Latest news with #Lilly
Mid East Info
2 hours ago
- Health
- Mid East Info
Lilly's oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs in first of two pivotal Phase 3 trials in adults with obesity
In ATTAIN-1, the investigational once-daily oral pill showed significant efficacy, and a safety and tolerability profile consistent with injectable GLP-1 therapies at 72 weeks Orforglipron achieved the primary and all key secondary endpoints, including demonstrating improvements in a number of cardiovascular risk factors With these results, Lilly is on track to submit orforglipron to global regulatory agencies by year-end and is making substantial investments to meet anticipated demand at launch Abu Dhabi, United Arab Emirates Aug.2025: Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 ATTAIN-1 trial, evaluating orforglipron, an investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist, in 3,127 adults with obesity, or overweight with a weight-related medical problem and without diabetes. At 72 weeks, all three doses of orforglipron, met the primary endpoint and all key secondary endpoints compared to placebo, delivering clinically meaningful weight loss as an adjunct to a healthy diet and physical activity. For the primary endpoint, orforglipron 36 mg, taken once per day without food and water restrictions, lowered weight by an average of 12.4% (27.3 lbs) compared to 0.9% (2.2 lbs) with placebo using the efficacy estimand.1 'Obesity is one of the most pressing global health challenges of our time, driving global chronic disease burden and impacting more than one billion people worldwide,' said Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health. 'With orforglipron, we're working to transform obesity care by introducing a potential once-daily oral therapy that could support early intervention and long-term disease management, while offering a convenient alternative to injectable treatments. With these positive data in hand, we are now planning to submit orforglipron for regulatory review by year-end and are prepared for a global launch to address this urgent public health need.' In the ATTAIN-1 trial, orforglipron met the primary endpoint of superior body weight reduction compared to placebo. Participants taking the highest dose of orforglipron lost an average of 27.3 lbs (12.4%) at 72 weeks using the efficacy estimand. In a key secondary endpoint, 59.6% of participants taking the highest dose of orforglipron lost at least 10% of their body weight, while 39.6% lost at least 15% of their body weight. In addition to achieving significant weight loss, orforglipron was also associated with reductions in known markers of cardiovascular risk, including non-HDL cholesterol, triglycerides and systolic blood pressure in pooled analyses across all doses. In a pre-specified exploratory analysis, the highest dose of orforglipron reduced high-sensitivity C-reactive protein (hsCRP) levels by 47.7%. For the treatment-regimen estimand,2 each dose of orforglipron led to statistically significant improvements across the primary and all key secondary endpoints. Percent weight reduction: -7.5% (-7.8 kg; 17.2 lbs; 6 mg), -8.4% (-8.6 kg; 19.0 lbs; 12 mg), -11.2% (-11.3 kg; 25.0 lbs; 36 mg), -2.1% (-2.4 kg; 5.3 lbs; placebo) Percentage of participants achieving body weight reductions of ≥10%: 33.3% (6 mg), 40.0% (12 mg), 54.6% (36 mg), 12.9% (placebo) Percentage of participants achieving body weight reductions of ≥15%: 15.1% (6 mg), 20.3% (12 mg), 36.0% (36 mg), 5.9% (placebo) The overall safety profile of orforglipron in ATTAIN-1 was consistent with the established GLP-1 receptor agonist class. The most commonly reported adverse events were gastrointestinal-related and generally mild-to-moderate in severity. The most common adverse events for participants treated with orforglipron (6 mg, 12 mg and 36 mg, respectively) were nausea (28.9%, 35.9% and 33.7%) vs. 10.4% with placebo, constipation (21.7%, 29.8% and 25.4%) vs. 9.3% with placebo, diarrhea (21.0%, 22.8% and 23.1%) vs. 9.6% with placebo, vomiting (13.0%, 21.4% and 24.0%) vs. 3.5% with placebo, and dyspepsia (13.0%, 16.2% and 14.1%) vs. 5.0% with placebo. Treatment discontinuation rates due to adverse events were 5.1% (6 mg), 7.7% (12 mg) and 10.3% (36 mg) for orforglipron vs. 2.6% with placebo. The overall treatment discontinuation rates were 21.9% (6 mg), 22.5% (12 mg) and 24.4% (36 mg) for orforglipron vs. 29.9% with placebo. No hepatic safety signal was observed. The detailed ATTAIN-1 results will be presented next month at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025 and published in a peer-reviewed journal. More results from the ATTAIN Phase 3 clinical trial program will be shared later this year, along with findings from the ACHIEVE Phase 3 clinical trial program evaluating orforglipron for adults with type 2 diabetes. About ATTAIN-1 and ATTAIN clinical trial program: ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron 6 mg, 12 mg and 36 mg as monotherapy to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, OSA or cardiovascular disease, who did not have diabetes. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan in 3:3:3:4 ratio to receive either 6 mg, 12 mg or 36 mg orforglipron or placebo. The primary objective of the study was to demonstrate that orforglipron (6 mg, 12 mg, 36 mg) is superior to placebo in body weight reduction from baseline after 72 weeks in people with a BMI ≥30.0 kg/m² or a BMI ≥27.0 kg/m² with at least one weight-related comorbidity and a history of at least one self-reported unsuccessful dietary effort to lose body weight. All participants in the orforglipron treatment arms started the study at a dose of orforglipron 1 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 6 mg (via steps at 1 mg and 3 mg), 12 mg (via steps at 1 mg, 3 mg and 6 mg) or 36 mg (via steps at 1 mg, 3 mg, 6 mg, 12 mg and 24 mg). Dose reduction was only allowed for GI tolerability if other mitigations failed. About Lilly: Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.
CNBC
8 hours ago
- Business
- CNBC
Meta shares fall on AI restructuring report, while Lilly shrugs off Novo's Ozempic price move
Every weekday, the CNBC Investing Club with Jim Cramer releases the Homestretch — an actionable afternoon update, just in time for the last hour of trading on Wall Street. Markets: Stocks aren't moving much Monday as Wall Street waits on retail earnings and a speech from Fed Chair Jay Powell later in the week. Monday's session lacks clear themes, but Meta Platforms stands out as a laggard after a report from The Information said the longtime Club holding is planning the fourth restructuring of its AI team in six months. The story is raising questions in light of Meta's significant investment in recruiting AI talent from other tech companies. Novo price cut : Shares of Club name Eli Lilly are relatively unchanged despite chief rival Novo Nordisk lowering prices for its popular GLP-1 medication. Novo Nordisk announced on Monday that it has cut the price of Ozempic, its popular GLP-1 for Type 2 diabetes, to $499 per month for cash-paying patients that use its NovoCare direct-to-patient program. Novo also announced that it has partnered with GoodRx to offer the same price for Ozempic and the weight-loss drug Wegovy at U.S. pharmacies. While the news may spark concerns that a price war is heating up in a battle for market share, we don't see this specific Ozempic development advancing that narrative. The main reason why is that the cash-pay market for GLP-1s to treat Type 2 diabetes is not as important as it is for their obesity counterparts. It all comes down to insurance coverage, which is much higher for these medications for diabetes than weight loss. Indeed, Lilly does not offer Type 2 diabetes treatment Mounjaro on its LillyDirect platform, while sister drug Zepbound for obesity is on there. Lilly executives were asked about this on the company's August earnings call, and the president of Lilly USA, Ilya Yuffa, had this to say: "With Mounjaro, we have significant coverage. So, over 90% coverage in both commercial as well as [Medicare] Part D. And so, we're not sure if [adding Mounjaro to LillyDirect] necessarily provides additional avenue. With Zepbound, we see significant growth because we do have coverage gaps in commercial. And obviously, we also have coverage gaps without having the ability to cover anti-obesity medications in Part D. So, we see this as an opportunity for us to meet that need. For what it's worth, we still like where Lilly sits in the obesity side of the GLP-1 market. Back in February, Eli Lilly announced that self-pay patients could get Zepbound single dose vials for $499 per month through its LillyDirect platform. That's on par with the price for Wegovy on NovoCare. Since head-to-head studies have found Lilly's Zepbound to be superior to Novo Nordisk's Wegovy on weight loss, patients should continue to prefer Lilly's GLP-1s. We initially downgraded our rating on Eli Lilly after its earnings a few weeks ago, partly due to concerns about a potential price war. However, we reversed course and upgraded the stock back to a buy-equivalent 1 following signs of confidence driven by significant insider buying activity. Nuclear win : Alphabet's Google and the nuclear energy company Kairos Power announced on Monday the deployment of an advanced nuclear plant to the grid. Per the agreement, a reactor operated by Kairos Power will deliver up to 50 megawatts of reliable, 24/7 energy to the Tennessee Valley Authority electric grid that powers Google data centers in Tennessee and Alabama. The electricity will come from Kairos' Hermes 2 plant, which is scheduled to begin operations in 2030. The collaboration underscores how hyperscalers are creating new partnerships with nuclear energy providers to secure, around-the-clock power supply toward the end of the decade. Unlike gas-fired electricity, nuclear power offers tech giants like Alphabet a way to run their data centers on clean energy while advancing their decarbonization goals. While Club name GE Vernova is probably best known for its heavy-duty gas turbines , the power generation company also makes small modular reactors that have gained in popularity, so nuclear developments are important to follow closely. Up next: Palo Alto Networks reports after the closing bell , the first of three Club stocks with earnings this week. Before the opening bell on Tuesday, we'll see earnings from Club name Home Depot , Medtronic , and Viking Holdings . On the data side, we'll see July housing starts and building permits, but we'll take are cue on the housing sector from what Home Depot management says on the earnings call. (See here for a full list of the stocks in Jim Cramer's Charitable Trust.) As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio. If Jim has talked about a stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB. NO SPECIFIC OUTCOME OR PROFIT IS GUARANTEED.
Business of Fashion
8 hours ago
- Business
- Business of Fashion
GLP-1 Pills Will Be Priced Similarly to Injections, Wall Street Predicts
US prices for obesity-treatment pills that Eli Lilly and Novo Nordisk aim to launch next year likely will be on par with their weight-loss injections, analysts and investors say, in a departure from the usual practice of charging more for new medicines despite pressure to cut prices. Neither drugmaker has disclosed pricing plans for their new daily oral medications. With regulatory approvals and launches still months away, pricing plans could change. Denmark-based Novo expects approval later this year and to launch soon after, while Indianapolis-based Lilly expects to launch by August 2026. Novo's Wegovy and Lilly's Zepbound, administered as weekly injections, are the only highly effective weight-loss drugs targeting the GLP-1 hormone, and the United States is their biggest market. US list prices are about $1,000 per month or more, with both companies offering a monthly supply for $499 to customers paying cash rather than using health insurance. Both companies have said they developed oral weight-loss drugs to meet patient needs and widen access to the market, mindful that some people are averse to injections. ADVERTISEMENT The pills, however, are not more effective than the injections. Lilly said this month its pill orforglipron cut weight by 12.4 percent after 72 weeks in a trial. That compares with weight loss of 15 percent for Novo's daily oral semaglutide. Both trail Lilly's injection at up to 21 percent. UBS analyst Trung Huynh said that will cap Lilly's pricing. The price is 'probably going to come on par with the current drugs today or slightly lower,' Huynh said. TD Cowen analyst Michael Nedelcovych said he expects Novo's pill to debut near Wegovy's price, citing the precedent of its diabetes pill Rybelsus being priced at parity with injection Ozempic, the diabetes-treatment version of Wegovy. Novo executives told analysts this month they were not in a hurry for discount pricing for the new pill. Oral GLP-1 drugs will fill a niche rather than displace injections, according to analysts. TD Cowen estimates that pills will account for a percentage share of the global obesity drug market in the mid-teens by 2030, which could reach $150 billion by then. Growing Cash Pay US doctors, patients and insurers are pressing for lower prices to make the weight-loss drugs more affordable for the 40 percent of Americans who are obese. Typically, drugmakers launch new drugs at higher prices, citing scientific advances. President Donald Trump and lawmakers from both parties have urged the companies to reduce US prices. Novo declined to comment on pricing, pointing to Aug. 6 comments by David Moore, its US operations head, saying that the company may tap customers paying cash directly via its new NovoCare pharmacy, which was launched this year to sell Wegovy outside of insurance. A Lilly spokesperson called it premature to comment on pricing and launch plans for its pill because the company has not yet submitted data for regulatory approval. Peak annual sales forecasts for Lilly's orforglipron fell to as low as $10 billion after its trial data from earlier estimates of up to $30 billion, according to a Reuters review of analyst estimates. HSBC forecasts $15 billion in peak annual sales for Novo's pill, while Barclays expects only $1 billion. ADVERTISEMENT Manufacturing Volume A key question is how much supply will be available at the time of launch. Shortages of injectable GLP-1s in 2023 and 2024 opened the US market to cheaper compounded versions as the manufacturers failed to anticipate the huge demand. 'It's all about scale and pricing,' said Kevin Gade, portfolio manager at Bahl & Gaynor, which owns Lilly shares. Gade pointed to Novo's manufacturing challenge. The pill form requires about 75 times more active ingredient than the highest-dose Wegovy injection, two analysts told Reuters. Lilly has said it already has $808.5 million in orforglipron inventory for next year's expected launch. Novo has said it will launch its pill without supply constraints after billions of dollars in investment to expand semaglutide production. Despite the high production needs, Novo is unlikely to debut its pill at a higher price than Wegovy, said Karen Andersen, healthcare strategist at Morningstar. 'Particularly in the growing cash-pay market, I doubt it can risk a launch at a premium to Wegovy,' Andersen added. By Maggie Fick and Bhanvi Satija; Editors: Caroline Humer and Will Dunham Sign up to The Business of Beauty newsletter, your complimentary, must-read source for the day's most important beauty and wellness news and analysis.
Daily Mirror
12 hours ago
- Entertainment
- Daily Mirror
Woman prepares to say goodbye to pet horse but something amazing happens
Libby Partidge was in tears as she prepared to say goodbye to her six-year-old horse, Lilly, before making a huge discovery that changed everything about her fate A woman who was getting ready to say an emotional goodbye to her horse has had her fate changed completely after making a huge discovery with her mare. Libby Partridge said earlier this year that she was close to closing the sale of her six-year-old mare, Lilly, after a "very serious buyer" stepped forward with an offer. They were due to come and visit the horse in April and would likely take her home the next day, leaving 18-year-old Libby in tears as she struggled with the thought of having to say goodbye to her beloved animal and potentially never seeing her again. However, the buyer's car broke down, and they were unable to meet the horse, which meant Libby could afford a few more precious days with her pet. These extra days would go on to be serendipitous for Libby, as just one week after the sale was supposed to go through, she made a groundbreaking discovery about her mare - she was pregnant and due to give birth very soon. If the sale had gone through as planned, Libby would likely have had no idea Lilly was expecting, and the buyer would have gotten more than they bargained for. Libby shared the emotional discovery on TikTok in a video that started with her crying over saying goodbye to Lilly, and then ended with shots of the tiny foal, whom she has named Coco. She wrote on the video: "Me crying knowing I was having to say goodbye to my horse, but she pops out this thing." Coco, however, is not a purebred horse. She's actually a mule, as Libby has discovered that the foal's dad is a donkey aptly named Donkey, who Libby bought after seeing a Facebook post. She told Newsweek: "I saw the dad, named Donkey, in a Facebook post and I knew we needed him. I was told that he was a castrated donkey, so I thought that's perfect. He arrived and he very clearly wasn't castrated. "I thought because he's quite old already, I wouldn't put him through the stress of surgery. So, I kept him intact in a separate field far away from Lilly. All was well until I woke up one morning with Donkey in Lilly's field." Libby thought nothing of it at the time and presumed that because Donkey was significantly smaller than Lilly, they wouldn't have been able to mate. But that assumption proved false on April 21st when Lilly gave birth to Coco. Since sharing the video documenting Coco's arrival, Libby has had "nothing but positive" comments on social media from over 550 people who have left heartwarming messages for the teenager. One comment reads: "She's like hang on, I'm duplicating." Another person joked: "She said nice try your stuck with me forever."
CNBC
14 hours ago
- Health
- CNBC
Eli Lilly's 170% UK price hike for Mounjaro is just the start as pharma firms bow to Trump's pricing pressures
Eli Lilly 's move to raise the U.K. list price of its blockbuster diabetes drug Mounjaro marks the start of prices hikes across Europe, analysts say, as pharmaceutical firms respond to U.S. President Donald Trump's drug pricing demands. Lilly said Thursday that it had reached an agreement with the U.K. government to raise the list price of its weekly injection from Sept. 1, while maintaining access for patients covered by the publicly funded National Health Service (NHS). The U.S. pharma giant said it is now working with some other governments to adjust prices by the start of next month, without providing details of the specific countries involved. Analysts expect other firms to follow suit. "Lilly doing this isn't shocking and I think that we'll see more to come," Kavita Patel, NBC News & MSNBC medical contributor and Stanford University professor, told CNBC's "Fast Money" on Thursday. President Trump earlier this month delivered an ultimatum to pharma firms as part of his ongoing campaign to stamp out what he deems as unfair pricing practices in the U.S. In letters sent to 17 major pharmaceutical firms, the president outlined the steps they must take by Sept. 29 to lower the price of U.S. prescription drugs to "most favored nation" (MFN) levels. Lilly's pricing decision takes the U.K. list price of its popular treatment from a range of £92 (about $124.57) to £122 a month, depending on the dose size, to between £133 and £330 — a 170% price jump. That compares to its U.S. list price of $1,079.77 a month, before insurance and other rebates. The U.S. consistently pays the most in the world for many prescription drugs, due in part to the country's highly complex and fragmented reimbursement system, and a lack of the types of national pricing control prevalent in much of Europe. Several European pharma firms have spoken out in support of the White House's pricing demands, with AstraZeneca CEO Pascal Soriot saying last month that Trump was "right" to push for price equalization. Novartis CEO Vas Narasimhan has cited "productive" conversations with the administration, while Roche Chief Executive Thomas Schinecker has suggested that U.S. prices could be cut in half if the government removed intermediaries, known as pharmacy benefit managers (PBMs). Stanford University's Patel noted that firms like Eli Lilly may also be willing to accede to Trump's pricing demands as they seek coverage for their weight loss drugs under forthcoming changes to the U.S. government's Medicare and Medicaid health insurance systems for low-income people and retirees. "The United States is their big market and having that share in both Medicare and Medicaid is everything for drugs like Mounjaro. So this is important and I don't think they'll be the only one that we see," she said. Indeed, rival diabetes and obesity drug giant Novo Nordisk is seeking to regain ground in the lucrative U.S. market after a series of missteps and supply shortages have seen it lose market share to both Lily and other cheaper compounded weight loss drugs. Novo Nordisk 's Chief Financial Officer Karsten Munk Knudsen said earlier this month that Trump's drug pricing demands had "resonated" with the company and that it was already lowering the price of its Wegovy and Ozempic treatments stateside. The company said Monday that it would reduce the cost of Ozempic for cash-paying patients to $499 per month, less than half of its monthly U.S. list price. Nevertheless, Knudsen previously suggested that it could be difficult to simultaneously raise prices in other markets, given stretched public finances and strict pharmaceutical price caps across Europe. "If we look ex-U.S. markets, there's rather limited history in terms of raising prices … I believe it will be challenging to significantly raise prices outside the U.S.," he told CNBC's "Squawk Box Europe." Industry bodies, meanwhile, have warned of the damaging impact sudden prices hikes could have on patient care if implemented to meet Trump's Sept. 29 deadline. Already, U.K. private pharmacies have reported a surge in orders for Lilly's Mounjaro following Thursday's announcement. "Short notice changes to pricing for medicines such as this also have a serious effect on access to an important public health service and pharmacy business themselves," Henry Gregg, chief executive of the U.K.'s National Pharmacy Association, said in a statement. "We are urging the manufacturers to ensure that pharmacies are treated equitably and that proper support is in place," he added.
