Latest news with #Soliris
Yahoo
15-05-2025
- Business
- Yahoo
New Biologics Reshape the gMG Landscape, but Growth Opportunities Persist for Established and Pipeline Therapies, According to Spherix Global
High rates of biologic naivety, limited switching, and ongoing unmet needs across the gMG landscape create opportunity for brand differentiation. EXTON, PA, May 15, 2025 (GLOBE NEWSWIRE) -- The treatment landscape for generalized myasthenia gravis (gMG) has entered a new era of therapeutic innovation. Since 2022, seven novel targeted biologics have launched, with a robust pipeline poised to continue this momentum. However, findings from Spherix Global Insights' latest Patient Chart Dynamix™: Generalized Myasthenia Gravis (US) reveal that the biologic market remains far from saturated. Adoption barriers on both the provider and patient sides create meaningful opportunities for current and emerging brands to expand their reach. In a survey of 147 biologic-prescribing neurologists, approximately half of gMG patients remain biologic-naïve. Notably, one-third are deemed clinically eligible for a targeted biologic but have not yet started treatment. This gap highlights the complex interplay of prescribing behaviors, patient hesitations, and the need for tailored manufacturer strategies to capture market share. The gMG biologic market continues to shift as recent and anticipated approvals reshape the field. In March 2025, Amgen launched Bkemv, the first Soliris biosimilar, followed by Teva's Epysqli just one month later. Shortly thereafter, argenx received FDA approval for a pre-filled syringe formulation of Vyvgart Hytrulo, enhancing patient convenience. Meanwhile, Johnson & Johnson's Imaavy, an FcRn inhibitor, gained FDA approval in late April, while Amgen's Uplizna is also expected to join the market soon. Pipeline innovation in the gMG landscape remains robust, with several candidates introducing novel mechanisms of action and more convenient delivery methods. Notable developments include Alexion/AstraZeneca's gefurulimab, a subcutaneous C5 inhibitor aimed at improving administration convenience; Regeneron's combination of pozelimab and cemdisiran, offering a dual-modality approach to potentially enhance treatment response; and Novartis' oral therapies—Fabhalta (iptacopan) and remibrutinib—positioned to advance the treatment paradigm. Additional promising candidates include EMD Serono's Mavenclad (cladribine) and RemeGen's telitacicept, both of which may offer differentiation through efficacy, ease of use, and the targeting of persistent unmet needs. According to Spherix's Patient Chart Dynamix™: Generalized Myasthenia Gravis (US), which audited 564 patient charts, the majority of gMG patients currently treated with a biologic remain on their initial therapy. This high level of brand retention underscores both the early stage of market development and the strong satisfaction neurologists report with available agents. However, the path to market success is far from guaranteed. In a landscape where switching remains limited, differentiation at launch is critical. Significant opportunity remains for products that can address clearly defined subpopulations—particularly those experiencing rapid disease progression, refractory to existing biologics, or presenting with rare serotypes such as anti-LRP4+ and seronegative gMG. These patient groups represent areas of persistent unmet need that neurologists continue to prioritize in treatment decisions. Importantly, while clinical positioning is essential, patient influence in treatment initiation cannot be overlooked. Spherix's findings reveal that half of biologic-naïve gMG patients play a significant role in the decision to start therapy. However, patient-initiated requests remain uncommon, indicating that uptake is largely driven by how neurologists frame and present available options. In this context, physician education must extend beyond product knowledge to include effective communication strategies that support shared decision-making and actively engage patients in the treatment journey. While surveyed neurologists generally identify as early adopters of new therapies, the future growth of the gMG market will depend heavily on strategic launch execution, comprehensive provider education, and precise targeting of high-opportunity patient segments. Manufacturers that recognize and respond to these dynamics, tailoring their approaches to meet both clinical and commercial needs, will be best positioned to succeed in an increasingly competitive and rapidly evolving treatment landscape. Spherix will continue to monitor launch performance, shifting prescriber attitudes, and patient-level dynamics through ongoing updates through their suite of gMG services. Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the 'why' behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. CONTACT: Bob Shewbrooks, Neurology Franchise Head Spherix Global Insights 4848794284 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
Business Standard
29-04-2025
- Business
- Business Standard
AstraZeneca says potential US tariffs manageable; faces another China fine
AstraZeneca expects only limited impact from potential U.S. tariffs on pharmaceutical imports, the drugmaker said on Tuesday, asserting it would maintain its 2025 forecasts if the levies end up being in line with other sectors. The tariffs and their erratic rollout by President Donald Trump have heightened fears of global supply chain disruptions, roiling industries that are heavily focused on the United States, the world's biggest consumer market. However, AstraZeneca Chief Executive Pascal Soriot said in a call with journalists that their shock would be something the company could absorb. "If tariffs were implemented in the range we have seen recently in other industries on medicines imported from Europe to the U.S., we would remain within the guidance range we indicated for 2025," he said. Most of the Anglo-Swedish drugmaker's sales come from drugs manufactured either domestically or in Europe, and the company was already shifting some additional manufacturing to U.S. sites, he added. "It's really something that we are going to manage," he added, noting that only minor volumes of U.S.-made drugs are exported to China, shielding the impact of tariffs in the country's second-biggest market after the United States. Also Read Shares in AstraZeneca fell as much as 5.4% before paring losses to trade down 3.2% at about 102 pounds by 0929 GMT, underperforming London's blue-chip FTSE 100, which rose 0.2%. Soriot spoke after the company reported total revenue of $13.6 billion for the first quarter, below company-compiled analysts' expectations of $13.8 billion. Sales of key oncology drugs missed forecasts, impacted partly by changes in U.S. Medicare price negotiations and the transition of rare disease patients from Soliris to newer drug Ultomiris, analysts said. The company also said it could face a new fine in China of up to $8 million over suspected unpaid taxes related to imports of breast cancer drug Enhertu. The update on investigations in China comes after it announced in February that it could face a fine of up to $4.5 million over imports of cancer drugs Imfinzi and Imjudo. Still, core earnings per share of $2.49 beat consensus estimates of $2.27. China accounted for about 12% of overall sales in 2024, while the United States made up 43%. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Business Recorder
29-04-2025
- Business
- Business Recorder
AstraZeneca says potential US tariffs manageable, faces another China fine
AstraZeneca expects only limited impact from potential U.S. tariffs on pharmaceutical imports, the drugmaker said on Tuesday, asserting it would maintain its 2025 forecasts if the levies end up being in line with other sectors. The tariffs and their erratic rollout by President Donald Trump have heightened fears of global supply chain disruptions, roiling industries that are heavily focused on the United States, the world's biggest consumer market. However, AstraZeneca Chief Executive Pascal Soriot said in a call with journalists that their shock would be something the company could absorb. 'If tariffs were implemented in the range we have seen recently in other industries on medicines imported from Europe to the U.S., we would remain within the guidance range we indicated for 2025,' he said. Most of the Anglo-Swedish drugmaker's sales come from drugs manufactured either domestically or in Europe, and the company was already shifting some additional manufacturing to U.S. sites, he added. 'It's really something that we are going to manage,' he added, noting that only minor volumes of U.S.-made drugs are exported to China, shielding the impact of tariffs in the country's second-biggest market after the United States. Shares in AstraZeneca fell as much as 5.4% before paring losses to trade down 3.2% at about 102 pounds by 0929 GMT, underperforming London's blue-chip FTSE 100, which rose 0.2%. AstraZeneca investing $2.5bn in China as drugmaker seeks to recover from scandals Soriot spoke after the company reported total revenue of $13.6 billion for the first quarter, below company-compiled analysts' expectations of $13.8 billion. Sales of key oncology drugs missed forecasts, impacted partly by changes in U.S. Medicare price negotiations and the transition of rare disease patients from Soliris to newer drug Ultomiris, analysts said. The company also said it could face a new fine in China of up to $8 million over suspected unpaid taxes related to imports of breast cancer drug Enhertu. The update on investigations in China comes after it announced in February that it could face a fine of up to $4.5 million over imports of cancer drugs Imfinzi and Imjudo. Still, core earnings per share of $2.49 beat consensus estimates of $2.27. China accounted for about 12% of overall sales in 2024, while the United States made up 43%.
Reuters
16-04-2025
- Business
- Reuters
AstraZeneca unit sued over alleged monopoly on blockbuster drug Soliris
April 16 (Reuters) - AstraZeneca's (AZN.L), opens new tab Alexion Pharmaceuticals was sued in Massachusetts federal court on Wednesday for allegedly misusing its patents to extend its monopoly on its blockbuster blood-disease drug Soliris. Health plan EmblemHealth said in the proposed class action lawsuit, opens new tab that Alexion wrongly obtained new patents to block biosimilar versions of Soliris for four years after its patents on the drug should have expired. EmblemHealth said the alleged scheme violated U.S. antitrust law and could cause overpayments of more than $2 billion for Soliris. Spokespeople for AstraZeneca did not immediately respond to a request for comment on the complaint. "We are concerned about practices that shut down competition and increase drug costs. That's what this litigation is about," an EmblemHealth spokesperson said. EmblemHealth is seeking to represent a class of U.S. Soliris buyers in the lawsuit. Soliris is used to treat rare blood disorders. AstraZeneca earned more than $1.4 billion from sales of the drug in the first half of 2024, according to a company report. EmblemHealth said in the lawsuit that AstraZeneca charges "one of the single highest drug costs in U.S. history" for Soliris, which costs "upwards of $500,000 per patient per year." AstraZeneca's patents covering Soliris should have expired in 2021, but the company misled the U.S. Patent and Trademark Office to obtain more patents with expiration dates "well into the future," according to the complaint. The lawsuit said AstraZeneca used the new patents to "extract settlements" from competitors and delay their biosimilars until March 2025 at the earliest. EmblemHealth asked the court for an order ending AstraZeneca's monopoly on Soliris and an unspecified amount of monetary damages. The case is EmblemHealth Inc v. Alexion Pharmaceuticals Inc, U.S. District Court for the District of Massachusetts, No. 1:25-cv-10985. For EmblemHealth: Thomas Sobol and Gregory Arnold of Hagens Berman Sobol Shapiro; and Mark Fischer and Rob Griffith of Rawlings & Associates
Yahoo
24-03-2025
- Business
- Yahoo
Forget the Correction: This Stock Is Defying the Sell-Off, and There Might Be More Upside Ahead
The tech-heavy Nasdaq Composite index recently entered correction territory. Though it was able to climb out of it, equities broadly remain down for the year. Still, some companies are performing well amid the volatility. AstraZeneca (NASDAQ: AZN), a U.K.-based pharmaceutical giant, is one of them; its stock is up by an impressive 16% since January. This performance so far in 2025 is not a fluke. And the stock may deliver strong returns, if not in the next few weeks, but for investors willing to hold onto its shares for years. AstraZeneca's shares fell off a cliff late last year when it announced the arrest of some of its executives in China, including Leon Wang, the drugmaker's president in the country. That's on top of an insurance fraud investigation in China it had been dealing with, and allegations that the company imported illegal pharmaceutical drugs into the country. Though these problems are worth monitoring, AstraZeneca's financial results certainly aren't an issue. Last year, its revenue jumped by 18% year over year to $54.1 billion, an excellent performance for a pharmaceutical giant. Adjusted earnings per share were $8.21, 13% higher than the previous fiscal year. AstraZeneca operates several segments focused on various therapeutic areas, and every one except "other medicines" saw sales move in the right direction in 2024. Even with the challenges that AstraZeneca is dealing with now, last year's decline in its share price may have been overdone, given the company's strong financial results. That's likely why the stock has performed well since December, and has kept that momentum through market volatility this year. If it's found liable for illegal drug importation in China, AstraZeneca could incur a fine. The potential fine in China could amount to 100% to 500% of the unpaid importation taxes of $0.9 million. At worst, AstraZeneca will pay $4.5 million if it's found guilty -- a drop in the bucket for a company that generates tens of billions of dollars in annual revenue. The company will also face two patent cliffs in the U.S. this year. The first is for Soliris, a medicine for a rare blood disease called paroxysmal nocturnal hemoglobinuria. The second is for Brilinta, a treatment used to reduce the risk of heart attacks. Neither of these patent expirations should be a game changer for AstraZeneca. Soliris' sales in 2024 totaled $2.6 billion, but declined 18% year over year due to patients switching to AstraZeneca's newer Ultomiris. Brilinta's revenue in 2024 came in at $1.3 billion, up 1% year over year -- it was already facing generic competition in other countries. Because Soliris and Brilinta contributed little (if anything at all) to the pharmaceutical giant's top-line growth last year, the loss of exclusivity for these medicines won't harm its prospects. AstraZeneca has a lot to offer investors: a vast and diversified lineup of medicines, a deep pipeline, and steady revenue and earnings growth. Its lineup featured 14 medicines that each generated over $1 billion in sales last year. Yes, some will lose patent exclusivity, but others will fill the gap. Breztri, a treatment for chronic obstructive pulmonary disease (COPD), came short of blockbuster status for AstraZeneca last year with sales of $978 million, but they were up by 44% compared to 2023. Several other drugs should also continue to help drive strong top-line growth for the pharmaceutical leader, including the newer cancer therapy Truqap. Meanwhile, AstraZeneca's pipeline will likely unearth more gems. Like other drugmakers, it's now seeking to join the promising weight loss area. The company's investigational oral GLP-1 therapy, AZD5004, is undergoing phase 1 and 2 clinical trials across diabetes, weight management, and several other potential indications. (All currently approved GLP-1 medicines are administered subcutaneously, so there could be a reasonable demand for an oral option.) The company's AZD9550 is another potential GLP-1 medicine in early-stage studies. Beyond that, AstraZeneca is running many clinical trials across various therapeutic areas. The company had over a dozen regulatory approvals or clinical trial readouts in the fourth quarter. You can expect more of the same every period, which should allow its financial results to remain strong over the long run, even as it faces patent cliffs. Investors should see past the headwinds -- many already are, since the stock is performing well right now. But it's still time to think about purchasing shares of AstraZeneca. The drugmaker could deliver excellent returns. Before you buy stock in AstraZeneca Plc, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and AstraZeneca Plc wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $721,394!* Now, it's worth noting Stock Advisor's total average return is 839% — a market-crushing outperformance compared to 164% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of March 18, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool recommends AstraZeneca Plc. The Motley Fool has a disclosure policy. Forget the Correction: This Stock Is Defying the Sell-Off, and There Might Be More Upside Ahead was originally published by The Motley Fool Sign in to access your portfolio
