Facility in the Jerusalem Har-Hotzim technology park is built at the highest GMP standards; capability to provide reliable supply of COVID-19 vaccines, if approved
NESS ZIONA, Israel – Oct. 7, 2020 – Mapi Pharma Ltd., a fully integrated, late clinical stage biopharmaceutical company, today announced that it will dedicate capacity at its manufacturing facility to support the global effort to provide COVID-19 vaccination to Israel, the EU and globally.
Mapi Pharma has state-of-the-art production facilities for sterile injectable Finished Dosage Forms (FDF). The Company’s large GMP approved facility is audited by the Israeli Ministry of Health. Israeli Ministry of Health approvals are mutually recognized by the EU, with Israeli manufacturers being exempt from the requirement to perform laboratory tests on shipments from Israel to Europe. Furthermore, results of audits performed by the institute for auditing and standards of medical products within the Ministry of Health are also recognized by the European countries.
Mapi is currently expanding its Jerusalem Fill & Finish facility which was originally established by Johnson & Johnson (J&J). Over $100 million has been invested in the facility which was built to supply J&J’s own needs of sterile products. Mapi is now adding a new line for sterile filling and finishing of liquids and powders for injections to the facility. This will support the global effort to bring a COVID-19 vaccine, once approved, to Israeli, EU citizens and potentially from many other countries.
Ehud Marom, Chairman and Chief Executive Officer of Mapi, said, “We are making available our production capacity, as well as our cold-chain and storage capacities, for the delivery of vaccines to Israeli and EU. The global supply chain of vaccinations is currently limited and requires agility to enable the supply of vaccines on a broad scale. By making our manufacturing capacity available, we hope to assist in the quick deployment of vaccines once they are approved by the heath authorities. We are in communications with the major vaccination developers and governments to join forces in the fight against this dangerous virus.”
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 in an agreement under which Mylan was granted an exclusive license to commercialize the GA Depot injection product for relapsing forms of 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, 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.
Contacts:
Alex Mogle
Vice President, Corporate Development
Mapi Pharma
+972 52 6080297
Bob Yedid
Managing Director
LifeSci Advisors, LLC
646-597-6979
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