Vectura stock has been on the rise over the weekend following regulatory clearance for the Seebri Breezhaler for COPD in Japan and Europe, marking the firm's first approval for a proprietary medicine.
On Friday came the announcement that the Japanese Ministry of Health, Labour and Welfare has issued a green light for the use of Seebri (glycopyrronium bromide) as a once-daily, long-term treatment for the relief of symptoms due to airway obstructive disease in chronic obstructive pulmonary disease (COPD).
This marked the first worldwide approval of glycopyrronium - which was licensed to Novartis in 2005 by Vectura and partner Sosei - and triggered a $2.5 million milestone to the UK group, as well as a new royalty stream representing around 5% of sales.
Then on Monday came the news that the product has also won approval in Europe, specifically as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
This released a $10 million milestone payment from Novartis to Vectura, and an additional stream of royalties on product sales.
"Such royalty income will be important in allowing the company to expand its business into the next stage of evolution", noted analysts at finnCap in a research note.
Approval came on the back of data from the GLOW trials, in which the Seebri Breezhaler improved lung function, reduced shortness of breath, reduced exacerbations, and improved quality of life over a 52-week period compared to placebo, the firm said.
The studies also showed that Seebri, a long-acting muscarinic antagonist (LAMA), was similar to Boehringer Ingelheim's LAMA blockbuster Spriva (tiotropium) in improving lung function.
Vectura said it expects the product to be available in Japan and Europe later this year.