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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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Large advertisements for the drug Vivitrol decorate the walls of Grand Central Station on June 15, 2017 in New York City. (Photo: Andrew Lichtenstein via Getty)

FDA slaps down Alk­er­mes for mis­lead­ing Viv­it­rol ads — don't for­get vul­ner­a­bil­i­ty to opi­oid over­dose

The ads piqued interest as soon as they started appearing in 2016: at Grand Central Station, on the Red Line in Cambridge, and on a billboard off the New Jersey Turnpike. All showed a young person, generally with his or her arms crossed, and the question, “what is Vivitrol?”

Vivitrol’s maker, Alkermes, was in the midst of a marketing and lobbying campaign to promote the anti-opioid addiction drug — a campaign that would face significant backlash for tarnishing competitors despite little evidence for Vivitrol’s superiority.

Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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FDA in-house re­view spot­lights an is­sue with one of Hori­zon's end­points but notes ef­fi­ca­cy for lead drug

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.

Seat­tle Ge­net­ics de­tails pos­i­tive OS and PFS da­ta for tu­ca­tinib in breast can­cer

Seattle Genetics $SGEN is showing off more positive data around tucatinib, its pivotal-stage drug for HER2 positive breast cancer.

A month after hearing about solidly upbeat hazard ratios, we learned today that the estimated progression-free survival rate at one year was 33% in the tucatinib arm compared to 12% for patients taking trastuzumab and capecitabine alone.

Median PFS was 7.8 months (95% CI: 7.5, 9.6) in the tucatinib arm, compared to 5.6 months (95% CI: 4.2, 7.1) in the control arm.

Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

It’s a case of some bad timing for Intec.

Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

For the cash-strapped Israeli drug developer, the failure to clinch the deal marks a big blow. As of the third quarter, the company has $15.7 million in cash and equivalents, which HC Wainwright analysts estimate will keep the lights on into mid-2020.

Bris­tol-My­ers shows off a low-pro­file AML con­tender it gained from Cel­gene buy­out — and they’re tak­ing it straight to the FDA

Bristol-Myers Squibb reaped an enormous pipeline with its much-criticized $64 billion megadeal to buy Celgene. And it got a few hidden gems in the deal.

One of those gems was brought out for display on Tuesday, with a late-breaker at ASH on CC-486, which is now being prepped for regulatory filings at the FDA and elsewhere.

Celgene top-lined the positive results in a maintenance setting for acute myeloid leukemia a few months ago, but at ASH investigators pulled back the curtains on the all-important data they believe will give them an advantage in the commercial wars to come.

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