Core Viewpoint - Scienture Holdings, Inc. has announced the FDA listing of two patents for its product Arbli, a novel oral liquid formulation of losartan, which is expected to enhance its market position and provide statutory exclusivity under the Hatch-Waxman Act [1][2][6]. Company Overview - Scienture Holdings, Inc. is a holding company focused on developing and distributing specialty pharmaceutical products that address unmet market needs [1][13]. - The company operates through its subsidiary, Scienture, LLC, which is dedicated to bringing unique specialty products to market [13]. Product Details - Arbli is the first FDA-approved ready-to-use oral liquid formulation of losartan, designed for patients over 6 years old, and is indicated for the treatment of hypertension and related conditions [3][4][8]. - The product is available in a 165 mL bottle with a peppermint flavor, has a shelf life of 18 months at room temperature, and does not require refrigeration [7]. Market Position - The patents for Arbli cover stable liquid formulations of losartan and methods of use, reinforcing Scienture's intellectual property position [2]. - Losartan is classified as an angiotensin receptor blocker (ARB) and is one of the most prescribed medications for hypertension, with annual sales of approximately $276 million and a prescription volume of 69 million in the U.S. market as of March 2025 [5]. Regulatory Milestone - The listing of Arbli in the FDA's Orange Book is considered a significant regulatory achievement for Scienture, validating its development efforts and enhancing its commercial pathway in the U.S. market [6][2].

Core Viewpoint - Scienture Holdings, Inc. is preparing for the commercial launch of Arbli, a novel oral liquid formulation of losartan, aimed at addressing unmet needs in the hypertension treatment market, with a targeted launch date in July 2025 [1][5]. Company Overview - Scienture Holdings, Inc. operates as a holding company for pharmaceutical companies focused on developing and distributing specialty products that enhance value for patients and healthcare providers [1][12]. - Scienture, LLC, a wholly owned subsidiary, is responsible for the manufacturing and distribution of Arbli [1][12]. Product Details - Arbli is the first FDA-approved ready-to-use oral liquid formulation of losartan in the U.S., designed for patients over 6 years old, particularly for hypertension and related conditions [2][4]. - The product is available in a 165 mL bottle with a peppermint flavor, has a shelf life of 18 months at room temperature, and does not require refrigeration [6]. Market Context - Losartan, classified as an angiotensin receptor blocker (ARB), is one of the most prescribed medications for hypertension, with annual sales of approximately $292 million and a prescription volume of 68 million in the U.S. market as of December 2024 [4]. - Arbli addresses the limitations of existing losartan products, which are only available in solid forms that require compounding for liquid formulations, thus providing a safer and more convenient option for patients [3][4]. Manufacturing and Distribution - Scienture, LLC has initiated supply chain activities and partnered with Saptalis Pharmaceuticals for the manufacturing of Arbli, ensuring readiness for the planned launch [1][5]. - The company has also established agreements with strategic partners for warehousing and distribution to various wholesalers [1].

Core Insights - Scienture Holdings, Inc. has appointed Michele Rath as Senior Vice President and Chief Commercial Officer of its subsidiary, Scienture, LLC, to enhance its commercial operations and market reach [1][2] - The company has established a strategic partnership with Syneos Health, which will act as its Contract Sales Organization, aiming to leverage Syneos Health's expertise in outsourced sales solutions [1][3] Company Overview - Scienture Holdings, Inc. operates through its subsidiaries, focusing on providing novel specialty pharmaceutical products to meet unmet market needs [5] - Scienture, LLC is dedicated to developing and marketing unique specialty products, with a team experienced in the pharmaceutical industry [5] Leadership and Strategy - Michele Rath brings over 20 years of experience from leading roles at Pfizer, CVS Caremark, and Aurobindo Pharma, focusing on sales strategy and market access [2] - Under Rath's leadership, Scienture, LLC aims to drive revenue growth, strategic partnerships, and customer engagement [2] Collaboration with Syneos Health - The partnership with Syneos Health will enhance Scienture, LLC's commercial capabilities through a comprehensive suite of services, including field sales and tech-enabled engagement strategies [3] - Syneos Health's Kinetic platform will provide predictive and adaptive analytics to streamline commercial solutions for Scienture, LLC [3] Product Launches - Scienture, LLC is preparing to launch two FDA-approved products: Arbli (losartan potassium) oral suspension and Rezenopy (naloxone HCl) nasal spray, with expectations of accelerated growth through the new commercial strategies [4]

TAMPA, FL, March 19, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, today announced it has completed a draw on its Equity Line of Credit (ELOC) to support the commercial launch of Arbli™ (losartan potassium) Oral Suspension, wh ...