While con­tro­ver­sy over Brex­it reach­es full boil, a phar­ma trade group sees the up­side in a draft deal

British prime min­is­ter There­sa May’s draft di­vorce deal from the Eu­ro­pean Union has spurred hoots of de­ri­sion from her grow­ing ranks of crit­ics in the UK, but the hard-fought and con­tro­ver­sial agree­ment has met with cau­tious op­ti­mism from the trade as­so­ci­a­tion rep­re­sent­ing the bio­phar­ma and life­sciences in­dus­try in the Unit­ed King­dom.

The As­so­ci­a­tion of the British Phar­ma­ceu­ti­cal In­dus­try (ABPI), which rep­re­sents bio­phar­ma­ceu­ti­cal com­pa­nies in the UK that sup­ply more than 80% of all brand­ed med­i­cines used by the Na­tion­al Health Ser­vice (NHS), said that al­though there was much work to be done, it wel­comed the agree­ment of a tran­si­tion pe­ri­od, which would mean its mem­bers can “con­tin­ue to sup­ply med­i­cines to pa­tients with­out de­lay or dis­rup­tion come March 2019.”

Even though con­tin­gency plan­ning has been put in place by phar­ma­ceu­ti­cal com­pa­nies to make sure med­i­cines are avail­able in any Brex­it out­come, this would be chal­leng­ing in a “no deal” sce­nario, ABPI said in a state­ment on Thurs­day.

Steve Bates

ABPI has been work­ing with the BioIn­dus­try As­so­ci­a­tion (BIA) — the trade as­so­ci­a­tion rep­re­sent­ing life sci­ences or­gan­i­sa­tions in the UK — to ad­vise par­lia­ment on the im­pact of a no-deal Brex­it on pub­lic health, which they say would pose a se­ri­ous chal­lenge for phar­ma­ceu­ti­cal com­pa­nies in sup­ply­ing med­i­cines to pa­tients in both the UK and the EU. May her­self has pre­vi­ous­ly said that the threat of a no-deal Brex­it was per­son­al to her as she is a di­a­bet­ic who is de­pen­dent on in­sulin made by a coun­try else­where in the Eu­ro­pean Union.

BIA chief Steve Bates al­so wel­comed the deal, with cau­tious op­ti­mism. “There re­mains a long way to go for cer­tain­ty on Brex­it for life sci­ences busi­ness­es but this is a key step on that jour­ney.”

Nathalie Moll

Mean­while, the Eu­ro­pean Fed­er­a­tion of Phar­ma­ceu­ti­cal In­dus­tries and As­so­ci­a­tions (EF­PIA), which rep­re­sents the phar­ma­ceu­ti­cal in­dus­try op­er­at­ing in Eu­rope, ex­pressed con­sid­er­able con­cern that the po­lit­i­cal de­c­la­ra­tion out­lin­ing the fu­ture re­la­tion­ship be­tween the UK and the EU – which ac­com­pa­nied the draft agree­ment – did not di­rect­ly ad­dress the is­sue of health. The de­c­la­ra­tion’s “fail­ure to con­tain an ex­plic­it ref­er­ence to the im­por­tance of se­cur­ing long-term, ex­ten­sive co­op­er­a­tion around the reg­u­la­tion of med­i­cines is not in the best in­ter­est of pa­tients,” said EF­PIA Di­rec­tor Gen­er­al Nathalie Moll.

An em­bat­tled May vowed to keep fight­ing to push the deal through on Thurs­day evening af­ter com­bat­ing mem­bers of her own par­ty in ad­di­tion to op­po­si­tion MPs ear­li­er in the day, as well as wran­gling with a string of cab­i­net de­par­tures and calls for a no-con­fi­dence mo­tion.

The deal, which still needs to be vot­ed on by par­lia­ment, is by no means a cer­tain­ty. Hav­ing at­tract­ed a clam­or of crit­i­cism by crit­ics on all sides of the aisle, it is ex­pect­ed to be thwart­ed by par­lia­ment, at which point all bets are off. Fail­ure to get the deal through could cul­mi­nate in a va­ri­ety of ways in­clud­ing a sec­ond ref­er­en­dum, an ex­ten­sion of the ne­go­ti­at­ing pe­ri­od, the pas­sage of a no-deal Brex­it or even a a na­tion­al elec­tion.

Im­age: There­sa May. AP IM­AGES

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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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.

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.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.