The FDA has approved a new facility in Manati, Puerto Rico, for Romark Laboratories. Approved use includes production of NT-300 (nitazoxanide), a drug considered promising for treatment of COVID-19, as well as its current formulation of the drug as a treatment for diarrhea under the brand name Alinia.
The 35,000 square foot facility currently employs 100 people, and the number is expected to increase to 400 within the next few years. Romark has invested $80 million already in the facility and expects to build it out to 100,000 square feet.
“This is a major milestone for us, as it allows us to expand our capacity to develop and deliver medicines,” said Marc Ayers, President and Chief Executive Officer of Romark.
Romark is producing NT-300, which was previously being trialed for use against influenza. Romark is now ready to roll out Phase 3 trials.
NT-300, an extended-release form of nitazoxanide, has been shown to inhibit the replication of a range of respiratory viruses, including cold and flu as well as coronaviruses. Since viruses cannot live or reproduce on their own, but must inhabit living creatures to spread, a medication that can keep the virus from reproducing in humans could prevent as well as cure COVID-19.
The trials will work with 800 elderly residents of care homes and 800 healthcare workers, both populations which are more likely than most to be exposed to COVID-19. Both groups will participate in double-blind studies in which they will receive either NT-300 or a placebo for 6 weeks.
At the end of the experiment, the infection rates of the control group will be compared with the treatment group to see whether NT-300 can reduce infection by the coronavirus.
There will be a third trial which will test NT-300 as a treatment for people already infected with COVID-19.
Since 5,000 patients have already been involved in clinical trials of the drug over the past decade, NT-300 could be ready to go to market sooner than other options. Trials have taken place at several sites worldwide, including Alabama.
Puerto Rico’s pharmaceutical factories
The new Romark facility brings FDA-approved pharmaceutical manufacturing plants in Puerto Rico at least to 50. More than half of the most popular prescription drugs in the world are made in Puerto Rico. The territory exports more U.S. medications than any State. This established pharmaceuticals industry gives Puerto Rico an advantage as the United States works to bring the medical supply chain home in the face of COVID-19.
Rep. Jenniffer González-Colón (R-PR) and Senator Marco Rubio (R-FL) recently introduced a bill designed to encourage pharmaceuticals and medical device manufacturers to use Puerto Rico as a hub, bringing medical supply chains back to the United States from China and India. Gonzalez-Colon has been working on this issue since the beginning of the pandemic.
President Trump recently issued an executive order encouraging manufacturers and buyers to work to strengthen U.S. medical supply chains.
The majority of the elements used to produce large-volume generic drugs like antibiotics for the U.S. market are currently manufactured in Asia.