Iroko Pharmaceuticals Announces International Regulatory Approval For ZORVOLEX®

PHILADELPHIA--(BUSINESS WIRE)--Iroko Pharmaceuticals Inc., a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced the Republic of Lebanon Ministry of Public Health (MOPH) has approved ZORVOLEX^®, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults and osteoarthritis (OA) pain. ZORVOLEX was approved by the U.S. Food and Drug Administration (FDA) in August 2014 for the management of OA pain and in October 2013 for the treatment of mild to moderate acute pain in adults¹.

“ZORVOLEX first became available in the United States in January 2014, gained FDA approval for an additional indication in August, and now we’re closing out the year with this international approval for both indications”

“This regulatory approval for ZORVOLEX marks an important milestone in the international commercialization strategy for our low dose NSAID portfolio. In less than a year, we initiated our fruitful partnership with Algorithm S.A.L, filed a marketing authorization application for ZORVOLEX with regulatory authorities in Lebanon and successfully gained approval,” said John Vavricka, President and CEO of Iroko Pharmaceuticals. “We’ve created a strong foundation with multiple agreements such as this, which will help us bring ZORVOLEX to patients around the world.”

This approval was the result of a licensing agreement signed in late 2013 by Iroko Pharmaceuticals Inc. and Algorithm S.A.L. under which Algorithm obtained the exclusive rights to register and market ZORVOLEX in countries in the Middle East and North Africa (MENA).

“We look forward to more approvals throughout the MENA region as we continue to foster our partnership with Iroko,” said Selim Ghorayeb, CEO of Algorithm.

Iroko Pharmaceuticals, LLC will continue to retain all marketing rights to ZORVOLEX in the U.S. Since late 2013, its affiliate, Iroko Pharmaceuticals Inc., has entered into six strategic agreements with pharmaceutical companies worldwide, who are obtaining the exclusive rights to market ZORVOLEX within their regions, and is in discussions with additional companies to bring ZORVOLEX to other international markets. Current agreements cover countries in the MENA region, Australia and New Zealand, Indonesia, and countries in Latin America, including the Central America region, Colombia, Venezuela, Mexico and Brazil.

“ZORVOLEX first became available in the United States in January 2014, gained FDA approval for an additional indication in August, and now we’re closing out the year with this international approval for both indications,” said Osagie Imasogie, Executive Chairman of the Board, Iroko Pharmaceuticals. “This milestone solidifies our goal of bringing the first product from our low dose NSAID portfolio to the millions of people living with acute and osteoarthritis pain worldwide.”

About ZORVOLEX
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 the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology™ and 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. In September 2014, ZORVOLEX was shortlisted in the Best New Drug category for the 10th Annual SCRIP Awards, an award which recognizes excellence in pharmaceutical development. For more information, visit www.ZORVOLEX.com.

ZORVOLEX is indicated for the management of mild to moderate acute pain and osteoarthritis pain.

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 that is higher than in users of either drug alone.

Most common adverse reactions in clinical trials (incidence =2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, alanine aminotransferase increased, blood creatinine increased, hypertension, 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.

For more information, visit www.ZORVOLEX.com.

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.

Iroko is at the forefront of the development of SoluMatrix® NSAIDs – new low dose drug products based on existing NSAIDs – using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™ exclusively licensed to Iroko for NSAIDs. ZORVOLEX is the first SoluMatrix® NSAID and is available in pharmacies; a second was approved by FDA in February 2014. 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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¹ ZORVOLEX Prescribing Information.