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March 30, 2015 1:13 PM ET

Pharmaceuticals

Company Overview of Iroko Pharmaceuticals, LLC

Company Overview

Iroko Pharmaceuticals, LLC, a pharmaceutical company, engages in the acquisition, development, and commercialization of therapeutic products. It develops Indocid (indomethacin) suppositories and oral suspension for use in a range of conditions, including moderate to severe rheumatoid arthritis, moderate to severe osteoarthritis, and acute bursitis and tendonitis of the shoulder. The company also develops Aldomet (methyldopa) tablets; and ZORVOLEX (diclofenac), a nonsteroidal anti-inflammatory drug for the treatment of osteoarthritis pain in adults. It offers its products through a distribution and sales network in Algeria, Argentina, Australia, Austria, Barbados, Belgium, Benin, Brazil, Burk...

One Kew Place

150 Rouse Boulevard

Philadelphia, PA 19112

United States

Founded in 2007

Phone:

267-546-3003

Fax:

267-546-3004

Key Executives for Iroko Pharmaceuticals, LLC

Co-Founder, Chief Executive Officer and President
Chief Financial Officer
Age: 67
Vice President and General Counsel
Age: 47
Senior Vice President of Commercial Operations - Europe & International
Senior Vice President of Strategy and Project Planning
Compensation as of Fiscal Year 2014.

Iroko Pharmaceuticals, LLC Key Developments

Iroko Pharmaceuticals Announces Acceptance of U.S. Filing for SoluMatrix® Meloxicam in Osteoarthritis Pain

Iroko Pharmaceuticals, LLC announced that the U.S. Food and Drug Administration accepted for review the New Drug Application for SoluMatrix® meloxicam, a low dose nonsteroidal anti-inflammatory drug (NSAID), for the proposed indication of management of osteoarthritis pain. SoluMatrix® meloxicam 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. SoluMatrix® meloxicam is the third low dose NSAID developed by Iroko using proprietary SoluMatrix Fine Particle Technology™ and contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. The NDA submission for SoluMatrix® meloxicam included data from a Phase 3, multi-center, double-blind and placebo-controlled study, of 402 patients, aged 40 and older, with osteoarthritis of the knee or hip who were randomized to receive treatment with once-daily SoluMatrix® meloxicam 5 mg, SoluMatrix® meloxicam 10 mg, or placebo over a period of 12 weeks. Data from this study showed that both SoluMatrix® meloxicam dosage strengths achieved efficacy at 33% lower doses than currently available meloxicam products. These data were presented at the 2014 European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Paris, France4. The NDA also included data from a 12-month open-label study that enrolled 600 patients.

Iroko Pharmaceuticals Secures Approval for Zorvolex

Iroko Pharmaceuticals reported that the Republic of Lebanon Ministry of Public Health has approved Zorvolex, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults and osteoarthritis (OA) pain. This regulatory approval for Zorvolex marks an important milestone in the international commercialization strategy for low dose NSAID portfolio.

Iroko Pharmaceuticals, LLC Reports Data for ZORVOLEX(R) in Osteoarthritis Patients

Iroko Pharmaceuticals, LLC announced that ZORVOLEX(R) (diclofenac) capsules was generally well tolerated and improved the health-related quality of life (HRQOL) in patients with osteoarthritis pain, based on a 12-month, open-label Phase 3 study. These data are being presented at the American College of Rheumatology 2014 Annual Meeting, November 14, 2014 -November 19, 2014 in Boston. ZORVOLEX, a nonsteroidal anti-inflammatory drug (NSAID), was approved by the United States Food and Drug Administration (FDA) in August 2014 for the management of osteoarthritis pain and in October 2013 for the treatment of mild to moderate acute pain in adults. The 12-month, open-label, multicenter, Phase 3 study evaluated ZORVOLEX in 601 patients with knee or hip osteoarthritis who were chronic NSAID or acetaminophen users. The majority of patients were women (372/601, 61.9%); patients ranged from 40 to 86 years of age; 45% of patients were older than 60. Patients initially received ZORVOLEX 35mg twice daily, although the dosing regimen could be increased to three times daily if necessary, and subsequently reduced as needed. In the study, 299 (49.8%) patients who initially received ZORVOLEX 35mg twice daily remained at this dosing regimen and 302 (50.2%) patients increased their ZORVOLEX dosage to 35mg three times daily at least once. 20% of patients whose dose was increased from twice daily to three times daily subsequently underwent a dose reduction back to twice daily. The majority of adverse events in the study were mild to moderate in severity. The most frequently reported adverse events included upper respiratory tract infection (47/601, 7.8%), headache (46/601, 7.7%) and urinary tract infection (44/601, 7.3%). Myocardial infarction was reported in two patients and was not considered related to study medication. Gastrointestinal ulcer was reported in one patient. These data provide long-term safety information on the use of ZORVOLEX in patients with osteoarthritis, a condition associated with chronic pain. ZORVOLEX capsules 35mg twice or three times daily were associated with improved HRQOL in patients with osteoarthritis pain. Patients receiving ZORVOLEX reported clinically meaningful improvement (>=5) in the Physical Component Score across the 52-week dosing period. The Short Form-36(TM) (SF-36v2) is a health-related, patient-reported outcomes tool that assesses physical and mental domains.

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