Mer­ck blue­prints $1.3B re­search hub in a post-Brex­it Lon­don, with 950 staffers

While the EMA is ex­it­ing Lon­don over the next 18 months, US phar­ma gi­ant Mer­ck plans to help fill the post-Brex­it gap with a new drug re­search hub and head­quar­ters with 950 staffers.

Mer­ck has be­gun to seek a site for its new re­search cen­ter in Lon­don, which will be es­tab­lished as Mer­ck con­cen­trates its US forces in Cam­bridge/Boston and the Bay Area.

Ke­nil­worth, NJ-based Mer­ck is will­ing to in­vest about $1.3 bil­lion in the new cen­ter, with plans to re­cruit 150 top sci­en­tists for the new hub op­er­a­tion. And City A.M. re­ports that Mer­ck will re­lo­cate staff cur­rent­ly at a fa­cil­i­ty in Hod­des­don, Hert­ford­shire. The move is be­ing timed to co­or­di­nate with the re­lease of the gov­ern­ment’s In­dus­tri­al Strat­e­gy White Pa­per.

Ac­cord­ing to a state­ment from Mer­ck, the phar­ma gi­ant plans to be up and run­ning with the new R&D hub by 2020, but they are al­ready gear­ing up and re­cruit­ing sci­en­tists to start work at a tem­po­rary fa­cil­i­ty.

The com­pa­ny is cur­rent­ly eval­u­at­ing sev­er­al po­ten­tial lo­ca­tions in the Lon­don re­gion with a tar­get date of 2020 for op­er­a­tional readi­ness. In the mean­time, MSD plans to es­tab­lish a small tem­po­rary re­search fa­cil­i­ty in the area and is ac­tive­ly re­cruit­ing for suit­ably qual­i­fied sci­en­tif­ic tal­ent.

The Fi­nan­cial Times is al­so re­port­ing that Qi­a­gen is hatch­ing plans to in­vest hun­dreds of mil­lions more in­to a new ge­nomics cen­ter in Man­ches­ter. And the FT adds that gov­ern­ment of­fi­cials are hint­ing at more such an­nounce­ments in the near fu­ture as they seek to re­as­sure the pub­lic in a strong post-Brex­it life sci­ences sec­tor.

The UK’s big an­chors in drug R&D re­main in the hands of Em­ma Walm­s­ley at Glax­o­SmithK­line and As­traZeneca’s Pas­cal So­ri­ot, who’s plan­ning to wrap a mas­sive new HQ and re­search cen­ter in Cam­bridge. The Gold­en Tri­an­gle of Lon­don, Ox­ford and Cam­bridge re­mains one of the world’s top biotech hubs.

Take­da has been clos­ing down some of its work in the coun­try, which fol­lows ex­its by No­var­tis, Pfiz­er and Roche.

Fo the UK gov­ern­ment, which has been un­der siege as it ex­e­cutes a messy di­vorce from the EU, Mer­ck’s move marks a bad­ly need­ed pub­lic re­la­tions coup.

Busi­ness Sec­re­tary Greg Clark said:

MSD’s com­mit­ment to­day, and the wider Sec­tor Deal in­vest­ment we have se­cured, proves the process out­lined in the In­dus­tri­al Strat­e­gy can give com­pa­nies the con­fi­dence and di­rec­tion they need to in­vest in the UK. It will en­sure Britain con­tin­ues to be at the fore­front of in­no­va­tion and rep­re­sents a huge vote of con­fi­dence in our In­dus­tri­al Strat­e­gy.

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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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#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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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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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.

Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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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.