Iroko Pharmaceuticals Inc., an affiliate of Iroko Pharmaceuticals, LLC, has signed licensing agreements with Algorithm SAL and PT Pratapa Nirmala (Fahrenheit), under which the two companies will obtain the exclusive rights to market and sell Zorvolex (diclofenac) capsules to countries in the Middle East, North Africa (MENA) and Indonesia, respectively.

Under the terms of both agreements, Algorithm and Fahrenheit will be responsible for achieving regulatory and pricing approval, as well as the marketing and supply of the medication, in their respective regions. Zorvolex was approved by the United States Food and Drug Administration (FDA) in October 2013, and is not currently approved for marketing in any other country.

“Our model has always been to utilize the expertise and knowledge of our valuable partners in different regions worldwide and, through collaborations, to bring our products to patients in those markets,” said John Vavricka, president and CEO of Iroko Pharmaceuticals. “It’s Iroko’s goal to make lower dose NSAIDs available to patients around the world in order to address unmet medical needs in analgesia. We are excited to be partnering with these leading companies to bring Zorvolex to the Middle East, North Africa and Indonesia.”

Iroko will continue to retain all marketing rights to Zorvolex in the United States, and is in discussions with additional companies to bring Zorvolex to other international markets.

“We are pleased to be partnering with Iroko to bring this important medication to patients and prescribers in the MENA region in order to provide a lower dose NSAID option,” said Selim Ghorayeb, CEO of Algorithm.

“Through this partnership with Iroko, we will be able to provide patients in Indonesia, who may benefit from a lower dose NSAID, with access to Zorvolex,” said Dr Hartoyo Sutandar, president of Fahrenheit.

Zorvolex is the first and only NSAID developed using proprietary SoluMatrix Fine Particle Technology. 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 other global professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration of time consistent with individual patient treatment goals.

Zorvolex is indicated for the treatment of mild to moderate acute pain in adults.

Algorithm, a Lebanon-based pharmaceutical manufacturer, is actively present in the MENA region and Cyprus. Algorithm is dedicated to offering quality products, either under license from reputable international companies or developed by the company’s product development team.

PT Pratapa Nirmala-Fahrenheit is a leading local pharmaceutical company in Indonesia. The production facilities of the company comply with the cGMP international standards. The company develops a wide range of ethical products for the cardiovascular, nephrology, respiratory, alimentary, genitor-urinary system, antibiotic and vitamins from simple oral to IV and injectable forms.

Iroko is a global specialty pharmaceutical company, based in Philadelphia, dedicated to advancing the science of analgesia.