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.

#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, gives California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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