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Pfizer to Remain Aggressive on Obesity Market After Setback
Pfizer (PFE.N) will remain aggressive in trying to break into the lucrative obesity market, even after dropping a high-profile weight-loss drug candidate late last year due to strong side effects, Chief Executive Albert Bourla said on Monday.
“Pfizer’s position is that we believe that obesity is a place that we have the ability to play and win. So we will have to play,” Bourla told reporters ahead of his presentation at the JPMorgan healthcare conference in San Francisco.
Analysts have forecast the overall obesity drug market could reach $100 billion by the end of the decade. Market leaders Eli Lilly (LLY.N) with Zepbound and Mounjaro and Novo Nordisk‘s (NOVOb.CO) Wegovy are already bringing in billions of dollars. The medicines belong to a class of drugs called GLP-1 agonists originally developed for type 2 diabetes, including Novo’s Ozempic, which has been used off-label for weight loss.
In early December, Pfizer said it would not advance its twice-daily oral weight-loss drug danuglipron into late-stage studies. Weeks later, it warned that 2024 sales would be as much as $5 billion below Wall Street expectations, mostly due to shortfalls in its COVID franchise.
Pfizer’s launch of its respiratory syncytial virus (RSV) vaccine Abrysvo last year has also been a disappointment, Bourla said, only taking roughly 35% of market share in the United States, badly lagging a rival vaccine from GSK (GSK.L).
Insurance Denials for Popular New Weight Loss Medications Leave Patients With Risky Choices
Wegovy can cost more than $1,300 a month without insurance, and Macarena Khoury couldn’t afford it. Since stopping the medication in September 2022, she has regained 40 pounds.
“You start regaining all the hunger back. You feel you haven’t eaten in a year, which is actually pretty accurate,” Khoury said with a laugh.
More and more people are finding themselves in the same tough situation: They’ve been successful with powerful new drugs for weight loss, but then they lose access to them.
Most employer insurance plans don’t cover popular GLP-1 medications like Wegovy and Zepbound — or any other medications for weight loss, for that matter. Medicare also doesn’t pay for weight loss medications.
Lilly CEO Says Weight-Loss Drug Zepbound Weekly Prescriptions Hit 25,000 in December
Eli Lilly (LLY.N) CEO David Ricks on Monday said the company’s powerful weight-loss drug Zepbound hit 25,000 new prescriptions per week at the end of December and that its 2024 supply may not be enough to meet demand.
Ricks declined to provide details on how much Zepbound Lilly can produce now or to forecast 2024 demand and eventual supply. Lilly in 2023 said it would expand its North Carolina plant and build a new facility in Germany.
The CEO said he expects wide coverage for the drug from pharmacy benefit managers (PBMs) and that at least one major PBM will start recommending coverage of the drug for its clients this year. But he cautioned that employers choosing not to cover weight loss drugs for their health plans would be a constraint on demand.
The drugmaker last week launched its website that allows people to order Zepbound directly from the company to ensure coupons that bring the cost of the drug down to $550 a month are applied, and encourage users away from compounded or fake versions of the medicine, Ricks said.
New Zealand Fudged the Data on How the Kidneys Fare After the COVID Vaccines
In a January 2023 preprint in The Lancet, the New Zealand government released a study showing a 70% increased rate of kidney injury following two doses of Pfizer mRNA vaccines. Even more telling of injury was the dose-dependent effect. That is, one dose of Pfizer showed a 60% increased rate of injury within three weeks post-injection, while two doses showed a 70% increased rate of injury three weeks post-injection.
“Acute kidney injury” was not defined by the authors but is understood in a clinical setting to include measurable changes in lab results and/or serious signs and symptoms such as bleeding, pain with urination, kidney stones, nephritis, nephrotic syndrome, or other renal dysfunction.
The data were drawn from a national database of over 4 million people over the age of 5 who had received the Pfizer vaccines. This number represented 95% of New Zealand adults and teenagers.
Then a strange thing happened to the New Zealand data. Not only did the above paper disappear, but the numbers of reported acute kidney injuries were cut nearly in half.
Updates on Gardasil Lawsuit Bellwether Discovery to Be Provided to U.S. Judge Presiding Over HPV Vaccine Litigation
The U.S. District Judge presiding over all federal Gardasil lawsuits will hold a hearing tomorrow to review the latest updates in the litigation, including the status of discovery and ongoing efforts to prepare a small group of representative claims for early test trials over injuries caused by the HPV vaccine.
There are currently more than 130 product liability lawsuits being pursued against Merck & Co. in the federal court system, each involving similar allegations that the drug maker failed to adequately warn about the potential side effects of Gardasil, which has been widely administered to teens and young adults in recent years, to protect against the development of HPV infections and cervical cancer.
Sanders, Democrats Launch Investigation Into Asthma Inhaler Pricing
Sen. Bernie Sanders (I-Vt.) and a group of Senate Democrats on Monday announced an investigation into the high costs of asthma inhalers.
Sanders, chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, sent letters to the CEOs of the four biggest manufacturers of inhalers sold in the United States — AstraZeneca, Boehringer Ingelheim (BI), GlaxoSmithKline (GSK) and Teva — demanding information and documents on internal strategic communications, patient assistance programs and the costs involved in the manufacturing of inhalers.
The letters were co-signed by Sens. Tammy Baldwin (D-Wis.), Ben Ray Luján (D-N.M.) and Ed Markey (D-Mass.). The lawmakers noted that in the past five years, AstraZeneca, GSK and Teva made more than $25 billion in revenue from inhalers alone.
Like many other prescription drugs, the companies’ inhalers sell for hundreds of dollars in the U.S. but for only fractions of that same cost overseas. The companies charge between $200 and $600 each for inhaler products that are typically purchased monthly.
JPM24: Amgen CEO Hopes to Take a Bite of Competitive Obesity Market With Unique Approach
After last year saw the rise of popular obesity treatments, biopharma’s interest in the field only appears to only be growing. As established players Novo Nordisk and Eli Lilly look to extend their foothold in the disease area, several competitors wait on the sidelines, eager to enter the ring.
For its part, Amgen didn’t “wake up one day and say gosh, there’s a big market for obesity medicines, maybe we ought to jump in,” CEO Robert Bradway remarked at the 42nd annual J.P. Morgan Healthcare Conference in San Francisco. Instead, the company has been eying the disease area over time and looking to “thoughtfully” make a play.
So far, the company has several assets to show for it. Aside from its phase 2 candidate MariTide, or maridebart cafraglutide, and an oral small molecule dubbed AMG 786 that’s currently in phase 1, Amgen has a preclinical pipeline of “a half dozen or so” obesity candidates that are “rapidly advancing.”
The drugmaker looks to stand out from the tough competition with a fresh approach.
Cell Therapy Bigwigs Endorse CAR-T in Nature Medicine Article Amid FDA Safety Probe
As an FDA investigation into patients developing secondary T-cell cancers rocked the CAR-T world, a group of cell therapy experts, including CAR-T pioneers Bruce Levine, Ph.D., and Carl June, M.D., are lending their support to the emerging immunotherapy in a commentary published in Nature Medicine.
Despite reports of post-treatment secondary malignancies, “the benefits of CAR-T therapies continue to outweigh the potential risks in the vast majority of cases,” the experts wrote in the article, with Levine from Penn Medicine serving as first author.
The FDA announced the probe in November after receiving reports of T-cell malignancies in patients who had taken marketed CAR-T therapies from clinical trials and the FDA Adverse Event Reporting System (FAERS). The agency said it has determined that the risk is applicable to all six approved products, including the first CAR-T, Novartis’ Kymriah, which June and Levine co-invented. The other five are Gilead Sciences’ Yescarta and Tecartus, Bristol Myers Squibb’s Breyanzi and Abecma, plus Johnson & Johnson and Legend Biotech’s Carvykti.
The researchers spotted 20 reports of T-cell malignancy among about 8,000 adverse events following CAR-T treatments in FAERS. Reporting to the FDA database is not mandatory, and the cases are self-reported by doctors and are therefore not verified by third parties.
