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February 12, 2024 Big Pharma

Big Pharma

Pharma Showed Up for the Big Game + More

The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.

Pharma Showed Up for the Big Game

Axios reported:

Menopause is in, toenail fungus is out. The big picture: A 60-second ad for Astellas’ new menopause treatment for hot flashes aired just before Super Bowl kickoff yesterday, while Pfizer had some of history’s greatest scientists rocking out to Queen to promote its cancer work.

Pfizer’s ad underscored the importance of its recent $43 billion acquisition of Seagen, a leader in oncology drugs, to lift a company that’s struggled since COVID-19 product sales fell off.

Zoom out: At over $6 billion annually, drug advertising is big business in the U.S., the only country besides New Zealand that allows pharma to pitch its wares directly to consumers.

Despite that, the Super Bowl hasn’t always been a big draw for drugmakers, partly because the ad format, with the requisite long list of possible side effects, often doesn’t play well on TV’s biggest stage, STAT previously posited.

Big Pharma Spends Billions More on Executives and Stockholders Than on R&D

Ars Technica reported:

When big pharmaceutical companies are confronted over their exorbitant pricing of prescription drugs in the U.S., they often retreat to two well-worn arguments: One, that the high drug prices cover costs of researching and developing new drugs, a risky and expensive endeavor, and two, that middle managers — pharmacy benefit managers (PBMs), to be specific — are actually the ones price gouging Americans.

Both of these arguments faced substantial blows in a hearing Thursday held by the Senate Committee on Health, Education, Labor and Pensions, chaired by Sen. Bernie Sanders (I-Vt.). In fact, pharmaceutical companies are spending billions of dollars more on lavish executive compensation, dividends, and stock buyouts than they spend on research and development (R&D) for new drugs, Sanders pointed out. “In other words, these companies are spending more to enrich their own stockholders and CEOs than they are in finding new cures and new treatments,” he said.

And, while PBMs certainly contribute to America’s uniquely astronomical drug pricing, their profiteering accounts for a small fraction of the massive drug market, Sanders and an expert panelist noted. PBMs work as shadowy middle managers between drugmakers, insurers, and pharmacies, setting drug formularies and consumer prices, and negotiating rebates and discounts behind the scenes. Though PBM practices contribute to overall costs, they pale compared to pharmaceutical profits.

Rather, the heart of the problem, according to a Senate report released earlier this week, is pharmaceutical greed, patent gaming that allows drug makers to stretch out monopolies, and powerful lobbying.

Pfizer Enlists Queen, Einstein and More for Super Bowl Ad Showing Its Role in the History of Science

Fierce Pharma reported:

Pfizer has touched down at the Super Bowl. The Big Pharma ran its “Here’s to Science” ad at the event, framing its work to “outdo cancer” as part of a history of breakthroughs dating back to Hippocrates.

The ad, which features a scene in a women’s medical school, touches on the contributions Pfizer made to the mass production of penicillin and the creation of vaccines against COVID-19. Katalin Karikó, who won the Nobel Prize in Physiology or Medicine for work on mRNA, features toward the end of the ad.

After a whistle-stop tour of scientific history, the on-screen text says “Here’s to the next fight” and shows a link to Pfizer’s cancer website. In the final frames, a young girl is discharged from the hospital and walks out of the building applauded by staff.

The Wall Street Journal reported that brands paid roughly $7 million for 30 seconds of ad time at the Super Bowl this year, suggesting Pfizer may have paid around $14 million on top of the cost of making the video. Pfizer laid off hundreds of workers last year and has continued to hand out pink slips in 2024.

Does Moderna’s RSV Vaccine Lose Efficacy Faster Than Others?

STAT News reported:

Analysts at Cowan took a look at follow-up data from Moderna’s Phase 3 mRNA vaccine trial for RSV and found that its efficacy dwindles faster than vaccines made by GSK and Pfizer.

Specifically, they point out, the vaccine saw a 25% decline in efficacy after 8.6 months, while GSK saw a 7% decline after 14 months. The endpoints are different, but the analysts “are concerned it could negatively affect [Moderna’s RSV vaccine] if confirmed with additional data.”

Initial data from Moderna, it should be noted, showed that in the first six months, its experimental vaccine was just as effective as GSK’s, and perhaps more so than Pfizer’s. The CDC will convene an advisory committee on February 28 and discuss Moderna’s vaccine candidate.

Novo Nordisk’s Controlling Shareholder Plans to Invest About $35 Billion by 2030

Reuters reported:

Novo Holdings, the controlling shareholder of Danish obesity drugmaker Novo Nordisk (NOVOb.CO), plans to invest about $35 billion by 2030, CEO Kasim Kutay told Reuters in an interview on Monday.

Novo Holdings would invest about $5 billion a year in the next five years, and that could go up to $7 billion a year by 2030, Kutay said.

Novo Nordisk Settles Two Lawsuits Over Copycat Versions of Ozempic and Wegovy

NBC News reported:

Novo Nordisk said Friday it settled two lawsuits against two businesses claiming to offer compounded versions of its blockbuster drugs Ozempic and Wegovy.

The drugmaker has filed a total of 12 lawsuits against clinics, med spas and compounding pharmacies in the U.S. that claim to offer semaglutide, the active ingredient in Ozempic and Wegovy.

Novo Nordisk holds the patent on semaglutide, and the drugmaker does not supply the ingredient to outside groups, leaving some experts wondering what exactly is being sold to consumers.

The settlements come as states have been cracking down on compounded versions of the drug, which they say may contain other ingredients that are not approved by the FDA.

Phenylephrine Sales Steady Before FDA Panel Called It Ineffective — But Reformulation of Products Containing OTC ‘Decongestant’ Could Affect the Supply Chain

MedPage Today reported:

Sales of the most commonly used over-the-counter (OTC) oral decongestant, which was deemed ineffective by FDA staff and advisors last year, remained steady through 2021, and researchers warn that pulling the drug could disrupt the supply chain.

In a cross-sectional study using data from 2012 to 2021, there were 19.8 billion units of phenylephrine products purchased, amounting to $3.4 billion in pharmacy expenditures, reported Timothy S. Anderson, MD, MAS, of the University of Pittsburgh, and co-authors.

As for pseudoephedrine products, 13.2 billion units of products were purchased, amounting to $3.8 billion in pharmacy expenditures, with units of phenylephrine purchased outpacing pseudoephedrine in all years, they noted in a research letter in JAMA.

The FDA began examining the efficacy of oral phenylephrine in 2007 following a citizen’s petition and held an advisory committee meeting on the issue that same year, with similar conclusions on a lack of efficacy.

Experimental mRNA Vaccine Against CMV Elicits Promising Immune Responses

News Medical reported:

An experimental mRNA vaccine against human cytomegalovirus (CMV), a common virus that can infect babies during pregnancy, elicited some of the most promising immune responses to date of any CMV vaccine candidate, according to a study by Weill Cornell Medicine investigators.

The study, published in the Journal of Infectious Diseases on Feb. 7, provided evidence that the new mRNA vaccine candidate, which is manufactured by Moderna, Inc., may protect adults against CMV. Thus, it could potentially prevent women from passing the harmful infection to their babies during pregnancy.

Compared with a previously moderately successful vaccine candidate called gB/MF59, the mRNA vaccine elicited responses that were better at preventing the CMV virus from infecting epithelial cells that line the mouth and nose and provide the first line of defense against viral infection. The mRNA vaccine was also more effective at triggering the immune system to destroy CMV-infected cells.

The Moderna vaccine has moved on to the first ever phase 3 clinical study for a CMV vaccine candidate, which will help determine if these differences in immune responses will lead to stronger protection against CMV. “After more than 50 years of research, we are closer than ever to having a licensed CMV vaccine,” Dr. Permar said. “The new mRNA platform has a lot of potential.”

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