Business Weekly - Cambridge, UK

The treatment – QVA149 – is a combination of NVA237, a once-daily long-acting muscarinic antagonist (LAMA) and indacaterol, a once-daily long-acting beta-2 agonist (LABA).

The new study will determine the effect of QVA149 and indacaterol on mean 24-hour heart rate in patients with moderate to severe COPD.

NVA237 was licensed to Novartis by Sosei and Vectura in 2005 in a deal in which the two companies could receive up to $375m in milestones as well as royalties on product sales. Indacaterol was discovered by Novartis and is currently in Phase III trials for COPD. NDA submissions have been projected for 2010.

Dr Chris Blackwell, chief executive of Vectura said: “Chronic respiratory diseases like COPD are often sub-optimally treated, and patients don’t always receive effective therapies. The market for COPD therapy is predicted to double in size to $11 billion by 2011.

“The progress Novartis is making with both NVA237 and QVA149 is therefore of interest to many.”

COPD is a chronic obstruction of the airways which in the developed world is caused primarily by smoking. It is currently the fourth most common cause of death and by 2020 is predicted to become the third most common cause of death and the fourth most important disability causing illness.

The total financial burden of lung disease in Europe amounts to nearly €102 billion with COPD contributing almost one half of this figure.

Japanese-owned Sosei, whose R & D nervecentre is at Chesterford, has also received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the Phase III clinical trial programme for its fentanyl sublingual spray (AD 923), an opioid analgesic for the treatment of cancer breakthrough pain.

Patient enrolment in the UK is expected to start before the end of the year and will be the subject of a separate announcement. Applications have been made in other European countries and further patient recruitment will be initiated as soon as approval is received from the relevant local regulatory body.

This first CTA in a major European country will also trigger the receipt of a project milestone payment under the AD 923 Licence Agreement signed with Mundipharma in June 2006.