Company Overview of Endo Pharmaceuticals Inc.
Endo Pharmaceuticals Inc. researches, develops, and sells pharmaceutical products. The company offers products for therapeutic areas that include pain management in the areas of postherpetic neuralgia, osteoarthritis, migraine, and chronic pain; urology and oncology for non-muscle invasive bladder and prostate cancer; and endocrinology for central precocious puberty and hypogonadism. It also provides clinical trials. The company was founded in 1994 and is headquartered in Malvern, Pennsylvania. Endo Pharmaceuticals Inc. operates as a subsidiary of Endo International plc.
1400 Atwater Drive
Malvern, PA 19355
Founded in 1994
Key Executives for Endo Pharmaceuticals Inc.
Compensation as of Fiscal Year 2014.
Endo Pharmaceuticals Inc. Key Developments
Endo and Biodelivery Sciences Announce Results from the Phase III Clinical Trial of BEMA(R) buprenorphine in Opioid-experienced Patients with Chronic Pain
Jul 7 14
Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. announced positive top-line results from its pivotal Phase III efficacy study of BEMA buprenorphine in opioid-experienced patients. BEMA buprenorphine is being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in both patients who are opioid naive and opioid experienced. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA buprenorphine resulted in significantly (p<0.0001) improved chronic pain relief compared to placebo. Additional secondary endpoints were supportive of the efficacy of BEMA buprenorphine compared to placebo. The most commonly reported adverse events in patients treated with buprenorphine compared to placebo were nausea (7.5% vs. 7.4%) and vomiting (5.5% vs. 2.3%). About the Phase III BEMA buprenorphine trial in opioid-experienced patients. The Phase III clinical trial was an enriched-enrollment, double-blind, randomized withdrawal study to evaluate the efficacy and safety of BEMA buprenorphine in the treatment of chronic lower back pain in opioid-experienced patients. A total of 511 patients who titrated to a well-tolerated, effective dose were randomized to either continue on that dose of BEMA buprenorphine, or receive placebo (BEMA film with no active drug), with treatment continuing for 12 weeks. The primary efficacy endpoint was the mean change in the daily average pain numerical rating scale (NRS-Pain) scores from baseline (just prior to randomization) to week twelve of the double-blind treatment period. Pain was self-reported daily on an 11-point numeric rating scale (daily NRS; 0=no pain, 10=worst possible pain).
Association Files Class Action against Endo Pharmaceuticals
May 27 14
A class action lawsuit alleges that Endo Pharmaceuticals engaged in anticompetitive conduct to prevent generic forms of its Lidoderm pain patch from entering the market. The lawsuit, filed by an association that provides health and dental plans to federal employees and their families, alleges Endo filed several citizen petitions with the Food and Drug Administration to prevent generic products from being approved for sale. When another company, Actavis, appeared to be on the verge of releasing a generic form of Lidoderm, Endo filed suit. According to the suit against Endo, the company resolved the claim with Actavis by agreeing to provide free products. In return, Actavis agreed to delay the release of its generic product. The lawsuit alleges that as a result of that misconduct, consumer had to continue paying a premium for Lidoderm beyond when they otherwise would have.
Noven Pharmaceuticals, Inc. Announces Settlement of Lidoderm(R) Patent Litigation with Endo Pharmaceuticals Inc., Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc
Apr 16 14
Noven Pharmaceuticals, Inc. announced that it has entered into an agreement with Endo Pharmaceuticals Inc., Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. to settle all outstanding patent litigation related to Noven's lidocaine topical patch 5% product. An Abbreviated New Drug Application for Noven's product is currently pending at the U.S. Food and Drug Administration (FDA). If approved, Noven's product would be a generic version of Endo's Lidoderm(R). The agreement allows Noven to launch its generic Lidoderm(R) product on or after March 1, 2015, if the product is approved by the FDA. The agreement provides for an earlier launch under certain circumstances. Pursuant to the agreement, the litigation on this matter, currently pending in U.S. District Court for the District of Delaware, will be dismissed. Other terms of the settlement were not disclosed. The settlement agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
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