Launch Therapeutics will take over management of clinical trials of Teva’s TEV-‘248 fluticasone / albuterol (salbutamol) DPI for the treatment of asthma, the companies have announced. In addition, Carlyle Group subsidiary Abingworth, a Launch Therapeutics backer, will invest up to $150 million toward funding continued development of TEV-‘248 and would receive milestone and sales-based payments in the event of FDA approval.
A Phase 3 trial of TEV-‘248, Study FpA-AS-30094, evaluating the combination DPI against albuterol alone, is currently underway. According to the announcement, another Phase 3 trial, Study FpA-AS-30093, is evaluating the efficacy of albuterol in the combination. Teva will retain full rights to the ICS / SABA inhaler and will continue to be responsible for manufacturing of the product, US regulatory activities, and commercialization activities if approved.
Teva Executive VP, Global R&D, and Chief Medical Officer Eric Hughes commented, “As we execute our Pivot to Growth Strategy, we are focused on accelerating our late-stage innovative pipeline and delivering meaningful new therapies to people living with unmet medical need. We are especially excited about the potential to deliver this new asthma therapy to patients working alongside the team at Launch Therapeutics, who have valuable experience in expediting clinical development programs.”
Launch CEO Anshul Thakral said, “Launch Therapeutics is excited to partner with Teva to co-develop its ICS-SABA (TEV-‘248) clinical program and to bring this vital therapy to asthma patients. Bridging together Teva’s deep therapeutic expertise with Launch Therapeutics’ profound clinical and operational expertise generates value to execute and accelerate this program. Launch Therapeutics is committed to upholding uncompromising standards for quality, achieving key milestones, and delivering this transformative therapy to patients.”
Abingworth Managing Partner, Chief Investment Officer, and Chief Operating Officer Bali Muralidhar added, “Abingworth is thrilled to enter this strategic development funding agreement with Teva around its exciting ICS-SABA (TEV-‘248) program. It is another great example of where we can put capital to work, alongside the operational expertise of Launch Therapeutics, to seek to accelerate the late-stage clinical development of a highly promising program towards patients in need of new therapies.”
Read the Teva and Launch Therapeutics press release.
