Mapi Pharma

Mapi Pharma, established in January 2008, is a late-stage clinical pharmaceutical company specializing in the development of life cycle management (LCM) products and high-barrier generic drugs. The company was founded by Ehud Marom, who serves as Chairman and CEO. Marom brings over 40 years of experience in the life sciences industry, having held senior roles at companies like Teva Pharmaceutical Industries, where he was involved in the launch of Copaxone®, and served as CEO for Gamida-Cell Ltd. and Makhteshim. His extensive background in chemical engineering and pharmaceutical management, particularly with Copaxone®, directly relates to Mapi's focus on developing an improved version of the same drug.

The company's core business revolves around creating proprietary, extended-release depot injectable versions of commercially successful drugs. This strategy aims to improve patient compliance, reduce side effects, and extend patent protection for drugs nearing patent expiration. Mapi's business model involves in-house development and manufacturing, followed by commercialization through co-development and marketing partnerships with large pharmaceutical companies. A key partnership is with Viatris (formerly Mylan), which holds an exclusive license to commercialize Mapi's lead product, GA Depot, for relapsing forms of multiple sclerosis (RMS).

Mapi's flagship product, GA Depot, is a long-acting, once-monthly intramuscular injection of glatiramer acetate, a modified version of Teva's Copaxone® which requires more frequent injections. This reduced dosing schedule is its main benefit, potentially improving patient adherence. A Phase III trial for RMS met its primary endpoint, showing a significant reduction in the annualized relapse rate compared to a placebo. However, the FDA issued a Complete Response Letter (CRL) in March 2024 for the New Drug Application (NDA), and the company is evaluating its next steps. GA Depot is also in Phase II trials for Primary Progressive Multiple Sclerosis (PPMS). Beyond GA Depot, the pipeline includes extended-release versions of drugs for neuropathic pain (Pregabalin ER), schizophrenia (Paliperidone Palmitate), and diabetes (GLP-1), among others. The company also markets its own generic versions of Fingolimod and Apremilast in certain regions.

Mapi Pharma is a fully integrated company with its headquarters in Ness Ziona, Israel. It operates R&D facilities in Israel and China, a GMP-approved API (Active Pharmaceutical Ingredient) production facility in Neot Hovav, and a sterile fill-and-finish manufacturing plant for injectable dosage forms in Jerusalem. Keywords: Mapi Pharma, Ehud Marom, GA Depot, glatiramer acetate, multiple sclerosis, long-acting injectables, depot technology, life cycle management, generic drugs, Viatris, pharmaceutical development, clinical trials, Copaxone, extended-release, drug formulation, API manufacturing, sterile injectables, neuropathic pain, schizophrenia treatment, Ness Ziona, Israel pharma