Phargentis has entered the clinical development phase for its second generic inhalation product – the COPD therapy containing indacaterol/glycopyrronium (85 mcg and 43 mcg) - today marketed by Novartis as Ultibro®Breezhaler®.
A pilot PK study was successfully completed in a group of 20 healthy subjects. The pilot study was intended to understand the in vivo variability of the development candidates as well as of the reference product, to confirm safety and tolerability of the developed formulations and device, and finally to enable the selection of the best candidate for further development stages.
The pilot PK study compared two generic test batches against the reference product (Ultibro®Breezhaler ®). Results in both batches were positive, confirmed safety and tolerability and showed good comparability between the test and the brand treatment, with Cmax fully supporting bioequivalence for both the active ingredients Indacaterol and Glycopyrronium.
The study outcome gives essential information on the in-vivo variability of the test and of the reference product, hence facilitates the selection of candidates for the next pivotal PK study.
The pilot study also showed low intra-subject variability for the two ingredients, highlighting the good administration procedure and the outstanding study conduct at the selected CRO.
Indacaterol/Glycopyrronium is a fixed-dose bronchodilator combination therapy for managing moderate to severe COPD. The most common market version is Ultibro®Breezhaler®. Globally, sales of Ultibro®Breezhaler® exceed 500 MUSD a year. EU sales in 2020 amounted to 373 MUSD.
Phargentis expects to launch its generic version of Ultibro®Breezhaler® in 2025, three years before the theoretical generic entry date of 2028 - a crucial part of the company’s signature early market entry strategy. The company has four generic versions of high-value asthma and COPD therapies in development, and a respiratory portfolio addressing a combined market value exceeding 3.5b USD.
CEO Andrea Tam: “These are milestone results for the company. Lung data and bioequivalence are notoriously complex and challenging. These solid, positive results confirm the excellence of our scientific and clinical strategy. They are a robust base for us to move forward confidently as we enter the next pivotal phase of development for this much-needed generic.”