Fluticasone furoate

SUNRISE, Fla., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Transpire Bio, an integrated clinical-stage biopharmaceutical company focused on developing inhaled therapeutics for pulmonary and systemic diseases, today announces that its abbreviated new drug application (ANDA) for fluticasone furoate and vilanterol inhalation powder, a generic version of Breo® Ellipta®1 100/25, has been accepted for filing by the U.S. Food and Drug Administration (FDA). Based on FDA’s public records,2 Transpire Bio believes that it was the first to file an ANDA with a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should its ANDA be approved by FDA, Transpire Bio believes it will be eligible for 180 days of market exclusivity. In the U.S., Breo® Ellipta® is indicated for the maintenance treatment of patients with asthma and the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). According to IQVIA, Breo® Ellipta® reported U.S. annual sales of $2.02 Billion3 in 2024. “The FDA’s acceptance of our ANDA for filing is an important achievement for our generic Breo Ellipta development program and our complex generic franchise as a whole,” said Dr. Xian-Ming Zeng, Chief Executive Officer of Transpire Bio. “I am proud of our highly experienced team in South Florida who have worked tirelessly with world class CDMOs and other partners since the inception of Transpire Bio to achieve this important milestone. We are now one step closer to providing patients suffering from asthma or COPD, an affordable option and improved access to this critical medication.” “This milestone represents the culmination of years of investment in the right technical competence and infrastructure and demonstrates Transpire Bio’s capabilities in developing complex drug device combination products,” said Dr. Abhishek Gupta, Chief Scientific Officer of Transpire Bio. In addition to its focused generic franchise, Transpire Bio is building a pipeline of innovative inhalation medicines for Idiopathic Pulmonary Fibrosis (IPF) where it has three assets in development. Transpire Bio is also developing therapies for Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, Parkinson Disease Psychosis and Glioblastoma. These products will all be developed and manufactured in Transpire Bio’s state-of-the-art manufacturing facilities located in South Florida, U.S. About Transpire Bio Inc. Transpire Bio Inc. is an integrated US-based, clinical-stage biopharmaceutical company headquartered in Sunrise, Florida. Transpire Bio harnesses its inhaled drug delivery expertise to improve patients’ lives by expanding access to important therapies and developing treatments for serious diseases where therapeutic options are significantly lacking. Transpire Bio has developed multiple proprietary inhalation technology platforms, including dry powder inhalers, soft-mist inhalers and metered-dose inhalers. For more information, please visit www.transpirebio.com. Breo® Ellipta® is a registered trademark of GSK group of companies.See FDA’s list of drug products for which an ANDA has been received by the Office of Generic Drugs containing a “Paragraph IV” patent certification.Data on file with the company. Contacts:Corporate info@transpirebio.com +1 954.908.2233 InvestorsStuart LoeschChief Commercial Officer, Transpire BioStuart.loesch@transpirebio.com

Having recently been selected for the second round of US drug price talks, GSK's chronic obstructive pulmonary disease (COPD) treatments Trelegy Ellipta and Breo Ellipta have received a boost from the Institute for Clinical and Economic Review (ICER) ahead of the start of negotiations.An analysis from the cost watchdog determined that GSK's two inhaled therapies "offer the advantage of requiring only one puff once a day" for the maintenance treatment of COPD. In contrast, comparator generics to Trelegy Ellipta require two inhalers administered twice daily, while for Breo Ellipta, they generally require at least one inhaler twice daily. According to ICER, observational data suggest that patients are more adherent to once-daily therapy, which may lead to fewer COPD exacerbations. The watchdog concluded that Trelegy Ellipta has comparable or incremental net health benefits compared with other generic triple therapies, with the same for Breo Ellipta versus generic inhaled corticosteroid/long-acting beta-agonist dual therapies administered twice daily.Breo Ellipta combines the inhaled corticosteroid fluticasone furoate with the long-acting beta-agonist vilanterol, while Trelegy Ellipta adds the long-acting muscarinic antagonist umeclidinium to this dual regimen. A recent analysis indicated that total Part D Medicare prescription drug costs for Trelegy Ellipta between November 1, 2023, and October 31, 2024, were $5.1 billion, and $1.4 billion for Breo Ellipta.ICER chief executive Sarah Emond noted that the new analysis "will be one of many inputs" considered by the Centers for Medicare & Medicaid Services in negotiations with GSK. "We hope that it will help them as they continue to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people."