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What a $200 Billion Blockbuster Drug Reveals About Big Pharma’s Playbook

The Wall Street Journal reported:

As the drug company AbbVie began a new life of its own following a spinoff from Abbott Laboratories in 2013, it faced a challenge that would preoccupy newly minted Chief Executive Officer Richard Gonzalez for the next decade: how to avoid sales falling off as competition to its top blockbuster neared. Back then, the arthritis drug Humira was generating about $9 billion in annual sales, about half the company’s revenue. Wall Street loved Humira’s growth, but investors worried about the looming patent expirations.

Humira went on to become one of the highest-grossing drugs of all time, peaking at $21 billion in annual sales in 2022, and generating more than $200 billion in revenue throughout its lifetime.

Those numbers have blown past Wall Street analysts’ wildest projections while giving the company additional time and cash to prepare for a future without Humira. Now that Humira is finally beginning to decline, Gonzalez can just about declare victory.

AbbVie announced on Friday that it expects its two newer anti-inflammatory drugs, Skyrizi and Rinvoq, which treat things such as Crohn’s disease and arthritis, to bring in $16 billion in sales this year. By 2027, the company forecasts that figure to grow to $27 billion, surpassing Humira at its peak. Investors are pleased, with AbbVie’s stock trading near a record.

FDA Mulls Extending Arexvy Approval to People Ages 50 to 59

CIDRAP reported:

The U.S. Food and Drug Administration (FDA) has accepted GSK‘s application for priority review for extended use of its respiratory syncytial virus (RSV) vaccine Arexvy in adults ages 50 to 59 at higher risk for complications.

In a press release today, GSK said its application is supported by promising results from a phase 3 trial in the age group. Arexvy is currently approved for use in adults ages 60 and older. GSK added that if approved, Arexvy would be the first RSV vaccine recommended for use in people in their fifties. The FDA expects to make a decision by June 7, 2024.

Drug regulators in the European Union and Japan are also reviewing GSK’s applications for use in people ages 50 to 59 at higher risk for RSV.

With Merck, J&J and BMS CEOs Set to Testify, Sanders Releases Scathing Report on Drug Prices

Fierce Pharma reported:

Two days ahead of a Senate hearing in which CEOs from three pharma majors will testify, Sen. Bernie Sanders, I-Vermont, has released a report shedding light on the system that allows the companies to charge more for drugs in the U.S. than in any other country.

The report, from the Senate Committee on Health, Education, Labor and Pensions (HELP), zeroes in on the three companies that will be under fire on Thursday. Scheduled to appear are CEOs Chris Boerner of Bristol Myers Squibb, Joaquin Duato of Johnson & Johnson and Robert Davis of Merck & Co.

Among the findings highlighted by the HELP Committee were that in 2022, J&J and BMS each spent $3.2 billion more on stock buybacks, dividends and executive compensation than they did on research and development.

The report also says that if Merck’s megablockbuster cancer treatment Keytruda was its own company, its 2022 sales “would rival McDonald’s annual revenue and exceed the revenue of hotel chain Marriott.” Since 2015, Merck’s sales of Keytruda in the U.S. came to $43.4 billion compared to $30 billion for the rest of the world, the report said.

AstraZeneca to Invest $300 Million in U.S. Facility for Cell Therapies

Reuters reported:

AstraZeneca (AZN.L) said on Tuesday it will invest $300 million in a facility in Rockville, Maryland, for the discovery and development of cell therapies.

More than 150 jobs will be created at the site in the United States to initially focus on manufacturing the cell therapies to enable clinical trials to be conducted, the company said, adding that the site may expand its focus to support other disease areas.

The Rockville facility marks the latest investment for AstraZeneca in cell therapies after its acquisition of Neogene Therapeutics and other agreements with cell therapy developers.

AstraZeneca is advancing early stage trials of several cell therapies in different types of cancer including liver and prostate cancer.

Pfizer Pumps $15M Into American Cancer Society’s Screening-Focused Health Equity Push

Fierce Pharma reported:

Pfizer is backing the American Cancer Society’s (ACS) work to address disparities in oncology outcomes, providing $15 million over three years to boost efforts to connect people to no- and low-cost screening opportunities.

Seeking to close the gaps, the ACS and Pfizer have partnered on “Change the Odds: Uniting to Improve Cancer Outcomes.” The new, three-year initiative is intended to “make a tangible, sustainable difference in communities that are disproportionately impacted by cancer, but medically underserved,” ACS CEO Karen Knudsen said in a Q&A published by Pfizer.

The partners are initially focusing on breast and prostate cancers “given their significant impact,” Knudsen said, but hope to expand the initiative to other tumor types over time. Pfizer made $5.9 billion from its breast cancer drug Ibrance and prostate cancer medicine Xtandi last year, helping its total sales hit $58.5 billion, and is pursuing other opportunities in both settings.

As well as working to connect patients to screening, the partners plan to try to raise awareness of clinical trials and inform people about opportunities to participate. The focus reflects the underrepresentation of ethnic and racial minority groups in clinical research.

Eli Lilly to Offer Low-Cost Insulin, Donate to Clinics in Minnesota Settlement

Reuters reported:

Eli Lilly (LLY.N) has settled a lawsuit by Minnesota that accused the three largest insulin makers of deceptively raising the price of the diabetes treatment.

The settlement filed on Wednesday in a New Jersey federal court calls for Lilly to offer Minnesota customers without insurance, who pay for its insulin drugs out of pocket, the option to pay no more than $35 a month for them.

Minnesota also sued Novo Nordisk (NOVOb.CO) and Sanofi (SASY.PA), in a lawsuit that began in 2018. Lilly’s settlement, which will last for five years, requires court approval.

Minnesota claimed that the drugmakers fraudulently set artificially high list prices for their products while offering rebates to pharmacy benefit managers (PBMs) in exchange for them covering the drug on behalf of health plans.

U.S. Appeals Court Finds Bayer Not Shielded From Roundup Lawsuit

Reuters reported:

A U.S. appeals court on Monday refused to dismiss a Georgia doctor’s lawsuit claiming that Bayer AG’s (BAYGn.DE) Roundup weedkiller caused cancer, the latest setback in the German company’s efforts to fend off thousands of similar cases carrying potentially billions of dollars in liability.

A three-judge panel of the Atlanta-based 11th U.S. Circuit Court of Appeals rejected Bayer’s argument that federal regulators’ approval of Roundup shielded the company from being sued under state law for failing to warn consumers of the product’s risks. Several other appeals courts had previously reached the same conclusion in similar lawsuits.

Bayer has said that it hopes a favorable Supreme Court ruling could eliminate much of its liability from the Roundup-related litigation, but the court has so far rebuffed its appeals.

Roundup-related lawsuits have dogged Bayer since it acquired the brand as part of its $63 billion purchase of Monsanto in 2018. The company settled most Roundup claims that were pending against it in 2020 for up to $10.9 billion, but still faces more than 50,000 claims over the product.

Novo Nordisk Parent to Buy Catalent for $16.5 Billion to Expand Wegovy Supply

CNBC reported:

Danish drugmaker Novo Nordisk’s parent company, Novo Holdings, on Monday said it will acquire drug manufacturer Catalent in a $16.5 billion deal that could help boost the supply of the highly popular weight loss injection Wegovy and diabetes shot Ozempic.

Catalent is the main supplier of fill-finish work, which involves filling and packaging syringes and injection pens, for Novo Nordisk’s Wegovy.

Novo Nordisk will then buy three of Catalent’s manufacturing sites from Novo Holdings for $11 billion. Novo Holdings owns almost 77% of the voting shares in Novo Nordisk.

Notably, some of Catalent’s factories that manufacture Wegovy have been linked to regulatory problems in the past. Reuters reported in July that Catalent’s factory in Brussels that fills Wegovy pens had repeatedly breached U.S. sterile safety rules in recent years and that staff had failed to perform required quality checks.

Measles Cases Continue to Crop Up in the U.S.

U.S. News & World Report reported:

Cases of measles continue to crop up across the U.S. as federal officials urge vaccination and warn of potential exposure to the disease.

The CDC is asking healthcare providers to be on the lookout for measles symptoms, as more cases have cropped up across the U.S. A total of 23 measles cases were reported to the Centers for Disease Control and Prevention between Dec. 1 and Jan. 23, according to a recent health alert.

The increased number of measles importations seen in recent weeks is reflective of a rise in global measles cases and a growing global threat from the disease,” according to the CDC health alert.

Last month, more than a dozen measles cases had been reported across the U.S. since the beginning of the year, including cases identified in Philadelphia, New Jersey, Delaware, Georgia, California, Missouri, Washington D.C., and Washington state.

J&J Faces Class Action Over Employees’ Prescription Drug Costs

Reuters reported:

Johnson & Johnson was hit with a proposed class action on Monday accusing the company’s employee health plans of failing to negotiate lower prices for prescription drugs, which cost workers millions of dollars in overpayments for generic drugs.

The lawsuit, filed in New Jersey federal court by Ann Lewandowski, a healthcare policy and advocacy director, accuses Johnson & Johnson of breaching its duty under the federal Employee Retirement Income Security Act of 1974 (ERISA) to prudently manage employee benefit plans.