EMA warns HQ move may cause ma­jor tur­moil, se­ri­ous­ly de­lay­ing new drug ap­provals

The Eu­ro­pean Med­i­cines Agency on Tues­day warned that it could lose a ma­jor­i­ty of its staff based on which of the 19 cities vy­ing to host the med­i­cines reg­u­la­tor is se­lect­ed by the Eu­ro­pean Coun­cil in No­vem­ber, threat­en­ing the pace of new drug ap­provals even in best-case sce­nar­ios for at least two years.

Based on the re­sults of a sur­vey com­plet­ed by 92% of EMA’s staff ear­li­er this month, the agency says it could lose be­tween 19% and 94% of its staff de­pend­ing on which city is se­lect­ed as its fu­ture host. Politi­co first re­port­ed that Am­s­ter­dam is the top choice among EMA staff.

Af­ter Am­s­ter­dam, just three ad­di­tion­al un­named cities are pro­ject­ed to pro­vide enough cov­er to main­tain the reg­u­la­tor’s ba­sic safe­ty mon­i­tor­ing mis­sion.  “For cer­tain lo­ca­tions staff re­ten­tion rates could be sig­nif­i­cant­ly less than 30% [re­ten­tion]. This would mean that the Agency is no longer able to func­tion and, as there is no back­up, this would have im­por­tant con­se­quences for pub­lic health in the EU,” the EMA says.

The Eu­ro­pean Com­mis­sion is ex­pect­ed the com­plete its as­sess­ment of the 19 of­fi­cial of­fers to host EMA in the next few days. And, fol­low­ing a po­lit­i­cal dis­cus­sion in Oc­to­ber, the 27 EU mem­ber states, mi­nus the UK, will vote on the agency’s fu­ture lo­ca­tion at the EU Gen­er­al Af­fairs Coun­cil meet­ing in No­vem­ber.

For the sur­vey, EMA staff were asked to rate how like­ly they were to stay with the agency for each of the 19 can­di­date cities. EMA then took the re­sults of the sur­vey and di­vid­ed the cities in­to four groups based on the lev­el of ex­pect­ed em­ploy­ee re­ten­tion.

Five cities fell in group 1 with 65% or greater em­ploy­ee re­ten­tion, an­oth­er five fell in group 2 with a 50-65% re­ten­tion rate, one city fell in group 3 with a 30-50% re­ten­tion rate and eight cities fell in group 4 with a less than 30% re­ten­tion rate.

While the sur­vey re­port does not iden­ti­fy the cities by name, EMA says the re­sults re­flect staff mem­bers’ per­son­al as­sess­ments of whether the can­di­date cities meet their needs based on the in­for­ma­tion pre­sent­ed in the cities’ of­fi­cial bids and staff mem­bers’ own re­search in­to the lo­ca­tions.

Ac­cord­ing to EMA, the agency needs at least 462 full-time equiv­a­lent em­ploy­ees to per­form its high­est pri­or­i­ty ac­tiv­i­ties, which in­clude as­sess­ing new drugs and safe­ty mon­i­tor­ing, and an­oth­er 140 FTEs to han­dle medi­um pri­or­i­ty pub­lic health ac­tiv­i­ties, such as curb­ing an­timi­cro­bial re­sis­tance and work­ing with health tech­nol­o­gy as­sess­ment bod­ies. An ad­di­tion­al 110 FTEs are need­ed for low­er pri­or­i­ty ac­tiv­i­ties, such as cor­po­rate gov­er­nance, au­dits and ad­min­is­tra­tive sup­port.

With those re­quire­ments, on­ly four cities would like­ly re­tain enough staff to per­form EMA’s high­est pri­or­i­ty ac­tiv­i­ties, and no cities would ful­ly meet the agency’s staffing needs for medi­um and low pri­or­i­ty ac­tiv­i­ties with­out ad­di­tion­al re­cruit­ment.

Even in the best case sce­nar­ios, EMA says to ex­pect de­lays in ap­prov­ing new med­i­cines and slowed progress on oth­er pub­lic health ini­tia­tives for the next two to three years.

In the worst cas­es, EMA says it would be “un­able to op­er­ate” and the EU and mem­ber states would need to im­ple­ment emer­gency mea­sures to pro­tect pub­lic health, such as re­ly­ing on third coun­tries for ap­proval de­ci­sions.

First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Im­age: EMA’s cur­rent head­quar­ters in Lon­don. Shut­ter­stock

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.