Profile: Endo International PLC (ENDP.OQ)
Endo International plc (Endo), incorporated on October 31, 2013, is a global specialty healthcare company focused on branded and generic pharmaceuticals and devices. The Company operates in four segments: U.S. Branded Pharmaceuticals, U.S. Generic Pharmaceuticals, Devices and International Pharmaceuticals. It has a portfolio of branded pharmaceuticals offered by its U.S. Branded Pharmaceuticals segment that includes brand names, such as Lidoderm, Opana ER, Voltaren Gel, Percocet, Fortesta Gel, Frova, Supprelin LA, Valstar, Vantas, Sumavel DosePro, Aveed and Natesto. Its non-branded U.S. Generic Pharmaceuticals portfolio consists of products, focused in pain management through a differentiated portfolio of controlled substances and liquids. Its Devices segment focuses on providing technology solutions to physicians treating men’s and women’s pelvic health conditions and operates in the business lines: men’s health, women’s health, and benign prostatic hyperplasia (BPH or prostate health) therapy. The International Pharmaceuticals segment includes a variety of specialty pharmaceutical products and certain medical devices for the Canadian, Latin American, South African and world markets.
U.S. Branded Pharmaceuticals
The Company’s Lidoderm (lidocaine patch 5%) is a topical patch product containing lidocaine for the relief of the pain associated with post-herpetic neuralgia, a condition thought to result after nerve fibers are damaged during a case of Herpes Zoster (commonly known as shingles). Opana ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Opana ER represents the drug, in which oxymorphone is available in an oral, extended-release formulation and is available in 5 milligrams (mg), 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablets. Voltaren Gel is a topical prescription treatment for the relief of joint pain of osteoarthritis in the knees, ankles, feet, elbows, wrists, and hands. The Company’s Percocet is for the treatment of moderate-to-moderately severe pain.
The Frova is indicated for the acute treatment of migraine headaches in adults. Its Fortesta Gel is a 2% testosterone transdermal gel and is a treatment for men suffering from hypogonadism, also known as low testosterone (Low-T). Supprelin LA (histrelin acetate) is a 12-month hydrogel implant-based on its hydrogel polymer technology that delivers histrelin acetate, a gonadotropin releasing hormone (GnRH) agonist and is indicated for the treatment of central precocious puberty (CPP) in children. Valstar is a sterile solution for intravesical instillation of valrubicin, a chemotherapeutic anthracycline derivative. Valstar is indicated for intravesical therapy of bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder in patients, for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
Vantas is a 12-month hydrogel implant-based on the Company’s hydrogel polymer technology that delivers histrelin acetate, a GnRH agonist, and is indicated for the palliative treatment of advanced prostate cancer. Sumavel DosePro is indicated for adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache. Sumavel DosePro is a needle-free injection that comes in two doses (4 mg and 6 mg) and is delivered subcutaneously to patients. The Company’s Aveed is a long-acting testosterone undecanoate for injection for the treatment of Low-T. Aveed is dosed only five times per year after the first month of therapy. In a clinical trial, nearly all men who received Aveed maintained average testosterone levels within the normal range for 10 full weeks after the third injection. Natesto is a testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism. Endo has sole and exclusive commercial rights to Natesto in the United States and Mexico.
U.S. Generic Pharmaceuticals
The Company’s generic products are sold across multiple therapeutic categories, including pain management and in various dosage forms, including solids, semi-solids and liquids. Generic pharmaceutical products are sold at prices less than the branded product.
The Company’s AMS 800 artificial urinary sphincter is designed for the treatment of moderate to severe male urinary incontinence, the involuntary release of urine from the body. It includes an inflatable urethral cuff to restrict flow through the urethra and a control pump that allows the patient to discreetly open the cuff when he wishes to urinate. The AMS 700 MS Series are penile implants to treat erectile dysfunction, which is the inability to achieve or maintain an erection sufficient for sexual intercourse. This product line contains a range of more naturally functioning inflatable prostheses. InhibiZone is intended to reduce the rate of revision surgery due to surgical infections.
The Monarc subfascial hammock is the Company’s device to treat female stress urinary incontinence, which generally results from a weakening of the tissue surrounding the bladder and urethra, which can be a result of pregnancy, childbirth and aging. It incorporates helical needles to place a self-fixating, sub-fascial hammock through the obturator foramen. The Company’s Devices segment offers the Elevate transvaginal pelvic floor repair system, for the treatment of pelvic organ prolapse, which may be caused by pregnancy, labor, and childbirth. Using an anatomically designed needle and self-fixating tips, Elevate allows for mesh placement through a single vaginal incision, avoiding an external incision.
The GreenLight XPS laser system is used to relieve restrictions on the normal flow of urine from the bladder caused by bladder obstructions. This therapy offers men experiencing a physical obstruction of the prostatic urethra an alternative to transurethral resection of the prostate (TURP). The GreenLight photovaporization of the prostate is designed to reduce the comorbidities associated with TURP. The GreenLight XPS and MoXy Liquid Cooled Fiber system provide shorter treatment times with similar long-term results. The GreenLight laser system offers an optimal laser beam that balances vaporization of tissue with coagulation to prevent blood loss and provides enhanced surgical control.
The Company’s Dexedrine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and in the adjunctive treatment of narcolepsy. Tridural once-daily tramadol product is a treatment option developed as a therapy for adult patients with moderate pain, who require treatment for several days or more that provides 24-hour pain relief from a single tablet taken once-daily. Metadol is an analgesic used in acute cancer pain, palliative care and chronic pain disorders and for detoxification or maintenance treatment of opioid-dependent individuals. Its Trandate is an antihypertensive agent used for treatment of hypertension. Pennsaid is a topical non-steroidal anti-inflammatory used for the treatment of osteoarthritis. Pennsaid allows the diclofenac solution to be delivered to a specific site via the surface of the skin and thus avoids complications associated with systemic delivery. In Canada, Plan B is a non-prescription, progestin-only pill developed to prevent pregnancy after a contraceptive failure.
The Company competes with Abbott Laboratories, Johnson & Johnson, Pfizer, Inc., Purdue Pharma, L.P., Allergan, Inc., Valeant Pharmaceuticals International, Actavis Pharmaceuticals, Inc., Actavis, Teva, Mylan Technologies Inc. and Sandoz, Inc.
Endo International PLC
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