Sosei, Vectura say phase 2b trial of NVA237 for COPD completed with promising results

By E. Janene Geiss

Philadelphia, June 28 - Sosei Co. Ltd. and Vectura Group plc said Wednesday that their collaborative product, NVA237, a novel inhaled once-daily treatment for chronic obstructive pulmonary disease, has successfully completed a phase 2b multiple dose-ranging clinical trial.

NVA237 is being developed and commercialized by Novartis both as a monotherapy and in combination with their once-daily bronchodilator indacaterol under a global license signed in April 2005, according to a company news release.

The outcome of the study supports the progression of NVA237, and Novartis is proceeding as planned with the development program, officials said.

The trial randomized 335 subjects in 35 European sites into a multi-center double-blind, placebo-controlled study, including an additional open label tiotropium group, to assess the efficacy, safety and tolerability of four doses of NVA237 inhaled once daily for 28 days in subjects with chronic obstructive pulmonary disease.

NVA237 demonstrated bronchodilatory efficacy, as determined by a range of pulmonary function measures, officials said.

NVA237 achieved statistical significance over a placebo in terms of the primary efficacy variable, trough FEV1 and was comparable to tiotropium. These data support the use of NVA237 as a once-daily bronchodilator, officials said.

Preliminary data also indicate that the majority of adverse events were mild and there were no marked differences in incidence or severity compared to a placebo or tiotropium, officials said.

Sosei and Vectura concluded a global development and commercialization agreement with Novartis in April 2005 for their collaborative product NVA237.

Novartis is responsible for developing and commercializing NVA237 both as a monotherapy and in combination with indacaterol, its once-daily, long-acting beta 2 agonist.

Under the agreement, Sosei and Vectura have already received $15 million each and will receive up to $172.5 million each for achieving clinical, regulatory and commercialization targets for both the monotherapy and combination product.

These potential milestones total up to $375 million, officials said.

In addition, royalties on product sales will be paid for the monotherapy and the combination product. If a third combination product is developed by Novartis, using NVA237, further milestones and royalties may be payable, officials said.

Sosei is a Tokyo biopharmaceutical company

Vectura is a Chippenham, England, biopharmaceutical company focused on inhaled drugs.

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