Update on NVA237 and QVA149 for COPD
2010-10-21 · Nxera Pharma UK Limited · original nxera.life ↗
21 October 2010 Tokyo, Japan Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) announce that Novartis have provided an update on NV A237 and QVA149 as part of their Q3, 2010 results presentation. Key points of note from the presentation: • NVA237 and QVA149 have expected launch dates of 2012 and 2013 respectively • An announcement of N VA237 Phase III data in CO PD is anticipated in Q2, 2011 NVA237 was licensed to Novartis by Sosei and its co-dev elopment partner Vectura in a 2005 deal in which the two companies could receive up to US$375 million in milestones as well as royalties on product sales. QVA149 is a once-daily, dry powder bronchodilator for inhalation combining a fixed dose of the once-daily beta 2–agonist QAB149 (indacaterol) and the long- acting muscarinic antagonist NVA237 (g lycopyrronium bromide) for the treatment of chronic obstructive pulmonary disease (COPD). Phase III trials for NVA237 and QVA149 commenced in June 2009 and May 2010 respectively. Novartis received European regulatory approval for indacaterol (Onbrez ® Breezhaler ® - indacaterol maleate) in November 2009 with the initial launch of the product in Germany in December 2009. US approval is subject to the FDA's review of additional clinical data that Novartis filed at the end of September 2010. - Ends - Update on NVA237 and QVA149 for COPD Enquiries: Sosei Group Corporation Tokyo Office London Office Hidetoshi TORAMI, Director of Finance Yumi YAMAMOTO, Manager, Finance and IR Europe +81-(0)3-5210-3399 +44-(0)20-7691-2081 [email protected] [email protected] Notes for Editors: About the NVA237 Licence Agreement with Novartis Sosei and Vectura conclude d a global licence agreement with Novartis in April 2005 for their collaborative product NVA 237. Novartis is responsible for developing and commercialising NVA237, a long-acting muscarinic antagonist (LAMA), both as a monotherapy and in combination with QAB149 (indacaterol), its once-daily, long-acting beta2-agonist (LABA), as QVA149. NVA237 entered Phase III trials in June 2009 which triggered a milestone payment of $7.5m to each company wit h a further payment of $7.5m being received by each company upon QVA149 entering Phase III in May 2010. Under the terms of the agreement, Sosei and Vectura will receive total milestones of up to $375 milli on for the achievement of pre-agreed clinical, regulatory and commercialisation tar gets for both the monotherapy and combination product. In addition, royaltie s on product sales will be paid for the monotherapy and the combination product. If additional combination products are developed by Novartis using NVA237 , further milestones and royalties will be payable. About COPD COPD is a chronic obstruction of the airways which affects 210 million people worldwide and is projected to be the thir d leading cause of deat h by 2030. It is a progressive lung disease with symptoms including chronic bronchitis and/or emphysema, which slowly progresses and eventually leads to a largely irreversible loss of lung function. Wh ile there is no cure, bronchodilators such as LAMAs and LABAs make breathing easier by enlarging the patient’s airways, and are recognised in international gui delines as an integral part of the treatment for COPD. About Sosei Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets. For further information about Sosei, please visit www.sosei.com. Forward-Looking Statements This press release contains “forward-looking statements”, including statements about the discovery, development and comme rcialisation of products. Various risks may cause Sosei’s actual results to differ materially from those expressed or implied by the forward-looking stat ements, including adverse results in clinical development programmes; failu re to obtain patent protection for inventions; commercial limitations impos ed by patents owned or controlled by third parties; dependence upon strategic al liance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market produc ts and services resulting from development efforts; the requirement for substant ial funding to conduct research and development and to expan d commercialisation activities; and product initiatives by competitors. As a result of these fa ctors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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