Bill Gates at the Global Investment Summit in London, Oct. 19, 2021 (Leon Neal/Pool via AP Images)

Gates Foun­da­tion pledges $120M to ramp up gener­ic sup­ply of Mer­ck­'s Covid-19 pill while ac­tivists blast Pfiz­er's dis­pro­por­tion­ate pow­er

Mer­ck’s mol­nupi­ravir may not be of­fi­cial­ly au­tho­rized any­where in the world yet, but who will get ac­cess to it has shaped up to be a huge is­sue. The Bill & Melin­da Gates Foun­da­tion is now step­ping up to en­sure low­er-in­come coun­tries won’t be left be­hind — and call­ing on oth­ers to fol­low its lead.

The oral an­tivi­ral pill, which was shown to dra­mat­i­cal­ly cut the risk of se­vere Covid-19 dis­ease and death in a Phase III study, is the lat­est ral­ly­ing sym­bol in the bat­tle against not just the coro­n­avirus but the in­equal­i­ty it’s ex­posed.

While ex­act de­tails are to be ham­mered out in con­sul­ta­tion with part­ners, the phil­an­thropy group says it’s re­serv­ing $120 mil­lion main­ly to fund the de­vel­op­ment and man­u­fac­tur­ing of gener­ic ver­sions of mol­nupi­ravir, a life-sav­ing drug be­ing co-de­vel­oped by Ridge­back Bio­ther­a­peu­tics.

“Mer­ck has tak­en im­por­tant steps to make this drug avail­able as a COVID-19 ther­a­py, in­clud­ing ne­go­ti­at­ing li­cens­es with gener­ics man­u­fac­tur­ers to in­crease sup­ply,” said Bill Gates, co-chair of the Gates Foun­da­tion. “We are pleased to work along­side these ef­forts to en­sure af­ford­abil­i­ty and avail­abil­i­ty in low­er-in­come coun­tries.”

Mer­ck stands to earn $1.2 bil­lion from its sup­ply deal with the US alone, and Mizuho an­a­lysts ex­pect the sales to swell to just un­der $5 bil­lion at peak based on the con­firmed price of $705 in the US and an es­ti­mat­ed “blend­ed rate” of $423 per course for the rest of the world. It’s un­clear how gener­ics may af­fect those num­bers (the WHO is al­so re­port­ed­ly lead­ing a con­sor­tium to pur­chase an un­spec­i­fied-but-prob­a­bly mol­nupi­ravir an­tivi­ral pill for $10).

The move comes amid a broad­er cam­paign to draw at­ten­tion to the in­equity in glob­al dis­tri­b­u­tion of Covid-19 vac­cines and treat­ments, with wealthy coun­tries hawk­ing the li­on’s share of sup­plies, leav­ing poor­er coun­tries even more vul­ner­a­ble as they fend for them­selves in the midst of out­breaks.

Ethiopia, for in­stance, has so far on­ly se­cured enough vac­cines to in­oc­u­late 2.1% of its en­tire pop­u­la­tion, ac­cord­ing to Bloomberg’s track­er.

Pfiz­er was the lat­est drug­mak­er to come un­der at­tack. Pub­lic Cit­i­zen, the ad­vo­ca­cy group that’s pre­vi­ous­ly called on Mod­er­na to share its vac­cine recipe, has pub­lished a lengthy let­ter de­cry­ing “Pfiz­er’s Pow­er” — as doc­u­ment­ed in con­tracts with mul­ti­ple na­tion­al gov­ern­ments over the sup­ply of its mR­NA shot.

Ac­cord­ing to Pub­lic Cit­i­zen, a look at draft or fi­nal con­tracts with Al­ba­nia, Brazil, Colom­bia, Do­mini­can Re­pub­lic, as well as the US, EU, UK and oth­ers re­veal a num­ber of oner­ous terms: Not on­ly does Pfiz­er re­serve the right to si­lence gov­ern­ments and go af­ter state as­sets, they al­so con­trol whether coun­tries can re­ceive do­na­tions from oth­ers, be pro­tect­ed from IP suits, set­tle con­trac­tu­al dis­putes in se­cret and “call the shots” on de­liv­ery sched­ules.

But there must be a bet­ter way, the group ar­gued.

High-in­come coun­tries have en­abled Pfiz­er’s pow­er through a fa­vor­able sys­tem of in­ter­na­tion­al in­tel­lec­tu­al prop­er­ty pro­tec­tion. High-in­come coun­tries have an oblig­a­tion to rein in that mo­nop­oly pow­er. The Biden ad­min­is­tra­tion, for ex­am­ple, can call on Pfiz­er to rene­go­ti­ate ex­ist­ing com­mit­ments and pur­sue a fair­er ap­proach in the fu­ture. The ad­min­is­tra­tion can fur­ther rec­ti­fy the pow­er im­bal­ance by shar­ing the vac­cine recipe, un­der the De­fense Pro­duc­tion Act, to al­low mul­ti­ple pro­duc­ers to ex­pand vac­cine sup­plies. It can al­so work to rapid­ly se­cure a broad waiv­er of in­tel­lec­tu­al prop­er­ty rules (TRIPS waiv­er) at the World Trade Or­ga­ni­za­tion.[20] A wartime re­sponse against the virus de­mands noth­ing less.

In con­trast, the Gates Foun­da­tion struck a much more am­i­ca­ble tone when it came to ac­cel­er­at­ing ac­cess to mol­nupi­ravir. Al­though Melin­da French Gates, the oth­er co-chair of the Gates Foun­da­tion, called the cur­rent re­al­i­ty “un­ac­cept­able,” she did not sin­gle out some­one to blame:

“To­day’s com­mit­ment will en­sure that more peo­ple in more coun­tries get ac­cess to the promis­ing drug mol­nupi­ravir, but it’s not the end of the sto­ry — we need oth­er donors, in­clud­ing foun­da­tions and gov­ern­ments, to act.”

The foun­da­tion has so far of­fered $1.3 mil­lion to Med­i­cines for All In­sti­tute and the Uni­ver­si­ty of Man­ches­ter to de­vel­op low-cost man­u­fac­tur­ing process­es that can re­duce the cost of raw ma­te­ri­als and get more prod­uct from each run. On top of that, it’s shelled out $2.4 mil­lion in grants to get gener­ic com­pa­nies ready to ap­ply for WHO pre­qual­i­fi­ca­tion and start man­u­fac­tur­ing as soon as pos­si­ble.

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

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.

Tedros Adhanom Ghebreyesus (Denis Balibouse/Pool Photo via AP Images)

WHO rec­om­mends against the use of con­va­les­cent plas­ma for Covid-19

The World Health Organization said late today that it’s not recommending the use of convalescent plasma as a treatment for Covid-19 for mild or severe cases, but some U.S. experts disagree with the recommendations and say there are patients who can benefit from the plasma of those who’ve recovered from Covid-19.

The recommendation is informed by a review of 16 RCTs and a “meta-analysis on antibodies and cellular therapies for covid-19,” the WHO said, adding in a statement:

Gilead re­calls 2 lots of Vek­lury af­ter in­ves­ti­ga­tion con­firms com­plaint of glass par­tic­u­lates

Two lots of the Covid-19 treatment Veklury have been recalled by Gilead, the company said last week, after the appearance of glass particulates. A customer complaint was confirmed by Gilead’s investigation.

Veklury, also known as remdesivir 100 mg for injection, is used in more than half of hospitalized patients with Covid-19, according to Gilead. It raked in around $2.8 billion last year, and was the only drug approved by the FDA for this setting. But a study out of Europe dubbed DisCoVeRy found that no clinical benefit was observed in patients who received the drug over those who got standard of care alone. And while previous studies have linked remdesivir to a faster time to recovery, that result was not seen in the DisCoVeRy trial.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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