Pharma co. Romark waiting on FDA approval of COVID-19 treatment
Research-based pharmaceutical company Romark Global Pharma has completed a clinical trial that showed that a tablet it is manufacturing at its Manatí plant can prevent about 80% of hospitalizations caused by COVID-19 in high-risk patients, company CEO Marc Ayers confirmed.
“We submitted data to the Food and Drug Administration in April and we’re now waiting for an authorization from them to be able to commercialize the product under an Emergency Use Authorization, or otherwise,” he said.
The tablet — the first of its kind — to treat the symptoms of the deadly virus is being manufactured in Manatí, which already has 25 million tablets available for distribution, he said.
“At this very moment, we’re scaling up to be able to manufacture as many as 20 million tablets per week from Puerto Rico and we want to distribute the product of course, in the United States, but ultimately this is a worldwide problem and a worldwide opportunity,” said Ayers in an aside during an event sponsored by the Puerto Rico Economic Development Alliance.
The organization held a roundtable discussion with 10 emerging pharmaceutical companies, which expressed their interest in Puerto Rico as a potential location for their headquarters.
Romark established its local manufacturing plant in 2019 and has since pumped more than $80 million into the 35,000 square-foot operation that in August 2020 got the FDA’s approval to produce Alinia tablets — used to treat intestinal infections — in the US market.
Now, gaining the FDA’s approval for the COVID-19 treatment “can be something that’s really tremendous for the pharmaceutical industry in Puerto Rico and an opportunity for us to do something that’s very special and has a big economic impact here in Puerto Rico,” Ayers said.
Acknowledging that developing the COVID-19 remedy is a capital-intensive project, Ayers said capital investment funding from state or federal governments is welcome.
“That would help us as we complete this project and to bring this product to market, which is direly needed at this present time,” Ayers said. “We believe that we can partner with the government of Puerto Rico, as well as with other state governments and with the federal government, to be able to bring a solution that can help us to curb and even to end the impact of this pandemic.”
Rodrigo Masses, director of the Puerto Rico Economic Development Alliance, said the goal of the meeting was to “meet the companies that are considering or have chosen Puerto Rico for their growth, their projects and challenges and what motivates them to select our island.”
“We want to provide the appropriate forum to discuss their vision of development, as well as to know the areas of opportunity that we have to attract and retain these industries that see us as an option to develop and establish their operation,” said Masses.
Among the points discussed, the companies agreed that establishing themselves in Puerto Rico represents added value because the island has “exceptional talent trained and experienced in the pharmaceutical industry as well as the ideal ecosystem for the development of the industry.”
Puerto Rico is also a US jurisdiction under the applicable laws and same currency, with access to global markets.
However, the participants noted that Puerto Rico’s challenges to continue developing the pharmaceutical industry are energy, changes in US tax laws, the COVID-19 pandemic, research and development infrastructure, and access to investment capital.