Mapi Pharma Explores U.S. Aseptic Manufacturing Facility to Support Growing Demand for Aseptic and Long-Acting Generic and innovative Injectables

Company to present investment opportunity at SelectUSA Summit

NESS ZIONA, Israel, May 04, 2026 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd. (“Mapi” or the “Company”), a late-stage clinical biopharmaceutical company specializing in long-acting injectable therapies, today announced that it is exploring the establishment of a U.S.-based aseptic manufacturing facility to support its expanding pipeline and growing global demand for aseptic and long-acting injectables.

Mapi will present this initiative as part of a corporate overview at the SelectUSA Investment Summit, to take place May 3–6, 2026, in National Harbor, Maryland, where the Company will also meet with potential partners and investors.

Long-acting injectable (LAI) therapies are increasingly recognized as a critical treatment option across multiple indications, offering improved patient adherence, consistent drug delivery, and reduced dosing frequency. However, these products are complex to develop and manufacture, requiring specialized expertise and infrastructure that are often not available through traditional contract manufacturing sources.

Mapi has built advanced R&D and GMP-compliant manufacturing capabilities in Israel, approved by the Israeli Ministry of Health and recognized by European regulatory authorities for global supply. Building on this foundation, the Company is evaluating the establishment of a U.S. aseptic manufacturing facility to serve both domestic and international markets.

The Company is exploring a partnership-based structure for the project, which may include the formation of a new entity supported by strategic and financial investors. Mapi will use its expertise and previous investment and will look for partner(s) for capital investment and potential commercial capabilities.

“The United States represents the largest and most important market for aseptic and long-acting injectables, including GLP-1 and CNS therapies,” said Ehud Marom, Chairman and Chief Executive Officer of Mapi Pharma. “Expanding our manufacturing footprint into the U.S. would position us to better support future commercialization and ensure reliable product supply for patients worldwide.”

Marom added, “Recent pharmacokinetic results from our ongoing long-acting Cariprazine Depot program mark an important milestone. The positive data aligns with our predictive models and support our planned Phase III initiation in 2027. We believe a long-acting formulation of Cariprazine Depot could address significant unmet needs in schizophrenia and bipolar disorder.”

The SelectUSA Investment Summit brings together representatives from U.S. states and territories, global companies, and government leaders to facilitate investment opportunities. Mapi’s management team will be available for one-on-one meetings to discuss strategic partnerships, including joint development opportunities and participation in the planned U.S. manufacturing initiative.

About Mapi Pharma
Mapi Pharma is a clinical-stage pharmaceutical company focused on the development of high-value, complex injectable therapies with significant barriers to entry. The Company’s portfolio includes long-acting depot formulations targeting large and growing markets, including central nervous system disorders and metabolic diseases. Key pipeline programs include long-acting formulations of Cariprazine, as well as GLP-1 therapies such as Semaglutide and Tirzepatide for diabetes and weight management. Mapi is also developing an AB-rated generic version of Naltrexone (Vivitrol^®) and markets generic versions of Fingolimod (Gilenya^®) and Apremilast (Otezla^®) in select regions. Mapi combines deep expertise in chemistry, pharmaceutical development, and clinical execution with a strong intellectual property portfolio, including numerous granted patents primarily focused on formulations. The Company operates dedicated R&D and aseptic manufacturing facilities for long-acting injectable dosage forms. For more information, please visit www.mapi-pharma.com.

Contacts:
Alex Mogle
Vice President, Corporate Development
Mapi Pharma
+972 52 6080297
alex@mapi-pharma.com

Brian Ritchie
Managing Director
LifeSci Advisors, LLC
britchie@lifesciadvisors.com

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