— Company Plans to File IND and Advance MMF Prodrug Formulations Into the Clinic in Mid 2014 —
DUBLIN--(BUSINESS WIRE)--Jan. 6, 2014-- Alkermes plc (NASDAQ:ALKS) today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. 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 prioritized 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 U.S. Food and Drug Administration (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 program 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,” stated Elliot Ehrich, M.D., 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 to 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.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, often disabling, disease that attacks the central nervous system (CNS), which is made up of the brain, spinal cord and optic nerves. Symptoms may be mild or severe, ranging from numbness in the limbs to paralysis or loss of vision. The progression, severity and specific symptoms of MS are unpredictable and vary from one person to another. MS affects more than 2.3 million people worldwide.1 Best current estimates indicate that there are at least 400,000 people with MS in the United States. 2
About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and manufacturing facilities in Gainesville, Georgia and Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
Alkermes Contacts:
For Investors: Rebecca Peterson, +1 781-609-6378
For Media: Jennifer Snyder, +1 781-609-6166