NESS ZIONA, Israel – April 30, 2019 – Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company will present two year clinical data from its Phase II study of GA Depot for the treatment of relapsing remitting multiple sclerosis (RRMS), at the American Academy of Neurology (AAN) Annual Meeting that will take place May 4-10, 2019. Mapi Pharma’s poster titled “Glatiramer Acetate Depot (Extended-Release) Phase II Study in Patients with Relapsing Remitting Multiple Sclerosis: Safety, Tolerability and Efficacy (No Evidence of Disease Activity) Two-Years Analysis” will be presented on May 7 between 5:30-6:30 pm EDT as Poster Number 2-052 | Poster Session P3 | Poster Neighborhood 2.
In the extension study, all participants received a 40mg dose of GA Depot once every 4 weeks. The number of adverse events (AEs) was considerably reduced during the second year of treatment compared with the first year. No immediate post-injection reactions, as are frequently seen with Copaxone® and generic glatiramer acetate, were detected. Efficacy results showed there was no significant change in mean Expanded Disability Status Scale (EDSS) score at two years compared with baseline in the per protocol population (PPP). No MRI disease activity was noted in any patients during that period. Eighty-one point eight percent (81.8%) of PPP patients achieved NEDA (No Evidence of Disease Activity) at two years. These excellent results support the design of the Phase III IND submission planned for May 2019.
Ehud Marom, Chairman and CEO of Mapi said, “The continued results of the GA Depot demonstrate the product’s safety, tolerability, and efficacy in RRMS patients. The continuous release of GA via our Depot technology creates efficacious administration to MS patients with minor safety issues. With such results and a near 100% compliance we will improve patients’ lives. Mapi has recently received complementary funding from the Israeli Government to build the Depot plant that will supply GA Depot’s global needs with significant tax benefits.”
Mylan President Rajiv Malik added, “We’re pleased to partner with Mapi to help bring GA Depot to market for relapsing remitting MS patients around the world. The results of the phase II study demonstrate the exciting advancements we’ve made in our development program and most importantly reinforce the benefit for patients as a once-monthly treatment. We look forward to continued progress as move into the Phase III study.”
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, and its ability to foster local cooperation and enduring relationships in all of the countries in which it operates. 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.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.
Contacts:
Alex Mogle
Vice President, Corporate Development
Mapi Pharma
+972 52 6080297
Bob Yedid
Managing Director
LifeSci Advisors, LLC
646-597-6979
