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.

From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

Pfizer, South San Francisco — Jeff Rumans for Endpoints News

UP­DAT­ED: Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

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A preda­tor's world? Top an­a­lyst sees the 'haves' and the 'haven't­s' di­verge as biotech bub­bles form — and col­lapse

Josh Schimmer

We’ve all seen the deluge of cash that’s been pouring into biotech from every angle: VCs, IPOs and follow-ons have generated billions in capital for new and emerging drug developers with ready access to some powerful new tech. But Evercore ISI’s Josh Schimmer is asking where we’re headed from here.

His answer is neither apocalyptic nor universally blissful, but if he’s right — and this is a discussion we’re hearing much, much more about at a time of growing economic and industry uncertainty — we may well be at a crossroads that could affect valuations, M&A and the entire global industry that has formed over the past 5 years.

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US mulls tar­iffs on Swiss drug ex­ports, weigh­ing on No­var­tis and Roche –  re­port

The leading Swiss newspaper has reported that the US is considering placing tariffs on pharmaceuticals from Switzerland. Roche and Novartis stock each fell 1% after the news broke.

Neue Zürcher Zeitung reported that US Trade Representative Robert Lighthizer told pharmaceutical representatives the Trump administration was considering the move. Tariffs do not appear to be in the immediate offing, but they would potentially affect Swiss giants Novartis and Roche along with other companies that manufacture in Switzerland, including Merck KGaA and US biotech Biogen, which is currently constructing a new facility in the country.

Neil Kumar, Endpoints

Bridge­Bio drops bid to re­claim Ei­dos af­ter di­rec­tors spurn 3 of­fers

A couple of months ago a newly public BridgeBio turned some heads by disclosing that it had made a bid for subsidiary Eidos Therapeutics in hopes of gobbling up the 34% stake that it doesn’t already own. Two offers later, the parties are calling it off.

A special committee of independent directors at the smaller biotech led by RA Capital’s Rajeev Shah and ex-Portola CEO William Lis first rejected the parent company’s initial offer — which would swap 1.3 BridgeBio shares for each Eidos share — on September 12. In the latest announcement, BridgeBio revealed that it eventually raised the offer to 1.5 shares and made $110 million available for all-cash or mixed consideration options, but Eidos still wasn’t interested.

Mark Foley, Revance

HR vi­o­la­tion push­es Re­vance co-founder out, vault­ing for­mer Zel­tiq chief to the helm

Months after Revance amended the terms of its Botox biosimilar collaboration with Mylan, the Newark, California-based drug developer disclosed its co-founder Dan Browne is stepping down, in what appears to be mysterious circumstances.

The company — which is also developing a rival to Allergan’s formidable Botox franchise — on Monday said Browne is departing “due to misjudgment in handling an employee matter,” that has also culminated in his resignation from Revance’s board of directors.

In-house FDA re­view flags a sus­pi­cious im­bal­ance in deaths as Sh­iono­gi hunts an OK for an­tibi­ot­ic

Shionogi has some big questions to answer if they plan to win an FDA panel’s backing for their new antibiotic.

While investigators have provided positive efficacy data for their new product to treat cases of complex urinary tract infections, an FDA review has flagged an imbalance of deaths between the antibiotic and a control arm. And they want the agency’s outside advisers to take a good hard look at that when they meet on Wednesday.

Cell ther­a­py start­up rais­es $16 mil­lion to fund its quest for the Holy Grail in re­gen­er­a­tive med­i­cine

In 2006, Shinya Yamanaka shook stem cell research with his discovery that mature cells can be converted into stem cells, relieving a longstanding political-ethical blockage and throwing open medical research on everything from curbing eye degeneration to organ printing.

But that process still has pitfalls, including in risk and scalability, and some researchers are exploring another way first hinted at years ago: new technology to convert mature cells directly into other mature cells without the complex and time-consuming process of first making them into stem cells.

Eye­ing $86M, Galera leads a pack of three mod­est biotech IPOs push­ing past high pro­file stum­bles

Exactly one year after kicking off a pivotal Phase III study for its lead drug — a companion for cancer patients receiving radiotherapy — Galera is looking to the Nasdaq for some new cash to complete the clinical work and fuel its commercial drive.

CEO Mel Sorensen has penciled in an $86 million ask, which was filed on the same day as liver disease company 89bio and rare disease diagnostics shop Centogene. The trio marks the first batch of IPO filings in the wake of two highly anticipated but ultimately disappointing public debuts by BioNTech and Vir, signaling dwindling biotech fervor on Wall Street. 89bio and Centogene are seeking $70 million and $69 million, respectively.