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TMCNet:  Iroko Pharmaceuticals Announces First International Filing for ZORVOLEX®

[July 08, 2014]

Iroko Pharmaceuticals Announces First International Filing for ZORVOLEX®

PHILADELPHIA --(Business Wire)--

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced the company affiliate's first regulatory submission outside of the United States for ZORVOLEX® (diclofenac) capsules. A new drug application was filed for the nonsteroidal anti-inflammatory drug (NSAID) with the Republic of Lebanon Ministry of Public Health (MOPH). ZORVOLEX was approved by the U.S. Food and Drug Administration (FDA) in October 2013 for the treatment of mild to moderate acute pain in adults and is not currently approved for marketing in any other country. A supplemental New Drug Application seeking approval for osteoarthritis pain is currently being reviewed by FDA.

"The first ZORVOLEX filing outside of the United States is a tremendous milestone for our company, building on a very busy first half of 2014, which included the ZORVOLEX U.S. launch, FDA approval of our second low dose NSAID and receipt of critical patents for both products," said John Vavricka, President and CEO of Iroko Pharmaceuticals.

This filing was the result of a licensing agreement signed late last year by the company's affiliate, Iroko Pharmaceuticals Inc., and Algorithm S.A.L. under which Algorithm obtained the exclusive rights to market and sell ZORVOLEX to countries in the Middle East and North Africa (MENA).

"We are pleased with this first milestone to come from our partnership with Iroko and look forward to bringing this low dose NSAID option to patients and prescribers throughout the MENA region," said Selim Ghorayeb, CEO of Algorithm.

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. ZORVOLEX has been available in U.S. pharmacies since January of this year, and has since seen continuing growth in prescriptions.

"We are delighted to see the first fruits of our partnership with Algorithm and are looking forward to expanding access to ZORVOLEX and eventually, other products from our low dose SoluMatrix® NSAID portfolio, across the MENA region and the rest of the world," said Osagie Imasogie, Executive Chairman of the Board, Iroko Pharmaceuticals.

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 Algorithm S.A.L.

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. The portfolio consists of innovative products as well as differentiated generics, focusing mainly on the following therapeutic areas: Cardiometabolic Diseases, Ortho-Rheumatology, Neurology, Onco-Hematology, Endocrinology, Uro-Gynecology, and Dermatology. For more information, visit www.algorithm-lb.com/en_Home.

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.


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