TOKYO, October 22 Sosei Group Corporation("Sosei"; TSE Mothers Index: 4565), announces that the Phase III trials withNVA237, which commenced in June 2009, are proceeding to plan. Initiation ofPhase III studies with QVA149 is now expected to occur during 2010. Receiptof the associated milestone payment of $7.5m is therefore expected during thefinancial year to 31 March 2011.
QVA149 is a novel once-daily, dry powder, fixed dose, bronchodilatorcombination of the once-daily beta2-agonist indacaterol and the long-actingmuscarinic antagonist NVA237 (glycopyrronium bromide), in development for thetreatment of chronic obstructive pulmonary disease (COPD). Novartis announcedon 25 September 2009 that indacaterol was recommended for approval inEuropean Union to treat patients with COPD following its regulatorysubmission in late 2008. Furthermore, Novartis received a Complete Responseletter from the FDA on 16th October requesting additional information on thedosing proposed for indacaterol.
Mr Shinichi Tamura, President and CEO of Sosei said: "Progress with PhaseIII studies evaluating NVA237, and the rapid review and recommendation forapproval of indacaterol in Europe, are both encouraging with regard to thedevelopment of QVA149. We were impressed with the positive data at theEuropean Respiratory Society meeting, and it continues to be our belief thatQVA149 has the potential to be the first once-daily LAMA/LABA combinationavailable to patients."
Notes for Editors:
About the NVA237 Licence Agreement with Novartis
NVA237 was licensed to Novartis in April 2005 by Sosei and itsco-development partner Vectura. Novartis intends to launch NVA237 as aonce-daily, long-acting muscarinic antagonist (LAMA) monotherapy for COPD andalso in combination with their once-daily, long-acting beta2-agonist (LABA)indacaterol (QAB149). The combination of NVA237 and indacaterol is known asQVA149.
NVA237 entered Phase III trials in June 2009 which triggered a$7.5million milestone payment to both Sosei and Vectura. Under the terms ofthe agreement, Sosei and Vectura will each receive up to $172.5 million forachieving pre-agreed clinical, regulatory and commercialisation targets forboth the monotherapy and combination product. These milestones total up to$375 million. In addition, royalties on product sales will be paid for themonotherapy and the combination product. If additional combination productsare developed by Novartis using NVA237, further milestones and royalties willbe payable
COPD is a chronic obstruction of the airways which affects 210 millionpeople worldwide and is projected to be the third leading cause of death by2030. Commonly caused by cigarette smoke and other harmful fumes COPD is aprogressive lung disease with symptoms including chronic bronchitis and/oremphysema, which slowly progresses and eventually leads to a largelyirreversible loss of lung function. While there is no cure, bronchodilatorssuch as LABAs and LAMAs make breathing easier by enlarging the patient'sairways, and are recognised in international guidelines as an integral partof the treatment for COPD.
Sosei is a leading international biopharmaceutical company withsignificant expertise in product discovery and development. It hasestablished a reduced risk business model primarily upon identifying new usesfor established drugs and exploiting its unique position within Japanese,European and North American pharmaceutical markets by acquiring compoundsfrom, and bringing compounds into, Japan. For further information aboutSosei, please visit www.sosei.com.
This press release contains "forward-looking statements", includingstatements about the discovery, development and commercialisation ofproducts. Various risks may cause Sosei's actual results to differ materiallyfrom those expressed or implied by the forward-looking statements, includingadverse results in clinical development programmes; failure to obtain patentprotection for inventions; commercial limitations imposed by patents owned orcontrolled by third parties; dependence upon strategic alliance partners todevelop and commercialise products and services; difficulties or delays inobtaining regulatory approvals to market products and services resulting fromdevelopment efforts; the requirement for substantial funding to conductresearch and development and to expand commercialisation activities; andproduct initiatives by competitors. As a result of these factors, prospectiveinvestors are cautioned not to rely on any forward-looking statements. Wedisclaim any intention or obligation to update or revise any forward-lookingstatements, whether as a result of new information, future events orotherwise.
SOURCE Sosei Group Corporation