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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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