August 30, 2014 8:53 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

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 Updates on 1st Regulatory Submission Outside U.S. for ZORVOLEX

Iroko Pharmaceuticals reported its affiliate's first regulatory submission outside of the United States for ZORVOLEX (diclofenac) capsules. Iroko said that a new drug application was filed for the nonsteroidal anti-inflammatory drug (NSAID) with the Republic of Lebanon Ministry of Public Health (MOPH). ZORVOLEX was approved by the U.S. Food and Drug Administration (FDA) in October 2013 for the treatment of mild to moderate acute pain in adults and is not currently approved for marketing in any other country. A supplemental New Drug Application seeking approval for osteoarthritis pain is currently being reviewed by FDA. This filing was the result of a licensing agreement signed late last year by the company's affiliate, Iroko Pharmaceuticals Inc., and Algorithm S.A.L. under which Algorithm obtained the exclusive rights to market and sell ZORVOLEX to countries in the Middle East and North Africa (MENA).

Iroko Pharmaceuticals, LLC Announces First International Filing for ZORVOLEX(R)

Iroko Pharmaceuticals, LLC announced the company affiliate's first regulatory submission outside of the United States for ZORVOLEX(R) (diclofenac) capsules. A new drug application was filed for the nonsteroidal anti-inflammatory drug with the Republic of Lebanon Ministry of Public Health. ZORVOLEX was approved by the U.S. Food and Drug Administration (FDA) in October 2013 for the treatment of mild to moderate acute pain in adults and is not currently approved for marketing in any other country. A supplemental New Drug Application seeking approval for osteoarthritis pain is currently being reviewed by FDA. This filing was the result of a licensing agreement signed late last year by the company's affiliate, Iroko Pharmaceuticals Inc., and Algorithm S.A.L. under which Algorithm obtained the exclusive rights to market and sell ZORVOLEX to countries in the Middle East and North Africa. 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. ZORVOLEX has been available in U.S. pharmacies since January of this year, and has since seen continuing growth in prescriptions.

Iroko Pharmaceuticals, LLC Announces Encouraging Results from Phase III Osteoarthritis Study

Iroko Pharmaceuticals, LLC announced Phase III results that showed osteoarthritis, or OA, patients treated with investigational SoluMatrix meloxicam 5mg and 10mg, a low dose nonsteroidal anti-inflammatory drug, or NSAID, reported significantly greater pain relief compared with placebo. In this Phase III, multi-center, double-blind and placebo-controlled study, 403 patients aged 40 and older with a clinical diagnosis of OA of the knee or hip were randomized to receive treatment with once-daily SoluMatrix meloxicam 5 mg, SoluMatrix meloxicam 10 mg, or placebo. The primary efficacy endpoint of the study was the mean change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score at week 12. Secondary efficacy endpoints included the Patient Global Impression of Change (PGIC), a patient reported outcome measure, as well as the amount of rescue medication (acetaminophen) used by each patient. At week 12, patients treated with SoluMatrix meloxicam 5 mg (P = 0.0005) and 10 mg (P = 0.0059) achieved significantly greater pain relief as measured by the WOMAC pain subscale score compared with patients receiving placebo. Patients in the SoluMatrix meloxicam 5 mg (P = 0.006) and 10 mg (P = 0.0013) treatment groups used significantly less rescue medication compared with patients in the placebo group. The most frequently reported adverse events (occurring in > 2% of patients) in patients treated with SoluMatrix meloxicam were diarrhea, headache and nausea.

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