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Maker of Wegovy, Ozempic Showers Money on U.S. Obesity Doctors
Dr. Lee Kaplan, a leading U.S. obesity specialist, took the stage with an urgent message, telling fellow physicians they have a powerful weapon to fight the American obesity crisis: their prescription pads. Kaplan’s solution for America’s weight problem closely tracks Novo Nordisk’s financial ambitions for Wegovy. The Danish drugmaker, long known for diabetes medicines, is transforming itself into the world’s biggest weight-loss company.
Novo tells investors its target market is the 764 million people with obesity across the globe. Its most lucrative region is the United States, where more than two-thirds of adults are overweight or have obesity and drugs frequently command the highest prices worldwide. Novo charges U.S. customers $1,300 a month for the weekly injection.
Kaplan, the chief of obesity medicine at Dartmouth College’s medical school, is a powerful standard bearer for Novo’s case. Until last year, the 69-year-old gastroenterologist led the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital and taught at Harvard Medical School. He’s also a highly paid messenger: Novo has spent $1.4 million on Kaplan for consulting work and travel between 2013 and 2022, according to a Reuters analysis of federal data.
Those payments are part of a campaign to convince U.S. doctors to make Wegovy one of the most widely prescribed drugs in history — and to persuade skeptical insurers to pay for it. Novo spent at least $25.8 million over the past decade on U.S. medical professionals to promote its two obesity drugs, Wegovy and Saxenda, the analysis found.
The Supreme Court Wrestles With OxyContin Maker’s Bankruptcy Deal, With Billions of Dollars at Stake
The Supreme Court on Monday wrestled with a nationwide settlement with OxyContin maker Purdue Pharma that would shield members of the Sackler family who own the company from civil lawsuits over the toll of opioids. The justices seemed by turns reluctant to break up an exhaustively negotiated agreement, but also leery of somehow rewarding the Sacklers.
The agreement hammered out with state and local governments and victims would provide billions of dollars to combat the opioid epidemic. The Sacklers would contribute up to $6 billion and give up ownership of the company, but retain billions more. The company would emerge from bankruptcy as a different entity, with its profits used for treatment and prevention. The high court put the settlement on hold during the summer, in response to objections from the Biden administration.
Arguments lasted nearly two hours in a packed courtroom, its doors draped in black in memoriam to retired Justice Sandra Day O’Connor, who died Friday. Chief Justice John Roberts offered a remembrance of the first woman to serve on the court. “She changed the world,” Roberts said.
Outside the court, a small but vocal group of protesters opposed the Purdue Pharma agreement. “Shame on Sackler,” one banner read. “No Sackler immunity at any $$,” read another.
A decision in Harrington v. Purdue Pharma, 22-859, is expected by early summer.
Pfizer to Discontinue Twice-Daily Weight Loss Pill Due to High Rates of Adverse Side Effects
Pfizer on Friday said it would stop developing the twice-daily version of its experimental weight loss pill after obese patients taking the drug lost significant weight but had trouble tolerating the drug in a mid-stage clinical study.
The drugmaker observed high rates of adverse side effects, which were mostly mild and gastrointestinal, among patients. A significant share of patients also stopped taking the pill, which aims to be a more convenient alternative to highly popular weight loss injections.
“At this time, twice-daily danuglipron formulation will not advance into Phase 3 studies,” the company said. But Pfizer said it still plans to release data on a once-a-day version of the drug in the first half of 2024, which will “inform a path forward.” The pharmaceutical giant will wait to see that data before deciding whether to start a phase three study on the once-daily pill, which Wall Street views as the more competitive form of the treatment.
Still, the data on the twice-daily drug is a blow to Pfizer’s hopes to win a $10 billion slice of the booming weight loss drug market, which CEO Albert Bourla has said could grow to $90 billion. The company is betting on a successful weight loss pill to help it rebound from plummeting demand for its COVID products and a roughly 40% share price drop this year.
Big Pharma Strikes $10 Billion Deal to Speed Ovarian Cancer Drug to Market
The Dallas Morning News reported:
AbbVie is buying ImmunoGen in a deal valued at about $10.1 billion with the goal of speeding the pharmaceutical’s entry into the market for ovarian cancer treatments.
ImmunoGen Inc. developed the ovarian cancer drug Elahere, which AbbVie says it sees as a potential multibillion-dollar future revenue generator.
U.S. regulators granted Elahere an accelerated approval in 2022, and the company is seeking full approval from the Food and Drug Administration as well as expansion in other markets. It also plans to expand Elahere’s use.
ImmunoGen said Elahere brought in $105.2 million in revenue in this year’s third quarter, or nearly all of the company’s total sales.
Lawmakers Want to Know Why It Took the FDA so Long to Rule on Decongestant Phenylephrine
Last year, roughly 250 products that contain the decongestant phenylephrine — including popular brands such as Sudafed, NyQuil, Benadryl and Tylenol — rang up sales of nearly $1.8 billion. Just one problem: Oral phenylephrine doesn’t work.
That was the unanimous conclusion of an FDA advisory committee three months ago, based on decades of mounting evidence.
Now, House Republicans want to know why it took the regulator so long to figure it out. Rep. Lisa McClain (Mich.), who chairs the House oversight subcommittee on health care and financial services, has sent a letter to FDA commissioner Robert Califf, requesting a briefing on the effectiveness of the over-the-counter (OTC) drugs by Dec. 11.
“We are concerned that phenylephrine has remained approved by the FDA as an OTC drug ‘generally recognized as safe and effective’ (GRASE) for nearly 50 years despite strong scientific evidence supporting the contrary,” McClain wrote.
Roche Enters Obesity Drugs Race With $2.7 Billion Carmot Deal
The race to grab a slice of the lucrative market for obesity treatments is heating up among drugmakers, with Swiss company Roche (ROG.S) becoming one of the latest entrants following its $2.7 billion deal to buy Carmot Therapeutics (CRMO.O).
The market for obesity treatments is estimated to be worth $100 billion by the end of the decade and already has Novo Nordisk and Eli Lilly making a big splash with their highly sought-after treatments.
EU Watchdog Seeks More Data From GLP-1 Drugmakers on Suicidal Thoughts
The EU’s drug watchdog will request more data from makers of a class of diabetes and weight-loss drugs including Novo Nordisk‘s (NOVOb.CO) popular therapies Ozempic and Wegovy to further investigate suicidal thoughts in some patients taking them.
“While at this point no conclusion can be drawn on a causal association, there are several issues that still need to be clarified,” the European Medicines Agency (EMA) said in a statement on Friday, making it the first major global regulator to provide an update on such reviews.
EMA had initially received reports from the Icelandic Medicines Agency, based on two cases involving liraglutide, the active ingredient in Saxenda, and one case for semaglutide, the active ingredient in Ozempic and Wegovy. The review was also based on at least 170 case reports from EudraVigilance, a system to register suspected adverse reactions to medicines.
Reuters reported in September that the U.S. Food and Drug Administration (FDA) had received 265 reports of suicidal thoughts or behavior in patients taking GLP-1 medication between 2010 and June 2023.
