Albuterol/Budesonide

Connect Biopharma (Nasdaq: CNTB) reported that an independent Data Monitoring Committee has reviewed interim efficacy data from its Phase II Seabreeze STAT studies of rademikibart in acute asthma and COPD exacerbations, recommending no change to sample size and identifying no safety concerns — a procedural checkpoint that keeps the program on track for mid-2026 topline readouts. The Seabreeze STAT Asthma and Seabreeze STAT COPD trials are randomized, double-blind, placebo-controlled Phase II studies evaluating rademikibart as add-on treatment in adults experiencing acute exacerbations of asthma or COPD with type 2 inflammation. The DMC’s interim review was triggered after a minimum of 50 patients in each study had completed at least 28 days of follow-up. The committee examined three pre-specified measures: treatment failure at 28 days, rate of new exacerbations through 28 days, and change from baseline in FEV1. No numerical efficacy results were disclosed. On safety, the company said there have been no treatment-related serious or severe adverse events and no discontinuations due to adverse events in either study. The absence of a sample-size adjustment is a procedural signal rather than an efficacy readout. DMCs typically recommend increases when interim data suggest the study is underpowered to detect a treatment effect, and reductions — or early stopping — when a benefit or harm threshold has been crossed. A recommendation to continue unchanged indicates the trial remains within its pre-specified operating assumptions, though it provides no information about the direction or magnitude of the treatment effect. Topline data remain the relevant evidentiary milestone. Rademikibart targets the interleukin-4 receptor alpha subunit, blocking both IL-4 and IL-13 signaling and thereby suppressing the Th2 inflammatory pathway implicated in type 2 airway disease. The mechanism is shared with dupilumab, the Sanofi and Regeneron anti-IL-4Rα antibody that generated Phase III COPD data in 2024 through the BOREAS and NOTUS trials. Those programs evaluated dupilumab as a maintenance therapy in patients with type 2 COPD, a distinct clinical context from the acute exacerbation add-on design Connect is pursuing. Cross-trial comparisons are limited by differences in patient population, dosing schedule, endpoints, and treatment setting. The acute exacerbation niche is mechanistically unoccupied by approved biologics. Current standard of care in acute asthma and COPD exacerbations centers on short-acting bronchodilators, systemic corticosteroids, and, in severe cases, intravenous magnesium sulfate. AstraZeneca’s Airsupra, a fixed-dose combination of albuterol and budesonide approved by the FDA in January 2023, introduced an anti-inflammatory rescue option but operates through inhaled corticosteroid rather than cytokine blockade. No biologic targeting the IL-4/IL-13 axis has been approved or previously studied in the acute exacerbation setting, which is the clinical rationale underlying the Seabreeze STAT program design. Whether that rationale translates into measurable benefit depends on whether rademikibart can act rapidly enough in an acute context to influence the endpoints the DMC reviewed. Biologics targeting cytokine receptors typically require days to weeks to exert meaningful anti-inflammatory effects, and the 28-day treatment failure endpoint in the Seabreeze STAT studies reflects that time horizon. Connect has cited preclinical and early clinical data suggesting a faster onset of FEV1 improvement than might be expected from the class, though that claim awaits Phase II confirmation. Connect said it plans to meet with the FDA to align on a Phase III program following the mid-2026 topline readouts from both Seabreeze STAT studies. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

iStock, fpm With pricing pressures climbing, Pfizer, Eli Lilly and other major drugmakers are looking to sell their products directly to patients. Analysts are skeptical that these efforts, including those announced to much fanfare from the White House, will result in meaningful reductions in drug spending. President Donald Trump has made lowering drug prices a cornerstone of his domestic policy agenda, the core of which is his Most Favored Nation (MFN) scheme , which seeks to force U.S. drug prices down to the same level as in similarly developed countries. In line with this, the government is gearing up to debut a direct-to-consumer (DTC) platform, dubbed TrumpRx, in January 2026 . While DTC has been a growing trend in biopharma for nearly two years now—Lilly launched LillyDirect in January 2024—the number of drugmakers looking to sell their products directly to patients has spiked in recent months. Drug pricing is a delicate issue and pharmas have long been under pressure to improve access to medicines. “The goal of drug pricing is to set them high enough so pharmaceutical companies are incentivized to fund the research and development needed to bring new drugs to the market,” Jason Shafrin, senior managing director of the Center for Healthcare Economics & Policy at FTI Consulting, told BioSpace in an email. On the flipside, drugs must be priced “so that the benefit to society outweighs the cost,” he added. On both counts, Shafrin, along with other experts that spoke to BioSpace for this piece, questioned the effectiveness of the DTC approach. “Even the best market-based DTC/generic solutions won’t address the much larger part of the market that’s made up of life-saving specialty drugs,” Vance Ginn, independent healthcare researcher and staff economist at Americans for Tax Reform. These measures, he continued, target the wrong patients: They typically provide discounts for drugs that are already affordable through insurance coverage or otherwise come with other forms of price cuts. Meanwhile, DTC typically overlooks “the smaller part of the population—cancer patients, the very sick, elderly—whose spending makes up the majority of drug pending,” Ginn explained. In this piece, BioSpace looks at some of the recent drug pricing efforts from pharma companies and assesses if any of these discounts—carried out principally through DTC offerings—are likely to have any tangible impact on patient spending. Pfizer’s Eucrisa, Xeljanz and Zavzpret List price: $821 per tube (Eucrisa), $6,150 per bottle (Xeljanz), $1,345 (Zavzpret) The latest drug pricing push across pharma is, in large part, thanks to Pfizer. In an Oct. 2 note to investors, analysts at Guggenheim Partners credited the pharma for “setting up a template for broader industry agreements” with the Trump administration. Pfizer in late September announced that it had reached an agreement with the Trump administration to offer a selection of its drugs on TrumpRx once it goes live next year. The pharma has yet to provide a full list of the drugs that will be included, only saying at the time that “the large majority” of its “primary care” treatments, as well as “select specialty brands,” will be made available on TrumpRx. But in its own announcement of the agreement , the White House named three Pfizer products: The eczema cream Eucrisa, offered at an 80% discount Xeljanz tablets, indicated for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis, for 40% cheaper. The migraine nasal spray Zavzpret, yielding 50% savings. Of these products, Xeljanz appears to be the most commercially impactful for Pfizer. The product made nearly $1.17 billion in 2024. Meanwhile, the pharma didn’t even bother reporting sales figures for Eucrisa and Zavzpret, suggesting they are on the lower end of the pharma’s revenue scale. Even then, putting Xeljanz on steep sale is unlikely to eat into Pfizer’s bottomline. The drug is already on the decline, with 2024 sales representing a 31% year-on-year drop. Major product patents for Xeljanz are set to expire next year, while Europe protections will last until 2028, according to the company’s annual report . Zavzpret, on the other hand, will have exclusivity until 2031—though Pfizer is looking to extend that until 2034. Eucrisa’s last qualifying patent will expire in 2030 , though the drug is already under generic challenge. Five drugmakers have filed for generic versions of Eucrisa, including Teva, Alkem and Dr. Reddys, which Pfizer sued in September 2021 for patent infringement. AstraZeneca’s Bevespi Aerosphere, Breztri Aerosphere and Airsupra List price: $548.25 (Bevespi Aerosphere), $664.49 (Breztri Aerosphere), $489.25 (Airsupra) AstraZeneca also signed on to the TrumpRx platform earlier this month. In an announcement of the deal, the pharma said that “eligible patients with prescriptions for chronic diseases” will have access to discounts reaching as high as 80%. As in the case of Pfizer, the White House provided a few examples of which drugs would be covered: The chronic obstructive pulmonary disease (COPD) inhaler Bevespi Aerosphere, given “at a discount equal to 654% of the deal price.” Breztri Aerosphere, another COPD inhaler, with a “discount equal to 98% of the deal price.” Airsupra, indicated for asthma, at a “discount equal to 96% of the deal price.” It is unclear what “deal price” the White House is referring to in its announcement, nor was it explained how a product can be discounted at more than 100% of its list price. AstraZeneca’s three disclosed TrumpRx products are unlikely to have a strong impact on the pharma’s sales, according to experts. In 2024, Breztri brought in $978 million worldwide , while Airsupra made $66 million. AstraZeneca did not report sales data for Bevespi Aerosphere. For patients, the pharma’s DTC drive could have a mixed effect, FTI’s Shafrin said, depending largely on insurance coverage. “Many insured Individuals—especially those under Medicare Part D—already face low or zero out-of-pocket costs due to coverage caps,” he explained. Still, he concedes that “some patients” may benefit from TrumpRx and other DTC offerings. “Only the uninsured or those with high-deductible plans might experience net savings through DTC purchases, while the majority of insured patients would pay less through traditional insurance channels,” Shafrin said. Amgen’s Repatha List price: $527.70 per monthly course Also taking the DTC route to drug discounts is Amgen, which in early October made its lipid-lowering drug Repatha available for direct purchase by patients—though not immediately in conjunction with TrumpRx. Through a new platform called AmgenNow, the pharma will offer Repatha for $239 per month, nearly 60% cheaper comapred to the drug’s current list price. Amgen said that this discounted price will be the lowest for Repatha among all countries belonging to the G7—a group composed of economically similar nations—and is “being offered exclusively for the first time to U.S. patients.” Still, it remains unclear how impactful this discount will be, Matt Phipps, group head of biotechnology equity research at William Blair, told BioSpace in an email. He pointed to Repatha’s own website , where Amgen itself acknowledges that Repatha “may cost less than you think.” With Medicare, for instance, around 74% of the drug’s prescriptions cost $50 or less, while about 99% of Medicaid prescriptions are $10 or less. These prices “are a lot less than the $239 cash pay price they are now offering,” Phipps said, noting that it’s “unlikely that many people would choose the $239 versus one of the other options.” This dynamic, he continued, is compounded by the fact that LDL reduction “isn’t exactly something patients seek out treatment for,” and is instead more reliant on being “convinced by their doctor.” Repatha is one of Amgen’s top products. In 2024, it made more than $2.2 billion worldwide , representing 36% year-on-year growth, with the pharma continuing to invest in its development. Earlier this month, for instance, just days before announcing the DTC offering, Amgen released Phase III results demonstrating Repatha’s value as a primary prevention option for cardiovascular disease, significantly lowering the risk of death from heart attack, ischemic stroke and coronary heart disease in high-risk patients. The drug is also in Phase III development for hypercholesterolemia . Some patents for Repatha are set to expire in 2028 . BMS’ Sotyktu List price: $6,678 for 30 tablets Bristol Myers Squibb is also putting a relatively more valuable product on the line. Last month, the pharma announced that starting in January 2026, patients would be able to purchase the plaque psoriasis drug Sotyktu directly. Offering Sotyktu this way will translate to 80% savings compared with the drug’s current list price, BMS said at the time. In July, BMS likewise opened a DTC offer for its Pfizer-partnered blood thinner Eliquis, shaving the price by 40% In 2024, Sotyktu brought in just under $250 million worldwide and is one of BMS’ fastest-growing assets with a 45% year-on-year increase. Meanwhile, at $13.3 billion, Eliquis ranked as the industry’s fourth best-selling drug last year. The factor Xa inhibitor was first approved in 2012 but continues to grow.n 2024 sales represented a 9% jump from 2023. Still, Phipps doesn’t anticipate these offerings will translate to actual, consequential savings for patients. “In talking to BMY . . . after these announcements, they don’t seem to think very many people would use these channels,” he told BioSpace . Echoing Shafrin’s sentiments, Phipps added that patients on insurance “can likely get the drugs for less co-pay” or through co-pay assistance programs. “Less than 10% of Americans are uninsured, so maybe they would be the ones interested in the cash pay price.” Deborah Williams, Founder of Health Policy Insight, agrees but is more direct: “These companies have created a DTC with prices far above coinsurance,” she said by email, noting that these initiatives are in turn, “not likely to have much impact for patients except for the well-off uninsured.” Talking about Eliquis in particular, Williams also pointed out that drugmakers tend to implement pricing measures for products with already “robust coverage.” Companies “will not want to undercut that payer channel,” she explained, which is why their own pricing proposal, in Williams’ words, “sucks.” “I don’t blame them,” she said. “Companies objectively do not want to trigger greater losses and it’s difficult for them to navigate the drug pricing rapids.” Novo Nordisk and Lilly’s GLP-1s List price: $1,349.02 per package Of all the products on this list, Wegovy stands out as the only drug for which a DTC program could lead to meaningful savings for patients, according to experts BioSpace spoke to. Novo, along with Lilly, struck a deal with the White House last week to offer its GLP-1 products for about $350 a month. This agreement releases a significant amount of pressure on pharma as a whole, BMO Capital Markets wrote on Nov. 6. Key is that both companies agreed to launch their new oral weight loss drugs at MFN prices. But both companies will maintain their grip on the weight loss market. “Even with pricing cuts, we see the impacts as largely muted relative to net prices we currently model, another positive to the deal structure,” BMO wrote. Tyler Young, an independent pharmacist and owner of Vashon Pharmacy, said via email prior to the White House announcement that GLP-1 drugs would be the most impactful for patients “by far” given how big the market is currently. And while Young insists that this recent DTC rush “will not move the needle in the wider drug market,” he conceded that it will be “effective for a select group of cash-paying patients.” “The cash market for GLPs is significantly higher” than that of other medicines, he added. The White House touted the pricing agreements as a way to help Americans lose billions of pounds, with officials suggesting that this agreement—after Pfizer and AstraZeneca—could be the most beneficial to patients yet. Williams agrees. If Wegovy—as well as Lilly’s Zepbound—come down to the Most Favored Nation pricing, she said, it could potentially have appreciable effects for patients, who have to shoulder a high cash pay, even with insurance. “It’s the perfect storm,” Williams told BioSpace . “Highly valued product, high list-based coinsurance when covered, coverage problems.” The deal will also see the GLP-1 drugs offered on Medicaid and Medicare, opening up the patient population for both companies. Novo launched a DTC platform called NovoCare in March this year, which offers Wegovy for just $499 per month, down from its current monthly cost of around $1,349. Then, in August, Novo linked up with online drug discount platform GoodRx to offer both Wegovy and its sister semaglutide brand Ozempic at $499, matching the NovoCare pricing. Lilly also offers its GLP-1 brands at prices similar to the White House agreement through the LillyDirect platform. Prior to the agreement, Trump had promised to bring Ozempic’s price down to $150 through negotiations with the Centers for Medicare & Medicaid Services. His team did secure $150 pricing for starting doses of the Wegovy pill, if approved. Last year, Wegovy made nearly $8.8 billion for Novo, while Ozempic brought in $16.9 billion, making it the second best-selling drug of 2024, just behind Merck’s cancer behemoth Keytruda. Lilly’s tirzepatide franchise just toppled Merck’s immuno-oncology heavyweight Keytruda as the best-selling drug , with $10.1 billion in sales recorded for the third quarter.