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 formerly known as Endo Laboratories LLC and changed its name to Endo Pharmaceuticals Inc. in 1997. The company was founded in 1920 and is based in Malvern, Pennsylvania. Endo Pharmaceuticals Inc. operates as a subsidiary of Endo International plc.
1400 Atwater Drive
Malvern, PA 19355
Founded in 1920
Key Executives for Endo Pharmaceuticals Inc.
Chief Executive Officer, President and Director
Compensation as of Fiscal Year 2014.
Endo Pharmaceuticals Inc. Key Developments
Endo Pharmaceuticals Inc. Announces Launch of NATESTO(TM)
Mar 16 15
Endo Pharmaceuticals Inc. announced the commercial availability of NATESTO(TM) (testosterone nasal gel), the first and only nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism. NATESTO(TM) was approved by the U.S. Food and Drug Administration (FDA) in May 2014 for replacement therapy in adult men with conditions associated with deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). NATESTO(TM) reduces the risk of transference via intranasal application. The launch of NATESTO(TM) further expands Endo's branded portfolio of men's health treatment offerings and highlights continuing commitment to ensuring that patients living with hypogonadism have access to high quality medicines. In 2014, Endo acquired the rights to NATESTO(TM) in the U.S. and Mexico from Trimel BioPharma SRL, a wholly-owned subsidiary of Trimel Pharmaceuticals Corporation, for $25 million plus additional payments upon the achievement of certain regulatory and sales milestones. Endo will collaborate with Trimel on all regulatory and clinical development activities regarding NATESTO(TM).
U.S. Food and Drug Administration accepts Endo Pharmaceuticals Inc.'s New Drug Application
Feb 23 15
Endo Pharmaceuticals Inc. and BioDelivery Sciences International Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the companies' BELBUCA(TM) (buprenorphine HCl) buccal film 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. FDA has indicated a standard review designation for the NDA and therefore the action date is expected 10 months from the NDA submission (October 2015). Additionally, the FDA recently accepted BELBUCA as the proprietary name for (buprenorphine HCl) buccal film.
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
Dec 23 14
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.
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