Watch out Ab­b­Vie: Gilead is fast on your heels at the FDA with ri­val JAK in­hibitor fil­go­tinib

Mov­ing fast with what it be­lieves is a block­buster fa­vorite in a crowd­ed mar­ket, Gilead has con­fi­dent­ly plot­ted an NDA fil­ing for fil­go­tinib by the end of the year, set­ting up a po­ten­tial 2020 launch in rheuma­toid arthri­tis.

Smooth progress here would min­i­mize Ab­b­Vie’s lead, as its ri­val JAK in­hibitor upadac­i­tinib is al­ready un­der pri­or­i­ty re­view with a PDU­FA date set for Q3. For an­a­lysts, it’s al­so a tes­ta­ment to new CEO Dan O’Day’s abil­i­ty to ex­e­cute on key pipeline ad­vances, hav­ing hint­ed at the quick fil­ing in an in­vestor call — though ques­tions about a cru­cial safe­ty study re­main unan­swered.

SVB Leerink anayl­sts call the sce­nario “bet­ter than our best case” as it sets up a po­ten­tial launch six months ahead of their pro­ject­ed time­line. Gilead’s part­ners at Gala­pa­gos $GLPG en­joyed a 6% ral­ly at the news.

Daniel O’Day Gilead

Gilead so­lid­i­fied its in­tent to file af­ter a re­cent meet­ing with the FDA, in which the com­pa­ny up­dat­ed reg­u­la­tors about the Phase III FINCH stud­ies as well as the on­go­ing Phase II safe­ty study dubbed MAN­TA. An­a­lysts have de­scribed that tri­al — which eval­u­ates the tox­i­c­i­ty of fil­go­tinib in men with mod­er­ate­ly to se­vere­ly ac­tive ul­cer­a­tive col­i­tis or Crohn’s dis­ease — as a “key over­hang” for the drug.

With the en­tire JAK class grap­pling with safe­ty is­sues — the FDA and EMA both is­sued stark warn­ings re­cent­ly about the dan­gers posed by Pfiz­er’s Xel­janz, and Eli Lil­ly was de­nied an ap­proval on the high dose of Olu­mi­ant — a clean score on this front is re­quired to stand out.

“Fil­go­tinib’s im­pres­sive safe­ty pro­file could be an im­por­tant dif­fer­en­tia­tor, po­ten­tial­ly key to dri­ving up­take de­spite like­ly be­ing the 4th JA­Ki to mar­ket,” Jef­feries’ Pe­ter Welford not­ed, re­fer­ring to the low­er rates of car­dio­vas­cu­lar events com­pared to place­bo.

There’s no word on when MAN­TA will read out, but the as­sump­tion is that reg­u­la­tors have agreed to judge the ap­pli­ca­tion on in­ter­im da­ta rather than wait­ing on the full dataset, ex­pect­ed in 2020.

As for ef­fi­ca­cy, an­a­lysts are in gen­er­al agree­ment that fil­go­tinib ap­pears sim­i­lar to upadac­i­tinib, Ab­b­Vie’s next-gen an­swer to the $20 bil­lion Hu­mi­ra fran­chise.

FINCH 1 and FINCH 3 saw ACR20/50/70 re­sults that over­shad­owed the sug­ar pill re­sponse lev­els as well as a methotrex­ate arm. While the low 100 mg da­ta were gen­er­al­ly in line with Hu­mi­ra, the 200 mg out­per­formed the ag­ing block­buster, set to lose patent pro­tec­tion no lat­er than 2023.

In case any­one needs a re­minder, the stakes are high. Welford sees $6 bil­lion in fil­go­tinib in terms of world­wide sales po­ten­tial across all in­di­ca­tions, with $3 bil­lion from rheuma­toid arthri­tis, $600 in Crohn’s, $400 mil­lion in ul­cer­a­tive col­i­tis and $2 bil­lion from oth­ers. Evan Seiger­man from Cred­it Su­isse, mean­while, fore­casts a more con­ser­v­a­tive $1 bil­lion in peak RA sales while oth­er in­di­ca­tions should bring in $1 to $2 bil­lion.

So­cial im­age: Kristof­fer Trip­plaar, AP Im­ages

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Covid-19 roundup: Left out no longer, No­vavax se­cures largest Warp Speed deal yet: $1.6B

It looks like Novavax won’t be left out of Operation Warp Speed after all.

A month after the Gaithersburg, MD biotech saw its shares tumble when it was left off the first reported list of finalists for the White House’s Covid-19 vaccine accelerator, HHS and the Department of Defense have announced a $1.6 billion deal to scale up their Covid-19 candidate. It is the largest deal HHS has announced yet, eclipsing the $1.2 billion deal the administration reached with AstraZeneca in May.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Sec­ond PhI­II study for Idor­si­a's sleep drug re­turns pos­i­tive re­sults, but al­so rais­es new ques­tions

Following a successful Phase III study in April showcasing the safety and potential of its new sleep drug, Idorsia posted some mixed news in the second Phase III study, but that won’t stop a planned filing aimed at regulatory approval.

The drug, a dual orexin receptor antagonist (DORA) called daridorexant, was found to significantly improve sleep maintenance and subjective total sleep time in 25 mg doses, replicating results from the first Phase III study. However, improvements in sleep onset and daytime functioning narrowly missed statistical significance, despite numerical consistency with the April study.

UP­DAT­ED: Im­munomedics spells out PFS ben­e­fit of Trodelvy in mTNBC, hunt­ing a full OK just weeks af­ter ac­cel­er­at­ed ap­proval

By the time the FDA finally granted an accelerated OK for Immunomedics’ Trodelvy, we already got a very strong hint that their confirmatory Phase III study in metastatic triple-negative breast cancer was a success.

That’s because the independent data safety monitoring committee recommended that the trial be stopped early. But just what pointed them to the conclusion was still unclear.

“We do not know the totality of their decision other than it’s pretty evident that the primary endpoint was met; otherwise they could not request to halt the study,” Behzad Aghazadeh, the executive chairman, told Endpoints News at the time.

Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

A lit­tle biotech slaps back at a 'crim­i­nal' short at­tack, vow­ing to pur­sue a pros­e­cu­tion of their case

As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

FDA lifts par­tial hold on ADC, clear­ing way for a 2021 read­out and two po­ten­tial near-term ap­provals

In throwing $267 million and a multi-billion dollar valuation at ADC Therapeutics for their May IPO, investors were betting that the partial hold the FDA had just placed on their second lead drug would prove immaterial. Time, it appears, has proven them right.

The FDA has lifted the partial hold, ADC said this morning. The move clears the way for an anticipated 2021 readout from their second pivotal study, a Phase II trial testing their experimental antibody drug conjugate camidanlumab tesirine, or Cami, in Hodgkin’s lymphoma.

Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

A boom­ing Drag­on­fly is tak­ing its TriN­KETs to Copen­hagen as the lat­est Bris­tol My­ers pact spurs ex­pan­sion plans — out­side the US

Bristol Myers Squibb is making a habit out of collaborating with the crew at Dragonfly, adding their 3rd deal in a series that now will take them into newly charted R&D territory. And the fast-growing team at the Cambridge-based biotech is adding a facility in Copenhagen for its next growth spurt, where the government is making it easy to recruit scientists internationally as the U.S. throttles back.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Ernest Loumaye, ObsEva CEO (ObsEva)

UP­DAT­ED: Ob­sE­va’s sec­ond uter­ine fi­broids PhI­II comes through, send­ing some in­vestors to the hills

In the three-company race to develop a new uterine fibroid treatment, ObsEva long lagged behind AbbVie and Myovant. Still, they hoped that better efficacy — including a 93.9% response rate in one Phase III trial — could ultimately deliver better sales.

Now, though, the second of those Phase III studies is out, and it has brought the Swedish biotech back to earth.

In the second of their Phase III trials, 75.5% of patients who took ObsEva’s experimental tablet linzagolix plus a hormone saw their bleeding reduced by at least 50% and at least 80 ml after 24 weeks. Pooling those results with new data from their first Phase III trial — which showed a 93.9% response rate at 24 weeks and a 91.6% response rate at 52 weeks — ObsEva calculated a collective 84.7% responder rate for patients taking their therapy and said the data “confirm potential best-in-class” status.