The fate of IL-33-targeting astegolimab will be determined by talks with regulators, after Roche AG’s Genentech unit rolled out mixed results from a pair of studies testing the compound vs. placebo on top of standard-of-care (SOC) maintenance therapy in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).
In the second largest M&A deal of the year, Merck & Co. Inc. has strengthened its cardiopulmonary portfolio with the $10 billion acquisition of London-based Verona Pharma plc. The deal brings Merck Ohtuvayre (ensifentrine) for chronic obstructive pulmonary disease.
The U.S. FDA granted approval of Verona Pharma plc’s ensifentrine on its PDUFA date of June 26, giving the chronic obstructive pulmonary disease (COPD) community its first new mechanistic option in a decade. The drug, branded Ohtuvayre, is also the first inhaled nonsteroidal therapy to treat a respiratory disease that combines both a bronchodilator and anti-inflammatory mechanism into one molecule. It is indicated for the maintenance treatment of COPD, which Verona said allows for broad use.
After posting positive top-line data in August from its phase III ENHANCE-2 study of ensifentrine for treating chronic obstructive pulmonary disease (COPD), Verona Pharma plc now has positive results from the companion phase III study. The ENHANCE-1 trial of ensifentrine as a COPD maintenance treatment hit its primary and key secondary endpoints, prompting the company to say it plans to submit an NDA for the treatment to the U.S. FDA sometime in the first half of 2023.
Top-line data from Verona Pharma plc’s phase III ENHANCE-2 study show its inhaled ensifentrine hit the primary and secondary endpoints in treating chronic obstructive pulmonary disease (COPD). Next up: data from the companion phase III, ENHANCE-1, which is expected by the end of 2022.
DUBLIN – Verona Pharma plc is adding $25 million cash to its balance sheet, as well as $15 million worth of stock in Nuance Biotech Co. Ltd., and could earn up to $179 million more in milestones linked to the development in the greater China region of ensifentrine, its candidate maintenance therapy for chronic obstructive pulmonary disorder (COPD).
DUBLIN – Verona Pharma plc raised $200 million in a combined private placement and share subscription, which ensures the London-based firm has the funds in place to proceed with a phase III program for its lead drug candidate, ensifentrine, as maintenance therapy in chronic obstructive pulmonary disease (COPD). It’s solid evidence that the company’s decision to bring in a new senior management team earlier this year is working. CEO David Zaccardelli and Chief Financial Officer Mark Hahn joined up in February, not long after they had led specialty pharma firm Dova Pharmaceuticals Inc. to a buyout deal with Stockholm-based Swedish Orphan Biovitrum AB, worth up to $915 million.
LONDON – Verona Pharma plc reported positive phase IIb results for the nebulized formulation of its dual phosphodiesterase (PDE) 3 and 4 inhibitor, ensifentrine (RPL-554), as an add-on to standard bronchodilation therapy in chronic obstructive pulmonary disorder (COPD).
