NESS ZIONA, Israel – March 30, 2022 – Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on introducing innovative long-acting depot injectable solutions mainly for neurological indications, announced today that the company has been granted U.S. Patent No. 11,167,003 entitled: “Methods for suppressing or alleviating primary or secondary progressive multiple sclerosis (PPMS or SPMS) using sustained release glatiramer depot systems.”
GA Depot is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone®/Glatopa®), designed to be administered as an intramuscular injection once every four weeks. GA Depot is currently in the final stages of a multinational Phase III clinical study where it is being evaluated for treatment of relapsing forms of multiple sclerosis (RMS). GA Depot is also currently being evaluated in a multinational Phase II for primary progressive multiple sclerosis (PPMS).
Ehud Marom, Chairman and Chief Executive Officer of Mapi, said, “Developing and extending our IP portfolio is an important part of Mapi’s strategy and we are pleased to have been granted this U.S. patent which covers our long-acting GA for both PPMS and secondary progression multiple sclerosis.”
Based on the initial efficacy and safety results in the ongoing Phase II study in PPMS and the patent protection, the company is seeking a partner to support the Phase III development and co-marketing of GA Depot for PPMS.
Mapi will present two posters featuring clinical data on GA Depot in RRMS and PPMS at the forthcoming American Academy of Neurology annual meeting, to take place April 2 – 7, 2022.
About Mapi Pharma
Mapi is a clinical stage pharmaceutical company, engaged in marketing its own generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) as well as development of high barrier-to-entry and high added-value life cycle management (“LCM”) products and AB Rated Depot injectable products that target large markets that include complex active pharmaceutical ingredients (“APIs”) and formulations. The GA Depot injection, administered once every four weeks, is the first in a series of depot long-acting injections in the company’s pipeline, for the treatment of MS. The product is a LCM version of Copaxone®, which requires injections daily or every other day. Mapi Pharma partnered with Viatris (NASDAQ: VTRS) for GA Depot in an agreement under which Viatris was granted an exclusive license to commercialize the GA Depot injection product for relapsing forms of multiple sclerosis. Mapi’s portfolio also includes a leading development of Depot GLP-1 for diabetes, weight control, Parkinson’s disease and potentially Alzheimer’s with innovative IP. Mapi is built on strong chemical and pharmaceutical R&D capabilities, a deep understanding of the global market and of regulatory needs. Mapi is headquartered in Israel, with R&D facilities in Israel and China, an API production facility in the Neot-Hovav Eco Industrial Park and an aseptic manufacturing and a Fill & Finish facility for injectable Finished Dosage Forms in Jerusalem. Mapi has a strong IP position, filing numerous patent applications for APIs and formulations. Mapi Pharma was founded by Ehud Marom who serves as Chairman & CEO of Mapi Pharma and Stem Cell Medicine. For more information, please visit: www.mapi-pharma.com
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