Chippenham-based specialist drugs group Vectura has received a boost potentially worth millions of pounds from the European Commission’s approval of its Seebri Breezhaler lung disease treatment in some parts of the EU.
Approval of the drug, an inhaled, once-daily treatment, follows a similar move in Japan last month. It has been developed with Japanese bio-pharma firm Sosei and is licensed to Novartis, the Swiss pharma giant.
In trials involving nearly 2,000 patients suffering chronic obstructive pulmonary disease (COPD), Seebri Breezhaler improved lung function, reduced shortness of breath and improved quality of life over a 52-week period compared with placebo.
Vectura chief executive Dr Chris Blackwell said: “This innovative therapy has the potential to reduce breathlessness and exacerbations, improve lung function and help improve overall quality of life.
“The approval of this drug is a landmark and value-enhancing event for Vectura, who along with its partner Sosei developed the drug to a Phase II proof-of-concept before licensing it to Novartis. This approval will trigger a $10m milestone to Vectura along with subsequent royalty streams.”
Vectura exclusively licensed Seebri Breezhaler to Novartis in April 2005 and its co-development partner Sosei. The US filing for the drug is expected in 2014.
COPD is a progressive disease linked mainly to tobacco smoking, air pollution or occupational exposure. It can cause obstruction of airflow in the lungs leading to debilitating bouts of breathlessness.
It affects an estimated 210m people worldwide and is predicted to be the third leading cause of death by 2020. Although COPD is often thought of as a disease of the elderly, half of patients are estimated to be between 50 and 65.
Vectura develops inhaled therapies principally for the treatment of respiratory diseases. Vectura’s main products target diseases such as asthma and COPD, a growing market estimated to be worth more than $25bn (£15.6bn)
Vectura has six products marketed by its partners and a portfolio of drugs in clinical and pre-clinical development, a number of which have been licensed to major pharmaceutical companies. It has development collaborations and licence agreements with several pharmaceutical companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter and GlaxoSmithKline (GSK).