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Pfizer Earnings and Revenue Top Expectations Despite COVID Vaccine Sales Decline

CNBC reported:

Pfizer on Tuesday reported first-quarter revenue and adjusted earnings that topped Wall Street’s expectations, despite a decline in sales driven by the lower demand for the company’s COVID vaccine.

The pharmaceutical giant’s stock edged lower Tuesday. Shares are down more than 23% year to date through Monday’s close, putting the company’s market value at around $221.3 billion.

The company reported first-quarter sales of $18.28 billion, down 29% over the same period a year ago. COVID-related sales contributed $7.1 billion to that number. Pfizer raked in $3 million in COVID vaccine revenue and $4 million in sales of its COVID antiviral pill Paxlovid.

The company also expects U.S. uptake of its COVID vaccine to decline this year and in 2024, Pfizer CEO Albert Bourla said. But the CEO noted that Pfizer expects vaccination rates to rebound starting in 2025 and “continuing in 2026 and beyond,” assuming the company successfully launches several COVID combination vaccine treatments.

Gilead, U.S. Square Off in Billion-Dollar HIV Drug Patent Trial

Reuters reported:

Gilead Sciences Inc (GILD.O) is headed to trial in Delaware federal court this week to fight claims that it owes the U.S. government a share of multibillion-dollar profits from its HIV-prevention drug regimen.

The government is seeking more than $1 billion from Gilead for allegedly failing to compensate the Centers for Disease Control and Prevention (CDC) for discovering that Gilead’s HIV-treatment drug Truvada could help prevent the disease.

Jury selection starts on Tuesday in the case, which marks one of the first times the U.S. government has sued a drug maker to enforce its patent rights.

Foster City, California-based Gilead collaborated with the CDC in the mid-2000s to test if Truvada could prevent HIV as well as treat it. Gilead made more than $2 billion last year from worldwide sales of Truvada and Descovy, according to a company report. Descovy, which earned Gilead over $1.8 billion last year, is its fourth-best-selling drug behind the HIV drugs Biktarvy and Genvoya and COVID-19 treatment Veklury.

Frustration Grows Over Wait on OxyContin Maker’s Settlement

Associated Press reported:

More than a year after OxyContin maker Purdue Pharma reached a tentative settlement over the toll of opioids that was accepted nearly universally by the groups suing the company — including thousands of people injured by the drug — money is still not rolling out.

Parties waiting to finalize the deal are waiting for a court to rule on the legality of a key detail: whether members of the Sackler family who own the company can be protected from lawsuits over OxyContin in exchange for handing over up to $6 billion in cash over time plus the company itself.

This week — days before the one-year anniversary of the April 29, 2022, appeals court arguments on the matter — lawyers told judges that the wait is causing problems.

A lawyer for creditors told a U.S. bankruptcy court in another filing this week that the wait is a problem for other reasons. The lawyer, Arik Preis, wrote that as long as the funds aren’t distributed, “the vast majority of more than $6 billion that could be put to use to abate the opioid crisis and compensate individual claimants continuing to accrue interest in Sackler accounts.”

Moderna Looks to the Future With Latest Campaign and a Flashy New Ad

Fierce Pharma reported:

Moderna’s new TV spot, “Welcome to the mRNAge,” is here to let people know that messenger RNA (mRNA) vaccines are not just a one-trick (COVID-19) pony.

The newest offering in the ongoing global mRNAge campaign is the 90-second TV spot created with the agency of record TBWA\Chiat\Day that artfully showcases some of the possibilities mRNA has to offer. The spot is definitely going for a vibe, and that vibe is not “corporate video.” Throughout the very visual and music-forward video, there is only one superfast white coat in a lab shot.

“Our mRNAge TV spot intentionally does not feel like a pharmaceutical ad,” Kate Cronin, Moderna’s chief brand officer, said in an interview. “Our intent is to show up differently and explain what else mRNA could do — shifting the focus to a broader picture of mRNA, while building familiarity, preference and trust with Moderna.”

Moderna, once a super funded clinical-stage biotech, burst onto the commercial scene in 2020 when it supplied one of the big three COVID-19 vaccines and was one of the first to ever use mRNA tech for an approved vaccine.

Wisconsin Legislators Approve Opioid Settlement Payout

Associated Press reported:

Wisconsin legislators decided Tuesday to accept the state’s share of a settlement stemming from another multistate lawsuit accusing drug manufacturers and distributors of contributing to the nation’s opioid crisis. A coalition of states and local governments secured settlements in November and December with opioid manufacturers Teva and Allergan as well as with pharmaceutical chains Walmart, Walgreens and CVS totaling $19.2 billion.

Wisconsin is in line to receive about $324.3 million, with 30% going to the state and 70% going to county governments. The Legislature’s Joint Finance Committee approved a motion to accept the money during a meeting Tuesday.

Teva and Allergan have agreed to limit opioid marketing, promotion, sale and distribution. The pharmacy chains will implement requirements addressing compliance structures and pharmacist judgment, according to documents prepared by the state Justice Department.

More than 3,000 lawsuits have been filed by state and local governments, Native American tribes, unions, hospitals and other entities in state and federal courts over the toll of opioids. Most allege the industry created a public nuisance in a crisis that has been linked to the deaths of 500,000 Americans over the past two decades.

Biden Administration Tests Vaccines to Fight Avian Flu

The Washington Post reported:

Agriculture officials in the Biden administration are testing four vaccines in hopes of stanching the latest outbreak of highly pathogenic avian influenza that has devastated U.S. poultry farms and driven up egg prices, with plans to launch a national vaccination campaign that would be the first-ever effort of its kind.

Two of the vaccines being tested by the U.S. Department of Agriculture were developed by that agency. The others, from animal drugmaker Zoetis and Merck Animal Health, were developed during the last large-scale outbreak in 2015 and not used, a USDA spokesman said.

Should the trials be successful, the next stage is identifying manufacturers, with many more steps before laying hens, domesticated turkeys and broilers are vaccinated. In a best-case scenario, the agency estimates an 18- to 24-month timeline before having a commercial quantity of vaccine available that matches the currently circulating virus strain, but the timeline could be expedited in an emergency.

Although there is little concern that the virus, known as H5N1 avian flu, could spark a human pandemic, it has become a major headache for the world’s poultry farmers. This has been the largest and most deadly outbreak ever. Nearly 60 million farm-raised birds in the United States have died or been killed to stop the virus’s spread.

Poland Calls Out Pfizer Over Vaccine Glut

Politico reported:

Poland has sent a public letter to Pfizer shareholders calling on the U.S. pharma giant to renegotiate its COVID-19 vaccines contract with the EU, marking an escalation in the ongoing dispute over excess doses.

The letter, seen by POLITICO, is dated Tuesday and signed by Poland’s health minister, Adam Niedzielski. In it, the minister appeals to Pfizer’s “Corporate Social Responsibility” and calls on the company to come to more favorable terms in negotiations to lower the total amount of doses it is sending to the EU and to spread them out over a longer time period.

Warsaw has been leading the charge in efforts to reopen the EU’s largest contract, for 1.1 billion doses of the Pfizer/BioNTech vaccine. The deal was signed at the height of the pandemic and locks the EU into buying nearly half a billion doses this year, even as vaccination rates have fallen off a cliff as the pandemic subsides.

Children Could Be Prescribed Weight-Loss Jabs on the NHS

The Guardian reported:

Children as young as 12 in England could be given weight-loss injections on the NHS after the government asked medical watchdog Nice to assess the potential benefits of prescribing them to under-18s.

Department of Health officials have asked the watchdog to evaluate the clinical and cost-effectiveness of giving semaglutide injections to obese children aged 12 to 17, “in addition to healthy nutrition and increased physical activity,” the Observer can reveal.

The appetite-suppressing drug, sold for weight loss under the brand name Wegovy, is already available for 12- to 17-year-olds in the U.S. and was recently approved for use on the NHS in England for obese adults with one weight-related comorbidity.

Beyond Wegovy and Ozempic: Biotechs Vie for Piece of Red-Hot Weight Loss Market With Novel Strategies

STAT News reported:

For nearly a decade, Novartis aggressively pursued a drug candidate for muscle disorders, testing it on people with chronic inflammation, elderly people with frailty, hip surgery patients and other groups. Time and again, the trials failed to show that the drug, bimagrumab, led to a significant enough improvement in patients’ physical function. But researchers noticed something else: The patients lost body fat.

In 2017, Novartis decided to run one more trial in people with obesity and diabetes. It found the drug caused an average loss of 21% in fat mass and also a 4% gain in lean mass — a combination that had not been seen before in any weight loss drug.

Joe Jimenez, the CEO of Novartis through much of bimagrumab’s development, and some other ex-Novartis employees saw potential. They launched a new startup called Versanis Bio to license the drug in 2021.

Now, as the new weight loss drug Wegovy surges in popularity and turns the industry’s focus back on obesity, Versanis sees potential for bimagrumab to become a key contender in the obesity market and leapfrog competitors with its ability to build muscle.

Inside the Hill’s Healthcare Reform Momentum

Politico reported:

Reining in the cost of healthcare — and medicines, in particular — remains a priority for lawmakers in both parties. What happens on Capitol Hill over the next few weeks could be pivotal for how the battle over prices plays out over the rest of the year, Megan reports.

Looking toward the 2024 elections, Senate Majority Leader Chuck Schumer is evidently hoping to seize the bipartisan moment to bring a package of drug pricing bills to the floor this month. The New York Democrat is interested in legislation that would cap the cost of insulin, make pharmacy benefit managers less opaque and bolster access to generic drugs.