Vectura Group and Sosei Group each said that they are owed $2.5 million milestone payments from Novartis after the EU accepted Novartis’s MAA for its QVM149 indacaterol/glycopyrronium/mometasone furoate DPI for the treatment of asthma that is inadequately controlled. Vectura said that approval of the MAA would trigger an additional milestone payment of $5 million. Vectura and Sosei licensed glycopryronium bromide to Novartis in 2005.
The announcement comes only a few days after Novartis announced new Phase 2 results for QVM149; said that Phase 3 trials were ongoing; and stated that it would “address the clinical and regulatory path forward for IND/GLY/MF delivered by Breezhaler” at future meetings.
Vectura CEO James Ward-Lilley commented, “We are pleased to see the progression of the QVM149 program and the acceptance of the EU registration dossier ahead of its original timeline. Based on the strong Phase 2 study results for QVM149 presented at ATS this week, we believe this new asthma treatment has the potential to have a competitive profile and provide an important and compelling additional option for physicians and patients.”
Sosei Heptares Chairman, President, and CEO Shinichi Tamura said, “The acceptance of the MAA submission for QVM149 is an important milestone in the development of this novel, once daily, inhaled combination therapy for asthma patients. More than one-third of asthma patients have uncontrolled disease despite the availability of multiple therapies. With the filing of the MAA for approval in Europe, we are greatly looking forward to see QVM149 become available to patients and improve the lives of those with uncontrolled asthma.”
According to the Novartis announcement, the Phase 2 CQVM149B2208 trial demonstrated statistically significant improvement in FEV1 for two doses of QVM149 compared to salmeterol/fluticasone propionate, and the Phase 2 CQVM149B2209 trial met its primary endpoint, demonstrating improvement in FEV1 for QVM149 versus placebo.
Novartis Linda Armstrong Respiratory Development Unit Head said, “These Phase 2 studies’ results are a promising stride forward for this once daily combination. Together with a dose-confirming Breezhaler inhalation device, which is well established in COPD, this new combination, if approved, has the potential to improve lives of those with uncontrolled asthma.”
Read the Vectura press release.
Read the Sosei press release.
Read the Novartis press release.
