Drugmaker plans Puerto Rico plant

EXPANSION: PharmaEssentia has market capitalization near US$20 billion and subsidiaries in the US, Japan, Hong Kong, China, South Korea and Singapore

Biopharmaceutical company PharmaEssentia Corp (藥華醫藥) is expanding its global manufacturing and commercial footprint, planning a US$46 million production facility in Puerto Rico to begin operations next year while consolidating its North American business to support the international growth of its blood cancer drug ropeginterferon alfa-2b (Ropeg).

The company said the expansion is part of its strategy to establish manufacturing bases in Taiwan and the US, enhance supply chain resilience and support Ropeg’s global growth following regulatory approvals for the drug to treat essential thrombocythemia (ET), a rare blood cancer characterized by excessive platelet production.

PharmaEssentia said that its board of directors in February approved the US$46 million investment in a Puerto Rico subsidiary, and it signed an investment agreement for the new facility in March.

People visit the PharmaEssentia Corp booth at the BIO Asia-Taiwan Exhibition at the Taipei Nangang Exhibition Center on July 16.

Photo: CNA

The plant outside of San Juan, Puerto Rico, is expected to begin operations next year, subject to regulatory approvals. It would be designed to meet the same quality standards as PharmaEssentia’s manufacturing facility in Taichung, with local staff scheduled to receive training in Taiwan as part of the technology transfer process, PharmaEssentia said.

The company said expanding manufacturing capacity outside Taiwan would help diversify production risks and enhance the resilience of its global supply chain.

PharmaEssentia also completed the acquisition of Canadian pharmaceutical company FORUS Therapeutics Inc in June for US$36.5 million, acquiring 100 percent of its shares. PharmaEssentia said the acquisition would enable the company to integrate the two businesses’ teams and resources, expand its presence in Canada and build a broader North American operating platform.

The overseas investments come as the company expands the applications of Ropeg, marketed under the brand name BESREMi, which was developed by PharmaEssentia founder and CEO Lin Ko-chung (林國鐘).

Lin developed Ropeg using proprietary PEGylation technology and advanced small-molecule synthesis techniques to link polyethylene glycol to interferon alpha, producing a long-acting interferon with a stable chemical structure and uniform composition, PharmaEssentia said.

Ropeg was first approved to treat polycythemia vera (PV), another rare blood cancer classified as a myeloproliferative neoplasm (MPN), in the EU in 2019, followed by the US in 2021 and Japan in 2023. It has since been approved and launched for PV treatment in about 50 countries, the company said.

In May, Taiwan approved Ropeg for adults with ET who are resistant to or intolerant of hydroxyurea treatment. Japan and the US followed with approvals in August, the company said.

PharmaEssentia said Ropeg is the first new treatment approved by the US Food and Drug Administration for ET in nearly three decades and the only drug currently approved by the agency to treat both ET and PV.

Clinical trials have shown that Ropeg can be administered once every two weeks, compared with the standard once-weekly regimen for Pegasys, a conventional pegylated interferon therapy, offering a less frequent injection schedule, the company said.

Meanwhile, the company said it is conducting a global Phase 3 clinical trial, HOPE-PMF, to evaluate Ropeg as a potential treatment for primary myelofibrosis (PMF), another rare blood cancer with limited treatment options.

The study focuses on patients with early-stage PMF, who are typically monitored without treatment because no drug therapies are approved for this stage of the disease, PharmaEssentia said.

From PV and ET to PMF, PharmaEssentia said it is expanding its MPN portfolio, hoping to bring accessible treatment options to more people worldwide.

Founded in 2003, PharmaEssentia specializes in biologics for hematologic cancers and has developed capabilities spanning drug discovery, clinical trials, manufacturing and global commercialization.

The company has established subsidiaries in the US, Japan, Hong Kong, China, South Korea and Singapore since 2017, while expanding into Europe and Latin America through licensing partnerships.

This year, PharmaEssentia’s market capitalization approached US$20 billion, making it Taiwan’s only biotechnology company among the country’s 50 largest listed companies by market value.