Novartis files COPD inhaler in Europe, triggers $5M milestone for Vectura

Novartis ($NVS) has submitted the once-daily inhaled combination drug QVA149 for approval in Europe for the treatment of COPD in adults. This triggered a $5 million milestone for licensee Vectura Group, founded and backed by British biotech entrepreneur Sir Chris Evans. QVA149 combines glycopyrronium bromide (licensed from Vectura and its co-development partner Sosei) and indacaterol with Novartis' Breezhaler single-dose dry powder inhaler (SDDPI).

The Breezhaler delivery device has low air flow resistance, making it easier for patients with lung problems to take the drug correctly. In clinical trials, wonderfully tagged IGNITE, ILLUMINATE, SHINE, SPARK and BRIGHT, the inhaler improved lung function and reduced exacerbations. A U.S. filing is expected at the end of 2014; this was delayed when fresh clinical data was needed for NVA237 (glycopyrronium bromide in the Breezhaler, now known as Seebri Breezhaler) in October 2011.

This follows approval of Seebri Breezhaler, a once-daily inhaled treatment for COPD that combines glycopyrronium bromide with the Breezhaler device, in Europe and Canada, and Seebri Inhalation Capsules in Japan.

The agreement between Novartis and Vectura/Sosei, signed in April 2005, is worth $375 million overall. Vectura has received $35 million to date, and could receive up to $152.5 million more in milestone payments, in addition to royalties on any product sales.

Vectura's share value has risen by 76% in the last year, and Evans is confident in the company he founded in 1998. He said to Wales Online: "I'm delighted that Vectura seems to be going from strength to strength as it matures in this important British industry. Vectura could realistically become a billion pound FTSE biotech business in the next few years. I look forward to it and am proud to have been associated with its formation."

- read the press release
- check out the article in Wales Online

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