Results for Glatiramer Acetate (GA) Depot 3 year analysis in RRMS, GA Depot safety results in RRMS and PPMS, and novel anti-BMP for remyelination will be presented
ECTRIMS 2019 to be held in Stockholm, Sweden on September 11-13
NESS ZIONA, Israel – September 4, 2019 – Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on introducing innovative solutions for neurological indications, announced today that the company will present recent advancements in its pipeline for treating MS at the leading MS conference, ECTRIMS 2019, which is being held in Stockholm, Sweden on September 11-13, 2019. Mapi was selected to present clinical results on breakthrough advancements in three of its development programs.
Ehud Marom, Chairman and Chief Executive Officer of Mapi, said, “Mapi is working to be the leading MS Company with a long acting GA Depot product for Relapsing Remitting Multiple Sclerosis (RRMS), a unique product for Primary Progressive Multiple Sclerosis (PPMS), a combination treatment of a Depot treatment and stem cells for Secondary Progressive Multiple Sclerosis (SPMS) and a novel treatment anti-BMP remyelination agent for MS.”
“We recently initiated the pivotal Phase III study of GA Depot for treating RRMS patients. Meeting this significant milestone is a culmination of our achievements over the past few years, including demonstrating our success in this R&D program, manufacturing a complex API and innovating finished dosage forms and a sterile injectable,” Mr. Marom added.
The continued strong results of GA Depot for both RRMS and PPMS demonstrate the product’s safety, tolerability, and efficacy in MS patients. These encouraging results, observed over the three-year period, are demonstrated in a stable mean EDSS score from baseline to three years. It further supports the assumption that GA Depot has the potential to improve MS treatment by significantly reducing frequency of injections, increasing adherence and providing a therapeutic benefit. Based on the initial safety results in the PPMS study we are looking for a partner to support development of GA Depot for the treatment of PPMS. Glatiramer acetate, the active material of Copaxone®, is the most common treatment for RRMS in the US.
Mapi’s focus on MS encompasses several technologies ranging from oral dosage forms, for which the company has successfully launched a generic form of Fingolimod (GilenyaTM) for RRMS, to long acting Depot injections, New Chemical Entities (NCE) for remyelination, as well as combinations with stem cells.
The Company welcomes attendees to meet with us at ECTRIMS 2019 to learn more about:
- GA Depot (extended-release) three-year Phase II analysis for RRMS (Late Breaking News Poster 12:15pm-2:15pm, Sep. 13)
- GA Depot accumulated safety for PPMS and RRMS (e-Poster)
- Novel Anti BMP for Remyelination for MS (5:15pm-7:15pm, Sep. 11)
About Mapi Pharma
Mapi is a clinical stage pharmaceutical company, engaged in the development of high barrier-to-entry and high added-value life cycle management (“LCM”) products that target large markets and generic drugs 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 Mylan N.V. (NASDAQ: MYL) for GA Depot injection in an agreement under which Mylan was granted an exclusive license to commercialize the GA Depot injection product for relapsing multiple sclerosis. 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, and an API production facility in the Neot–Hovav Eco Industrial Park south of Beersheba, Israel. Mapi has a strong IP position, filing numerous patent applications for APIs and formulations. For more information, please visit: www.mapi-pharma.com.
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