What’s ahead for UK biotechs in the wake of Brex­it? It's not a pret­ty pic­ture

Seem­ing­ly al­most overnight the sen­ti­ment in the UK over Brex­it changed from Re­main to Leave. That sud­den switch-up leaves the UK’s bio­phar­ma in­dus­try fac­ing a lengthy pe­ri­od of fi­nan­cial and reg­u­la­to­ry un­cer­tain­ty. And biotech, where every­thing is un­cer­tain, hates un­cer­tain­ty.

Of­fi­cial­ly, the biotech in­dus­try quick­ly adopt­ed a clas­sic British at­ti­tude to a cri­sis: Keep calm and car­ry on.

“The life sci­ences sec­tor is a re­silient com­mu­ni­ty, un­fazed by new chal­lenges and staffed by great man­age­ment teams used to work­ing in a glob­al en­vi­ron­ment,” not­ed the UK BioIn­dus­try As­so­ci­a­tion, with con­sid­er­able phlegm. “The fun­da­men­tals of UK bio­science re­main strong. In terms of po­ten­tial new ther­a­pies in the pipeline, the UK is by far the strongest in Eu­rope. But sev­er­al key is­sues for our sec­tor are now in flux.”

These key is­sues in­clude an abrupt change in po­lit­i­cal lead­er­ship, a bank­ing and fi­nan­cial cri­sis, a like­ly eco­nom­ic con­trac­tion with in­fla­tion as the pound drops in val­ue and a brand new reg­u­la­to­ry/re­search sup­port struc­ture to con­sid­er.

In fact, the UK biotech in­dus­try is any­thing but un­fazed. The sec­tor is like­ly to feel the bit­ter winds of po­lit­i­cal change much more than their Big Phar­ma brethren at Glax­o­SmithK­line and As­traZeneca. The glob­al gi­ants are al­ready op­er­at­ing on the world stage, where the FDA and the EMA will con­tin­ue to play the big roles in reg­u­la­to­ry ap­provals (un­less this vote pre­cip­i­tates the end of the EU as more coun­tries go their own way).

That ex­plains why GSK and AZ en­joyed an in­crease in their stock prices to­day. In­vestors love a good port in a storm. The vast ma­jor­i­ty of pub­lic British biotech com­pa­nies, though, wit­nessed sharp drops in their share price as in­vestors fret­ted about their fu­ture.

And there are oth­er con­sid­er­a­tions as well.

One of the key ob­jec­tives of British politi­cians like George Free­man has been to make the UK a bet­ter place for big play­ers to do drug re­search. But that re­quires a pre­dictable reg­u­la­to­ry and re­search en­vi­ron­ment, and that just van­ished. British sci­en­tists are al­so sig­nal­ing deep fears that a ma­jor source of fund­ing is about to van­ish.

The UK biotech in­dus­try is not strong. It has been in re­cov­ery mode for sev­er­al years. But since a se­ries of dis­as­ters af­flict­ed the in­dus­try about 7 years ago, blight­ing gen­er­al­ist in­ter­est in the sec­tor, biotech has been slow­ly on the mend.

More in­vest­ment cash, in­clud­ing a mod­est­ly swelling flow of transat­lantic VC cash along with new in­vest­ments by Neil Wood­ford’s funds, etc, has been back­ing the im­pres­sive aca­d­e­m­ic and in­dus­try spin­outs that have been pop­ping up in re­cent years. Com­pa­nies like Adap­ti­m­mune have gone pub­lic on Nas­daq and the LSE. As­traZeneca, mean­while, has com­mit­ted to keep­ing a large R&D or­ga­ni­za­tion in place around Cam­bridge, af­ter some sig­nif­i­cant down­siz­ing.

Good biotech VCs, mean­while, are built to with­stand an eco­nom­ic down­turn and ques­tions over longterm ex­its. And there are some very deep pock­ets that play in the Gold­en Tri­an­gle, in­clud­ing New En­ter­prise As­so­ci­ates. The LSE had al­ready been large­ly benched as Nas­daq played the court that re­mained in the wake of a sav­age biotech bear mar­ket.

The end of a sin­gle con­ti­nen­tal reg­u­la­to­ry group for drug de­vel­op­ers may ac­tu­al­ly wind up a pos­i­tive for the UK, if they can keep it sim­ple and sup­port­ive.

But there’s no cer­tain­ty about that, and some two years of ne­go­ti­a­tions lie ahead in sep­a­rat­ing the UK from the rest of Eu­rope. Dur­ing that time, you can ex­pect the in­dus­try con­cen­trat­ed in Lon­don, Cam­bridge and Ox­ford to fo­cus more than ever on the U.S. mar­ket, where the reg­u­la­to­ry en­vi­ron­ment has im­proved marked­ly for drug de­vel­op­ers and in­vest­ment mon­ey con­tin­ues to flow.

“In the longer term, it is my view that the tra­jec­to­ry of the UK econ­o­my, and more im­por­tant­ly the world econ­o­my, will not be in­flu­enced sig­nif­i­cant­ly by to­day’s out­come,” not­ed Neil Wood­ford con­fi­dent­ly in a blog post. “Con­se­quent­ly, the port­fo­lio strat­e­gy will not change.”

Wood­ford al­so didn’t change course when his in­vest­ment in North­west Bio ($NWBO) and more re­cent­ly Cir­cas­sia (LSE: $CIR) went sour. But Brex­it is one more dev­il­ish headache that it like­ly to cause the cel­e­brat­ed in­vestor some sec­ond thoughts about mak­ing biotech a cen­tral fo­cus of his funds.

Crises do end. And not all dis­rup­tion is bad. But Brex­it came at a bad time for the UK biotech in­dus­try.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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