J&J wins FDA OK for their nasal spray ver­sion of a par­ty drug, now ap­proved for treat­ment-re­sis­tant ma­jor de­pres­sion

There it is. 

De­spite some se­ri­ous clin­i­cal fail­ures, the FDA has ap­proved J&J’s new drug es­ke­t­a­mine for ma­jor de­pres­sion, which will now hit the mar­ket as Spra­va­to.

An in­tranasal for­mu­la­tion of ke­t­a­mine, a horse tran­quil­iz­er that is bet­ter known in par­ty cir­cles as Spe­cial K, the drug won a warm as­sess­ment by FDA in­sid­ers as well as an over­whelm­ing vote in its fa­vor by a pan­el of out­side ex­perts or­ga­nized by the FDA.

The ex­perts and reg­u­la­tors were won over by the fact that most were aware of ke­t­a­mine’s years-long rep­u­ta­tion for deal­ing quick­ly with the most se­vere kinds of de­pres­sion. J&J tout­ed the da­ta that they had ac­quired in late-stage re­search, down­play­ing the fail­ures. But in de­pres­sion physi­cians are al­ready well used to deal­ing with hit-and-miss ther­a­peu­tic strate­gies, armed with a hap­haz­ard set of de­pres­sion drugs that of­ten don’t work.

This drug will be giv­en on­ly un­der care­ful su­per­vi­sion and a black box warn­ing re­gard­ing the risk of se­da­tion and dis­so­cia­tive be­hav­ior. It is one of J&J’s top late-stage pro­grams, tapped as a po­ten­tial block­buster.

“There has been a long-stand­ing need for ad­di­tion­al ef­fec­tive treat­ments for treat­ment-re­sis­tant de­pres­sion, a se­ri­ous and life-threat­en­ing con­di­tion,” said Tiffany Far­chione, the act­ing di­rec­tor of the Di­vi­sion of Psy­chi­a­try Prod­ucts in FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search. “Con­trolled clin­i­cal tri­als that stud­ied the safe­ty and ef­fi­ca­cy of this drug, along with care­ful re­view through the FDA’s drug ap­proval process in­clud­ing a ro­bust dis­cus­sion with our ex­ter­nal ad­vi­so­ry com­mit­tees, were im­por­tant to our de­ci­sion to ap­prove this treat­ment. Be­cause of safey con­cerns, the drug will on­ly be avail­able through a re­strict­ed dis­tri­b­u­tion sys­tem and it must be ad­min­is­tered in a cer­ti­fied med­ical of­fice where the health care provider can mon­i­tor the pa­tient.” 

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.

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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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.