PharmaEssentia will spend $46 million to build a new manufacturing facility in Puerto Rico. The move forms part of the Taiwanese biotech’s global production expansion strategy, with the goal that the plant will eventually support the supply of PharmaEssentia's rare blood disease treatment, Besremi.
The project is expected to provide PharmaEssentia with enhanced supply security, operational flexibility, cost efficiencies and scalable manufacturing capacity for the future, the company said in a Feb. 9 press release.
In its first phase, the plant is expected to create nearly 100 jobs, with room for the site's workforce to eventually grow in line with further scale-up projects, a company spokesperson told Fierce.
The 40,000-square-foot facility will incorporate robust redundancy and contingency measures—like backup generation and infrastructure safeguards—to ensure uninterrupted operations and product supply, the spokesperson explained.
“Expanding manufacturing capacity outside Taiwan is a core strategic priority for PharmaEssentia as we continue to strengthen supply resilience, scalability, and geographic diversification,” Ko-Chung Lin, Ph.D., PharmaEssentia’s founder and CEO, said in a statement. “We are proud to take this important step toward establishing U.S.-based manufacturing, with Puerto Rico serving as a future center for the U.S. market.”
In January, the biotech unveiled plans to potentially expand the reach of its FDA-approved Besremi to another rare blood disorder after reviewing encouraging results from a phase 3 study.
The company last month said it would head to regulators soon with data from its late-stage SURPASS-ET trial. In the study, which pitted Besremi against platelet-reducing anagrelide as a second-line therapy for patients with essential thrombocythemia (ET), PharmaEssentia's treatment was linked to durable clinical responses and also met a secondary endpoint concerning reductions in JAK2 V617F allelic burden.
ET is a rare blood cancer typically caused by genetic mutations that cause bone marrow to produce too many platelets.
The FDA approved Besremi in 2021 as the first polycythemia vera treatment that patients can take regardless of their treatment history, as well as the first interferon drug approved for the disorder.