Acorda Therapeutics is paying Medtronic $3 million up front for worldwide rights to a Phase II-ready magnesium formulation, designated AC105, which will be evaluated as an acute treatment for patients with neurological trauma including spinal cord injury (SCI) and traumatic brain injury (TBI). Medtronic could earn an additional $32 million in development and regulatory milestones and will receive single-digit sales royalties.
The deal gives Acorda exclusive rights to certain formulations of the licensed compound in all fields. For other formulations Acorda’s rights are exclusive in its designated areas of interest, including SCI, TBI, stroke, and all other traumatic and ischemic central nervous system indications. Medtronic and Acorda share development rights to the formulation in other areas including some pain and musculoskeletal indications.
“This acquisition of AC105 is an important addition to our existing pipeline, providing a clincial-stage compound to complement GGF2, which is in early Phase I clinical trials for the treatment of heart failure, as well as our preclincial programs in remyelination and spinal cord injury,” comments Ron Cohen, M.D., Acorda president and CEO.
Medtronic has already carried out Phase I studies with AC105, and Acorda is planning an initial Phase II study in SCI as well as potentially other studies in other CNS indications including TBI and stroke. In preclinical studies AC105 demonstrated neuroprotective effects and the improvement of locomotor function in SCI. It also showed improved cognitive function in TBI when therapy was initiated within four hours or injury.
FDA granted AC105 fast track designation in 2009 for use in improving the functional recovery of acute SCI patients. Acorda says it expects to apply for orphan drug designation for the acute SCI indication in the U.S. and possibly in Europe and other territories.
Acorda’s lead product, Ampyra (dalfampridine) extended release tablets, was approved in the U.S. in January 2010 to help improve walking in patients with multiple sclerosis. EMA's Committee for Medicinal Products for Human Use recommended approval of the drug (registered as Fampyra® outside the U.S.) in May.
Fampyra is being developed and marketed by Biogen Idec outside the U.S. Marketing approval in Europe would trigger a $25 million payment to Acorda from Biogen Idec. Also in May Fampyra was approved by the Australian regulators.