Israeli drug development company Mapi Pharma announced today that it will dedicate capacity at its manufacturing facility in Jerusalem’s Har Hotzvim industrial park to produce Covid-19 vaccine for Israel, the EU and internationally. Mapi Pharma is in talks with at least one of the leading companies in the race to produce a Covid-19 vaccine.
There are currently five major pharmaceutical companies in advanced trials with the US FDA or equivalent European authorities for a Covid-19 vaccine. Pfizer and its German partner BioNTech plan to publish results about its Phase III trial later this month and US company Moderna expects initial results next month. Johnson & Johnson hopes to publish results before the end of the year. UK company AstraZeneca is in Phase III trials in Britain but parallel trials in the US have stalled due to the serious side-effect suffered by one of the participants. A fifth candidate Novavax is about to begin Phase III trials. In Israel, the Israel Institute for Biological Research (IIBR) have started human clinical trials and expect to be ready for the market by July next year. In additions vaccine candidates have been approved for emergency use in Russia and China.
If and when a safe and effective vaccine is available, the struggle will begin by countries around the world to obtain enough doses of vaccine to administer to their citizens. Many countries in Europe and North America have already signed contracts with the aforementioned companies to reserve vaccine when available. Israel has already signed a deal with Moderna for a limited amount of vaccine. But if an Israeli company like MAPI Pharma is permitted to produce the vaccine for one of the aforementioned companies in the country, it is likely to make it easier for the Israeli government to get hold of larger amount of the vaccine.
Mapi Pharma says it 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 whose 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 and 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.
Mapi chairman and CEO Ehud Marom 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 health authorities. We are in communications with the major vaccination developers and governments to join forces in the fight against this dangerous virus.”
Mapi‘s lead product, currently in clinical trials, is a slow release generic version of multiple sclerosis treatment Copaxone for administering just once a month, instead of the current three times per week.
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 and as the Chairman of Pharma Two B.
For more information, please visit: www.mapi-pharma.com.
SOURCE: Globes, Israel business news – en.globes.co.il – on October 7, 2020
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