FDA ex­perts gun down a big part of Sanofi's pitch for their con­tro­ver­sial vac­cine

Sanofi has tak­en its con­tro­ver­sial dengue vac­cine to the FDA, but a pan­el of out­side ex­perts just hand­ed down a mixed de­ci­sion that could re­duce — or even elim­i­nate — any mar­ket po­ten­tial it may have in the US.

In a se­ries of votes Thurs­day af­ter­noon, the FDA’s vac­cine ad­vis­ers hand­ed down split votes on safe­ty and ef­fec­tive­ness for the phar­ma gi­ant’s tar­get pop­u­la­tion, from 9 to 45. They lost the ef­fi­ca­cy vote 6 to 7, with one ab­sten­tion, with a straight 7-7 split on safe­ty.

That’s not good when you’re look­ing for a clean bill of health from the au­thor­i­ties.

They did note a more fa­vor­able opin­ion for a small­er group of pa­tients aged 9 to less than 17, vot­ing 13 to 1 on ef­fi­ca­cy and 10 to 4 on safe­ty.

None of that will build con­fi­dence in the vac­cine, once tapped as Sanofi’s next big block­buster. Those dreams all flat­lined af­ter the Philip­pines used it in a mass vac­ci­na­tion cam­paign for 800,000 chil­dren, just be­fore it was wide­ly linked with hos­pi­tal­iza­tions and a high­er risk of death when the vac­cine was a child’s first ex­po­sure to the virus, set­ting up a much more se­vere re­ac­tion to a sec­ond ex­po­sure of wild type dengue.

Just days ago Philip­pine of­fi­cials said they were prepar­ing crim­i­nal charges against a slate of Sanofi staffers in­volved in the vac­ci­na­tion cam­paign — a de­vel­op­ment that the Paris home of­fice crit­i­cized.

This time around, Sanofi sought an OK for pa­tients who had a proven ex­po­sure to the virus ahead of their vac­ci­na­tion. The FDA’s in­ter­nal re­view high­light­ed why:

In the ini­tial analy­ses of long term fol­low-up da­ta, i.e., through 60 months post-dose 1, a safe­ty sig­nal be­came ap­par­ent for in­creased risk of se­vere dengue in the younger co­horts of Deng­vax­ia re­cip­i­ents, par­tic­u­lar­ly in sub­jects 2 to 5 years of age. To in­ves­ti­gate this sig­nal, the spon­sor per­formed ad­di­tion­al lab­o­ra­to­ry test­ing and re-an­a­lyzed the long-term fol­low-up da­ta on se­vere/hos­pi­tal­ized VCD from the ef­fi­ca­cy stud­ies CYD14, CYD15, and CYD23. Al­though age could not be ruled out as a con­tribut­ing fac­tor, the pri­ma­ry vari­able as­so­ci­at­ed with in­creased rel­a­tive risk of hos­pi­tal­ized VCD in Deng­vax­ia re­cip­i­ents was dengue non-im­mune sta­tus at base­line. Based on these analy­ses, the spon­sor is re­quest­ing ap­proval for use on­ly for in­di­vid­u­als 9 through 45 years of age with lab­o­ra­to­ry-con­firmed pre­vi­ous dengue in­fec­tion and liv­ing in en­dem­ic ar­eas.

But the re­stric­tions still weren’t good enough for the pan­el for the broad age group they sought to cater to. The fi­nal de­ci­sion rests with the FDA. Sanofi, mean­while, con­tin­ues to in­sist that it did noth­ing wrong with their vac­cine, which it con­tin­ues to push in the wake of the glob­al con­tro­ver­sy. Take­da, mean­while, has a ri­val vac­cine in late-stage de­vel­op­ment.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

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.