Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that its affiliate, Iroko Pharmaceuticals Inc., has signed a licencing agreement with EMS for the exclusive rights to market and sell Zorvolex (diclofenac) capsules in Brazil.

EMS, the largest pharmaceutical company in Brazil, will be responsible for obtaining regulatory and pricing approval, as well as the marketing and supply of the medication, in that territory. Zorvolex was approved by the United States Food and Drug Administration (FDA) in October 2013 for the treatment of mild to moderate acute pain in adults and is now available by prescription. Zorvolex is not currently approved for marketing in any other country.

“This new strategic partnership will allow us to utilise the expertise and knowledge of EMS to further expand access and availability of zorvolex to regions outside of the United States where patients continue to have needs for additional treatment options for acute pain,” said John Vavricka, president and chief executive officer, of Iroko Pharmaceuticals.

Iroko will continue to retain all marketing rights to Zorvolex in the United States. In late 2013, Iroko entered into strategic agreements with Algorithm SAL and PT Pratapa Nirmala (Fahrenheit), under which the two companies obtained the exclusive rights to market and sell Zorvolex in countries in the Middle East, North Africa (MENA) and Indonesia, respectively.

“As a company that is committed to bringing new treatment options to people living in Brazil, we are pleased to be entering into such an agreement with Iroko, which will offer Zorvolex access to patients and prescribers throughout the country. Expanding EMS’s operations into innovation-driven segments is a strategy defined by EMS in order to maintain its differentiation in the Brazilian market and its leadership position,” said Marcus Sanchez, vice president of Institutional Marketing of EMS.

Zorvolex is the first low dose FDA-approved NSAID developed using proprietary SoluMatrix Fine Particle Technology that is now available by prescription. Zorvolex contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. Zorvolex was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals. Zorvolex is not approved for the treatment of osteoarthritis pain. A supplemental New Drug Application seeking approval for this indication is currently being reviewed by FDA.Zorvolex is indicated for the treatment of mild to moderate acute pain in adults.   

EMS is the largest pharmaceutical company in Brazil, a market leader and second largest pharmaceutical company in Latin America1. With 50 years of experience, the company specializes in producing branded and generic prescription drugs, as well as over-the-counter medications, for a wide range of therapeutic categories.