Landiolol Hydrochloride

WILMINGTON, Del.--(BUSINESS WIRE)--AOP Health US, LLC today announced that the first patient in the United States has been treated with Rapiblyk® (landiolol) at The Valley Hospital, Paramus, NJ. This marks a key milestone in the company’s U.S. expansion and its efforts to address high unmet medical needs in critical care. AOP Health US is now positioned on a national stage to support clinicians and care teams with an innovative therapeutic option for patients with acute cardiac arrhythmias. Bringing Rapiblyk® into clinical practice in the U.S. enables AOP Health to support critical care teams with a fast-acting treatment option. “This milestone represents an important step forward in improving access to innovative therapies for patients and the clinicians who treat them,” said John Kimmet, General Manager of AOP Health US. “Bringing Rapiblyk® into clinical practice in the U.S. enables us to support critical care teams with a fast-acting treatment option and reflects our commitment to addressing unmet medical needs.” Rapiblyk® (landiolol) is an ultra-short-acting, highly selective beta-1 adrenergic receptor blocker designed for rapid and controlled heart rate management. It is administered intravenously in a monitored hospital setting, particularly in critical care environments. Therapy Approved for All Ages Landiolol received U.S. Food and Drug Administration (FDA) approval in November 2024 and was previously approved for use in Europe, Japan, and Canada. The therapy is approved for all ages and is used to treat abnormal heart rhythms such as atrial fibrillation and atrial flutter. “Cardiac critical care teams require fast, precise tools to stabilize patients with complex and life-threatening conditions,” said Yonathan Litwok, MD, Director of Cardiac Critical Care at The Valley Hospital. “Having access to new treatment options supports our ability to provide high-quality, responsive care to patients in critical situations.” Cardiac critical care is a specialized field focused on patients with severe or unstable cardiovascular conditions requiring continuous monitoring, advanced therapies, and rapid intervention. Effective management in these settings depends on coordinated, team-based care and timely therapeutic options. About Rapiblyk® Rapiblyk® (landiolol) is an ultra-short-acting, selective beta-1 adrenergic receptor blocker indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia (SVT) or irregular rapid heart rate, including atrial fibrillation and atrial flutter, especially in perioperative, postoperative, or critical-care settings. Rapiblyk® provides rapid onset and offset of action, allowing clinicians to achieve precise, controlled rate management with a favorable hemodynamic profile. The product is supplied as an intravenous infusion designed for use in a monitored hospital setting. INDICATION RAPIBLYK® (landiolol) for injection is a beta-adrenergic blocker indicated for the short-term reduction of ventricular rate in: Adults with supraventricular tachycardia, including atrial fibrillation and atrial flutter Pediatric patients with supraventricular tachycardia Important Safety Information Contraindications RAPIBLYK® is contraindicated in patients with: Severe sinus bradycardia Sick sinus syndrome Heart block greater than first degree Decompensated heart failure Cardiogenic shock Pulmonary hypertension Hypersensitivity to landiolol or any of the inactive ingredients Warnings and Precautions Patients with hemodynamic compromise, hypovolemia, or receiving interacting medications are at increased risk of hypotension. Monitor blood pressure closely. Reduce or discontinue RAPIBLYK if hypotension occurs. Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest, may occur. Monitor heart rate and rhythm. Reduce or discontinue RAPIBLYK for bradyarrhythmia. Beta-blockers may cause depression of myocardial contractility and may precipitate heart failure or cardiogenic shock. At the first sign of impending cardiac failure, discontinue RAPIBLYK and initiate supportive therapy. Beta-blockers may exacerbate bronchospasm. Use caution in patients with reactive airway disease. Discontinue infusion if bronchospasm occurs. Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and may increase the risk for severe or prolonged hypoglycemia. Monitor blood glucose in patients with diabetes or those at risk. Infusion site reactions including pain, swelling, and erythema have occurred. Avoid infusions into small veins or through butterfly catheters. Use an alternative site if reactions develop. Abrupt discontinuation of beta-blocker therapy in patients with coronary artery disease may result in exacerbations of angina, myocardial infarction, or ventricular arrhythmias. Monitor for signs of myocardial ischemia when discontinuing RAPIBLYK. Beta-blockers may increase serum potassium. Monitor electrolytes during therapy, especially in patients with renal impairment. Beta-adrenergic blockade may mask clinical signs of hyperthyroidism. Abrupt withdrawal may precipitate thyroid storm. Patients at risk of anaphylaxis may be more reactive to allergen exposure and may be unresponsive to usual doses of epinephrine. Adverse Reactions The most common adverse reaction was hypotension in adults and pediatric patients. Drug Interactions Avoid concomitant use with negative inotropes or medications that slow heart rate or cardiac conduction. Beta-adrenergic agonists may antagonize the effects of RAPIBLYK. Use caution with catecholamine-depleting drugs due to increased risk of hypotension or bradycardia. For more information about RAPIBLYK, see Full Prescribing Information About AOP Health AOP Health is a global enterprise with roots in Austria and a mission to address unmet medical needs through innovative, science-driven therapies in cardiovascular and rare disease. Since 1996, the AOP Health Group has been recognized as a pioneer in developing integrated therapy solutions that combine deep scientific expertise with a strong commitment to patient and physician needs. Building on this foundation, AOP Health US, LLC was established in 2025 to expand the company’s impact in the United States. The team is focused on introducing its 2024 US FDA approved product for use in the critical care setting, while building the infrastructure to support healthcare professionals and the patients they serve. Rapiblyk® is a USPTO registered trademark of AOP Orphan Pharmaceuticals GmbH (Austria). © 2026 AOP Health. All rights reserved.

VIENNA--(BUSINESS WIRE)--Today, the Higher Regional Court of Frankfurt upheld the February 20251 partial final ICC arbitral award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in its dispute with PharmaEssentia Corp. (“PharmaEssentia”). The ruling confirms the award which found the Taiwanese company to be liable for certain damages. The ruling confirms the award which found PharmaEssentia Corp. to be liable for certain damages. Dr. Rudolf Widmann, one of the two founders of AOP Health, explains: “We very much welcome the Frankfurt Higher Regional Court’s decision that confirms our position. In the interest of our patients, we are dedicated to maintaining stable and sustainable access to BESREMi® and to responsibly navigating future challenges.” The Product in Dispute The conflict centers around BESREMi® (ropeginterferon alfa-2b), a product launched in 2019 and developed by AOP Health into an innovative treatment for rare blood cancers, particularly polycythemia vera, through a comprehensive clinical trial program. This makes BESREMi® the best investigated interferon in clinical trials in this indication as documented in the major relevant guidelines2. AOP Health had acquired the rights for both BESREMi®’s development and commercialization in the European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009. In its seventh year after its approval by European Medicines Agency (“EMA”), AOP Health has successfully made BESREMi® available to an estimated 12,600 patients in AOP Health’s licensed territory. First Arbitration and Set-aside Proceedings Since 2017, PharmaEssentia repeatedly attempted to terminate its agreement with AOP Health regarding BESREMi®. In October 2020, an ICC Arbitral Tribunal rejected these attempts and awarded AOP Health approx. EUR 143 million in damages and dismissed PharmaEssentia’s counterclaims in its entirety. Subsequent set-aside proceedings confirmed the arbitral award in its essentials, but found procedural flaws with respect to damage quantification, impacting the damages awarded. Second Arbitration In November 2020, PharmaEssentia initiated a legal action against AOP Health, alleging damage claims. AOP Health in turn claimed damages for delays in BESREMi®’s European approval caused by PharmaEssentia, and the misuse of AOP Health’s clinical trial data for PharmaEssentia’s US marketing authorization. The result was a partial final ICC arbitral award in favor of AOP Health, received on 17 February 2025, which found PEC guilty of intentional breaches and liable for several claims. The tribunal’s decision on the quantum of those claims is yet to be made. Ruling of Higher Regional Court of Frankfurt Confirms AOP Health’s Position In May 2025, PharmaEssentia filed an application with the Frankfurt Higher Regional Court to set aside the partial final ICC arbitral award dated 10 February 2025, arguing among other things that the award violated public order and PharmaEssentia’s right to be heard. On 24 April 2026, the Frankfurt Higher Regional Court dismissed this application in its entirety and declared the award enforceable. An appeal to the German Federal Court of Justice is possible. AOP Health believes this decision confirms its position and reinforces its commitment to patients. The company will continue to supply patients in need of ropeginterferon alfa-2b (BESREMi®), maintaining the high standards of quality patients depend on. About BESREMi® BESREMi® is the first interferon that was approved for polycythemia vera, a myelo­proliferative neoplasm (MPN), indicated in the European Union as monotherapy in adults for treatment of polycythemia vera without symptomatic enlarged spleen. Its overall safety and efficacy were demonstrated in multiple clinical studies. BESREMi® (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks initially, or up to every 4 weeks after stabilization of blood values. BESREMi® is designed to be self-administered subcutaneously with a pre-filled pen. For the EMA Summary of Product Characteristics please visit: BESREMi® About AOP Health AOP Health is a global healthcare group with roots in Austria, where the headquarters of AOP Orphan Pharmaceuticals GmbH ("AOP Health") is located. Since 1996, the AOP Health Group has been dedicated to developing innovative solutions to address unmet medical needs, particularly in the fields of rare diseases and intensive care medicine. At the end of 2024, AOP Health received its first U.S. FDA approval for RapiblykTM, a medication aimed at patients in intensive care units, thereby further strengthening its commitment to making therapies available for patients worldwide. The AOP Health Group has established itself internationally as a pioneer in integrated therapy solutions and operates worldwide through subsidiaries, representations, and a strong network of partners. With the claim "Needs. Science. Trust." the AOP Health Group emphasizes its commitment to research and development, as well as the importance of building relationships with physicians and patient advocacy groups to ensure that the needs of these stakeholders are reflected in all aspects of the AOP Health Group’s actions. 1 https://www.aop-health.com/global_en/press/press-releases/icc-arbitral-tribunal-ruling-aop-health/ 2 ELN Guideline (2022), NCCN Guideline (2024), Onkopedia Leitlinie (2023)