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August 01, 2015 11:05 AM ET

Pharmaceuticals

Company Overview of Iroko Pharmaceuticals, LLC

Company Overview

Iroko Pharmaceuticals, LLC, a specialty pharmaceutical company, develops and commercializes pharmaceutical products. It focuses on treatment options to address patient needs in pain management. The company markets and distributes Indocid (indomethacin) capsules and suppositories; Aldomet (methyldopa) tablets; TIVORBEX (indomethacin) capsules; and ZORVOLEX, a nonsteroidal anti-inflammatory drug for the management of osteoarthritis pain and for the treatment of mild to moderate acute pain in adults. It markets and sells its products through distribution and sales network in the United States and internationally. The company was founded in 2007 and is based in Philadelphia, Pennsylvania. Iroko ...

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 and Senior Vice President
Age: 68
Senior Vice President and General Counsel
Age: 48
Senior Vice President of Commercial Operations - Europe & International
Senior Vice President of Strategy and Project Planning
Compensation as of Fiscal Year 2015.

Iroko Pharmaceuticals, LLC Key Developments

Iroko Pharmaceuticals Launches Tivorbex (indomethacin) Capsules, Nonsteroidal Anti-Inflammatory Drug

Iroko Pharmaceuticals launched Tivorbex (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), in the US for the treatment of acute pain. Currently, Tivorbex capsules are now available by prescription at pharmacies across the country. Tivorbex 20mg and 40mg dosage strengths are 20% lower than the 25mg and 50mg indomethacin products currently on the market. The US Food and Drug Administration (FDA) has approved Tivorbex for the treatment of mild to moderate acute pain in adults.

Iroko Pharmaceuticals, LLC Appoints Pierre Legault to its Board of Directors

Iroko Pharmaceuticals, LLC announced the appointment of Pierre Legault to its board of directors. Mr. Legault, who is currently Chief Executive Officer of NephroGenex Inc., brings extensive commercialization experience to the company. He formerly served as Chief Executive Officer at Prosidion Ltd. and has held senior management positions at OSI Pharmaceuticals, Eckerd, Rite Aid Corporation, and Sanofi-Aventis. Mr. Legault joined NephroGenex in 2013, having previously served as a member and Executive Chairman of its board of directors. He has previously held management positions at other pharmaceutical and biotechnology companies, including the roles of CEO of Prosidion Ltd., and Executive Vice President, Chief Financial Officer and Treasurer of OSI Pharmaceuticals. Mr. Legault also brings pharmacy operations experience to Iroko, having served as Executive Vice President and Chief Administrative Officer of Rite Aid Corporation, and President of Eckerd Group. Mr. Legault has also held several senior positions with Sanofi-Aventis.

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.

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