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

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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