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Antech™ Expands Vector-Borne Disease Portfolio with Enhanced Accuplex™ and Most Comprehensive PCR Panel to Date

Antech™ Expands Vector-Borne Disease Portfolio with Enhanced Accuplex™ and Most Comprehensive PCR Panel to Date

Business Wire12-05-2025
LOVELAND, Colo.--(BUSINESS WIRE)--Antech™, a global veterinary diagnostics, technology and imaging company, today announced the launch of two new vector-borne disease diagnostics in their expanding portfolio: enhanced Accuplex™, a reference lab canine vector-borne disease (CVBD) screening test which now detects seven pathogens, and an enhanced vector-borne disease PCR profile, the veterinary industry's most comprehensive PCR panel of its kind.
Based on current testing data disseminated by the Companion Animal Parasite Council (CAPC), Antech scientists estimate that tens of millions of dogs in North America are not tested for exposure to CVBDs annually. As cases of canine heartworm disease and tick-borne pathogens continue to rise in both endemic and emerging regions, Antech is committed to expanded care for dogs being exposed to these serious diseases.
Enhanced Accuplex can now detect antibodies to three Ehrlichia species, and two Anaplasma species, alongside heartworm (Dirofilaria immitis) antigen, and antibodies to confirm exposure to Lyme borreliosis (Borrelia burgdorferi). With the rising prevalence of tick-borne diseases across North America, this expanded detection capability ensures broader coverage and greater confidence in diagnostic results, ultimately supporting informed clinical decision-making.
Antech is also offering a new enhanced vector-borne disease PCR panel for dogs and cats to ensure veterinarians have comprehensive diagnostic offerings to meet emerging disease risks. While the traditional 'big four' vector-borne diseases (heartworm, Lyme borreliosis, anaplasmosis, and ehrlichiosis) remain the most diagnosed in North America, rising cases and increased geographical spread of Rocky Mountain spotted fever, babesiosis, cytauxzoonosis, and others demand wider flexibility in testing. Antech's enhanced vector-borne disease PCR panel is unique in the industry in providing veterinarians with the most comprehensive array of vector-borne pathogens in the veterinary industry to date.
The launch of enhanced Accuplex and the comprehensive vector-borne disease PCR panel follows the March 2025 announcement of Antech's new patient-side vector-borne disease screening test, trūRapid™ FOUR, a lateral flow test using whole blood, serum, or plasma to detect heartworm antigen and the complete suite of tick-borne antibodies encompassed in the enhanced Accuplex reference lab offering.
Jimmy Barr, DVM, DACVECC, Chief Medical Officer for Mars Petcare's Science & Diagnostics division and Antech, said: 'Today, we celebrate our capability to offer veterinarians the flexibility to screen for these life-threatening vector-borne diseases with a complete portfolio of reference lab and in-house diagnostic offerings, meaning no other lab matches Antech in the breadth and depth of parasite and vector-borne diseases screening. The addition of two new Ehrlichia markers and one new Anaplasma marker to our Accuplex reference lab platform, as well as the launch of our PCR panel, will help ensure we can test more comprehensively for exposure to the most common vector-borne pathogens in North America.'
For more information, please visit antechdiagnostics.com.
Notes to editors
Key Features of enhanced Accuplex include:
Expanded Pathogen Detection: Accuplex now detects three Ehrlichia species and two Anaplasma species, increasing test sensitivity and allowing broader vector-borne disease screening across more regions.
Reference Lab Testing: Ensures reproducibility and reduces variability with highly trained technicians performing each assay.
Peace of Mind: Provides reliable and precise testing, fostering confidence among veterinarians and pet owners alike.
Key Features of enhanced Vector-Borne Disease PCR include:
Broader pathogen detection: This panel detects more vector-borne pathogens giving clinicians the best opportunity to identify the underlying cause of illness.
PCR vs. serology: While antibody production can lag behind infection, PCR is often the better choice for when VBD is suspected but not confirmed. It's also highly valuable when serology may miss early infection.
Common yet overlapping clinical signs: Vector-borne diseases frequently present with nonspecific or overlapping signs; improved PCR helps clarify these complex cases.
Resistance marker: The panel includes a new resistance marker, specifically detecting atovaquone resistance - a growing concern in the treatment of Babesia and Cytauxzoon infections. This supports responsible antimicrobial use and better-informed treatment decisions.
Antech at AVMA
Visit Antech at the AVMA Convention 2025 and the 40th World Veterinary Association Congress which will take place July 18-22, 2025 in Washington, D.C. to find out more about our vector-borne disease portfolio and to speak to a sales representative.
About Antech
Antech is a global veterinary diagnostics company, driven by our passion for innovation that helps veterinarians deliver better animal health outcomes. Our products and services span 90+ reference laboratories around the globe; in-house diagnostic laboratory instruments and consumables, including rapid assay diagnostic products and digital cytology services; local and cloud-based data services; practice information management software and related software and support; veterinary imaging and technology; veterinary professional education and training; and board-certified specialist support services.
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Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1
Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1

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Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that all primary and secondary endpoints were met in two Phase 3 randomized, double-blind, placebo-controlled studies of oveporexton (TAK-861), a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist, in narcolepsy type 1 (NT1). NT1 is caused by the loss of orexin-producing neurons in the brain. Orexin agonists are designed to address this underlying orexin deficiency. For the first time, this mechanism of action has been validated in Phase 3 studies demonstrating significant improvement across a broad range of symptoms. These results reinforce the potential of oveporexton to transform the standard of care. Oveporexton is a testament to Takeda's strength in discovering and developing a potential new class of medicines for difficult to treat diseases such as narcolepsy type 1. Share 'We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda's strength in discovering and developing a potential new class of medicines for difficult to treat diseases such as narcolepsy type 1,' said Christophe Weber, president and chief executive officer at Takeda. "Our leadership in orexin biology and building a multi-asset orexin franchise with transformative potential will position Takeda for long-term future growth.' The FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies were two large, global Phase 3 studies conducted in 19 countries. Both studies achieved statistically significant improvement compared to placebo with p-values of <0.001 for all primary and secondary endpoints across all doses at week 12. The primary and secondary endpoints measuring objective and patient reported improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions demonstrate statistically significant and clinically meaningful improvements achieving near normal ranges across the broad range of symptoms investigated. Oveporexton was generally well-tolerated with a safety profile from the Phase 3 studies overall consistent with oveporexton studies to date including the Phase 2b study. No serious treatment-related adverse events were reported. The most common adverse events were insomnia, urinary urgency and frequency. More than 95 percent of the participants who completed the studies enrolled in the ongoing long-term extension (LTE) study. 'We are grateful to the patients who took part in these clinical studies and to their families, the investigators and clinical staff. The studies were accelerated at an unprecedented pace with the aim to bring this potential treatment to people living with narcolepsy type 1 as quickly as possible,' said Andy Plump, M.D., Ph.D., president of R&D at Takeda. 'The comprehensive assessments from our Phase 3 studies build on the transformative results we saw with our Phase 2b study with most participants reaching normative ranges and reporting clinically meaningful improvement across a broad range of symptoms at the end of the 12-week treatment period. The positive results also reinforce the continued momentum for our late-stage pipeline, which we believe will deliver value to the patients we serve around the world.' Takeda intends to present the results at upcoming medical congresses and plans to submit a New Drug Application with the United States Food and Drug Administration and additional global regulatory authorities in fiscal year 2025. Results from the Phase 3 studies have no significant impact on the full year consolidated forecast for the fiscal year ending March 31, 2026. About Narcolepsy Type 1 (NT1) and Orexin Science NT1 is a chronic, rare neurological disease that results in a range of debilitating symptoms including excessive daytime sleepiness (EDS), cataplexy, disrupted nighttime sleep, sleep paralysis and hallucinations upon falling asleep or waking. Additionally, individuals living with NT1 often report cognitive symptoms, including difficulty thinking clearly, remembering, concentrating and paying attention. NT1 is caused by loss of the orexin-producing neurons in the brain, which regulate wakefulness and sleep, and is also believed to be essential to other functions such as attention through activation of orexin receptors. Currently, the standard of care is limited to symptomatic therapies that may only partially address some of the symptoms people face. About Oveporexton (TAK-861) Oveporexton (TAK-861) is an investigational orexin receptor 2 (OX2R)-selective agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency that causes narcolepsy type 1 (NT1). By activating OX2Rs, oveporexton is designed to promote wakefulness and reduce abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy, to address the broad spectrum of daytime and nighttime symptoms. About the FirstLight and RadiantLight Phase 3 Studies FirstLight (TAK-861-3001; NCT06470828) and RadiantLight (TAK-861-3002; NCT06505031) are global, multicenter, placebo-controlled studies to evaluate the efficacy, safety and tolerability of oveporexton compared to placebo in patients with narcolepsy type 1 (NT1) over 12 weeks. The studies were conducted in 19 countries with enrollment completed within six months. The FirstLight study enrolled 168 participants randomized to one of three dosing arms (high dose, low dose and placebo). The RadiantLight study enrolled 105 participants randomized to two dosing arms (high dose and placebo). The primary endpoint in both studies was improvement in excessive daytime sleepiness (EDS) as measured by the Maintenance of Wakefulness Test (MWT), a standard measure of wakefulness. Key secondary endpoints included improvement in EDS as measured by the Epworth Sleepiness Scale (ESS) and in the Weekly Cataplexy Rate (WCR), a measure evaluating cataplexy. The studies also evaluated the effect of oveporexton on participants' ability to maintain attention, participants' overall quality of life, the spectrum of narcolepsy symptoms and daily life functions, as well as the safety and tolerability of oveporexton. About Takeda's Orexin Agonists for Sleep-Wake Disorders Takeda is leading the field of orexin science with a multi-asset franchise. Orexin is a key regulator of sleep and wake patterns and contributes to other essential functions including attention, mood, metabolism and respiration. Oveporexton (TAK-861) is the lead investigational orexin receptor 2 (OX2R) agonist asset in Takeda's orexin franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 (NT1) from the U.S. Food and Drug Administration and the Center for Drug Evaluation of China's National Medical Products Administration. The company is also investigating other orexin agonists in populations with orexin levels in the normal range, including TAK-360, an oral OX2R agonist initially being investigated for the treatment of narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and other potential indications where orexin signaling is implicated. ​ About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit Important Notice For the purposes of this notice, 'press release' means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ('Takeda') regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, 'Takeda' is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words 'we', 'us' and 'our' are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as 'targets', 'plans', 'believes', 'hopes', 'continues', 'expects', 'aims', 'intends', 'ensures', 'will', 'may', 'should', 'would', 'could', 'anticipates', 'estimates', 'projects', 'forecasts', 'outlook' or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

U.S. FDA Approves KERENDIA ® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review
U.S. FDA Approves KERENDIA ® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review

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U.S. FDA Approves KERENDIA ® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) approved KERENDIA ® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, 1 following the agency's Priority Review of its supplemental New Drug Application (sNDA). Even with guideline-directed medical treatment, the approximately 3.7 million adults in the U.S. with HF with LVEF ≥40%, also known as mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF), face high rates of hospitalization for HF, impacting survival and placing considerable strain on healthcare systems. 2 Each hospitalization is associated with a more than two-fold increase in patients' risk of cardiovascular (CV) death. 3 The approval was based on results from the Phase III FINEARTS-HF trial, which showed that, on top of standard of care, KERENDIA achieved a 16% relative risk reduction of the composite primary endpoint of CV death and total HF events, defined as hospitalization for HF or an urgent HF visit, compared to placebo on top of standard of care (RR=0.84, 95% CI: 0.74-0.95, p=0.007). 1 The treatment effect was consistent across all prespecified subgroups including with or without SGLT2i use. 1 KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys, 1,4,5 taking aim at HF with LVEF ≥40% from a different angle. 1 The overall safety profile of KERENDIA was consistent across all studied indications. 1 From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), hyponatremia (1.9% vs 0.9%), 6 and events related to worsening renal function (18% vs 12%). 1 Detailed results from the Phase III FINEARTS-HF trial were published in the New England Journal of Medicine. 7 'The FDA's approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40% – a large and growing group of patients with a poor prognosis,' said Scott D. Solomon, MD, Professor of Medicine, Harvard Medical School, Director, Clinical Trials Outcomes Center, Mass General Brigham, and Chair of the Executive Committee for the FINEARTS-HF study. 'Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care.' 'People with heart failure with left ventricular ejection fraction ≥40% face the very real possibilities of hospitalization for heart failure or CV death due to their disease,' 2,3 said Alanna Morris-Simon, MD, MSc, Senior Medical Director of U.S. Medical Affairs at Bayer. 'Even with current treatments, 21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or CV death, 8 and 25% who experience hospitalization are readmitted due to heart failure within one year of discharge. 9 Now, as a core pillar of treatment, KERENDIA can help patients reduce these risks.' Since July 2021, KERENDIA has been approved to reduce the risk of CV death, hospitalization for HF, non-fatal myocardial infarction (MI), sustained estimated glomerular filtration rate (eGFR) decline, and end-stage kidney disease in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). 1 This new indication expands KERENDIA's established cardiovascular benefit to a new patient population not limited to CKD associated with T2D—adult patients with HF with LVEF ≥40%. 1 About FINEARTS-HF 10 The FINEARTS-HF trial, a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III trial evaluated the efficacy and safety of KERENDIA for the reduction of risk of CV death and total HF events in patients with a diagnosis of symptomatic HF (New York Heart Association class II-IV) with an LVEF ≥40%, measured by local imaging within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of CV death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. Approximately 6,000 participants were randomized to receive either KERENDIA or placebo once daily for up to 42 months in addition to their background HF therapies. The FINEARTS-HF trial is part of KERENDIA's MOONRAKER program, which is expected to be one of the largest HF study programs to date. With more than 15,000 patients worldwide, MOONRAKER aims to establish a comprehensive body of evidence for KERENDIA across a broad spectrum of patients and clinical settings. 11 About KERENDIA's Clinical Trial Program KERENDIA's clinical trial program—called FINEOVATE—currently comprises 10 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL). The MOONRAKER program includes FINEARTS-HF as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF, 12 CONFIRMATION-HF 13 and FINALITY-HF. 14 The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD as well as the ongoing investigational studies FIND-CKD, 15 FIONA, 16 FIONA-OLE, 17 and FINE-ONE. 18 About KERENDIA ® (finerenone) 1 INDICATIONS: KERENDIA (finerenone) is indicated to reduce the risk of: sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets) cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets) IMPORTANT SAFETY INFORMATION 1 CONTRAINDICATIONS: Hypersensitivity to any component of this product 1 Concomitant use with strong CYP3A4 inhibitors 1 Patients with adrenal insufficiency 1 WARNINGS AND PRECAUTIONS: Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. 1 Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium. 1 Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed. 1 Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m 2 is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function. 1 MOST COMMON ADVERSE REACTIONS: CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%). 1 HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). 6 Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%). 1 DRUG INTERACTIONS: Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice. 1 Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate. 1 Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers. 1 Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions. 1 USE IN SPECIFIC POPULATIONS: Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment. 1 Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B). 1 Please see the Prescribing Information for KERENDIA. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to Find more information at Follow us on Facebook: Follow us on X: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports, which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 1 Bayer Pharmaceuticals. Kerendia (finerenone) [package insert]. U.S. Food and Drug Administration. Available at: Accessed July 1, 2025. 2 Bozkurt B, Ahmad T, Alexander K, et al. HF STATS 2024: Heart Failure Epidemiology and Outcomes Statistics An Updated 2024 Report from the Heart Failure Society of America. J Card Fail. 2025;31(1):66-116. doi:10.1016/ 3 Huusko J, et al. ESC Heart Fail. 2020;7(5):2406-2417. doi:10.1002/ehf2.12792. 4 Kolkhof P, Jaisser F, Kim SY, Filippatos G, Nowack C, Pitt B. Steroidal and Novel Non-steroidal Mineralocorticoid Receptor Antagonists in Heart Failure and Cardiorenal Diseases: Comparison at Bench and Bedside. Handb Exp Pharmacol. 2017;243:271-305. doi:10.1007/164_2016_76. Available at Accessed July 1, 2025. 5 Kolkhof P, Joseph A, Kintscher U. Nonsteroidal mineralocorticoid receptor antagonism for cardiovascular and renal disorders - New perspectives for combination therapy. Pharmacol Res. 2021;172:105859. doi:10.1016/ Available at Accessed July 1, 2025. 6 Data on file. 7 Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024;391(16):1475-1485. doi:10.1056/NEJMoa2407107. 8 Chatur S, Vaduganathan M, Claggett BL, et al. Outpatient Worsening Among Patients With Mildly Reduced and Preserved Ejection Fraction Heart Failure in the DELIVER Trial. Circulation. 2023;148(22):1735-1745. doi:10.1161/CIRCULATIONAHA.123.066506 9 Cheng RK, et al. Am Heart J. 2014;168(5):721-730. doi:10.1016/ 10 Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity & Mortality in Participants With Heart Failure and Left Ventricular Ejection Fraction Greater or Equal to 40% (FINEARTS-HF). Clinical trial registration No. NCT 04435626. Accessed June 26, 2025. 11 Data on file. 12 A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF). Clinical trial registration No. NCT 06008197. Accessed March 10, 2025. 13 A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) (CONFIRMATION). Clinical trial registration No. NCT06024746. Accessed March 10, 2025. 14 A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF). Clinical trial registration No. NCT06033950. Accessed March 10, 2025. 15 A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). Clinical trial registration No. NCT05047263. Accessed March 10, 2025. 16 A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children with Chronic Kidney Disease and Proteinuria (FIONA). Clinical trial registration No. NCT05196035. Accessed March 10, 2025. 17 A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria (FIONA OLE). Clinical trial registration No. NCT05457283. Accessed March 10, 2025. 18 A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE). Clinical trial registration No. NCT05901831. Accessed March 10, 2025. Expand

Samsung Bioepis' European Whitepaper Proposes Solutions to Bridge Policy Gaps that Hinder Healthy Market Competition and Timely Access to Biosimilar Medicines
Samsung Bioepis' European Whitepaper Proposes Solutions to Bridge Policy Gaps that Hinder Healthy Market Competition and Timely Access to Biosimilar Medicines

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Samsung Bioepis' European Whitepaper Proposes Solutions to Bridge Policy Gaps that Hinder Healthy Market Competition and Timely Access to Biosimilar Medicines

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today published a whitepaper titled ' Solving the Biosimilar Void in Europe ' that proposes policy recommendations to fully recognize the value of biosimilars and ensure a more sustainable market in Europe. Policies should take a patient-centric approach, positioning biosimilars as part of the solution to expand access, improve patient outcomes, ensure supply continuity, and strengthen system resilience. Share Biosimilars have played a significant role in alleviating the financial burden on the European healthcare system, having delivered €56 billion in cumulative cost savings across Europe over the past 11 years (2013-2024). 1 However, the current policy environment in Europe, particularly the post-launch pathways, is misaligned to incentivize biosimilar competition. With post-marketing challenges, on top of high development costs, many biologics will not face biosimilar competition at the point of loss of exclusivity (LoE) within the next decade. The whitepaper proposes several measures to improve current practices that hinder healthy market competition and timely access to biosimilar medicines: Health Technology Assessment (HTA) needs to be tailored for biosimilars: With its origin in innovative medicine, HTA is a multidisciplinary process that evaluates the medical, social, economic, and ethical implications of health technologies. Some countries often have oversimplified HTA requirements for biosimilars, where reimbursement decisions are solely based on price comparisons and do not take into account biosimilars' additional benefits or where the reference biologic is not reimbursed. In many cases, HTA is relevant, but with limited guidance to properly assess the biosimilar's value. HTA can be more streamlined and tailored to speed up the entry of biosimilars to the market. In some countries, pricing and reimbursement (P&R) policies focus on achieving the lowest possible prices through mechanisms such as price linkage and reference pricing, thereby accelerating price erosion: Out of 28 European countries, 12 countries use external reference pricing methods and 17 countries mandate arbitrary discounts on biosimilar prices at an average of 28% below reference product. 2 Already set at significantly lower levels, biosimilar prices are driven further downward as competition begins, often leading to price erosion that drives players out of the market. Instead of arbitrary price-controls, free pricing will allow price discounts to be achieved naturally through free competition. Tenders often favor a single-winner system and tend to overlook broader qualitative factors such as supply stability and quality assurance: National, regional, and local tenders should support supply diversification and fair competition through multi-winner systems, with greater transparency in communication and more periodic tender reopenings so that late entrants are also given opportunities to participate. Security and stability of supply should be given higher priority in tenders to enhance demand predictability and incentivize manufacturers to secure more robust supply chains. Biosimilar uptake cannot be achieved without the support of physicians and pharmacists who prescribe and dispense these medicines: Incentives extended to healthcare professionals to encourage the prescribing and dispensing of biosimilars vary significantly across European countries. In some countries, prescriber incentives are misaligned, discouraging the use of biosimilar medicines. Incentive programs should be based on shared decision-making between physicians and patients, rather than automatic switching. Gainsharing can be introduced to stimulate biosimilar uptake while preserving competition and autonomy. Education programs for physicians, pharmacists, and patients should be continued to support wider use of biosimilars. 'Biosimilars are not one-size-fits-all, and establishing a sustainable framework for biosimilars requires a nuanced understanding of their heterogeneous applications across clinical settings. It is vital to tailor key solutions that address the unique challenges faced by different product types, prescribing patterns, and patient and disease characteristics. It is also important to consider the future viability of the market when reshaping policies, as the market needs clear signals of long-term sustainability to encourage continued investments in the biosimilar pipeline,' said Adam Levysohn, Vice President and Head of Commercial Strategy Europe, at Samsung Bioepis. 'It is important for healthcare systems to recognize that biosimilars are not merely a cost-saving tool for organizations. Policies should take a patient-centric approach, positioning biosimilars as part of the solution to expand access, improve patient outcomes, ensure supply continuity, and strengthen system resilience.' Samsung Bioepis is a biopharmaceutical company that develops and manufactures high-quality biosimilars to accelerate patient access to biologic medicines. As a world leader in biosimilars, Samsung Bioepis has a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Of the 11 biosimilars approved worldwide, eight products are available across Europe. To access the report Solving the Biosimilar Void in Europe, please visit HERE. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. 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