Our Company

Our Company

We are a late clinical stage pharmaceutical company, engaged in the development of improved extended-release versions of existing commercially successful products, which we refer to as life cycle management, or LCM products, that target large markets, as well as high-barrier to entry and high-added value generic drugs.

Clinical stage
pharmaceutical
company

Our core capabilities are in long acting depot injectable drugs that are complex formulations in sterile production. We are fully integrated in our activities and are 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 a sterile manufacturing and Fill & Finish for injectable Finished Dosage Form facility in Jerusalem.

Life Cycle Management Products

Our LCM products are new, proprietary forms of marketed drugs which offer advantages over existing formulations, such as improved patient compliance and reduced side effects and allow extended patent protection and regulatory exclusivity due to different formulations of product components. Our LCM product candidates seek to improve patients’ disease management and to increase their treatment adherence as well as to add value to drugs that are expected to go off-patent by integrating off-patent active pharmaceutical ingredients, or APIs, with our proprietary formulations, resulting in a new proprietary final combinations.

Glatiramer Acetate Depot

a once-monthly injection for the treatment of patients with multiple sclerosis

Our lead product candidate is Glatiramer Acetate Depot, a once-monthly injection for the treatment of patients with multiple sclerosis, in contrast to the daily 20 mg and the thrice-weekly 40 mg dosage of Copaxone®, Teva Pharmaceutical Industries Ltd.’s approved product. We have successfully completed an open-label Phase II clinical trial in Israel and are currently in the course of a single pivotal Phase III clinical trial to support a marketing application under the 505(b)(2) regulatory pathway. We have partnered with Mylan N.V. (NASDAQ: MYL), a global 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. Concurrently, we are running a Phase II trial in primary progressive multiple sclerosis (PPMS).

Unique and proprietary pipeline

We are developing other LCM products targeting large markets such as Pregabalin ER, an extended release oral form of Lyrica®, Pfizer, Inc.’s Pregabalin-based drug, for the treatment of neuropathic pain and epilepsy, GLP-1 peptides as long acting injectable and Buspirone ER an anti- anxiety drug. We are also developing Paliperidone, Aripiprazole for the treatment of schizophrenia and bipolar disorder as identical Qualitative and Quantitative (QQ) composition versions to the currently marketed drugs.

Complex
APIs

In addition to our LCM product platform, we are also developing finished dosage formulations, or FDFs, and a portfolio of complex APIs for the development, manufacture and sale of generic pharmaceuticals. We specifically intend to develop FDFs for generic versions of branded drugs that are scheduled to come off patent, including generic versions of the thrice-weekly 40 mg dosage of Copaxone®, which we expect to develop under abbreviated new drug applications, or ANDAs. Some of the FDFs we intend to develop will utilize complex APIs owned and developed by us. We intend to commercialize our LCM products, APIs and FDFs through forming co-development and marketing partnerships with large pharmaceutical companies.