Iroko Pharmaceuticals Signs New Strategic Agreement With Landsteiner Scientific to Bring ZORVOLEX® to Mexico

PHILADELPHIA--()--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 Landsteiner Scientific, S.A. de C.V., for the exclusive rights to market and sell ZORVOLEX® (diclofenac) capsules in Mexico. Landsteiner Scientific will be responsible for obtaining regulatory and pricing approval, as well as the marketing and distribution of the medication.

“This additional licensing agreement with Landsteiner Scientific continues to expand potential access of ZORVOLEX to patients in Mexico, and marks Iroko’s third international agreement in the past four months,” said John Vavricka, President and CEO of Iroko Pharmaceuticals. “This is an important milestone for the company, as we look to increase our global commercialization footprint.”

ZORVOLEX is approved by the United States Food and Drug Administration (FDA) for the management of mild to moderate acute pain and osteoarthritis pain1. ZORVOLEX is not currently approved for marketing in any other country.

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. In July 2014, Iroko announced that Algorithm S.A.L. submitted a new drug application for ZORVOLEX with the Republic of Lebanon Ministry of Public Health (MOPH), marking the first international filing acceptance. Additionally, in July 2014 Iroko entered into strategic licensing agreements with EMS and CALOX DE COSTA RICA S.A. to market and sell ZORVOLEX in specified countries in Latin America.

“We are excited at the opportunity to partner with Iroko in order to bring ZORVOLEX to eligible patients in Mexico, who may benefit from additional treatment options for pain,” said Francisco Kuri-Brena, New Developments Director of Landsteiner Scientific, S.A. de C.V.

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 Landsteiner Scientific, S.A. de C.V.

Landsteiner Scientific, S.A. de C.V. engages in the research and development, manufacture, distribution, and marketing of healthcare products in Mexico and other Latin markets. The company was founded in 1998 and is based in Mexico City, Mexico with additional offices in Chapel Hill, North Carolina, Toluca, Monterrey, and Guadalajara, Mexico.

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.

Contacts

For Iroko Pharmaceuticals, LLC
Jessica Donnelly, 212-798-9819
or
Iroko Pharmaceuticals, LLC
Kate de Santis, 267-546-1682

Contacts

For Iroko Pharmaceuticals, LLC
Jessica Donnelly, 212-798-9819
or
Iroko Pharmaceuticals, LLC
Kate de Santis, 267-546-1682