PHILADELPHIA. - Tuesday, July 22nd 2014 [ME NewsWire]

(BUSINESS WIRE) Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that its affiliate, Iroko Pharmaceuticals Inc., signed a licensing agreement with CALOX DE COSTA RICA S.A. for the exclusive rights to market and sell ZORVOLEX® (diclofenac) capsules in specified countries in Latin America. CALOX will be responsible for obtaining 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. 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.

“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,” said John Vavricka, President and CEO of Iroko Pharmaceuticals.

Iroko will continue to retain all marketing rights to ZORVOLEX in the U.S. 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. Additionally, in July 2014, Iroko entered into a strategic agreement with EMS to market and sell ZORVOLEX in Brazil.

“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,” said Andrés Finol, CEO of CALOX de Costa Rica S.A.

About ZORVOLEX

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. For more information, visit www.ZORVOLEX.com.

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

Important Safety Information about ZORVOLEX

Cardiovascular Risk

Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

ZORVOLEX is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

ZORVOLEX is contraindicated in patients with: a known hypersensitivity to diclofenac or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

ZORVOLEX should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Elevation of one or more liver tests may occur during therapy with ZORVOLEX. Physicians should measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with ZORVOLEX. ZORVOLEX should be discontinued immediately if abnormal liver tests persist or worsen.

NSAIDS, including ZORVOLEX, can lead to the new onset or worsening of existing hypertension which may contribute to the increased incidence of cardiovascular events. Blood pressure should be monitored closely during treatment with ZORVOLEX. NSAIDs may diminish the antihypertensive activity of thiazides, loop diuretics, ACE inhibitors and angiotensin II antagonists.

Fluid retention and edema have been observed in some patients taking NSAIDs. ZORVOLEX should be used with caution in patients with fluid retention or heart failure.

Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. ZORVOLEX should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors.

Treatment with ZORVOLEX in patients with advanced renal disease is not recommended.

Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to ZORVOLEX and should be discontinued immediately if an anaphylactoid reaction occurs.

NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens – Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. ZORVOLEX should be discontinued if rash or other signs of local skin reaction occur.

Starting at 30 weeks gestation, ZORVOLEX and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur.

Concomitant administration of diclofenac and aspirin or anticoagulants is not generally recommended because of the risk of increased GI bleeding higher than users of either drug alone.

Most common adverse reactions in clinical trials (incidence ≥2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, flatulence, pain in extremity, and dyspepsia.

ZORVOLEX capsules do not result in an equivalent systemic exposure to diclofenac as other oral formulations. Therefore, do not substitute similar dosing strengths of other diclofenac products for ZORVOLEX.

Please see full Prescribing Information for additional important safety and dosing information.

About CALOX de Costa Rica S.A.

CALOX de Costa Rica S.A. is a leading manufacturer and marketer of pharmaceutical products with headquarters in San José, Costa Rica. The company is engaged in the production and marketing of high quality medicines, and focuses on the principles of productivity, consistency and independence. To learn more about CALOX de Costa Rica S.A., please visit www.calox.com.

About Iroko Pharmaceuticals, LLC

Iroko is a global specialty pharmaceutical company, based in Philadelphia, dedicated to advancing the science of analgesia. The company develops and globally commercializes pharmaceutical products. In addition to the Iroko products that are marketed worldwide, the company has a robust pipeline of investigational low dose NSAID products being developed using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™. For more information, visit www.iroko.com.

SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and the technology is licensed to Iroko for exclusive use in NSAIDs.

SoluMatrix® is a trademark of iCeutica Pty Ltd and is licensed to Iroko.

Contacts

For Iroko Pharmaceuticals, LLC

Jessica Donnelly, 212-798-9819

Iroko Pharmaceuticals, LLC

Kate de Santis, 267-546-1682