Pharmaceutical Business review

Iroko Pharmaceuticals, CALOX partner to commercialize Zorvolex in Latin America

Under the deal, CALOX will be responsible for securing regulatory and pricing approval, as well as the marketing and supply of the medication, in countries including Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Nicaragua, Honduras, Panama and Venezuela.

In October 2013, the US Food and Drug Administration (FDA) had approved Zorvolex for the treatment of mild to moderate acute pain in adults and is currently available by prescription.

The company said that the drug is currently not approved for marketing in any other country and will continue to retain all marketing rights to Zorvolex in the US.

Iroko Pharmaceuticals president and CEO John Vavricka said: "Coming on the heels of our first international regulatory submission, this agreement with CALOX will help us further expand access to Zorvolex into a number of countries in Latin America, with nine new countries in the region covered."

In 2013, Iroko entered into strategic agreements with Algorithm and PT Pratapa Nirmala (Fahrenheit), under which the two firms secured exclusive rights to market and sell Zorvolex in countries in the Middle East, North Africa (MENA) region and Indonesia, respectively.

In July 2014, the company had entered into a strategic agreement with EMS to market and sell Zorvolex in Brazil.

CALOX CEO Andrés Finol said: "This partnership with Iroko is exciting as we can now bring an important new low dose NSAID option to patients living with acute pain in the countries where we operate in Central and South America."