Fampridine-SR is under FDA review and is ready to be submitted to the EMEA.
Biogen Idec paid $110 million up front for rights outside the U.S. to Acorda Therapeutics’ MS drug, Fampridine-SR. The compound is currently under FDA review as a therapy to improve walking ability in patients with multiple sclerosis (MS) with a PDUFA date of October 22. Acorda previously reported that the EMEA notified the firm that Fampridine-SR was eligible to be submitted for an MAA.
The exclusive collaboration and license agreement calls for another $400 million in regulatory and sales milestones. Biogen Idec is responsible for regulatory activities and future clinical development of Fampridine-SR in non-U.S. markets. It will commercialize Fampridine-SR and any aminopyridine products developed under the agreement in these markets. Biogen Idec will make tiered, double-digit royalty payments based on non-U.S. sales.
This transaction represents a sublicensing of an existing agreement between Acorda and Elan Pharma International. It also includes a supply agreement, under which Elan will continue to manufacture commercial supply of Fampridine-SR. Acorda will pay Elan 7% of the up-front and milestone fees that it receives.
The amount Biogen Idec pays for products will reflect all amounts due from Acorda to Elan for non-U.S. sales, including royalties owed. The parties can also carry out future joint development activities under a cost-sharing arrangement.
