Thumbs Up/Thumbs Down: The UN fum­bles bad­ly over ac­cess to drugs while de­vel­op­ers think again about R&D strate­gies


End­points as­sess­es the big bio­phar­ma R&D sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

  The UN has a ter­ri­ble idea for re­solv­ing the drug pric­ing is­sue

The brouha­ha over drug prices this year has now helped stir up one of the worst pro­pos­als we’ve heard of so far. This one comes from the UN, which we oc­ca­sion­al­ly for­get ex­ists at all. The prob­lem with drugs, says the UN, is that all that nasty IP used by bio­phar­ma com­pa­nies to con­trol these prod­ucts is al­low­ing them to price ther­a­pies be­yond the reach of the poor. The US and oth­er coun­tries should do what they can to de­mand ready ac­cess to the drugs tax­pay­ers help pro­vide re­search sup­port for, says the UN. We beg to dif­fer. Any so­lu­tion re­gard­ing drug pric­ing is go­ing to have to be mar­ket-based, un­less you just want to de­stroy the mar­ket. If you de­stroy the mar­ket, there aren’t go­ing to be many drug prices to fight over, be­cause we’ll have far few­er ther­a­pies. There are mar­ket-based ini­tia­tives — let’s all ap­plaud Brent Saun­ders on that score — which can go a long way to re­solv­ing this de­bate. Man­u­fac­tur­ers, we note, have al­so been go­ing a long way to de­vel­op pric­ing struc­tures for each econ­o­my. As for the UN, it might want to find an­oth­er cri­sis to ad­dress. They’re al­ready ir­rel­e­vant on the drug pric­ing de­bate.

New rev­e­la­tions from ge­net­ics re­search help dri­ve a new ap­proach to R&D

Ei­sai’s new re­search group in An­dover, MA, which we cov­ered this week, il­lus­trates once again how drug de­vel­op­ment has been un­der­go­ing a ma­jor re­vamp. Groups like this promise to start with a clean slate and build new drugs from the ground up, do­ing more with fresh rev­e­la­tions about ge­net­ics to crack some very dif­fi­cult tar­gets like Alzheimer’s. We may even­tu­al­ly find our­selves with a few bad-to-mediocre drugs for this dis­ease, plucked out of the cur­rent late-stage crop, but a clean-slate ap­proach of­fers a much bet­ter shot at mak­ing a mean­ing­ful dif­fer­ence for pa­tients. De­nali, run by some ex-Genen­tech ex­ecs in San Fran­cis­co, is on the same track. Yes, this will all re­quire years of ex­plo­ration and plen­ty of mis­steps along the way, but the ul­ti­mate pay­off will like­ly be well worth the wait.

In the ab­sence of news on eteplirsen, we’re left with tea leaves

In the ab­sence of an FDA de­ci­sion, we’re all left read­ing tea leaves when it comes to cov­er­ing Sarep­ta. This week it was the news about Ron Farkas’ de­par­ture from the FDA that pro­vid­ed the ba­sis for a fresh round of spec­u­la­tion about their Duchenne mus­cu­lar dy­s­tro­phy drug. Ad­vo­cates who booed Farkas’ harsh crit­i­cism of Sarep­ta’s case for this drug saw it as a big win. Skep­tics didn’t see how one reg­u­la­tor’s ex­it could make much of a dif­fer­ence. We’ve been wait­ing for the FDA to make up its mind on this drug, and the tiny study used to back up its case for an ac­cel­er­at­ed ap­proval, all year long. It’s time for the FDA to stop dither­ing and make a de­ci­sion. Pa­tients need to know where the agency stands on this.

Stat will need to back up its next slap­down in biotech

I’ve been cov­er­ing bio­phar­ma for a long time, and jumped in­to jour­nal­ism close to four decades ago. If there’s one thing I’ve learned, if you want to re­al­ly ex­pose a bad­ly run com­pa­ny, you had bet­ter be able to es­tab­lish the facts. Stat, an on­line pub­li­ca­tion which has done much wor­thy work, claimed it had the goods on Mod­er­na, but woe­ful­ly failed to de­liv­er. The open­ing para­graphs of that sto­ry promised ex­plo­sives, and it de­liv­ered a few fire­crack­ers. And most, if not all, of those fire­crack­ers were thrown by anony­mous crit­ics. Stat un­for­tu­nate­ly dis­pens­es with stan­dards when it wants to stir up a con­tro­ver­sy. Next time, they should do the hard work, in the way that the Wall Street Jour­nal demon­strat­ed with its cov­er­age of Ther­a­nos. We’re wait­ing.

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.