Mapi Pharma
Mapi Pharma is a clinical stage pharmaceutical company focused on developing complex active pharmaceutical ingredients, long-acting depot injections, and formulations. The company aims to meet unmet patient needs with innovative long-acting treatments, particularly for multiple sclerosis, and has a strong pipeline of products including GA Depot for MS. Mapi is committed to high-quality R&D, regulatory compliance, and strategic partnerships to bring advanced therapies to large markets.
Industries
Nr. of Employees
small (1-50)
Mapi Pharma
Weizmann Science Park, 16 Einstein St., Ness Ziona, Israel 7403620
Patents
Method for suppressing or alleviating primary or secondary progressive multiple sclerosis (PPMS or SPMS) using a sustained release depot formulation comprising glatiramer acetate
US-12343371-B2
View DetailsDepot systems comprising glatiramer or pharmacologically acceptable salt thereof
US-RE50301-E1
View DetailsTreatment of inflammatory bowel disease with long acting glatiramer and adipose-derived stem cells
US-12161688-B2
View Details
Method for suppressing or alleviating primary or secondary progressive multiple sclerosis (PPMS or SPMS) using a sustained release depot formulation comprising glatiramer acetate
US-12343371-B2
View DetailsDepot systems comprising glatiramer or pharmacologically acceptable salt thereof
US-RE50301-E1
View DetailsTreatment of inflammatory bowel disease with long acting glatiramer and adipose-derived stem cells
US-12161688-B2
View DetailsProducts
Long-acting intramuscular depot formulation of glatiramer acetate (once-monthly injection)
An extended-release intramuscular formulation of glatiramer acetate designed for administration once every four weeks; advanced through Phase II/III clinical development with randomized, placebo-controlled pivotal data.
Complex API process technologies and process patents (examples: fingolimod, tapentadol)
Process chemistry and intermediate compound development for complex APIs, with granted patents covering intermediate compounds and scalable synthetic routes.
Long-acting intramuscular depot formulation of glatiramer acetate (once-monthly injection)
An extended-release intramuscular formulation of glatiramer acetate designed for administration once every four weeks; advanced through Phase II/III clinical development with randomized, placebo-controlled pivotal data.
Complex API process technologies and process patents (examples: fingolimod, tapentadol)
Process chemistry and intermediate compound development for complex APIs, with granted patents covering intermediate compounds and scalable synthetic routes.
Services
Clinical and commercial sterile filling and finishing services for liquid and powder injectables, including capacity for vaccine fill & finish and audited GMP production.
Preclinical and clinical formulation development for extended-release depot injections and complex oral extended-release products, including small-scale manufacturing for IND-enabling studies.
Route scouting, intermediate synthesis, pilot production and scale-up to mid-scale commercial reactors; development of cost-effective, scalable synthetic routes.
End-to-end clinical program management for pivotal trials, regulatory strategy for 505(b)(2) and NDA filings, and coordination for multinational trials.
Structuring and executing co-development and commercialization agreements, including milestone-based funding and licensing arrangements for global and regional markets.
Clinical and commercial sterile filling and finishing services for liquid and powder injectables, including capacity for vaccine fill & finish and audited GMP production.
Preclinical and clinical formulation development for extended-release depot injections and complex oral extended-release products, including small-scale manufacturing for IND-enabling studies.
Route scouting, intermediate synthesis, pilot production and scale-up to mid-scale commercial reactors; development of cost-effective, scalable synthetic routes.
End-to-end clinical program management for pivotal trials, regulatory strategy for 505(b)(2) and NDA filings, and coordination for multinational trials.
Structuring and executing co-development and commercialization agreements, including milestone-based funding and licensing arrangements for global and regional markets.
Expertise Areas
- Long-acting injectable development
- Clinical trial management (Phase II/III)
- Complex API synthesis and scale-up
- Sterile manufacturing and aseptic fill & finish
Key Technologies
- Sustained-release depot injectable formulations
- Intramuscular depot delivery
- Aseptic fill & finish technology
- Design of Experiments (DoE)
News & Updates
Mapi Pharma will participate in the 7th Annual Evercore HealthCONx Conference to discuss potential partnerships for its depot products.
Mapi Pharma announced plans for further studies and presented latest clinical results on GA Depot for MS at ECTRIMS-ACTRIMS 2023.
FDA has accepted the NDA for GA Depot, supported by positive Phase III trial results, with a PDUFA date of March 8, 2024.
The patent covers a long-acting depot formulation enabling monthly treatment for MS patients.
The patent covers intermediate compounds and processes for the preparation of Fingolimod, supporting development of a generic version.
Mapi Pharma will participate in the 7th Annual Evercore HealthCONx Conference to discuss potential partnerships for its depot products.
Mapi Pharma announced plans for further studies and presented latest clinical results on GA Depot for MS at ECTRIMS-ACTRIMS 2023.
FDA has accepted the NDA for GA Depot, supported by positive Phase III trial results, with a PDUFA date of March 8, 2024.
The patent covers a long-acting depot formulation enabling monthly treatment for MS patients.
The patent covers intermediate compounds and processes for the preparation of Fingolimod, supporting development of a generic version.