Inhalation

INH1021

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Recent news about companies that support development of OINDPs plus news on R&D and progress in the treatment of respiratory diseases, such as asthma and COPD, as well as news about other topics, including COVID-19. Inhalation OctOber 2021 9 Industry news Glenmark launches Tiogiva ® utilizing Merxin MRX003 MUMBAI, INDIA—Glenmark Phamaceuticals announced the launch of Tiogiva ® Tiotropium Bromide Dry Powder Inhaler (DPI) in the UK. e bioequiv- alent version of Boehringer Ingel- heim's Spiriva ® Handihaler ® (Ingelheim am Rhein, Germany) is used to treat chronic obstructive pulmonary disease (COPD) and is powered by Merxin's MRX003 capsule device. The launch is Merxin's first commercial suc- cess in the regulated pharmaceuti- cal market. Merxin (King's Lynn, UK) designs and supplies generic and customized inhaler devices. Its MRX003 is a capsule DPI, avail- able for licensing with tiotropium in India, China, Brazil, Pakistan and Bangladesh, and for other molecules throughout the world. e Glenmark news release noted the company has a strategic exclu- sive in-licensing arrangement to market the Tiotropium DPI in Western Europe and the UK and is planning additional launches. Fixed-dose combination of albuterol and budesonide demonstrated significant benefits in Phase III trials W I L M I N G T O N , D E L A - WARE—AstraZeneca and Avil- lion announced positive, high-level results from two clinical phase III trials of PT027, which they describe as a potential first-in-class, inhaled, fixed-dose combination of albuterol, a short-acting beta 2 -ago- nist (SABA), and budesonide, an inhaled corticosteroid (ICS), in a pressurized metered dose inhaler (pMDI) that uses AstraZene- ca's Aerosphere ® delivery tech- nology. The MANDALA and DENALI Phase III trials, at both 180/160 mcg and 180/80 mcg doses, met all primary endpoints, demonstrating statistically sig- nificant benefits in patients with asthma versus individual compo- nents albuterol (salbutamol) (180 mcg) and budesonide (160 mcg). The MANDALA trial, in 3,132 patients with mild to moderate asthma, met the primary endpoint, with PT027 demonstrating sta- tistically significant and clinically meaningful reductions in the risk of severe exacerbations compared to albuterol, when used as a res- cue medicine in response to symp- toms. e DENALI trial, in 1,001 patients, met the dual primary endpoints, with PT027 showing a statistically significant improve- ment in lung function measured by forced expiratory volume in one second (FEV 1 ), compared to the individual components albuterol and budesonide, and compared to placebo. respIratory medIcIne news High prevalence of asthma, allergy, obesity symptoms in school children in India D E L H I , I N D I A — C N B C 1 8 reported results of a survey across schools in Delhi, Kottayam and continued on page 31

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