Indacaterol Maleate

A respiratory biotech that launched Tuesday morning aims to take advantage of excitement in COPD drug development spurred by two recent deals. AeroRx Therapeutics took the wraps off a $21 million Series A that it’s using to get its lead program through Phase 2b testing in chronic obstructive pulmonary disease, or COPD. It’s the same category that spurred Merck’s $10 billion acquisition of Verona Pharma and GSK’s partnership with Hengrui Pharma that could be worth $12 billion if everything pans out. The AeroRx drug, known as AERO-007, is a nebulized reformulation of two approved compounds — indacaterol and glycopyrrolate — that use different mechanisms of action. Indacaterol is a long-acting beta agonist (LABA), while glycopyrrolate is a long-acting muscarinic agonist (LAMA). Combining LABAs and LAMAs is common when treating COPD. AeroRx CEO Ahmet Tutuncu said the FDA has approved five such products. An inhaler combination of indacaterol and glycopyrrolate was approved in 2015 as Utibron, which was developed by Novartis and out-licensed to Sunovion Pharmaceuticals a year later. (Sunovion is now owned by Sumitomo Pharma.) All the approvals are for inhalers with dry powder, which is more difficult for older and sicker patients to use, Tutuncu said. AeroRx believes it can be the first company to offer a nebulized formulation as a first-line maintenance therapy in COPD. “It’s a different delivery technology, or full dose delivery, for those patients who need to be on nebulized medicines,” Tutuncu said. “A significant number of COPD patients who are typically getting older, they are on inhalers, but they are the ones who end up in hospitals with exacerbations for symptom control, and therefore they need to be on nebulized medicine.” So far, AeroRx has run a small Phase 2a study with 16 patients that suggested AERO-007 could be dosed once daily. In the Phase 2b trial, researchers plan to test once-daily and twice-daily doses. Most other details about the trial remain undisclosed until after discussions with the FDA, according to Tutuncu, including how long it’s expected to last. But because both components of AERO-007 are already approved, Tutuncu expects an “abbreviated” late-stage development process comprising the Phase 2b and Phase 3 trials. The trials will also enroll all COPD patients, and if AERO-007 wins approval, AeroRx plans to market it for patients older than 65 years old. The company also has another preclinical program called AERO-111, which is a triple combination nebulized COPD treatment. (There are two approved triple-combo inhalers.) In addition to a LABA and LAMA compound, AERO-111 also includes a corticosteroid. Tutuncu said the company is still figuring out which one to use. AeroRx’s Series A comes about 18 months after it closed a $6 million seed round in the spring of last year. With the new cash in hand, AeroRx is aiming to capitalize on the recent momentum in COPD following the Merck and GSK deals. “Those were two really important validation points for the interest from big pharma for nebulized delivery in the respiratory space, and particularly in the COPD space,” Tutuncu said. “We’re very excited about that potential for collaboration with pharma down the road.”

Pictured: Entrance to the FTC’s office in Washington, DC iStock, hapabapa In a bid to improve competition in the industry, the U.S. Federal Trade Commission is challenging the patents of 20 different pharmaceutical products, disputing the accuracy and relevance of their patents. The U.S. Federal Trade Commission on Tuesday sent warning letters to 10 pharmaceutical companies, challenging patents for several drugs including Novo Nordisk ’s blockbuster diabetes treatment Ozempic (semaglutide) and GSK ’s asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol). The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate. “By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina Khan said in a statement. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need,” Khan added. In addition to Ozempic and Trelegy Ellipta, the FTC’s latest round of patent challenges also targets Novo’s Saxenda (liraglutide) and Victoza (liraglutide)—both indicated for type 2 diabetes—and Novartis ’ inhaler products Seebri Breezhaler (glycopyrronium bromide) and Utibron Neohaler (indacaterol and glycopyrrolate), approved for chronic obstructive pulmonary disease. The pharma companies now have 30 days to either withdraw or amend their disputed listings, or confirm “under penalty or perjury” that these patents indeed comply with the statutory and regulatory requirements. A GSK spokesperson in a statement to Endpoints News said that the company is reviewing the FTC’s letter. GSK takes “the FTC’s views seriously; however, we will also do our own analysis as the law requires. Once complete, we will respond to the FDA and FTC.” Meanwhile, a Boehringer Ingelheim spokesperson said that the pharma “has never wrongfully submitted patents for listing in the Orange Book.” Tuesday’s warnings follow an initial salvo in November 2023, when the FTC challenged more than 100 patents by 10 pharma companies including AbbVie, AstraZeneca and subsidiaries of GSK and Teva Pharmaceuticals. At the time, the antitrust watchdog targeted a wide range of pharmaceutical products, including inhaler devices, multidose bottles and epinephrine autoinjectors. Aside from the FTC, members of Congress have also started targeting the high cost of medication in the U.S., paying particular attention to Ozempic. Last week, Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, launched a probe into the ‘outrageously high prices’ of Ozempic, as well as its sister weight-loss therapy Wegovy (semaglutide). Sanders in a letter to Novo CEO Lars Fruergaard Jørgensen asked for additional information regarding Ozempic and Wegovy, including revenue, prices paid by public and private payers, R&D spending and the pharma’s tactics to extend their exclusivity. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com .