Fac­ing a deep­en­ing po­lit­i­cal cri­sis, PhRMA launch­es a ma­jor coun­ter­at­tack against its le­gion of crit­ics

Un­der the most heat­ed po­lit­i­cal at­tack the drug in­dus­try has ever faced on Capi­tol Hill, the lob­by­ing pow­er­house PhRMA is rolling out its most am­bi­tious pub­lic re­la­tions cam­paign in its his­to­ry.

Just months af­ter rais­ing dues to gen­er­ate an ex­tra $100 mil­lion for its war chest, PhRMA is re­port­ed­ly spend­ing tens of mil­lions of dol­lars on a new cam­paign aimed to win hearts and minds in the grow­ing bat­tle over drug prices. PhRMA’s cam­paign will ini­tial­ly hit hard on the sci­en­tif­ic ad­vances that are be­ing made, spot­light­ing big ad­vances in R&D to the gen­er­al pub­lic. And then they want to spon­sor more dis­cus­sions in pub­lic fo­rums while pur­su­ing their leg­isla­tive agen­da.

The cam­paign has been in the works for months now. But it comes just days af­ter Pres­i­dent Don­ald Trump went on a tirade against the in­dus­try, say­ing that drug mak­ers had been “get­ting away with mur­der” on pric­ing and vow­ing to rein in costs. Lat­er, Trump ex­plained that he planned to al­low Medicare to di­rect­ly ne­go­ti­ate drug prices for the first time, putting Big Phar­ma on no­tice that it would soon lose one of its most prized po­lit­i­cal ac­com­plish­ments.

Hillary Clin­ton had more crit­i­cisms for phar­ma dur­ing the pres­i­den­tial cam­paign, but Trump has made up on any lost ground, adopt­ing what is like­ly to be a wide­ly pop­u­lar stance on drug prices.

The most ex­plo­sive el­e­ment in drug prices, and the most po­tent po­lit­i­cal­ly, has fo­cused on com­pa­nies like Tur­ing, My­lan, Valeant and Mallinck­rodt, which all jacked the price on old meds, un­fet­tered by any laws or reg­u­la­tions that might pro­hib­it price goug­ing. But there has al­so been con­sid­er­able crit­i­cism of the in­dus­try’s wide­spread prac­tice of push­ing an­nu­al price hikes on their port­fo­lio drugs. And the price of many new drugs of­ten reach well in­to six fig­ures, adding to the gen­er­al dis­con­tent that could spawn leg­is­la­tion that would have a wide in­flu­ence on all bio­phar­ma com­pa­nies.

PhRMA CEO Stephen Ubl touched on the up­com­ing cam­paign at a pan­el dis­cus­sion I host­ed at JP Mor­gan a few weeks ago. He said:

At PhRMA and with­in the in­dus­try, we’re fo­cused on two things. First, we’re go­ing to launch a very am­bi­tious, com­pre­hen­sive, na­tion­al com­mu­ni­ca­tions and pub­lic af­fairs ef­fort. One com­po­nent will be ad­ver­tise­ments that are fo­cused on the ex­cit­ing break­throughs in sci­ence that we’ve not been, again, re­port­ing on in my view. But more im­por­tant­ly, it’s not just about ads. The ef­fort is go­ing to be putting the in­dus­try in a lead­er­ship role and con­ven­ing stake­hold­ers to talk about how we move the sys­tem from vol­ume to val­ue and what our role in that is. We need to come to the ta­ble with so­lu­tions, whether they’re FDA re­forms, bar­ri­ers to in­no­v­a­tive con­tract­ing, con­sumer-ori­ent­ed trans­paren­cy.

One of the ma­jor themes in this cam­paign is ex­pect­ed to be the ex­tra­or­di­nary cost in­volved in drug de­vel­op­ment as cheap gener­ics con­tin­ue to lim­it the amount of mon­ey spent on drugs in gen­er­al. Pfiz­er has tak­en that stance al­ready. But even with a high lev­el of bi­par­ti­san sup­port in Con­gress, ev­i­dent in the re­cent pas­sage of the 21st Cen­tu­ry Cures Act, PhRMA and phar­ma face a big and grow­ing deficit of pub­lic trust.

This new cam­paign is like­ly to elic­it com­par­isons to the “Har­ry and Louise” cam­paign that the health in­sur­ance lob­by used to help beat back threat­en­ing leg­is­la­tion. But it will come at many times the cost of that $20 mil­lion ef­fort.

Drug prices may ac­tu­al­ly on­ly ac­count for a frac­tion of the health­care dol­lar, but there’s no ques­tion it’s a high-pro­file item for the pub­lic. A few days ago The Har­ris Poll found that on­ly 9% of Amer­i­cans be­lieve that drug com­pa­nies put pa­tients ahead of prof­its.

That’s a dan­ger­ous­ly weak po­si­tion to be in.

“There are un­de­ni­able rep­u­ta­tion­al risks for phar­ma­ceu­ti­cal and health in­sur­ance com­pa­nies – more so than oth­er parts of the health care ecosys­tem,” said Wendy Sa­lomon, vice pres­i­dent of rep­u­ta­tion man­age­ment and pub­lic af­fairs at Nielsen. “Rep­u­ta­tion mat­ters to pa­tients, care providers, in­vestors, em­ploy­ees, and po­ten­tial hires. Pos­i­tive rep­u­ta­tions can pave the way in times of cri­sis, in times of tran­si­tion – and when it’s crit­i­cal to have a seat at the pol­i­cy-set­ting ta­ble.”


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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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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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

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.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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