President Trump listens to FDA Commissioner Stephen Hahn speaking at a press briefing on the Covid-19 pandemic with members of the Coronavirus Task Force at the White House in Washington on March 19, 2020. Photo by Yuri Gripas/Abaca/Sipa USA(Sipa via AP Images)

Drug­mak­er re­thinks its de­ci­sion to dou­ble price of a gener­ic af­ter Trump calls it a coro­n­avirus life­saver — re­ports

Af­ter Pres­i­dent Trump on Thurs­day im­plied a decades-old malar­ia drug was sanc­tioned by the FDA to fight the new coro­n­avirus, re­ports emerged that late last year the drug’s mak­er dou­bled the price of the com­pound, but has now re­stored the orig­i­nal price tag as the virus en­velops much of the globe.

Made by New Jer­sey-based Ris­ing Phar­ma­ceu­ti­cals — the drug, called chloro­quine phos­phate — saw a hike of rough­ly 98% to $7.66 for a 250 mg tablet, STAT and the Fi­nan­cial Times re­port­ed, cit­ing da­ta from re­search and pub­lish­ing firm El­se­vi­er.

As FDA com­mis­sion­er Stephen Hahn was forced to clar­i­fy that the drug was still be­ing eval­u­at­ed for use against coro­n­avirus on Thurs­day, the com­pa­ny sug­gest­ed the price hike came months ahead of the out­break snow­balled in­to a pan­dem­ic, and be­fore re­searchers be­gan to spec­u­late it might help in­fect­ed pa­tients.

The com­pa­ny — which in De­cem­ber agreed to pay a fine of more than $3 mil­lion af­ter be­ing charged with con­spir­ing to fix prices for a gener­ic hy­per­ten­sion drug — has re­vert­ed back to chloro­quine phos­phate’s orig­i­nal price set in 2015.

“As soon as we saw the in­crease in de­mand and the po­ten­tial that this was go­ing to be uti­lized in the way some folks are pro­ject­ing it to be, we re­scind­ed that price in­crease to the same price it has been on the mar­ket for since 2015,” an ex­ec­u­tive told the FT.

Al­though the drug is be­ing used as part of com­pas­sion­ate use pro­grams in some coun­tries, there is no de­fin­i­tive ev­i­dence sug­gest­ing it helps pa­tients in­fect­ed with the new coro­n­avirus, al­though even Tes­la founder Elon Musk — who has pre­vi­ous­ly sug­gest­ed the “dan­ger of pan­ic” still far ex­ceeds the dan­ger of coro­n­avirus — has tak­en no­tice of its promise.

The drug, now a gener­ic, is de­rived from the bark of the chin­chona tree and has been in use since World War II. It is un­der­stood to be gen­er­al­ly safe in mild-to-mod­er­ate cas­es, but can be tox­ic at high dos­es. Apart from its use against malar­ia, an ill­ness caused by a par­a­site and spread to hu­mans via mos­qui­to bites, the med­i­cine is al­so de­ployed for use in cer­tain au­toim­mune con­di­tions.

Ear­ly da­ta emerg­ing out of France, test­ing a less tox­ic de­riv­a­tive of chloro­quine — hy­drox­y­chloro­quine — on a few dozen pa­tients with Covid-19, sug­gest it may help curb the pe­ri­od that peo­ple with the dis­ease are in­fec­tious. Mean­while, Chi­na’s Min­istry of Sci­ence and Tech­nol­o­gy has al­so sug­gest­ed that chloro­quine phos­phate should be in­clud­ed in the stan­dard Covid-19 reg­i­men, af­ter show­ing promis­ing re­sults in tri­als across 10 hos­pi­tals.

On Thurs­day, Ger­man drug­mak­er Bay­er an­nounced in a press re­lease that it was do­nat­ing 3 mil­lion tablets of its ver­sion of chloro­quine phos­phate for use in US pa­tients.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.