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Iroko Pharmaceuticals Enters into Strategic Agreements to Expand Commercialization of ZORVOLEXTM (diclofenac) Outside the U.S.
Associated Press
2013-12-12 03:01 AM

PHILADELPHIA--(BUSINESS WIRE)--Dec 11, 2013--Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that its affiliate, Iroko Pharmaceuticals Inc., 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.

About ZORVOLEX? (diclofenac) Capsules

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.

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 ?V 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? ?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 .

About PT Pratapa Nirmala-Fahrenheit

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. The company's sales come from more than 10,000 respected doctors with strong customer base of surgeon, internist, gastroenterologist, anesthesiologist, hepatologist and cardiologist. Fahrenheit's marketing network covers almost the entire country with 32 base towns and a sales team of more than 300 members. For further information, please kindly visit our website at

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 lower dose NSAID products being developed using iCeutica Pty Ltd's proprietary SoluMatrix Fine Particle Technology?. For more information, visit .

SoluMatrix Fine Particle Technology? is a trademark of iCeutica Pty Ltd, and is licensed to Iroko for exclusive use in NSAIDs.

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CONTACT: for Iroko Pharmaceuticals, LLC

Jessica Donnelly, 212-798-9819

or

Iroko Pharmaceuticals, LLC

Kate de Santis, 267-546-1682

KEYWORD: LEBANON UNITED STATES ASIA PACIFIC NORTH AMERICA AFRICA PENNSYLVANIA MIDDLE EAST INDONESIA

INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL OTHER HEALTH FDA

SOURCE: Iroko Pharmaceuticals, LLC

Copyright Business Wire 2013

PUB: 12/11/2013 11:39 AM/DISC: 12/11/2013 11:39 AM

http://www.businesswire.com/news/home/20131211005999/en

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