28th Jun 2006 07:41
Vectura Group PLC28 June 2006 VECTURA AND SOSEI ANNOUNCE SUCCESSFUL OUTCOME OF PHASE IIb TRIAL OF NVA237 FOR COPD Embargoed until 7.30am (London), 3.30pm (Tokyo) 28 June 2006 Chippenham, UK and Tokyo, Japan - 28 June 2006: Vectura Group plc ("Vectura";LSE: VEC) and Sosei Co. Ltd ("Sosei"; TSE Mothers Index: 4565), announced todaythat their collaborative product, NVA237, a novel inhaled once daily treatmentfor chronic obstructive pulmonary disease (COPD), had successfully completed aPhase IIb multiple dose-ranging clinical trial. NVA237 is being developed andcommercialised by Novartis both as a monotherapy and in combination with theironce daily bronchodilator indacaterol, under the terms of a global licenceagreement signed in April 2005. The outcome of the study supports the progression of NVA237 and Novartis areproceeding as planned with the development programme. The trial randomised 335 subjects in 35 European sites into a multi-centredouble-blind, parallel group, placebo controlled study, including an additionalopen label tiotropium group, to assess the efficacy, safety and tolerability offour doses of NVA237 inhaled once daily for 28 days in subjects with COPD. NVA237 demonstrated bronchodilatory efficacy, as determined by a range ofpulmonary function measures. NVA237 achieved statistical significance overplacebo in terms of the primary efficacy variable, trough FEV1 and wascomparable to tiotropium. These data support the use of NVA237 as a once dailybronchodilator. Preliminary data indicate that the majority of adverse events were mild andthere were no marked differences in incidence or severity compared to placebo ortiotropium. COPD is a chronic obstruction of the airways which in the developed world iscaused primarily by smoking. Symptoms include chronic bronchitis and/oremphysema which slowly progress and eventually lead to a largely irreversibleloss of lung function. COPD is currently the fourth most common cause of deathand by 2020 is predicted to become the third most common cause of death and thefourth most important disability causing illness. The total financial burden oflung disease in Europe amounts to nearly €102 billion with COPD contributingalmost one half of this figure. Around three-quarters of patients with advancedCOPD are unable to perform normal everyday activities. The current market forCOPD drug therapy is estimated to be worth around $5.5 billion per annum and ispredicted to double to over $11 billion by 2011 as a result of increasingdiagnosis and treatment and the growth of high value new products. Mr Shinichi Tamura, President & CEO of Sosei, said: "These results furthervalidate the clinical profile of NVA237 and support the potential of the productto provide an important addition to the available therapeutic options to treatCOPD, a common and costly disease with high unmet patient need." Dr Chris Blackwell, Chief Executive of Vectura, added: "We are proud to havedelivered pharmaceutical and clinical data to Novartis in a timely mannerallowing the development of NVA237 to continue on track. This positive efficacydata, taken together with the human pharmacokinetic data published at the recentATS congress, show great promise for NVA237." Enquiries:Vectura Group plc Tel +44 (0)1249 667700Dr Chris Blackwell, Chief Executive Sosei Co. Ltd. Tel +44 (0)1799 532350Dr Julian Gilbert, Chief Business Officer Financial Dynamics Tel: + 44 (0)207 831 3113David Yates / Julia Phillips /Sarah MacLeod The Trout Group Tel: +1 212 477 9007(for Sosei US enquiries)Brandon Lewis (extension 15)Thomas Fechtner (extension 31) Notes for Editors: About the NVA237 licence agreement with Novartis Sosei and Vectura concluded a global development and commercialisation agreementwith Novartis in April 2005 for their collaborative product NVA237. Novartis areresponsible for developing and commercializing NVA237 both as a monotherapy andin combination with indacaterol, its once daily, long acting beta 2 agonist. Under the terms of the agreement Sosei and Vectura have already received $15million each and will receive up to $172.5million each for achieving pre-agreedclinical, regulatory and commercialisation targets for both the monotherapy andcombination product. These potential milestones thus total up to $375 million.In addition, royalties on product sales will be paid for the monotherapy and thecombination product. If a third combination product is developed by Novartis,using NVA237, further milestones and royalties may be payable. About Vectura Vectura's principal focus is the development of a range of inhaled drugs for thetreatment of both lung diseases and other conditions where optimised deliveryvia the lungs can provide significant benefits, such as a rapid onset of action,improved efficacy and improved tolerability compared with current therapies. Vectura's products combine its proprietary, innovative, pulmonary formulationand device technologies (Aspirair(R), GyroHaler(R) and PowderHale(R),) withexisting, off-patent drugs either for use in new indications or to provideinhalation as an improved route of administration. Using drugs that have alreadybeen approved in some form in at least one major pharmaceutical market lowersthe risk of product development failure compared to new chemical entities,Vectura is able to secure patent protection for its portfolio by identifying newindications for off-patent compounds and applying the Company's proprietarydelivery technologies to create new methods of administration. The Company hasdevelopment collaborations with a number of companies, including BoehringerIngelheim, Novartis, GSK and Chiesi and an un-named leading internationalpharmaceutical company. For further information, please visit Vectura's website at www.vectura.com About Sosei Sosei Co. Ltd. is a leading international biopharmaceutical company withsignificant expertise in product discovery and development. It has established areduced risk business model primarily upon identifying new uses for establisheddrugs and exploiting its unique position within Japanese, European and NorthAmerican pharmaceutical markets by acquiring compounds from, and bringingcompounds into, Japan. For further information about Sosei, please visit www.sosei.com This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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