QVA149 Phase II Data Presented at the European Respiratory Society Annual Meeting
- Promising Efficacy and Tolerability for Novel Combination COPD Therapy
Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) announce thatNovartis have presented the results of their two Phase II studies evaluatingthe efficacy, safety and tolerability of QVA149 at the annual congress of theEuropean Respiratory Society (ERS) in Vienna. QVA149 is a novel once-daily,dry powder fixed dose bronchodilator combination of the once-dailybeta2-agonist QAB149 (indacaterol) and the LAMA, NVA237 (glycopyrroniumbromide) for the treatment of chronic obstructive pulmonary disease (COPD).
NVA237 was licensed to Novartis by Sosei and Vectura in 2005 in a deal inwhich the two companies could receive up to US$375 million in milestones aswell as royalties on product sales.
One of the randomised, cross-over double-blind, placebo-controlledstudies compared inhaled administration of QVA149 300/50 (QAB149 300micrograms + NVA237 50 micrograms) with two doses of QAB149 (300 micrograms,600 micrograms) to evaluate bronchodilatory effect in terms of trough FEV1(forced expiratory volume in one second) after 7 days of therapy. One hundredand thirty-five patients with moderate to severe COPD completed the studywith an observed clinically relevant mean improvement in trough FEV1 betweenQVA149 and placebo on Day 7 of 226 mL. Similarly, the estimated meantreatment differences between QVA149 and QAB149 300 micrograms and600micrograms were 123 mL and 117 mL, respectively. Similar results wereobserved on Day 1 of the study and both QVA149 and QAB149 were well tolerated.
The other placebo-controlled trial evaluated the safety and tolerabilityof 3 doses of QVA149 (600/100, 300/100 and 150/100) and QAB149 (300micrograms) in 255 patients during 14 days of treatment. In this study,QVA149 had no significant effect on change in 24 hour mean heart rate frombaseline to Day 14, there was no clinically relevant effect on QTc intervalat 1, 7, or 14 Days and QVA149 was well tolerated with overall adverse eventrates similar to placebo.
Mr Shinichi Tamura, President & CEO of Sosei, said: "These resultssupport the perceived benefit of combining two potent bronchodilators in aconvenient once-daily therapy with an attractive efficacy and safety profile.QVA149 has the potential to be the first such product to come to market andprovide an important addition to the available options to treat COPD."
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 investigational once-daily, long-actingbeta2-agonist (LABA) indacaterol (QAB149), which was filed for approval withthe regulatory authorities as a monotherapy treatment for COPD at the end of2008. The combination of NVA237 and indacaterol is known as QVA149. NDAsubmissions are expected to be filed by Novartis for both NVA237 and QVA149in 2011.
NVA237 entered Phase III trials in July 2009 which triggered a US$7.5million milestone payment to both Sosei and Vectura. Under the terms of theagreement, Vectura and Sosei will each receive up to US$172.5 million forachieving pre-agreed clinical, regulatory and commercialisation targets forboth the monotherapy and combination product. These milestones total up toUS$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. It is a progressive lung disease with symptoms including chronicbronchitis and/or emphysema, which slowly progresses and eventually leads toa largely irreversible loss of lung function. While there is no cure,bronchodilators such as LABAs and LAMAs make breathing easier by enlargingthe patient's airways, and are recognised in international guidelines as anintegral part of 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 http://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
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