Glycopyrrolate/Indacaterol Maleate

Two months after posting proof-of-concept data supporting its nebulised approach to treating chronic obstructive pulmonary disease (COPD), AeroRx Therapeutics has bagged a $21-million series A to kick off a Phase IIb trial of AERO-007.The biotech's candidate is poised to become the first nebulised combination of a long-acting beta agonist (LABA) and a long-acting muscarinic antagonist (LAMA) for first-line maintenance treatment of COPD, CEO Ahmet Tutuncu told FirstWord. While dual LABA/LAMA bronchodilation delivered via handheld inhaler is the standard first-line therapy, a subset of patients with COPD can't effectively use the devices, or prefer nebulised treatments, he explained."Up to 75% of COPD patients, particularly older and sicker individuals, do not receive the optimal dose from inhalers, leading to poor symptom control, more frequent exacerbations, and hospitalisations," Tutuncu said. "By contrast, nebulised delivery is designed to provide the full intended dose regardless of disease severity or patient technique, using normal, passive breathing. This ensures more consistent drug delivery, improves adherence, and gives the patients and clinicians greater confidence that patients are receiving effective therapy."However, there are no approved nebulised LABA/LAMA combinations — and that's where AeroRx and AERO-007 come in. In July, the company reported results from a Phase IIa study showing that in 16 adults with moderate-to-severe COPD, both low- and high-doses of AERO-007 led to clinically meaningful, statistically significant improvements in forced expiratory volume in one second compared with placebo, with rapid-onset and sustained 24-hour bronchodilation.Additionally, the treatment was well tolerated, with a systemic drug exposure profile similar to that of other LABAs and LAMAs. With the proceeds from the series A — led by Avalon BioVentures, with participation from Correlation Ventures and Alexandria Venture — AeroRx plans to launch a Phase IIb dose-optimisation study in early 2026. The 14-day, placebo-controlled crossover study will randomise patients with COPD to evaluate once- versus twice-daily dosing, and to select the dosage of AERO-007 for Phase III testing. "Our goal has always been simple: ensure that every patient can receive the best-in-class treatment their condition demands, regardless of their ability to use an inhaler," Tutuncu said. "This financing moves us closer to that vision."

Federal Trade Commission Chair Lina Khan argued that pharma companies are using "bogus patent listings" in the FDA Orange Book to "block competition and inflate the cost of prescription drugs." The U.S. Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. After an initial round of challenges launched in November against more than 100 patents by nine drugmakers, the FTC is back targeting another 300-plus patent listings by eight pharma firms in the FDA’s Orange Book. The FTC argues those patents for altogether 20 brand-name products are “junk” listings that could be used by pharma companies to stymie competition and inflate drug prices. AstraZeneca, Boehringer Ingelheim, GSK and Teva once again found themselves in the crosshairs of the U.S. antitrust watchdog. But the most high-profile products involved in this wave of disputes, as spelled out by the FTC, are perhaps Novo Nordisk’s GLP-1 drugs Ozempic, Saxenda and Victoza. In response to a Fierce Pharma request for comment, Novo said it’s reviewing the warning letter received from the FTC. The antitrust agency in a Tuesday release mistakenly identified Ozempic as a weight loss drug when it’s only approved by the FDA to control Type 2 diabetes. Novo’s Wegovy, which contains the same GLP-1 receptor agonist semaglutide as Ozempic, is approved for obesity. The two brands, while both coming in an injectable pen administered weekly, are available in different maintenance dose strengths.   The FDA Orange Book records branded drug patents that serve as reference for generic drug developers. The FTC argued that by putting up sham patents, biopharma companies have exploited a policy that blocks the FDA from approving a generic drug for 30 months if an originator timely files an infringement lawsuit against a generic over a patent listed in the Orange Book. The FTC first warned in September that it would scrutinize improperly listed drug patents in the FDA database. Then, in November, it challenged more than 100 patents for several drug products that deploys special delivery devices, such as an inhaler or an injector. In response, GSK, Amneal’s Impax Laboratories and Kaleo have delisted some patents. GSK also voluntarily removed certain patents that were not challenged by the FTC. Earlier this year, Boehringer Ingelheim, AZ and GSK all committed to capping their inhalers’ monthly out-of-pocket costs at $35. This time around, the FTC is once again eyeing some drug-device combos. Besides the Novo drugs, AstraZeneca’s Bydureon pen for diabetes is also part of the FTC’s challenge. Four GSK inhalers using the Ellipta device, such as the chronic obstructive pulmonary disease and asthma therapies Breo and Trelegy, were included. A GSK spokesperson confirmed receipt of the new warning letter and said the company will do its own analysis as the law requires. Previously, GSK retracted four of five patents flagged by the FTC from the Orange Book back in November. “Once complete, we will respond to the FDA and FTC in accordance with the FDA’s process,” the GSK spokesperson said of the latest review. For Novartis, its COPD drugs Seebri and Utibron landed on the FTC’s radar. Boehringer saw patents for its Striverdi and Stiolto inhalations using the Respimat technology under the agency’s microscope. In a statement shared with Fierce Pharma, Boehringer said it has “never wrongfully submitted patents for listing in the Orange Book—not for any of our inhaler products or any other products in our portfolio.” The company believes its patents in the FDA database are “valid, enforceable and properly listed.” “Drug-and-device combination products are complex and costly to develop and manufacture, and we file patents to protect our investment in innovations like these that benefit people and improve their lives.” Teva had the most patents implicated among the drugmakers, with about 60 patents targeted across five brands using the Respiclick, Digihaler or Redihaler platforms between it and its Norton Waterford subsidiary. The company did not immediately reply to a request for comment. Covis Pharma and Amphastar Pharmaceuticals round out the eight companies, The FTC is currently challenging the patents under the FDA’s regulatory dispute process, but the antitrust agency warned that it retains the right to take any further action. The FTC has yet to bring any additional sanctions against companies that have refused to remove patents in the agency’s first round of scrutiny.