January 31, 2015 8:29 AM ET

Pharmaceuticals

Company Overview of Endo Pharmaceuticals Inc.

Company Overview

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

United States

Founded in 1994

Phone:

484-216-0000

Fax:

610-558-8979

Key Executives for Endo Pharmaceuticals Inc.

Chief Executive Officer
Age: 47
Senior Vice President
Compensation as of Fiscal Year 2014.

Endo Pharmaceuticals Inc. Key Developments

Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain

Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. announced that they have submitted a New Drug Application (NDA) for Buprenorphine HCl Buccal Film to the U.S. Food and Drug Administration (FDA). Buprenorphine HCl Buccal Film is under development 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. The drug uses BDSI's patented BioErodible MucoAdhesive (BEMA®) drug delivery technology to efficiently and conveniently deliver buprenorphine across the buccal mucosa (inside lining of the cheek). Buprenorphine, a Schedule III controlled substance, is a partial opioid agonist and a potent analgesic with a relatively long duration of action. Buprenorphine HCl Buccal Film is being developed and will be commercialized through a worldwide license and development agreement between Endo Pharmaceuticals and BDSI. The two pivotal phase 3 studies for demonstration of safety and efficacy were double-blind randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain. One study (BUP-307) was conducted in opioid experienced subjects, and the second study (BUP-308) was conducted in subjects naïve to opioid therapy. Both studies met the primary efficacy endpoint of change from baseline to week 12 of mean daily pain intensity score from placebo (BUP- 307; p <0.00001; BUP 308; p= 0.001). Buprenorphine HCl Buccal Film was generally well tolerated demonstrating a low incidence of typical opioid like side effects.

Endo Pharmaceuticals and Impax Laboratories Face Second Proposed Class Action Lawsuit

Endo Pharmaceuticals and Impax Laboratories are facing a second proposed class action lawsuit over an alleged pay-to-delay deal that put off a generic launch of Endo's pain medication Opana ER. The Pennsylvania Employees Benefit Trust Fund filed a complaint against the brand and generics drugmakers in the U.S. District Court for the Northern District of Illinois, alleging that the delayed launch of Opana ER (oxymorphone hydrochloride) forced it to pay supracompetitive prices on the brand version for its members. The claims closely mirror ones made in a June lawsuit against Endo and Impax brought by the Rochester Drug Co-operative. Both lawsuits charge that in 2010, Endo settled patent infringement litigation against Impax's Paragraph IV ANDA against Opana ER with a deal to keep a generic version off the market for three more years. In exchange, the lawsuits allege, Endo agreed to pay Impax at least $112 million and as much as $142 million to hold off the generic launch. Endo also promised not to compete with Impax by launching its own generic, the complaints allege. Because Impax was the first to file against Opana, Endo was able to use its deal as a bottleneck against other ANDAs from generics makers Roxane, Actavis and Sandoz. Endo took full advantage of the delay, getting a revised, more crush-resistant version of the drug, Opana ER CRF, approved by the FDA. The drugmaker used the three year delay from its alleged 2010 deal with Impax until the 2013 generic launch to replace batches of Opana ER on the market with Opana ER CRF. That, in turn, further delayed generics competition by effectively neutralizing ANDAs that were not deemed by the FDA to be substitutable with the new version.

Endo and Biodelivery Sciences Announce Results from the Phase III Clinical Trial of BEMA(R) buprenorphine in Opioid-experienced Patients with Chronic Pain

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).

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Recent Private Companies Transactions

Type
Date
Target
Merger/Acquisition
June 2, 2014
Endo Pharmaceuticals Inc., Early Stage Drug Discovery Portfolio
 

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