Company plans to file IND and advance MMF prodrug formulations into the clinic in mid 2014
The US Patent and Trademark Office (USPTO) has issued a Notice of Allowance to Alkermes for US Patent Application 14/032,736, entitled 'Prodrugs of fumarates and their use in treating various diseases'. The allowed composition of matter claims will cover Alkermes’ MMF prodrug, ALKS 8700, a proprietary, small-molecule prodrug of monomethyl fumarate (MMF) for the treatment of multiple sclerosis.
The Notice of Allowance resulted from a prioritised examination granted by the USPTO, and the allowed claims are directed toward a novel MMF prodrug that is designed to rapidly and efficiently convert to MMF in the body. Alkermes expects to file an Investigational New Drug (IND) application with the US FDA and initiate a phase 1 study of ALKS 8700 in mid 2014.
'This patent allowance is a critical step in solidifying our intellectual property protection for our MMF prodrug programme and our lead MMF prodrug candidate, ALKS 8700, which we continue to advance toward an IND filing and phase 1 study initiation in mid 2014,' said Elliot Ehrich, Chief Medical Officer of Alkermes. 'Our world-class formulation expertise and prodrug capabilities put Alkermes in a unique position to create and develop prodrug formulations that rapidly and efficiently convert to MMF in the body and that are designed to offer differentiated dosing and tolerability, as compared with the currently marketed dimethyl fumarate prodrug, TECFIDERA.'
Alkermes expects this patent to issue within the next few months and to expire no earlier than 2033. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application.