Covid-19 roundup: In­vestors call to link CEO salaries to vac­cine ac­cess; Why there aren't more ini­tial sup­plies of the Pfiz­er pill

A group of in­sti­tu­tion­al in­vestors from No­mu­ra, BMO, GAM and more than 60 oth­ers rep­re­sent­ing tril­lions in as­sets are now call­ing on Covid-19 vac­cine de­vel­op­ers to link their ex­ec­u­tives’ pay to en­sure the vac­cines are avail­able glob­al­ly.

“It is clear that cur­rent­ly a large part of the world pop­u­la­tion still does not have suf­fi­cient and eq­ui­table ac­cess to vac­cines,” the in­vestors said in ex­plain­ing their rea­son­ing be­hind Thurs­day’s let­ter to the ex­ecs at Pfiz­er, Mod­er­na, As­traZeneca and J&J.

The push comes as all of the com­pa­nies have pledged to make low­er-cost ver­sions of their vac­cines avail­able, but many coun­tries still lack cru­cial sup­plies. The WHO has sought to reach the mark of 70% vac­ci­nat­ed in every coun­try af­ter al­most half of its par­tic­i­pat­ing mem­ber coun­tries failed to reach 40% vac­ci­nat­ed in 2021, ac­cord­ing to the Fi­nan­cial Times.

House Re­pub­li­can calls for Omi­cron treat­ment hear­ing

Rep. Michael Burgess (R-TX) is call­ing for a hear­ing with fed­er­al pol­i­cy lead­ers to get a bet­ter un­der­stand­ing of how Con­gress can im­prove the US re­sponse, in­clud­ing via the dis­tri­b­u­tion of ef­fec­tive treat­ments, to bat­tle the new vari­ant Omi­cron, ac­cord­ing to a let­ter sent yes­ter­day to House En­er­gy & Com­merce com­mit­tee chair Frank Pal­lone (D-NJ).

“It would be ben­e­fi­cial to in­vite var­i­ous agen­cies such as the Cen­ters for Dis­ease Con­trol and Pre­ven­tion, the Food and Drug Ad­min­is­tra­tion, and the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty to tes­ti­fy on the de­vel­op­ment process for COVID-19 ther­a­peu­tics and an­tivi­rals, such as mol­nupi­ravir and sotro­vimab, and how we can en­sure ad­e­quate dis­tri­b­u­tion of these op­tions,” he wrote.

Burgess al­so not­ed how due to its ex­pect­ed ef­fec­tive­ness against the Omi­cron vari­ant, ship­ments of Glax­o­SmithK­line and Vir’s sotro­vimab were paused to en­sure re­serves would not be de­plet­ed as the vari­ant spread. “Though this de­ci­sion has since been re­versed, I am very con­cerned about the lim­it­ed sup­ply cur­rent­ly avail­able,” he wrote.

The Sen­ate health com­mit­tee is set to meet next Tues­day to hear from CDC, FDA and NIH of­fi­cials, in­clud­ing act­ing FDA com­mis­sion­er Janet Wood­cock and Pres­i­dent Biden’s top med­ical ad­vi­sor Tony Fau­ci.

Man­u­fac­tur­ing dif­fi­cul­ties mean there will be a lot more of Mer­ck’s pill than Pfiz­er’s in the next few months

Un­til at least March, the US is go­ing to have hun­dreds of thou­sands of more cours­es of Mer­ck’s pill to treat Covid-19, known as mol­nupi­ravir, than Pfiz­er’s pill Paxlovid, even as the US has pur­chased 20 mil­lion pills from Pfiz­er.

Part of the rea­son for this ear­ly dis­crep­an­cy is that while Pfiz­er’s pill might be more ef­fec­tive than Mer­ck’s pill (no one ran a head-to-head tri­al), Pfiz­er’s pill is al­so dif­fi­cult to man­u­fac­ture.

Chemist Derek Lowe wrote in Sci­ence re­cent­ly about how and why Pfiz­er’s pill is dif­fi­cult to make, and how there are short­ages of the reagents used to make it.

“So there’s a short­age of the stuff, that’s used to make the stuff, that’s used to make the stuff, that’s used to make two of the start­ing ma­te­ri­als for Paxlovid. And that’s just one of the reagents,” he wrote. “Re­mem­ber, as com­pli­cat­ed as this may seem, there’s a lot more to set­ting up a pro­duc­tion sup­ply chain than this! What it all means is that when some­one says ‘Oh, we can just make Paxlovid in plants all over the world’, they have left out the rest of the sen­tence, which is ‘. . .if we can get the start­ing ma­te­ri­als’.”

White House coro­n­avirus re­sponse co­or­di­na­tor Jeff Zients al­so re­cent­ly said in a press brief­ing that the US is of­fer­ing what­ev­er it can to help Pfiz­er, but the com­plex chem­istry in­volved in cre­at­ing the ac­tive in­gre­di­ent in the pill means pro­duc­tion takes about six to eight months.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.