Will Ab­b­Vie bite? De­ci­sion time af­ter Abl­ynx's rheuma­toid arthri­tis drug fails a key study

Abl­ynx has come to the cross­roads with Ab­b­Vie on their block­buster deal to de­vel­op a new IL-6 drug for rheuma­toid arthri­tis. And the Bel­gian biotech com­pa­ny has some ex­plain­ing to do.

This morn­ing Abl­ynx re­leased an­oth­er messy set of Phase IIb da­ta on vo­bar­il­izum­ab. Com­bined with methotrex­ate, the com­bi­na­tion of vo­bar­il­izum­ab and methotrex­ate failed on the pri­ma­ry end­point, un­able to sig­nif­i­cant­ly dis­tin­guish it­self on most out­comes tied to the key mea­sure: An im­prove­ment of at least 20% on a dis­ease rat­ing score – ACR20 – af­ter 12 and 24 weeks of treat­ment. The drug even fell short on mea­sur­ing pa­tients’ abil­i­ty to func­tion bet­ter, with 71% in the methotrex­ate arm re­port­ing a clin­i­cal­ly mean­ing­ful im­prove­ment in phys­i­cal func­tion com­pared to 65% tak­ing a com­bi­na­tion of vo­bar­il­izum­ab and methotrex­ate.

The drug/methotrex­ate com­bo did bet­ter on ACR50 and ACR70 scores as well as scores for low dis­ease ac­tiv­i­ty. But in an in­tense­ly com­pet­i­tive field, Ab­b­Vie is fac­ing a Q4 dead­line to de­cide whether it will buy the drug and square off against far more ad­vanced ri­vals like Eli Lil­ly and In­cyte (baric­i­tinib), GSK and J&J (sirukum­ab) and Re­gen­eron/Sanofi (sar­ilum­ab). Ab­b­Vie al­so has its own Phase III ef­fort un­der­way, which it has high hopes for.

Shares of Abl­ynx {Eu­ronext Brus­sels: $ABLX} ini­tial­ly surged Tues­day, but slumped by mid-morn­ing, trad­ing down about 4%.

It can be hard to com­pare da­ta on these drugs. Abl­ynx chose to sim­ply se­lect pa­tients al­ready on methotrex­ate to com­pare their com­bo. The com­pe­ti­tion, though, has been rack­ing up late-stage suc­cess­es among treat­ment-re­sis­tant pa­tients or in head-to-head stud­ies with Ab­b­Vie’s Hu­mi­ra, the world’s biggest drug fran­chise at $14 bil­lion in 2015 rev­enue.

The lat­est da­ta set comes just one month af­ter Abl­ynx al­so demon­strat­ed that their drug was at best a matchup against Roche’s Actem­ra (ap­proved in 2010) on the key ACR scores, though it did bet­ter on dis­ease ac­tiv­i­ty scores.

Abl­ynx is paint­ing all of this as a sol­id suc­cess point­ing to “best-in-class po­ten­tial,” hop­ing to per­suade an­a­lysts to fo­cus in on the high scores or eas­i­er treat­ment reg­i­men for their drug and ig­nore what they’re call­ing a high place­bo re­sponse. Pay­ers, though, are like­ly to de­ter­mine that the drug proves that gener­ic methotrex­ate or an ex­ist­ing brand­ed drug is ei­ther as good or al­most as good as the ex­per­i­men­tal drug in com­bi­na­tion with methotrex­ate. And it will have a hard time catch­ing up with oth­er drugs that are much far­ther along in the pipeline.

Ab­b­Vie has to de­cide now whether it will take a chance on the drug, and take it in­to Phase III as oth­ers are look­ing for an ap­proval.

Ab­b­Vie paid $175 mil­lion up­front to part­ner with Abl­ynx on this drug, a big piece of an $840 mil­lion deal that gives Ab­b­Vie the op­tion to take it through Phase III. Ab­b­Vie, though, can be dis­tinct­ly un­sen­ti­men­tal about mar­gin­al drugs, as it proved with its de­ci­sion to bag its deal with In­fin­i­ty af­ter a suc­cess­ful, but com­mer­cial­ly un­con­vinc­ing, study of a lead can­cer drug.

Michael Sev­eri­no, Ex­ec­u­tive Vice Pres­i­dent, Chief Sci­en­tif­ic Of­fi­cer, Ab­b­Vie

There’s al­so a pre­ferred late-stage pro­gram at Ab­b­Vie to con­sid­er. Last fall, Ab­b­Vie axed a col­lab­o­ra­tion it has in place with Gala­pa­gos for their JAK1 in­hibitor fil­go­tinib (GLP0634), say­ing it pre­ferred to take their in-house pro­gram for ABT-494 in­to Phase III for arthri­tis.

“We be­lieve ABT-494 has the po­ten­tial to be­come a best-in-class ther­a­py, par­tic­u­lar­ly in the most chal­leng­ing pa­tient pop­u­la­tion of TNF-in­ad­e­quate re­spon­ders,” Ab­b­Vie CSO Michael Sev­eri­no not­ed af­ter the Phase II da­ta came out in Sep­tem­ber. The Phase III start­ed in Jan­u­ary.

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.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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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.

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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.

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.

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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.”