Some wor­thy ini­tia­tives out of the FDA fall far short of an ef­fec­tive fed­er­al plan to rein in drug prices

Over the last five months I’ve spent more time watch­ing video streams out of the na­tion’s cap­i­tal than I did in all of the past five years (thank you C-Span). Law­mak­ers, over­all, have been very oblig­ing to the bio­phar­ma in­dus­try on a bi­par­ti­san ba­sis. And when there was ir­reg­u­lar news to re­port from DC, it gen­er­al­ly dealt with is­sues like an ex­tend­ed pe­ri­od of ex­clu­siv­i­ty for bi­o­log­ics or fresh de­mands for swifter drug re­views cou­pled to new in­cen­tives.

Iron­i­cal­ly, the drug in­dus­try proved one of the very few ar­eas where Re­pub­li­cans and De­moc­rats gen­er­al­ly found it easy to co­op­er­ate on a bi­par­ti­san ba­sis.

That all changed the day Don­ald Trump was sworn in as pres­i­dent.

Trump made pub­licly whip­ping bio­phar­ma a reg­u­lar spec­ta­cle. The in­dus­try had too many over­seas jobs, he de­clared with pop­ulist fer­vor, didn’t in­vest in Amer­i­ca and more than any­thing, en­gaged in rip­ping off the coun­try with out­ra­geous­ly high drug prices.

Phar­ma ex­ec­u­tives are a sen­si­tive sort when it comes to pric­ing dis­cus­sions in gen­er­al, and you’d be hard pressed to find any ma­jor play­er who isn’t painful­ly aware of the new pric­ing en­vi­ron­ment.

The big dis­count price on sar­ilum­ab from Sanofi and Re­gen­eron re­flects in part the im­pact Trump has had. Most of the biggest com­pa­nies have al­so come up with some new method for cal­cu­lat­ing ac­cept­able drug price in­creas­es. That didn’t hap­pen in a vac­u­um.

Ge­of­frey Porges, Leerink

So some in­dus­try in­sid­ers may have found it odd that Leerink’s Ge­of­frey Porges thinks that the whole Big Phar­ma as­sault from DC may well just pe­ter out, leav­ing a few scuff marks be­hind af­ter limbs had been threat­ened.

I was think­ing that when I watched FDA com­mis­sion­er Scott Got­tlieb tes­ti­fy in front of a Con­gres­sion­al sub­com­mit­tee on Thurs­day. Got­tlieb has a few good ideas on drug pric­ing. It’s sim­ple com­mon sense that clear­ing up a back­log of gener­ics ap­pli­ca­tions and specif­i­cal­ly tar­get­ing the ap­proval path­way for com­plex gener­ics can have a re­al ef­fect on what this coun­try pays for drugs. Gener­ic com­pe­ti­tion can shred a brand­ed price in months. And we’ll like­ly see biosim­i­lars start to have an im­pact af­ter we see a num­ber of ri­vals ap­pear for every ag­ing block­buster.

If that’s it — with no Medicare ne­go­ti­a­tions or tough fed­er­al for­mu­la­ries that can kick off the most ex­pen­sive meds — then the in­dus­try chiefs will have dodged a can­non ball. Bio­phar­ma can deal with the mar­ket re­al­i­ties of gener­ics. And aban­don­ing the end-game of pro­tect­ing fran­chise drugs with var­i­ous de­lay­ing tac­tics is in the pub­lic in­ter­est.

But that won’t ad­dress the un­der­ly­ing is­sue of brand­ed drug prices in the US.

FDA com­mis­sion­er Scott Got­tlieb

Ul­ti­mate­ly, mar­ket forces may be left as the on­ly vi­able tool for re­strict­ing new drug prices. That’s not nec­es­sar­i­ly a bad thing. But the way it works now cre­ates huge is­sues for pa­tients.

Left to their own de­vices, pay­ers have come up with their own way to de­ny the peo­ple they cov­er ac­cess to ex­pen­sive drugs. Step ther­a­py has be­come a 100 mile jour­ney for some pa­tients. Rules sup­pos­ed­ly aimed at re­strict­ing cov­er­age to those who can ben­e­fit from a drug are of­ten just drawn up to bar cov­er­age. Out-of-pock­et ex­pens­es keep go­ing high­er to wave off prop­er use.

US con­sumers should have ac­cess to new drugs at a fair price.

There has to be a bet­ter way than this to man­age the pric­ing is­sue. But we may not see it any­time soon. And that means the pric­ing con­tro­ver­sy will con­tin­ue to fes­ter in­def­i­nite­ly.

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.