ue to grow steadi­ly.

Marc Frahm

“In­cyte post­ed a rea­son­able quar­ter…We are en­cour­aged that In­cyte has de­cid­ed to dis­con­tin­ue co-fund­ing of baric­i­tinib as we viewed that prod­uct as “dam­aged goods” based up­on its DVT/TE risk. We think in 2019 in­vestors will seek con­fi­dence that In­cyte’s broad on­col­o­gy and in­flam­ma­tion pipeline con­tains growth as­set(s). With mul­ti­ple pipeline op­por­tu­ni­ties (itac­i­tinib, pemi­ga­tinib, top­i­cal rux­oli­tinib, etc.) be­gin­ning to emerge we re­main at Out­per­form,” Cowen’s Marc Frahm wrote in a note.

Shares of the Wilm­ing­ton, Delaware-based drug­mak­er were up near­ly 5% at $78.01 in ear­ly Tues­day trad­ing.

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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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.

Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

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