With re­lo­ca­tion vote loom­ing, the EMA is open­ly fret­ting as cities jock­ey for at­ten­tion

The biggest de­ci­sion that the EMA faces has noth­ing to do with any drug an­gling for a Eu­ro­pean ap­proval or how it’s do­ing rel­a­tive to the FDA in pro­vid­ing ef­fi­cient prod­uct re­views. In 10 days the EU will vote on which of the 19 prospec­tive cities will win the right to host the agency in one of the most hot­ly con­test­ed com­pe­ti­tions to come out of the UK’s vote in fa­vor of Brex­it.

The win­ner will im­me­di­ate­ly get the full at­ten­tion of the lead­ers of the EMA, who have a list of de­mands ready to go.

In this case, though, the Lon­don-based or­ga­ni­za­tion now re­sid­ing on Ca­nary Wharf is ab­solute­ly pow­er­less. So it’s been do­ing the on­ly thing it’s able to do — fu­ri­ous­ly flag­ging in­ter­nal fears that a po­lit­i­cal de­ci­sion will force them in­to some back­wa­ter lo­ca­tion in East­ern Eu­rope with­out a suit­able place to do gov­ern­ment busi­ness.

From their state­ment Wednes­day:

The most press­ing is­sue that needs the im­me­di­ate at­ten­tion of EMA and the host coun­try is the Agency’s new premis­es.

Just fit­ting out its new head­quar­ters will take 12 to 15 months, says the EMA. Build­ing one in time will re­quire fast ac­tion and a hur­ry-up con­struc­tion sched­ule. Up to 900 house­holds will have to be moved — un­less the EU goes with an un­wel­come lo­ca­tion, in which case a ma­jor­i­ty of the EMA’s staff say they’ll just find oth­er jobs.

And school­ing for hun­dreds of their chil­dren? That all has to start be­ing sort­ed out in a mat­ter of months.

The EMA has made its pref­er­ences clear, rank­ing all 19 cities from A — with Am­s­ter­dam in the top 5 — to Z; for Za­greb in the bot­tom five.

What will the EU do? No one re­al­ly knows, giv­en the rules around the No­vem­ber 20 bal­lot. And that like­ly isn’t help­ing mat­ters in­side a jit­tery EMA.

“It’ll be a blood­bath,” one anony­mous se­nior diplo­mat told Reuters. “Every­one will be fight­ing their cor­ner. It will have noth­ing to do with the mer­its of these cities.”

Brent Saun­ders

That won’t calm any fears at the EMA. But this is one de­bate where every­one has a strong opin­ion.

Al­ler­gan CEO Brent Saun­ders, for ex­am­ple, is do­ing what he can this week to steer the EMA to Dublin — a rather weak num­ber 9 on the EMA’s list. Al­ler­gan is based in Ire­land pri­mar­i­ly for tax rea­sons, along with a num­ber of oth­er bio­phar­ma com­pa­nies, but that doesn’t make Saun­ders’ list of every­thing the coun­try has go­ing for it.

We chose Ire­land as our home be­cause of its com­mit­ment to sci­en­tif­ic ad­vance­ment, its tech-savvy work­force, gov­ern­ment in­tegri­ty, qual­i­ty of life, com­mit­ment to the Eu­ro­pean Union and ex­cel­lent air­line con­nec­tions to Eu­rope and Amer­i­ca.

And be­sides, every­one speaks Eng­lish and you can hop on a flight to Lon­don al­most any­time.

We’ll know in 10 days just how im­por­tant that is to the EU.


Im­age: The EMA’s cur­rent HQ in Lon­don’s Ca­nary Wharf Shut­ter­stock

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.