Gilead, Gala­pa­gos claim PhI­Ib/III win for fil­go­tinib in ul­cer­a­tive col­i­tis — which pales in com­par­i­son to ri­vals

A cut of late-stage da­ta on one of Gilead’s high­est-pro­file ex­per­i­men­tal drugs be­fore remde­sivir made its come­back has thrust­ed the com­pa­ny back to the pre-pan­dem­ic mode of biotech — where claims of suc­cess­es are nec­es­sar­i­ly scru­ti­nized and don’t al­ways trans­late to stock gains.

Gilead and its part­ners at Gala­pa­gos char­ac­ter­ized the topline Phase IIb/III re­sults for fil­go­tinib, their oral JAK1 in­hibitor, in mod­er­ate­ly to se­vere­ly ac­tive ul­cer­a­tive col­i­tis as “pos­i­tive.” But a few para­graphs down, they not­ed that on­ly the 200 mg achieved the clean sweep across all pri­ma­ry end­points, while the 100 mg failed to in­duce clin­i­cal re­mis­sion at week 10.

The small­er biotech’s shares $GLPG dropped 10% im­me­di­ate­ly, and is now trad­ing at €188.75 af­ter some re­cov­ery. Gilead $GILD saw a small dip pre-mar­ket to $73.89.

With­in each dose arm, pa­tients were strat­i­fied by their pre­vi­ous ex­pe­ri­ence with bi­o­log­ics in the two-part tri­al. Clin­i­cal re­mis­sion — de­fined as “an en­do­scop­ic sub­score of 0 or 1, rec­tal bleed­ing sub­score of 0, and ≥ 1 point de­crease in stool fre­quen­cy from base­line to achieve a sub­score of 0 or 1” — was ob­served in 26.1% of bi­o­log­ic-naïve pa­tients tak­ing 200 mg of fil­go­tinib ver­sus 15.3% (p=0.0157) on place­bo. Among the bi­o­log­ic-ex­pe­ri­enced co­hort, the num­bers were 11.5% and 4.2%, re­spec­tive­ly (p=0.0103).

Af­ter 10 weeks, those who achieved clin­i­cal re­sponse or re­mis­sion were re-ran­dom­ized to drug or place­bo through week 58. At that point, 37.2% of all pa­tients on 200 mg fil­go­tinib main­tained re­mis­sion com­pared to 11.2% on place­bo (p˂0.0001).

Sum­ma­rized Cowen an­a­lyst Phil Nadeau:

The 10.8% place­bo-ad­just­ed in­crease in clin­i­cal re­mis­sion at wk 10 is com­pa­ra­ble to da­ta gen­er­at­ed by PFE’s Xel­janz, though be­low that demon­strat­ed for AB­BV’s Rin­voq, and like­ly on the low­er end of in­vestor ex­pec­ta­tions.

Walid Abi-Saab

It was no sur­prise, he ex­plained, that the tri­al would suc­ceed giv­en that the JAK in­hi­bi­tion mech­a­nism had al­ready been borne out by the ri­val drugs. But in­vestors were like­ly hop­ing for a best in class pro­file, which the da­ta didn’t seem to sup­port.

Mer­dad Parsey

In a pre­emp­tive de­fense, both Gilead CMO Mer­dad Parsey and Walid Abi-Saab, his coun­ter­part at Gala­pa­gos, em­pha­sized that the tri­al in­clud­ed pa­tients who were re­frac­to­ry to pri­or treat­ment.

If fil­go­tinib can’t win on ef­fi­ca­cy, can it stand out on safe­ty, where Xel­janz has run in­to trou­ble?

Al­though the da­ta aren’t avail­able yet, Gilead and Gala­pa­gos said “(r)ates of se­ri­ous in­fec­tions, her­pes zoster, ve­nous throm­bo­sis, pul­monary em­bolism and gas­troin­testi­nal per­fo­ra­tion were low and com­pa­ra­ble across treat­ment groups in both the in­duc­tion and main­te­nance phas­es of the study.”

The way Baird’s Bri­an Sko­r­ney read it, that means fil­go­tinib might have avoid­ed in­creas­ing CV risk, a side ef­fect that’s plagued the JAK class.

“How­ev­er, it is prob­a­bly un­like­ly that fil­go­tinib will be able to avoid get­ting a black box warn­ing for throm­bo­sis,” he wrote in a note.

All of that leaves plen­ty of room for Gilead and Gala­pa­gos to duke it out with the ri­vals. And the stakes are high: Nadeau es­ti­mates a mar­ket op­por­tu­ni­ty of over $4 bil­lion from the 90,000 US UC pa­tients who fail con­ven­tion­al ther­a­py and an an­ti-TNF.

The com­pa­nies have filed for a first ap­proval in rheuma­toid arthri­tis in the US, Eu­rope and Japan, while al­so test­ing fil­go­tinib in Crohn’s dis­ease and oth­er in­di­ca­tions.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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