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 Insights - Scienture Holdings, Inc. has transitioned from a health services IT focus to a branded specialty pharmaceutical company, emphasizing the development of innovative specialty products [2][3] - The company has two FDA-approved products set for launch in the second half of 2025, including Arbli and REZENOPY, with a strong commercial operations strategy in place [3][9] - Scienture, LLC aims to address critical gaps in patient care through a diverse product pipeline and strategic partnerships, enhancing value for patients and healthcare systems [4][11] Company Transformation - The company completed a significant transformation by selling assets of its subsidiary TRXaDE Inc. for $22.5 million and merging with Scienture, Inc. in a deal valued at $103 million [2] - The focus has shifted to developing a novel specialty product pipeline, with plans to divest legacy subsidiaries related to healthcare IT and pharmaceutical wholesaling [3] Product Development - Scienture has achieved key milestones in product development, including the filing and approval of the NDA for Arbli and the acquisition of REZENOPY [6][8] - The company is developing multiple products, including an injectable pen for migraine treatment and a non-opioid pain management solution, with regulatory pathways being established [7] Business Development - Scienture has secured exclusive U.S. rights to launch REZENOPY, which is positioned as the most potent naloxone product available, with an estimated annual sales potential of $189 million [8] - The company is leveraging its industry networks to identify revenue opportunities and enhance its business development efforts [15] Commercial Operations - A robust commercial operations strategy is in place to support the launch of Arbli and REZENOPY, focusing on various functional areas such as digital marketing, payor contracting, and distribution [9][10] - The company aims to expand access and improve clinical outcomes through innovative product offerings and a flexible commercialization model [11] Future Outlook - Over the next 12 months, the company will concentrate on executing its commercial strategy, enhancing its workforce, and driving market performance [10][15] - The focus will be on creating value for patients, caregivers, and shareholders through innovative solutions and effective product launches [12]

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 ...