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Yahoo
3 days ago
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Gilead commits to HIV prevention rollout for low-income countries despite funding uncertainty
By Julie Steenhuysen and Deena Beasley (Reuters) -Gilead Sciences says it still plans to supply its twice-yearly injection for preventing HIV infection in low-income countries if it wins U.S. approval despite funding uncertainty over the Trump Administration's pullback in aid spending. Some AIDS experts, including activists and doctors, say the Gilead drug, lenacapavir, could help end the 44-year-old epidemic that infects 1.3 million people a year and is estimated by the World Health Organization to have killed more than 42 million. An FDA approval decision is expected by June 19 for lenacapavir, which proved to be nearly 100% effective at preventing HIV in large trials. If the Food and Drug Administration green lights the drug, and its view is seconded by the WHO, the shots could start to roll out early in 2026 to at least 2 million people in 18 low-income countries based on Gilead's agreement with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, a worldwide partnership targeting HIV, tuberculosis and malaria. Gilead agreed to provide lenacapavir at cost for two-to-three years while six generic drugmakers, which were granted licenses to make the medicine for low-income countries, ramp up production. Experts said a successful launch of a long-acting HIV prevention drug could help stall the epidemic. Until recently, the only pre-exposure prophylaxis (PrEP) options for people at high risk of infection were daily pills, requiring careful adherence to be effective. "You can foresee a day where there are no new HIV diagnoses. It doesn't happen if we only do this in the U.S.," Gilead Chief Commercial Officer Johanna Mercier said. "We need to make sure we have a global approach to this launch." PEPFAR being part of the effort is Gilead's intent and goal, Mercier said. "Unfortunately, if they're not part of that mix, our goal is still to meet that objective of 2 million people getting access." Wall Street has a close eye on lenacapavir, one of the highest-profile drugs to undergo FDA review since President Donald Trump named Robert F. Kennedy Jr. as health secretary and promised to upend the status quo. Most of the drug's profits are expected in the U.S., with annual sales reaching $1 billion by next year, according to analysts' estimates compiled by LSEG. 'INCREDIBLE DISMAY' Whether all of the agreed funding for low-income countries - most of which are in Africa - will come through is unclear. Countries that rely on aid are already reeling from funding cuts by the Trump Administration, including to PEPFAR, and AIDS researchers are bracing for the worst. The United Nations program on HIV/AIDS earlier this month said many HIV prevention programs supported by PEPFAR were stalled, although services for pregnant and breastfeeding women were technically exempt from the cuts. Peter Sands, executive director of the Global Fund, told Reuters the group intends to fund as much of the lenacapavir rollout as possible, but it will need to start slowly. "It's not just the uncertainty over PEPFAR's funding that's an issue, but the uncertainty over our funding," Sands said, adding that the group's first priority is treating people already infected with the deadly virus. Much will depend on the success of the Global Fund's effort to raise $18 billion to fund its work from 2027-2029. The U.S. is its largest donor, committing $6 billion in the previous funding round. It is unclear what the U.S. may provide this round, or whether other big governments will step up. UNAIDS estimates that the permanent discontinuation of HIV prevention and treatment programs supported by PEPFAR would lead to an additional 6.6 million new HIV infections between 2025 and 2029. The U.S. State Department, which oversees PEPFAR, did not respond to a request for comment. Gilead declined to comment on its manufacturing cost for lenacapavir, whose U.S. price is likely to be on par with current preventive medications at around $25,000 per year. ViiV Healthcare's Apretude, an injection given every two months, costs about 124.20 pounds ($168) in low- and middle-income countries. Mitchell Warren, executive director of the AIDS nonprofit AVAC, estimates the eventual annual cost at $100-$120. The lower the price, the more people who could receive it, he said. Warren said PEPFAR could still participate, and others may come forward. The Gates Foundation and the Children's Investment Fund Foundation are "actively involved in all of these conversations," he said, as is the Elton John AIDS Foundation. Linda-Gail Bekker of the University of Cape Town, who led lenacapavir clinical trials in South Africa and Uganda, said she was elated when she first saw the findings. "The huge feeling I have now is one of incredible dismay," said Bekker of uncertainty over the Trump administration's commitment to PEPFAR and HIV prevention in poor nations. "It felt like the stars were aligning, and one of the stars has fallen out of the sky."
Yahoo
22-05-2025
- Health
- Yahoo
Prices for new US drugs doubled in 4 years as focus on rare disease grows
By Deena Beasley (Reuters) -U.S. prices for newly-launched pharmaceuticals more than doubled last year compared to 2021, as companies leveraged scientific advances to develop more therapies for rare diseases, which typically command high prices, a Reuters analysis found. The median annual list price for a new drug was over $370,000 in 2024, according to the Reuters survey of 45 medicines. In 2021, the median price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published in JAMA based on the same criteria. The median launch price was $300,000 in 2023 and $222,000 in 2022. The increase in prices has occurred even as the U.S. government tries to rein in prescription costs. Drug pricing has become a populist issue for President Donald Trump, who has called for drugmakers to bring U.S. prices in line with other high-income nations that pay far less. William Padula, professor of pharmaceutical and health economics at the University of Southern California, said there is no indication that the trend will slow — at least until there is progress in lowering the cost of developing new therapies. "For years we've had pretty good technology and solutions for a lot of the common conditions that many people have, like high cholesterol, high blood pressure, and managing the more common forms of cancer," Padula said. For rare diseases, there are fewer patients "and therefore the price per course of treatment is going to go up," he said. The percentage of drugs launched for orphan diseases, meaning they affect fewer than 200,000 Americans, rose to 72% in 2024 from 51% in 2019, according to the Iqvia Institute for Human Data Science. Over 40% of the orphan launches were for oncology. The other 28% included drugs for larger populations, such as schizophrenia drug Cobenfy, sold by Bristol Myers at a list price of $22,500 a year. The leading industry trade group, the Pharmaceutical Research and Manufacturers of America, said focusing on list prices for drugs that treat rare diseases "misses the broader context of how these drugs contribute to overall prescription drug spending, healthcare costs and value to patients." FOLLOWING THE SCIENCE Decoding of the human genome, completed in 2003, has paved the way for better understanding of the genetic and biological underpinnings of rare diseases, leading to advancements in medical science. Drugmakers are given incentives to invest in research for rare diseases, including longer periods of market exclusivity, in part because potential sales may be limited. Boston Consulting Group projected the 2024 crop of drug launches would reach peak annual sales of $60 billion, significantly lower than past averages due to the absence of mega-blockbusters, a term used to describe drugs with annual sales above $10 billion. The FDA approved 57 novel drugs last year, including seven new cell and gene therapies at the agency's biologic division. In 2023, the agency approved 55 drugs and 17 new biologics. Reuters surveyed the makers of 45 new drugs launched last year. The price analysis excludes imaging agents, vaccines, drugs used intermittently such as antibacterials, and products that have not yet launched commercially. The highest price for a drug taken consistently was over $1 million a year for Zevra Therapeutics' Miplyffa for Niemann-pick disease type C, an inherited metabolic disorder diagnosed in about 900 people in the United States. Orchard Therapeutics' Lenmeldy gene therapy for a rare inherited disorder that affects the brain and nervous system, was launched last year at a record-high price of $4.25 million for a one-time treatment. Pfizer's hemophilia gene therapy Beqvez was priced in 2024 at $3.5 million, but the company pulled it from the market less than a year later citing soft demand. Pharmaceutical companies say new medicines offer cost-saving value, including potentially fewer emergency room visits and hospital stays, and with some treatments using gene editing, the possibility of a cure. Drugmakers also stress they do not determine the portion of drug costs that are born by patients under health insurance plans. Many offer savings cards and other programs to reduce out-of-pocket costs, while insurers can receive discounts and rebates from manufacturer list prices, especially if competing treatments are available. (Reporting By Deena Beasley; Editing by Caroline Humer and Bill Berkrot) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-05-2025
- Health
- Yahoo
Trump calls out weight-loss drugs as target of price-cut push
By Deena Beasley (Reuters) -The Trump administration on Monday singled out powerful new weight-loss drugs including Wegovy and Zepbound as targets in its push to lower prescription drug prices. President Donald Trump's executive order demands that drugmakers cut prices on their products in the coming months to hew more closely to what they charge in other developed countries, or face new regulations and enforcement actions, from export restrictions to tariffs. At the signing ceremony, Trump described a conversation with a businessman friend who lamented how much more expensive weight-loss treatments are in the United States. "'I'm in London, and I just paid for this damn fat drug I take,'" Trump quoted the man as saying. "'I just paid $88 and in New York I paid $1,300. What the hell is going on? ... It's the same box made in the same plant by the same company.'" He didn't name the medicine. Injected weight-loss drugs Wegovy, from Novo Nordisk, and Eli Lilly's Zepbound have U.S. list prices of over $1,000 a month. For some patients, much of that cost is covered by health insurance. For those without coverage, both Novo and Lilly recently began selling their drugs directly to U.S. consumers at a cash price of $499 a month. But with 40% of Americans estimated to have obesity, U.S. politicians and healthcare experts have urged both companies to make the treatments more affordable. A White House official told reporters on Monday that Trump's executive order will have "a particular focus on drugs where there is the largest disparities and the largest expenditures." "It would be fair to expect that GLP-1s, given that they hit both of those categories, will be a focus," the official said, referring to the class of drugs for weight loss that Wegovy and Zepbound, as well as related diabetes medicines Ozempic and Mounjaro, belong to. "There will be an expectation that those prices should come down, and then if they don't, that we will be looking at our various policy levers that can be used to force those prices down." Lilly on Monday said it agreed that costs for breakthrough medicines should be shared more fairly across developed countries. But the Indianapolis-based drugmaker said that could only happen if intermediaries within the U.S. healthcare system, such as pharmacy benefit managers, take a smaller share of sales transactions. Danish drugmaker Novo Nordisk said it agrees "that Americans need more access to affordable medication, and we will continue to engage with policymakers." Countries where health insurance is mainly provided by the government often negotiate lower prices with pharmaceutical companies. In Japan, for instance, the monthly price for a 10 milligram Zepbound injection pen is $61.68. The trade-off is that some drugs are not covered under the government-run plans. In the UK, access to the new obesity drugs within the National Health Service is very limited, while Germany's health plan does not cover the medications for weight loss. "These drug pricing issues resonate for a lot of people on GLP-1s," said Benedic Ippolito, a senior fellow in economic policy studies at the American Enterprise Institute. Many U.S. patients had also come to rely on much cheaper copycat versions of GLP-1s made by compounding pharmacies, a practice that will soon come to an end under a crackdown by the Food and Drug Administration now that the brand name medicines are no longer in shortage. (Reporting By Deena Beasley in Los Angeles; Additional reporting by Maggie Fick in London; Editing by Bill Berkrot)
Yahoo
12-05-2025
- Health
- Yahoo
Trump calls out weight-loss drugs as target of price-cut push
By Deena Beasley (Reuters) -The Trump administration on Monday singled out powerful new weight-loss drugs including Wegovy and Zepbound as targets in its push to lower prescription drug prices. President Donald Trump's executive order demands that drugmakers cut prices on their products in the coming months to hew more closely to what they charge in other developed countries, or face new regulations and enforcement actions, from export restrictions to tariffs. At the signing ceremony, Trump described a conversation with a businessman friend who lamented how much more expensive weight-loss treatments are in the United States. "'I'm in London, and I just paid for this damn fat drug I take,'" Trump quoted the man as saying. "'I just paid $88 and in New York I paid $1,300. What the hell is going on? ... It's the same box made in the same plant by the same company.'" He didn't name the medicine. Injected weight-loss drugs Wegovy, from Novo Nordisk, and Eli Lilly's Zepbound have U.S. list prices of over $1,000 a month. For some patients, much of that cost is covered by health insurance. For those without coverage, both Novo and Lilly recently began selling their drugs directly to U.S. consumers at a cash price of $499 a month. But with 40% of Americans estimated to have obesity, U.S. politicians and healthcare experts have urged both companies to make the treatments more affordable. A White House official told reporters on Monday that Trump's executive order will have "a particular focus on drugs where there is the largest disparities and the largest expenditures." "It would be fair to expect that GLP-1s, given that they hit both of those categories, will be a focus," the official said, referring to the class of drugs for weight loss that Wegovy and Zepbound, as well as related diabetes medicines Ozempic and Mounjaro, belong to. "There will be an expectation that those prices should come down, and then if they don't, that we will be looking at our various policy levers that can be used to force those prices down." Lilly on Monday said it agreed that costs for breakthrough medicines should be shared more fairly across developed countries. But the Indianapolis-based drugmaker said that could only happen if intermediaries within the U.S. healthcare system, such as pharmacy benefit managers, take a smaller share of sales transactions. Danish drugmaker Novo Nordisk said it agrees "that Americans need more access to affordable medication, and we will continue to engage with policymakers." Countries where health insurance is mainly provided by the government often negotiate lower prices with pharmaceutical companies. In Japan, for instance, the monthly price for a 10 milligram Zepbound injection pen is $61.68. The trade-off is that some drugs are not covered under the government-run plans. In the UK, access to the new obesity drugs within the National Health Service is very limited, while Germany's health plan does not cover the medications for weight loss. "These drug pricing issues resonate for a lot of people on GLP-1s," said Benedic Ippolito, a senior fellow in economic policy studies at the American Enterprise Institute. Many U.S. patients had also come to rely on much cheaper copycat versions of GLP-1s made by compounding pharmacies, a practice that will soon come to an end under a crackdown by the Food and Drug Administration now that the brand name medicines are no longer in shortage. (Reporting By Deena Beasley in Los Angeles; Additional reporting by Maggie Fick in London; Editing by Bill Berkrot) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
01-05-2025
- Business
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Amgen quarterly profit tops Wall Street view, sales up 11%
By Deena Beasley (Reuters) -Amgen on Thursday said its first-quarter profit rose 24%, handily exceeding Wall Street expectations, as product sales increased 11% and profit margins widened. The biotechnology company reported adjusted earnings per share of $4.90 for the quarter, sailing past the average analyst estimate of $4.30, as compiled by LSEG. Overall revenue rose 9% to $8.1 billion, which was in line with Wall Street estimates. "Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects," Amgen CEO Robert Bradway said in a statement. The company is slated to present at a medical meeting next month full results from a mid-stage trial of its experimental weight-loss drug MariTide, viewed by many investors as a potential blockbuster. Amgen is conducting late-stage trials of the drug in patients with and without diabetes, and said results from a Phase 2 diabetes trial will be announced in the second half of this year. The company also said the U.S. Food and Drug Administration has lifted its clinical hold on an early-stage trial of a different experimental weight-loss drug known as AMG 513. For the full year, Amgen said it still expects adjusted earnings per share of $20.00 to $21.20 on revenue of $34.3 billion to $35.7 billion. Analysts, on average, have estimated earnings of $20.63 per share on revenue of $35.1 billion. Amgen said its 2025 outlook includes the impact of implemented tariffs, but does not account for any future levies, including potential sector-specific tariffs. U.S. President Donald Trump's administration has opened a national security investigation into pharmaceuticals in a bid to demonstrate why the U.S. needs tariffs to boost domestic manufacturing. Amgen's first-quarter sales of bone drug Prolia rose 10% to $1.1 billion, but the company said it expects lower sales of the medication later in the year as biosimilar competitors are launched. Sales of cholesterol-lowering medication Repatha rose 27% to $656 million, while sales of much older arthritis drug Enbrel fell 10% to $567 million. In the rare disease space, sales of thyroid eye disease drug Tepezza fell 10% to $381 million, and sales of gout treatment Krystexxa were flat at $236 million. Both drugs were acquired with Amgen's purchase of Horizon Therapeutics. Net operating income for the quarter rose 20% to $1.2 billion. (Reporting By Deena BeasleyEditing by Bill Berkrot) Sign in to access your portfolio
