Af­ter un­ex­pect­ed tie, Am­s­ter­dam wins 'coin toss' for new EMA HQ

Well, that was un­ex­pect­ed. The EU’s third and fi­nal vote on the new lo­ca­tion of the Eu­ro­pean Med­i­cine Agency tied be­tween Mi­lan and Am­s­ter­dam, with Am­s­ter­dam win­ning the prover­bial coin toss tie-break­er (EU of­fi­cials drew the city’s name out of a bowl).

The re­sults may sur­prise those fol­low­ing the first two vot­ing rounds close­ly, as Mi­lan came in the lead on the pre­vi­ous ses­sions. Both cities ranked ex­tra­or­di­nar­i­ly well on the EMA’s score­card, with the lo­ca­tions es­pe­cial­ly pop­u­lar with the agency’s 900-per­son staff. The EMA said ear­li­er this month that 65% or more of its staff would be will­ing to re­lo­cate to both Mi­lan and Am­s­ter­dam. Ac­cord­ing to a staff sur­vey in Sep­tem­ber, Am­s­ter­dam would woo the most EMA staffers to re­lo­cate, while Mi­lan ranked fourth.

Staffers like­ly breathed a sigh of re­lief that oth­er top-ranked cities like Bratisla­va and Bucharest did not end up in the top three. Less than 30% of staffers were will­ing to move to those cities, which would have put the EMA in a tough po­si­tion — un­der­staffed and on­ly able to work on top pri­or­i­ty ef­forts.

The EMA has called Lon­don home since 1995, when it was first es­tab­lished. From there, it mon­i­tors and ap­proves drugs across 28 Eu­ro­pean Union mem­ber states and 500 mil­lion peo­ple. Fol­low­ing the Unit­ed King­dom’s vote to ex­it the EU in 2019, the EMA has been scram­bling to choose a site that will meet all of its (many) needs. The re­lo­ca­tion caused a fren­zy of bids from ma­jor cities through­out Eu­rope, first to­tal­ing 19 prospec­tive cities but with three drop­ping out ear­ly this morn­ing: Mal­ta, Za­greb, and Dublin.

The EU’s top cri­te­ria for the EMA’s new home city is ac­ces­si­bil­i­ty to in­ter­na­tion­al trav­el and bilin­gual ed­u­ca­tion for the staffer’s chil­dren. The EMA’s staff has been a ma­jor con­cern, as an ex­o­dus of em­ploy­ees would mean a slow down of process­es. The EMA warned last month that, worst-case sce­nario, its re­lo­ca­tion from Lon­don could per­ma­nent­ly dam­age the med­i­cines reg­u­la­to­ry sys­tem, trig­ger­ing a pub­lic health cri­sis.

If it can’t com­pen­sate for large staff loss­es fol­low­ing its re­lo­ca­tion, it would be forced to in­voke its Brex­it pre­pared­ness busi­ness con­ti­nu­ity plan. The plan has the EMA de­creas­ing its ac­tiv­i­ties to on­ly in­clude those with high pri­or­i­ty. Ac­tiv­i­ties such as cor­po­rate gov­er­nance, au­dits and con­fer­ences are list­ed as the low­est pri­or­i­ties. The top pri­or­i­ties in­clude the as­sess­ment and safe­ty mon­i­tor­ing of med­i­cines and ac­tiv­i­ties vi­tal for main­tain­ing the in­fra­struc­ture of the Eu­ro­pean med­i­cines reg­u­la­to­ry net­work.

To con­tin­ue car­ry­ing out its high­ly pri­or­i­tized ac­tiv­i­ties, the EMA says it needs 462 full time equiv­a­lent (FTE) staff — close to 50% of its cur­rent staff. It needs an­oth­er 140 to car­ry out medi­um pri­or­i­ty work and a fur­ther 110 to con­tin­ue to per­form its low­est pri­or­i­ty ac­tiv­i­ties.

Am­s­ter­dam has a num­ber of things go­ing for it, ac­cord­ing to the EMA’s score­card. It has good flight con­nec­tiv­i­ty to oth­er Eu­ro­pean Eco­nom­ic Area cap­i­tal cities and in­ter­na­tion­al lo­ca­tions. It has ex­cel­lent pub­lic trans­port be­tween the air­port and the pro­posed premis­es of the EMA. It al­so has lots of hous­ing and “high qual­i­ty ac­com­mo­da­tion” with­in walk­ing dis­tance to the pro­posed HQ site. And there’s lots of Eu­ro­pean-ori­ent­ed schools.

Mi­lan had many of the same things go­ing for it, ex­cept the city al­so in­clud­ed de­tails on cur­rent and fu­ture school ca­pac­i­ty for the staffer’s chil­dren, which may have eased wor­ry about putting hun­dreds of new stu­dents in­to lo­cal schools.

Now, the EMA has plen­ty on its plate. The agency has to take up new op­er­a­tions at the Am­s­ter­dam site by March 2019. Fit­ting out the new head­quar­ters alone will take 12-15 months, the agency es­ti­mates. Build­ing one in time will re­quire fast ac­tion and a hur­ry-up con­struc­tion sched­ule.

Re­ac­tions

Here’s Steve Bates, CEO of the UK’s BioIn­dus­try As­so­ci­a­tion:

“Lon­don’s loss is Am­s­ter­dam’s gain. To­day’s de­ci­sion on the lo­ca­tion of the Eu­ro­pean Med­i­cines Agency means a 1000 high qual­i­ty jobs leav­ing the UK, dis­rupt­ing a thou­sand fam­i­lies as a di­rect re­sult of Brex­it, with im­pli­ca­tions for thou­sands more. Busi­ness­es now need cer­tain­ty. The best way to do this is by an ear­ly agree­ment to a tran­si­tion time­frame and con­tin­ued close reg­u­la­to­ry co-op­er­a­tion. We must now en­sure Brex­it does not dis­rupt the safe sup­ply of vi­tal med­i­cines to tens of mil­lions of fam­i­lies in the EU 27 and the UK.”


Mar­tine Dehlinger-Kre­mer, VP of Glob­al Med­ical and Reg­u­la­to­ry Af­fairs at in­ter­na­tion­al CRO Syn­ter­ac­tHCR, says Am­s­ter­dam has all the cri­te­ria to be a suc­cess­ful move:

Am­s­ter­dam is a very dy­nam­ic city and an in­ter­na­tion­al­ly ori­ent­ed city. The Nether­lands of­fers all the fa­cil­i­ties nec­es­sary for the agency to re­lo­cate quick­ly and ef­fi­cient­ly. Am­s­ter­dam will be able to pro­vide good hous­ing, in­ter­na­tion­al schools and health­care for the EMA em­ploy­ees as well as ac­cess to the labour mar­ket for their part­ners. Am­s­ter­dam is well recog­nised med­ical and sci­ence in­dus­try. Am­s­ter­dam has even been nom­i­nat­ed as the Eu­ro­pean Cap­i­tal of In­no­va­tion by the Eu­ro­pean Union. Am­s­ter­dam of­fers one of Eu­rope’s biggest air­ports which will al­low easy and fast ac­cess to the EMA vis­i­tors.”


And Pier­lui­gi Parac­chi, CEO of Italy’s Genen­ta:


Im­age: Am­s­ter­dam Shut­ter­stock

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.