FDA clears short­er treat­ment reg­i­men for Ab­b­Vie's hep C treat­ment, Mavyret. Will pa­tients ben­e­fit?

Ab­b­Vie $AB­BV has ob­tained FDA ap­proval to ad­min­is­ter its Mavyret he­pati­tis C pill as a two-month reg­i­men, ver­sus the 12-week course it was orig­i­nal­ly cleared for — a move that may help ex­pand op­tions for the mar­gin of cov­ered pa­tients who need a short­er reg­i­men.

“While over 100,000 pa­tients have been pre­scribed Mavyret for chron­ic HCV in the US, there are still a sig­nif­i­cant num­ber of pa­tients that need op­tions,” Janet Ham­mond, Ab­b­Vie’s vice pres­i­dent of gen­er­al med­i­cine and vi­rol­o­gy ther­a­peu­tic area, said in a state­ment.

Vin­cent Lo Re, a Uni­ver­si­ty of Penn­syl­va­nia School of Med­i­cine pro­fes­sor spe­cial­iz­ing in he­pati­tis, told End­points News that the raft of treat­ments ap­proved since 2014 have been quite ef­fec­tive in cur­ing the dis­ease in most pa­tients. Those who con­tin­ue to suf­fer do so for a va­ri­ety of rea­sons: al­co­holism, drug abuse, men­tal health prob­lems or a com­bi­na­tion of these, mak­ing it an up­hill task to com­plete the 12-week reg­i­men.

Vin­cent Lo Re Perel­man

This cat­e­go­ry of pa­tient, there­fore, could ben­e­fit from the short­er 8-week treat­ment pe­ri­od, he said.

“The re­al­i­ty is that we’ve treat­ed many pa­tients who have been wait­ing for he­pati­tis C ther­a­py,” he said. “The pa­tients that are now of­ten pre­sent­ing for eval­u­a­tion and con­sid­er­a­tion for treat­ment of­ten have many oth­er co-mor­bidi­ties, so­cial chal­lenges that make even once-dai­ly ther­a­py dif­fi­cult to ad­here to.”

Mavyret de­buted in Au­gust 2017 as the cheap­er al­ter­na­tive to Gilead’s $GILD block­buster-yet-wal­let-bust­ing So­val­di, which came in at $84,000 for a three-month reg­i­men. Still, Ab­b­Vie’s op­tion costs $13,200 per 4-weeks or $26,400 for 8-weeks and so on (at the time some forms of the virus were cured with­in that time­frame, oth­ers af­ter 12 or 16 weeks).

Many in­sur­ers were will­ing to pay the price of these treat­ments, as it saved mon­ey in the long run, but some plans such as Med­ic­aid were un­able to pro­vide it to their pa­tients due to fi­nan­cial con­straints. The dis­ease has now be­come a light­ning rod in the ever-heat­ing de­bate around in­no­va­tion and ac­cess — both an ex­am­ple of the kind of cu­ra­tive ther­a­pies the cur­rent R&D sys­tem can pro­duce and the high costs that tend to de­ny ac­cess to those most in need.

Janet Wood­cock FDA

“I would nev­er have thought, ever, in the ’90s, that if some­body came up with a cure for he­pati­tis C, that peo­ple wouldn’t be able to be treat­ed. That was in­con­ceiv­able,” CDER chief Janet Wood­cock told the Break­throughs in Med­i­cine Con­fer­ence this month. “But fast-for­ward to now, and that’s the re­al­i­ty we’re see­ing.”

But oth­ers have point­ed to the hep C cure as an ex­am­ple of the Amer­i­can sys­tem at work, with Gilead ac­tu­al­ly of­fer­ing the drug for less than they and in­de­pen­dent re­searchers said would max­i­mize their prof­it.

Fol­low­ing mod­els first in­tro­duced abroad, drug com­pa­nies have re­cent­ly turned to­ward in­no­v­a­tive meth­ods of mak­ing their prod­ucts avail­able while main­tain­ing prof­it mar­gins. Gilead and Ab­b­Vie have each signed “Net­flix” style agree­ments with Louisiana and Wash­ing­ton, re­spec­tive­ly, to de­liv­er es­sen­tial­ly un­lim­it­ed quan­ti­ties of the drug to prison and Med­ic­aid pa­tients for a flat rate from the state. These mod­els may not lead to low­er prices for the state gov­ern­ment but do pro­vide cost cer­tain­ty. Oth­er states may fol­low suit.

Ex­act sta­tis­tics are hard to come by and the field is chang­ing with each drug and pric­ing de­vel­op­ment, but a 2018 Open Fo­rum In­fec­tious Dis­ease study found 35% of 9,025 tracked pa­tients were pre­scribed an HCV cure but then de­nied cov­er­age. Those with pri­vate in­sur­ance were the most like­ly to be de­nied.

“Un­for­tu­nate­ly for many pa­tients,” wrote an­oth­er group of re­searchers this year in the Amer­i­can Jour­nal of Med­i­cine, cit­ing the OFID study among oth­ers, “their state of res­i­dence is the de­ci­sive fac­tor for whether they will re­ceive life­sav­ing treat­ment.”

So­cial im­age: Ab­b­Vie

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.

President Trump (AP Images)

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President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

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It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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