Sterile injectable facility will enable the supply of commercial needs as part of the agreement with Mylan
NESS ZIONA, Israel – July 15, 2019 – Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company announced today that is has signed a long term lease agreement at the Har-Hotzvim Hi-Tech Park in Jerusalem for the establishment of a new sterile production plant for GA Depot injectable products. The ~50,000 square foot plant was previously part of Omrix Biopharmaceuticals, Inc., a Johnson & Johnson Company (JNJ: NYSE), and was an FDA-approved facility.
The new leased area will be used for commissioning a commercial scale production facility for GA Depot and is a scale-up to the current Israeli Ministry of Health (MOH) GMP approved facility the Company operates to supply the ongoing clinical trials (Phase II, III). The plant includes clean-room infrastructure that was constructed to a very high standard.
Ehud Marom, Chairman and CEO of Mapi said, “As we prepare for the future commercialization of GA Depot, which we believe has multi-billion dollar sales potential, we were happy find the right infrastructure and professionals at a convenient Jerusalem location and look forward to expanding our production footprint in the city. This is consistent with Mapi’s overall strategic plan to commercialize a market leading product for treating MS and manufacture it in Israel.”
The new facility is partially funded by a grant of over $2.5 million (approximately 9 million NIS) received in March 2019 from the Israeli Ministry of the Economy, as part of an overall investment in equipment of approximately $13 million. The plant is located in a Zone A region, allowing tax and grants benefits, and its establishment will lead to the hiring of tens of employees. All sales are expected to be exported. The new facility will be an important element in Mapi’s production capacity which includes a GMP approved API facility in Neot Hovav and a GMP approved QA laboratory in Ness Ziona.
GA Depot, a long-acting Glatiramer Acetate (Copaxone®) injection is currently being investigated for treating relapsing remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS). In April 2018 Mapi Pharma partnered with Mylan N.V. (NASDAQ: MYL), a leading global pharmaceutical company, in an agreement which granted Mylan an exclusive license to commercialize GA Depot injection for relapsing multiple sclerosis. Under the term of the agreement, Mapi will supply GA Depot to Mylan for commercial sale.
About Mapi Pharma
Mapi is a late 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.
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