Acorda Therapeutics, Inc. (ACOR) recently announced that it has been awarded a research contract worth $2.67 million by the US Army Medical Research and Material Command (:USAMRMC). The research contract will support the development of AC105.
The company plans to initiate a phase II trial evaluating the safety and tolerability of the candidate in patients suffering from acute spinal cord injury (SCI). Enrollment process for the study is expected to start in the first half of 2013.
AC105 enjoys fast-track status in the U.S. for the improvement of functional recovery in acute SCI patients. Acorda intends to seek orphan drug status from the US Food and Drug Administration (:FDA) and other regulatory authorities for the acute treatment of SCI. The company also plans to evaluate the use of AC105 for other central nervous system indications, such as traumatic brain injury (TBI) and stroke.
In preclinical studies, the candidate demonstrated neuroprotective properties and improvement of locomotor function in SCI and cognitive function in TBI when the therapy was initiated within four hours of injury.
In Jun 2011, Acorda entered into a licensing agreement with Medtronic, Inc. (MDT) to acquire worldwide development and commercialization rights to AC105. Per the terms of the deal, Acorda will pay up to $32 million to Medtronic on the achievement of development and regulatory milestones in addition to the $3 million upfront payment already paid. Medtronic will also be entitled to receive a single-digit royalty on product sales.
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