Phase 3 Data from Iroko Pharmaceuticals’ SoluMatrix® NSAID Portfolio to be Presented at EULAR 2014

First Reporting of SoluMatrix® Meloxicam Data Selected for Presentation

PHILADELPHIA, MAY 22, 2013 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today that data from the company’s portfolio of low dose nonsteroidal anti-inflammatory drugs (NSAIDs) developed using the SoluMatrix Fine Particle Technology™  were accepted for publication/presentation at the upcoming 2014 European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, taking place June 11-14 in Paris, France.  One of the abstracts being presented is new data from a Phase 3 study of Iroko’s investigational SoluMatrix® meloxicam in osteoarthritis pain.

“With two FDA approved products and a pipeline of four additional compounds, we are at the forefront of a new era in analgesia,” said Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals. “This new meloxicam data demonstrates Iroko’s progress in bringing new low dose NSAID options to patients and healthcare providers.”

Details of the Iroko Pharmaceuticals data to be presented follow:

Abstract Title & Number

Authors

Presentation Date & Time

Lower-Dose SoluMatrix® Meloxicam: Efficacy and Safety in a Phase 3 Study in Adults with Osteoarthritis Pain

Abstract   #THU0200

Altman, Roy D. MD; Hochberg, Marc MD, MPH; Gibofsky, Allan FACP,   JD, MD; Parenti, Dennis MD; Young, Clarence MD

Thursday, June 12 at 11:45 a.m. UTC/5:45 a.m. EDT

Lower-Dose Indomethacin: Combined  Safety Data from Two Phase 3 Studies in   Patients with Acute Pain Following Elective Surgery

Abstract   #THU0337

Altman, Roy D. MD; Gibofsky, Allan FACP, JD, MD; Parenti, Dennis   MD; Young, Clarence MD

Thursday, June 12 at 11:45 a.m. UTC/5:45 a.m. EDT

Lower-Dose SoluMatrix® Indomethacin Efficacy in Acute Pain:   Results from Two Phase 3 Studies

Abstract   #THU0336

Altman, Roy D. MD; Gibofsky, Allan FACP, JD, MD; Parenti, Dennis   MD; Young, Clarence MD

Thursday, June 12 at 11:45 a.m. UTC/5:45 a.m. EDT

Pharmacokinetics and Safety of Lower-Dose SoluMatrix® Meloxicam   in Healthy Adults

Abstract   #AB0869

Olugemo, Kemi; Parenti, Dennis MD; Young, Clarence MD

Abstract to be published in the meeting abstract book

All data being presented at the meeting are under embargo until 7:01 p.m. Eastern Daylight Time on Tuesday, June 10, 2014. For more information, please visit the EULAR website.

About Iroko’s SoluMatrix® NSAIDs

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. Iroko’s portfolio includes ZORVOLEX® (diclofenac) capsules – the first NSAID developed using proprietary SoluMatrix Fine Particle TechnologyTM that is now available in pharmacies – and TIVORBEX™ (indomethacin) capsules. Both ZORVOLEX and TIVORBEX were recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate acute pain in adults1,2.

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.

For more information, visit www.ZORVOLEX.com.

Important Safety Information about TIVORBEX

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.

TIVORBEX 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.

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

TIVORBEX 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 NSAIDs, including TIVORBEX.  Physicians should measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with TIVORBEX.  TIVORBEX should be discontinued immediately if abnormal liver tests persist or worsen.

NSAIDs, including TIVORBEX, 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 TIVORBEX.  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.  TIVORBEX 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. TIVORBEX 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 TIVORBEX in patients with advanced renal disease is not recommended.

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

Indomethacin may aggravate depression, and other psychiatric disturbances, epilepsy, or parkinsonism, and should be used with caution in patients with these conditions.  Indomethacin may cause drowsiness; therefore patients should be cautioned about engaging in activities requiring mental alertness and motor coordination.  Discontinue TIVORBEX if severe central nervous system (CNS) adverse reactions develop.

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

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

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

Most common adverse reactions in clinical trials (incidence ≥2%) include:   nausea, post procedural edema, headache, dizziness, vomiting, post procedural hemorrhage, constipation, pruritus, diarrhea, dyspepsia, post procedural swelling, presyncope, rash, upper abdominal pain, somnolence, generalized pruritus, hyperhidrosis, decreased appetite, hot flush, and syncope.

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

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.

 

Contacts:

Meredith Jarblum for Iroko Pharmaceuticals, LLC, 212-798-9775

Kate de Santis, Iroko Pharmaceuticals, LLC, 267-546-1682

 

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

SoluMatrix® is a trademark of iCeutica Pty Ltd.

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1ZORVOLEX Prescribing Information, pg. 1

2TIVORBEX Prescribing Information, pg. 1