Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions — study

Pfiz­er and BioN­Tech will sell 500 mil­lion dos­es of their Comir­naty Covid-19 vac­cine to the US at cost as part of an ex­pand­ed agree­ment to dri­ve do­na­tions to low- and mid­dle-in­come na­tions, the drug­mak­er said Wednes­day.

The ex­pand­ed pact dou­bles Pfiz­er/BioN­Tech’s com­mit­ment to the US ef­fort, which will ship do­na­tions to CO­V­AX, a glob­al clear­ing­house for up to 92 tar­get na­tions, as well as the 55 mem­ber states of the African Union, Pfiz­er said. De­liv­er­ies start­ed in Au­gust and are ex­pect­ed to run through Sep­tem­ber 2022.

Pfiz­er ex­pects to cen­ter pro­duc­tion for this or­der at its sites in Kala­ma­zoo, MI, An­dover, MA, Chester­field, MO, and McPher­son, KS, the drug­mak­er said.

Ugur Sahin

“In the short term, we have pledged to de­liv­er at least one bil­lion dos­es this year and at least one bil­lion dos­es next year to low- and mid­dle-in­come coun­tries,” BioN­Tech CEO Ugur Sahin said in a state­ment. “In par­al­lel, we are ex­plor­ing how to build a sus­tain­able mR­NA pro­duc­tion in­fra­struc­ture in low-in­come coun­tries to de­moc­ra­tize ac­cess to vac­cines in the mid- and long-term. This ap­plies to both in­di­vid­ual pro­duc­tion steps and com­plete man­u­fac­tur­ing.”

Pfiz­er says it has com­mit­ted 2 bil­lion dos­es of its vac­cine to low- and mid­dle-in­come coun­tries through 2022, much of that com­ing through its US agree­ment. The drug­mak­er, mean­while, has inked di­rect sup­ply agree­ments with in­di­vid­ual coun­try gov­ern­ments and sep­a­rate­ly with CO­V­AX for 40 mil­lion dos­es in 2021.

Gilead’s remde­sivir helps pre­vent hos­pi­tal­iza­tions with ear­ly use — study

Remde­sivir has shown mixed re­sults over the course of the pan­dem­ic in hos­pi­tal­ized Covid-19 pa­tients, but Gilead could have a case for the an­tivi­ral’s use in the out­pa­tient set­ting, new da­ta show.

A three-day course of remde­sivir cut the risk of Covid-19 hos­pi­tal­iza­tion or all-cause death by 87% com­pared with place­bo (p=0.008) at the 28-day mark in non-hos­pi­tal­ized, high-risk pa­tients, ac­cord­ing to re­sults from a 562-pa­tient Phase III study un­veiled Wednes­day. On a sec­ondary end­point re­duc­ing the risk of med­ical vis­its or all-cause death, remde­sivir beat out place­bo by 81% (p=0.002). There were no deaths re­port­ed in ei­ther arm of the study dur­ing the 28-day pe­ri­od.

It’s a big win for remde­sivir, but it’s worth con­sid­er­ing one big grain of salt: The study stopped en­rolling pa­tients in April, well be­low its tar­get goal of 1,264, “re­flect­ing the chang­ing epi­demi­ol­o­gy and adop­tion of ad­di­tion­al treat­ment op­tions at the time,” Gilead said.

With that point in mind, remde­sivir’s po­ten­tial in the out­pa­tient set­ting could be lim­it­ed giv­en the rapid­ly chang­ing stan­dard of care, the rise in vac­ci­na­tion rates and the emer­gence of the Delta vari­ant. But Gilead is still tout­ing the da­ta as a win and a po­ten­tial path for­ward for out­pa­tient EUA.

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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