Mallinckrodt has entered into a licensing agreement for development and commercialisation of NeuroproteXeon’s investigational, pharmaceutical-grade xenon gas for inhalation therapy being evaluated to improve survival and functional outcomes for patients resuscitated after a cardiac arrest.
If approved, xenon gas for inhalation will expand Mallinckrodt’s portfolio of hospital drug-device combination products providing therapies for critically ill patients.
Under the terms of the agreement, Mallinckrodt will pay $10 million upfront with cash on hand to reimburse NeuroproteXeon for certain product development costs. The company will also gain exclusive rights to commercialise the therapy, if approved, in the U.S., Canada, Japan and Australia.
Mallinckrodt will make additional payments of up to $25 million dependent on the achievement of clinical, regulatory and sales milestones as well as a tiered, net-sales-based royalty.
NeuroproteXeon will continue to be responsible for the cost of development and will manage the development of the product in collaboration with Mallinckrodt.
Rates of resuscitation following cardiac arrest have risen modestly over time, but physicians say they still are not as high as they could or should be. Even when patients are successfully resuscitated, their outcomes are frequently still not positive, and post-arrest care and management continues to be an area of very high unmet medical need.
Dr. Steve Romano, Executive Vice President and Chief Scientific Officer, said: “The Phase 3 xenon gas for inhalation registration trial that will begin in early 2018 is designed to confirm a potential clinical benefit associated with the positive biomarker outcome as demonstrated on magnetic resonance imaging scans of patients treated with hypothermia therapy plus xenon gas for inhalation that was seen in a Phase 2b study. Those results showed a measurable reduction in brain damage. The Phase 3 trial, being conducted under an FDA Special Protocol Agreement, or SPA, will seek to measure the clinical benefit of xenon gas for inhalation in terms of improved 30-day survival and improved functional outcomes.”