Plant will enable Mapi to supply the initial commercial needs of GA Depot
NESS ZIONA, Israel – March 18, 2019 – Mapi Pharma Ltd., a fully integrated, clinical, late stage biopharmaceutical company, announced today that it has received complementary funding from the Israeli Ministry of the Economy to build a new sterile production plant for GA Depot injectable products. The approved financing plan is for a pioneering production plant for the manufacturing of a slow release formulation of Glatiramer Acetate (GA) (Copaxone®) for treating multiple sclerosis. The plant will be built in Jerusalem, a Zone A region, allowing tax and grants benefits, in an investment of over 46 million NIS, of which the grant is set at over 9 million NIS. The plant will lead to the hiring of an additional 30 employees and all sales are expected to be exported.
GA Depot, a long-acting Glatiramer Acetate (Copaxone®) injection is currently being tested for treating relapsing remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS). Mapi Pharma partnered with Mylan N.V. (NASDAQ: MYL), a leading global specialty and generic pharmaceutical company, 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. For RRMS, a Phase III trial is planned to begin this year. For PPMS, Mapi is planning to initiate a Phase III study in the EU in 2020 and is seeking a co-marketing partner. The new facility is intended to accommodate demand for both indications.
“I am pleased that, as a result of the combined evaluation process conducted by the Israel Innovation Authority and the Israel Investment Authority, these entities have again expressed their confidence in Mapi Pharma and are committed to supporting our future plans to become a fully integrated biopharmaceutical company with in-house production, marketing and R&D capabilities,” said Ehud Marom, Chairman and CEO of Mapi Pharma.
Dr. Nahum Itzkovitz, the Director of the Israel Investment Authority, said: “Mapi Pharma is a leading company in its field. As a strategy, the Israel Investment Authority is promoting biotechnology and biopharmaceutical companies so these companies will be able to pass the regulatory hurdles and develop meaningful production processes in Israel. The Israel Investment Authority is pleased with Mapi Pharma’s development and, in case additional action and support within the scope of the Israel Investment Authority charter is needed, we will be wholeheartedly be willing to do so.”
The funding from the Israeli Ministry of the Economy will support Mapi’s future expansion of production facilities to enable the commercial launch of GA Depot as well as other depot products which are in the Company’s product pipeline.
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.
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