EMA says sym­bol­ic good­bye to Lon­don HQ as it sets up shop in Am­s­ter­dam

Eu­rope’s med­i­cines reg­u­la­tor, hav­ing been based in Lon­don since 1995, is gear­ing up for its move to Am­s­ter­dam as West­min­ster’s un­cer­tain­ty re­gard­ing Brex­it shows no signs of abat­ing and drug­mak­ers is­sue warn­ings about the dis­rup­tion to drug sup­plies.

The de­ci­sion to move the Eu­ro­pean drug watch­dog was trig­gered by Britain’s 2016 de­ci­sion to leave the EU. In No­vem­ber 2017, Am­s­ter­dam was cho­sen as the EMA’s new home by EU mem­ber states, which bode well for staff who re­port­ed­ly in a sur­vey put the city at the top of the list of places they would fol­low the agency to.

How­ev­er, the EMA ex­pects about 25% of its 900 em­ploy­ees to leave as it makes the move, the agency said in an an­nounce­ment last week. “We are al­ready con­duct­ing a mas­sive pro­gramme for re­cruit­ment so that we can re­place staff who might choose not to fol­low the Agency; we have re­ceived and screened over 5,000 ap­pli­ca­tions for the var­i­ous po­si­tions we have ad­ver­tised,” a spokesper­son for the reg­u­la­tor told End­points News.

EMA is set to leave its premis­es at Lon­don’s Ca­nary Wharf on 1 March 2019. Last Fri­day, a pri­vate cer­e­mo­ny for staff was held to sym­bol­i­cal­ly say good­bye to the of­fice at the British cap­i­tal.

From 4 to 8 March, the agency will op­er­ate on the ba­sis of ex­tend­ed tele­work­ing, it said. Dur­ing this week a small num­ber of staff will be present in the new tem­po­rary build­ing, the Spark build­ing in Am­s­ter­dam Slo­ter­dijk, to deal with any po­ten­tial emer­gen­cies. Be­tween 11-15 March EMA staff will grad­u­al­ly move in­to the build­ing.

“Whilst re­lo­cat­ing…the fo­cus will be on the au­tho­ri­sa­tion, main­te­nance and su­per­vi­sion of med­i­cines, on­go­ing Brex­it pre­pared­ness/im­ple­men­ta­tion ac­tiv­i­ties and prepar­ing for the im­ple­men­ta­tion of the new vet­eri­nary leg­is­la­tion,” the spokesper­son added. EMA’s new per­ma­nent head­quar­ters, a tai­lor-made build­ing in the Zuidas busi­ness dis­trict of Am­s­ter­dam, are planned for com­ple­tion in No­vem­ber 2019, but from 4 March on­wards it will be con­sid­ered the agency’s of­fi­cial ad­dress.

Mean­while, it looks like Britain is set to leave the EU on March 29, with or with­out a deal.

Im­age: EMA

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.