In an­oth­er win for Trump, Mer­ck takes the drug pric­ing pledge. Its cuts are a joke, but is this an in­dus­try tip­ping point?

You can add Mer­ck to the list of phar­ma gi­ants tak­ing the pledge to ei­ther hold off on any price hikes or mov­ing to cut them. And there are grow­ing signs that oth­er ma­jors may soon join the par­ty as at least one top ex­ec re­port­ed­ly met with Pres­i­dent Don­ald Trump at the White House Thurs­day.

Fol­low­ing the lead of Pfiz­er and No­var­tis, Mer­ck put out a state­ment Thurs­day af­ter­noon that it has com­mit­ted to hold the line on any drug price hikes to the av­er­age in­fla­tion rate. In ad­di­tion, they have a spe­cial in mind. The com­pa­ny is slash­ing the price of their hep C com­bo Zepati­er by 60% while al­so promis­ing a 10% cut on oth­er ther­a­pies.

And they are not done.

The Mer­ck prod­ucts se­lect­ed were based on a range of fac­tors in­clud­ing the gap be­tween list price and ac­tu­al dis­count­ed (net) prices paid in the mar­ket, the con­trac­tu­al oblig­a­tions un­der ex­ist­ing arrange­ments with pay­ers, and the op­por­tu­ni­ty to broad­en ac­cess to treat­ment.

Go­ing for­ward, we will con­tin­ue to eval­u­ate our port­fo­lio of prod­ucts to look for op­por­tu­ni­ties to fur­ther re­duce costs for pa­tients and the health care sys­tem.

There’s been a con­sid­er­able amount of scoff­ing by in­dus­try ob­servers about these pric­ing promis­es, par­tic­u­lar­ly as it re­lat­ed to Pfiz­er CEO Ian Read’s promise to hold the line for just a few months. No­var­tis al­so was sub­ject­ed to con­sid­er­able scorn for of­fer­ing to rein it in, af­ter rais­ing prices on­ly re­cent­ly.

In this case, Mer­ck is cut­ting the price of a drug that con­tributes on­ly a tiny slice of its rev­enue — and which is fast fad­ing to noth­ing — in a dis­ease are­na dom­i­nat­ed by Gilead and Ab­b­Vie. Hep C was al­ready a los­er. And its oth­er 5 drugs in the cut­ting block are re­port­ed­ly off patent, mean­ing they are giv­ing up pre­cise­ly noth­ing in the way of mean­ing­ful cuts.

Mer­ck’s move, though, may in­di­cate that a fun­da­men­tal bio­phar­ma shift is un­der­way as the in­dus­try deals with the di­rect as­sault mount­ed by Pres­i­dent Trump. Trump may not ever get the free-falling prices he promised were on the way, but mar­ket lead­ers are falling in­to line in what may yet prove to be a durable truce on the drug price de­bate.

And love him or hate him, that’s a big win for Trump — even if this is just op­tics for now. HHS Sec­re­tary Alex Azar was quick to boast about it on Twit­ter:

The Pres­i­dent’s plan is work­ing—drug prices are com­ing down. Thanks Mer­ck for low­er­ing prices on 6 drugs, in­clud­ing a He­pati­tis C drug by 60% and com­mit­ting to keep fu­ture price in­creas­es be­low in­fla­tion. Look­ing for­ward to oth­ers do­ing the same to put Amer­i­can Pa­tients First!

Trump — who ear­li­er ex­co­ri­at­ed Pfiz­er af­ter news of price hikes hit — al­so ex­pressed his ap­pre­ci­a­tion in a new Tweet of his own:

Ac­cord­ing to Politi­co, Read met with Trump to­day in Wash­ing­ton DC as top CEOs in the in­dus­try hun­kered down in a PhRMA strat­e­gy ses­sion.

There’s no love lost be­tween Mer­ck CEO Ken Fra­zier and Trump. Fra­zier dis­tanced him­self from the White House af­ter the con­tro­ver­sy over the pres­i­dent’s re­marks about the ac­tiv­i­ties of ex­trem­ist groups dur­ing a dead­ly protest in Vir­ginia. That al­most cer­tain­ly rules out a di­rect call to Fra­zier from Trump.

I’ve asked Mer­ck, though, if any­one in the ad­min­is­tra­tion — per­haps Azar — had been in touch. No one has re­spond­ed.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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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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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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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.