Mer­ck KGaA sells off its biosim­i­lars port­fo­lio in €670M deal; uniQure boost­ed by PRIME; Strug­gling Oph­thotech gets new CEO

→ With its new ap­proval for the check­point drug avelum­ab in the bank, so to speak, Mer­ck KGaA has com­plet­ed a deal to sell off its port­fo­lio of biosim­i­lars. The Ger­man Mer­ck says Fre­se­nius is bag­ging the lot for €170 mil­lion up­front and €500 mil­lion more in mile­stones. Biosim­i­lars are start­ing to stack up as the first wave of knock­offs ar­rive in the US. And that might ex­plain a rel­a­tive­ly mod­est up­front for these drugs. “We have in­creas­ing con­fi­dence in our Bio­phar­ma pipeline and this trans­ac­tion will help pri­or­i­tize in­no­v­a­tive drug de­vel­op­ment of high qual­i­ty and first-to-mar­ket best-in-dis­ease as­sets,” com­ment­ed Belén Gar­i­jo, mem­ber of the Ex­ec­u­tive Board of Mer­ck KGaA and CEO of their Health­care unit: “The part­ner­ship with Fre­se­nius will al­low us to ex­ploit our Biosim­i­lars port­fo­lio to full po­ten­tial while grant­i­ng us a sub­stan­tial re­turn on pri­or in­vest­ments.”

→ The Dutch biotech uniQure $QURE got a big boost from the news that its he­mo­phil­ia B gene ther­a­py AMT-060 has re­ceived a PRIME des­ig­na­tion from the EMA. Its shares jumped 9% on the news, which close­ly fol­lowed a de­ci­sion to scrap its $1.2 mil­lion treat­ment Gly­bera, which was large­ly un­used. Stat­ed Matthew Ka­pus­ta, chief ex­ec­u­tive of­fi­cer of uniQure: “Sim­i­lar to the Break­through Ther­a­py des­ig­na­tion that AMT-060 re­ceived from the U.S. Food and Drug Ad­min­is­tra­tion ear­li­er this year, we look for­ward to this en­hanced col­lab­o­ra­tion with the EMA to ad­vance the clin­i­cal de­vel­op­ment of  this po­ten­tial­ly trans­for­ma­tive ther­a­py for he­mo­phil­ia B pa­tients.”

→ Playa Vista, CA-based Sci­ence 37 has raised $29 mil­lion for its Se­ries C, de­signed to fur­ther its work on us­ing a telemed­i­cine ap­proach to cre­at­ing site-less clin­i­cal tri­als. The biotech has now raised $67 mil­lion. Glynn Cap­i­tal Man­age­ment led the round with a con­tri­bu­tion from GV, for­mer­ly Google Ven­tures. The round in­clud­ed a new in­vest­ment from Am­gen Ven­tures, as well as par­tic­i­pa­tion from all ex­ist­ing in­vestors: Lux Cap­i­tal, Red­mile Group, dRx Cap­i­tal (a Qual­comm and No­var­tis joint in­vest­ment com­pa­ny), and Sanofi Ven­tures.

Arch Ven­ture Part­ners and Ven­vest have led a $40 mil­lion round for West­lake Vil­lage, CA-based Si­en­na Bio­phar­ma­ceu­ti­cals. The biotech is in­vest­ing in a pipeline of top­i­cal ther­a­pies for con­di­tions like pso­ri­a­sis, atopic der­mati­tis and ac­ne. “We are very pleased with the sup­port of in­vestors who share our com­mit­ment to de­vel­op­ing in­no­v­a­tive and dis­rup­tive new prod­ucts in med­ical der­ma­tol­ogy and aes­thet­ics,” said Fred­er­ick C. Bed­ding­field III, Si­en­na’s Pres­i­dent and Chief Ex­ec­u­tive Of­fi­cer. “We have built out an ac­com­plished team and a di­ver­si­fied mul­ti-as­set pipeline. We be­lieve this fi­nanc­ing will en­able us to ad­vance our de­vel­op­ment pro­grams, which span piv­otal clin­i­cal tri­als to pre­clin­i­cal pro­grams.”

→ The share price of Oph­thotech $OPHT fell off a cliff last fall af­ter two Phase III stud­ies of a wet-AMD drug — part­nered with No­var­tis in a $1 bil­lion deal — failed bad­ly. And now, with its busi­ness de­vel­op­ment team on the hunt for new deals to re­or­ga­nize the pipeline, the biotech is mov­ing CEO David Guy­er to the ex­ec­u­tive chair­man’s role while pro­mot­ing CFO Glenn P. Sblendo­rio to the CEO spot. “As the Com­pa­ny con­tin­ues to re­view strate­gic al­ter­na­tives and ac­tive­ly ex­plores po­ten­tial­ly ob­tain­ing rights to ad­di­tion­al prod­ucts, prod­uct can­di­dates and tech­nolo­gies to treat oph­thalmic dis­eases, par­tic­u­lar­ly those of the back of the eye, David Guy­er’s ex­ten­sive ex­per­tise and ex­pe­ri­ence brings a wealth of oph­thal­mol­o­gy knowl­edge that is crit­i­cal as we ex­e­cute a strat­e­gy to max­i­mize share­hold­er val­ue,” stat­ed Mr. Sblendo­rio.

→ Trans­gene has struck a deal with Bris­tol-My­ers Squibb to put a com­bi­na­tion of its can­cer vac­cine TG4010 in­to a Phase II tri­al for front­line non-squa­mous non-small cell lung can­cer com­bined with Op­di­vo.

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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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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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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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.