As JP­Mor­gan mad­ness sub­sides, De­moc­rats will un­veil a leg­isla­tive pack­age to ad­dress drug price hikes

On the night be­fore the start of JP Mor­gan — a con­fer­ence where bio­phar­ma ex­ec­u­tives big and small waxed lyri­cal about in­no­va­tion, adorned with name badges fea­tur­ing a gold DNA cap­sule — Pres­i­dent Don­ald Trump tweet­ed his dis­plea­sure that drug­mak­ers were not hon­or­ing their promis­es to rein in prices. He wasn’t wrong. Da­ta sug­gest drug­mak­ers have re­turned to busi­ness as usu­al. And now, af­ter De­moc­rats clawed back con­trol of the House, they’re ex­pect­ed to un­veil a leg­isla­tive pack­age to­day to ad­dress what the White House has so far at­tempt­ed in vain to do: cut prices for pre­scrip­tion drugs.

At least three bills are be­ing tout­ed in the pack­age — in­clud­ing one re­vealed last No­vem­ber from Sen­a­tor Bernie Sanders and Rep­re­sen­ta­tive Ro Khan­na that as­serts Amer­i­cans should not pay more for pre­scrip­tion drugs than the me­di­an price in five ma­jor coun­tries, re­sem­bling a Trump ad­min­is­tra­tion pro­pos­al pre­sent­ed the pre­ced­ing month. Oth­er parts of the leg­is­la­tion pro­pos­es al­low­ing HHS to ne­go­ti­ate prices for Medicare Part D di­rect­ly with drug­mak­ers, in­stead of mid­dle­men like phar­ma­cy ben­e­fit man­agers — as well as im­port­ing med­i­cines at a low­er price from coun­tries such as Cana­da.

Last year, un­der pres­sure from the Trump ad­min­is­tra­tion and in re­sponse to pub­lic out­rage, a num­ber of high pro­file drug­mak­ers made pledges to freeze prices. Since then, the Trump ad­min­is­tra­tion has al­so in­tro­duced two pro­pos­als to tem­per prices. But de­spite in­ten­si­fy­ing po­lit­i­cal and me­dia scruti­ny, drug­mak­ers have re­turned to hikes on at least a por­tion of their port­fo­lio. That in turn has trig­gered an in­tense pub­lic back­lash, which is dri­ving this new leg­isla­tive on­slaught.

The phar­ma­ceu­ti­cal in­dus­try, along with its well con­nect­ed lob­by, has ve­he­ment­ly fought against pro­pos­als to im­port over­seas prices, sug­gest­ing such schemes will sti­fle in­no­va­tion and po­ten­tial­ly ush­er un­safe med­i­cines in­to the coun­try.

Stephen Ubl, CEO of PhRMA, at an End­points News event at the 2019 JP Mor­gan con­fer­ence Jeff Ru­mans for End­points News

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How­ev­er, da­ta show that de­spite the high cost of health­care, the Unit­ed States ac­tu­al­ly per­forms worse across var­i­ous health mea­sures ver­sus a num­ber of oth­er high-in­come na­tions. And Amer­i­cans them­selves are des­per­ate­ly seek­ing change: at­tack­ing drug price goug­ing is one of the few sub­jects that has wide­spread bi­par­ti­san sup­port. Ac­cord­ing to a re­cent Politi­co/Har­vard poll, an over­whelm­ing ma­jor­i­ty of Amer­i­cans ranked ad­dress­ing the cost of med­i­cines as a top pri­or­i­ty for the new Con­gress.

On Wednes­day, for­mer Lil­ly ex­ec­u­tive and HHS sec­re­tary Alex Azar tweet­ed: “For those lis­ten­ing in the phar­ma­ceu­ti­cal in­dus­try: The list price in­creas­es must stop. Prices must start com­ing down.”

But an­a­lysts are not as con­vinced po­lit­i­cal pres­sure will have the im­pact some an­tic­i­pate. Bern­stein’s Ron­ny Gal in a note in No­vem­ber 2018 wrote: “phar­ma does not have to be as nice to PO­TUS now that CMS has pol­i­cy ideas that are an­ti­thet­i­cal to in­dus­try in­ter­est…At the very least, threat­en­ing to raise prices gives in­dus­try a bar­gain­ing chip to ne­go­ti­ate some of these poli­cies away.” More re­cent­ly in Jan­u­ary, Cowen an­a­lysts pub­lished a sur­vey of US drug buy­ers — in­clud­ing HMOs, PBMs and hos­pi­tals who col­lec­tive­ly bought more than $42 bil­lion in drugs in 2017 — to as­cer­tain the mo­men­tum of US drug prices over the next 3 years.

“Re­spon­dents ex­pect U.S. brand drug prices will con­tin­ue to rise over the next 3 years, at a rate sim­i­lar to the past,” the an­a­lysts found.

When asked about the flur­ry of de­bate sur­round­ing the is­sue of pric­ing, Bio­Marin chief Jean-Jacques Bi­en­aime said “It’s not a re­al prob­lem; it’s all pol­i­tics” in an in­ter­view with Bloomberg on the eve of JP Mor­gan.

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).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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Alk­er­mes adds bipo­lar I dis­or­der to its FDA wish­list; Con­go con­firms first Ebo­la case in large city

→ An ever-ambitious Alkermes $ALKS team plans to add bipolar I disorder to its list of conditions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alkermes says they were persuaded to add bipolar I disorder after a pre-NDA meeting with the agency, which came about 7 months after the biotech reported positive data for schizophrenia. The drug is a combo using olanzapine/samidorphan, which they hope will be shown to be as effective as olanzapine without the substantial increase in the risk of weight gain.

Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

Pe­ter Kolchin­sky and Raj Shah raise a $300M fund de­vot­ed to biotech star­tups

Peter Kolchinsky and Raj Shah have another $300 million-plus to play with on the biotech venture side of their investment business. 

The two announced Monday morning that they’ve put together their first pure-play venture fund at RA Capital Management, which has been known to bet on just about every angle in healthcare investing — from rounds to follow-on investments at public companies. This new fund of theirs arrives well into a go-go era of new startup financing, with a particular focus on building new biotechs.

Boehringer buys Swiss biotech in its lat­est M&A deal, go­ing the next-gen can­cer vac­cine route

Boehringer Ingelheim has snapped up a Swiss biotech startup and added their group as a new platform for the oncology pipeline. 

The German biopharma company has bagged Geneva-based AMAL Therapeutics, paying out an unspecified upfront in a $358 million deal — cash, milestones and everything else, all in. Plus there’s 100 million euros on the line for commercial milestones.

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Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

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Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.