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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).