Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Bris­tol My­er­s' next-gen im­munol­o­gy med busts Am­gen's Ote­zla in head-to-head study. Is a show­down com­ing?

In an im­munol­o­gy mar­ket packed with block­buster bi­o­log­ics, Bris­tol My­ers Squibb hopes that its oral drug for milder cas­es could carve out a lu­cra­tive foothold. Now, with its eyes set on bust­ing Am­gen’s Ote­zla, the drug­mak­er is rolling out full da­ta from a pair of late-stage stud­ies that bode well for its can­di­date.

Bris­tol My­ers’ TYK2 in­hibitor deu­cravac­i­tinib sig­nif­i­cant­ly cut pso­ri­a­sis pa­tients’ dis­ease ac­tiv­i­ty and spurred clear­er skin at four months than pa­tients dosed with Am­gen’s Ote­zla or place­bo, ac­cord­ing to da­ta from two Phase III stud­ies pre­sent­ed Fri­day at the vir­tu­al Amer­i­can Acad­e­my of Der­ma­tol­ogy meet­ing.

In terms of PASI 75, a mea­sure of dis­ease sever­i­ty, 58.7% and 53.6% of pa­tients on deu­cravac­i­tinib achieved PASI 75 re­sponse re­spec­tive­ly, in the PO­E­T­YK-PSO-1 and PO­E­T­YK-PSO-2 stud­ies. Mean­while, just 12.7% and 9.4% of place­bo pa­tients and 35.1% and 40.2% of pa­tients on Ote­zla achieved the same.

Even more promis­ing for Bris­tol My­ers, deu­cravac­i­tinib main­tained its edge over Ote­zla be­tween 24 and 52 weeks of treat­ment. At the six-month check-in, 69.0% and 59.3% of pa­tients on deu­cravac­i­tinib hit PASI 75 ver­sus 38.1% and 37.8% on Ote­zla. Of those deu­cravac­i­tinib pa­tients who hit the PASI 75 mark at six months, 82.5% and 81.4% main­tained that re­sponse at the one-year check in.

Deu­cravac­i­tinib showed sim­i­lar­ly high­er rates of skin clear­ance than place­bo and Ote­zla with a slight­ly high­er rate of se­vere side ef­fects than Am­gen’s drug.

Bris­tol My­ers is call­ing the re­sults sig­nif­i­cant even though the da­ta didn’t come with p-val­ues. Ei­ther way, it’s a strong show­ing from its drug, a TYK2 in­hibitor Bris­tol My­ers hopes will ush­er in a next gen­er­a­tion of im­munol­o­gy meds.

The drug­mak­er un­corked top-line da­ta from these stud­ies back in Feb­ru­ary, high­light­ing deu­cravac­i­tinib’s im­por­tant role in dri­ving the com­pa­ny’s pipeline suc­cess. At JP Mor­gan in Jan­u­ary, Bris­tol My­ers tout­ed the drug as one of four ma­jor block­buster pro­grams in the pipeline with the po­ten­tial to earn more than $4 bil­lion a year. The oth­er three were mava­camten, ac­quired in the MyoKar­dia buy­out, along with the ane­mia drug Re­blozyl and the can­cer cell ther­a­py fran­chise.

Un­like the bi­o­log­ics that have come to dom­i­nate the mar­ket, Bris­tol My­ers is aim­ing deu­cravac­i­tinib at milder pa­tients who pre­fer a more con­ve­nient oral dose. Re­searchers hope the TYK2 path­way will of­fer a safer al­ter­na­tive than the JAK class, which has been dogged by safe­ty flags since its in­cep­tion. The case in point there is Pfiz­er’s Xel­janz, which has failed to cap­i­tal­ize on its ear­ly promise with a black box warn­ing for throm­bo­sis and se­ri­ous in­fec­tions, among oth­er things.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.