Romark was founded in October 1994 by Jean-François Rossignol and Marc S. Ayers to continue research initiated by Dr. Rossignol in search of an effective treatment for the emerging apicomplexan protozoan, Cryptosporidium parvum (Crypto). Crypto had just stepped into the spotlight in 1993 with a drinking water-related outbreak that affected approximately 400,000 people, and it had also gained prominence as one of the leading opportunistic infections in patients with Acquired Immune Deficiency Syndrome (AIDS). There was no treatment.
Rossignol proposed nitazoxanide, a broad-spectrum antiparasitic drug with activity against intestinal protozoa and helminths, for development as a treatment of Crypto and quickly led testing demonstrating activity of the drug in cell culture assays and in several animal models against Crypto infection.
Nitazoxanide was first registered in Mexico in 1996. The product was marketed as Daxon® by Romark's licensee, Laboratorios Columbia S.A. de C.V. (Mexico D.F.), and the indications included treatment of parasitic infections caused by five intestinal protozoa, six intestinal nematodes, two intestinal cestodes and one liver trematode. These indications are not FDA-approved in the United States. Roemmers SAICF (Buenos Aires, Argentina) later registered nitazoxanide for the same indications in 17 other countries of Latin America. The product has also been registered in India, Bangladesh and Egypt.
Alinia® (nitazoxanide) for Oral Suspension, 100 mg/5 mL was approved for marketing in the United States in 2002, and Alinia (nitazoxanide) Tablets, 500 mg gained FDA approval in 2004. Alinia for Oral Suspension (patients 1 year of age and older) and Alinia Tablets (patients 12 years and older) are FDA-approved for the treatment of diarrhea caused by Giardia lamblia and Cryptosporidium parvum. Alinia for Oral Suspension and Alinia Tablets were not shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients. Cryptosporidium and Giardia are the two most common parasitic infections in the United States.
Romark established a commercial organization in the United States in 2003 to promote its Alinia products and future products that may be partnered, acquired or developed by the company.
In 2013, Romark acquired a manufacturing facility in Landen, Belgium and established a wholly-owned subsidiary, Lapicor BVBA, to manufacture Active Pharmaceutical Ingredient (API) for its products. In 2015, Romark established a new pharmaceutical manufacturing operation in Manatí, Puerto Rico.
During its twenty-year history, Romark has grown from a small research and development organization to become a vertically integrated pharmaceutical company with its own drug discovery, development, manufacturing and commercial capabilities. We continue to take on new challenges in the field of medicine and public health with the same spirit that has characterized our company and its employees from the beginning – expanding our footprint with a vision toward positively impacting the lives of people worldwide.