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news.Acorda Therapeutics has received worldwide development and commercialization rights to Medtronic’s proprietary magnesium formulation - AC105 as an acute treatment for spinal cord injury (SCI) and traumatic brain injury (TBI).
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Medtronic will receive a $3m upfront payment and up to $32m in regulatory and development milestone payments.
Medtronic will also receive single-digit sales royalty if AC105 is commercialized by Acorda.
For other formulations, Acorda’s rights are exclusive for indications of interest to Acorda, including SCI, TBI, stroke and all other traumatic and ischemic central nervous system indications, while Medtronic has non-exclusive (with Acorda) development rights in specific areas, including certain areas of pain and musculoskeletal indications.
In preclinical studies, AC105 demonstrated neuroprotective properties and improved locomotor function in SCI and cognitive function in TBI when therapy was initiated within four hours of injury.
Acorda plans to conduct Phase 2 clinical trial program in SCI, with the potential for subsequent studies in other central nervous system indications, such as TBI and stroke.
Acorda expects to apply for FDA orphan drug designation for the acute treatment of SCI and will explore orphan drug designations in Europe and in other parts of the world given its worldwide development and commercialization rights.
Acorda president and CEO Ron Cohen said the acquisition of AC105 is an important addition to existing pipeline, providing a clinical stage compound to complement GGF2, which is in early Phase 1 clinical trials for the treatment of heart failure, as well as preclinical programs in remyelination and spinal cord injury.