Iroko Pharmaceuticals Inc. has announced that it has entered into a licensing agreement with LABORATORIOS SAVAL S.A. for the exclusive rights to market and sell ZORVOLEX® (diclofenac) capsules, a nonsteroidal anti-inflammatory drug, in an additional five countries in South America.
LABORATORIOS SAVAL S.A. will be responsible for obtaining regulatory and pricing approval as well as provide marketing and distribution in Bolivia, Chile, Ecuador, Paraguay and Peru. Iroko has previously announced international licensing agreements for ZORVOLEX with other partners that cover the South American countries of Brazil, Colombia and Venezuela, as well as Mexico and countries in Central America.
“This agreement with LABORATORIOS SAVAL S.A. now means we have partnerships in more than 90 percent of South American territories for ZORVOLEX and will further expand the global reach of Iroko’s first low dose SoluMatrix® NSAID,” said Osagie Imasogie, Executive Chairman of the Board and Chief Executive Officer of Iroko Pharmaceuticals. “With the signing of this agreement, we now have the opportunity to introduce ZORVOLEX in more than 45 countries around the world.”
ZORVOLEX is approved by the United States Food and Drug Administration (FDA) for the management of mild to moderate acute pain and osteoarthritis pain, and is available at pharmacies across the U.S. ZORVOLEX is also approved by the Republic of Lebanon Ministry of Public Health (MOPH) for these indications, and is now available in 18 mg and 35 mg dosage strengths by prescription.
“We are excited to be partnering with Iroko to bring this valuable treatment to South America, where effective low dose options are needed to treat patients suffering from acute and chronic pain conditions,” said Emilio Saval, Chairman and Owner of LABORATORIOS SAVAL S.A. “We hope this partnership will lead to more patients gaining access to an innovative therapeutic treatment option.”
Additional licensing agreements for ZORVOLEX cover countries across South America, as well as in the Middle East & North Africa (MENA) region, Southern African countries, Australia and New Zealand, and Indonesia.
Iroko is in discussions with additional potential distribution and marketing partners in other international markets. Iroko Pharmaceuticals, LLC, an affiliate of Iroko Pharmaceuticals Inc., will continue to retain all marketing rights to ZORVOLEX in the U.S.