Profile: Endo Health Solutions Inc (ENDP.OQ)
12 Dec 2013
Endo Health Solutions Inc., incorporated on November 18, 1997, is a specialty healthcare solutions company focused on branded and generic pharmaceuticals, devices and services. The Company has a portfolio of branded pharmaceuticals that includes brands, such as Lidoderm , Opana ER, Voltaren Gel, Percocet , Frova , Supprelin LA, Vantas , Valstar and Fortesta Gel. The Company operates in four segments: Endo Pharmaceuticals, Qualitest, AMS, and HealthTronics. Through the Company's HealthTronics segment, the Company provides lithotripsy services, prostate treatment services, anatomical pathology services, medical products manufacturing, sales and maintenance, and information technology solutions.
The Company provides lithotripsy services, which is a medical procedure where a device called a lithotripter transmits high energy shockwaves through the body to break up kidney stones. The Company's lithotripsy services are provided principally through limited partnerships and other entities that the Company manages, which use lithotripters. The Company provides treatments for benign and cancerous conditions of the prostate. In treating benign prostate disease, the Company deploys three technologies: photo-selective vaporization of the prostate (PVP), trans-urethral needle ablation (TUNA), and trans-urethral microwave therapy (TUMT) in certain partnerships. For treating prostate and other cancers, the Company uses a procedure called cryosurgery, a process which uses lethal ice to destroy tissue, such as tumors for therapeutic purposes. The Company also manufactures both the medical devices and related consumables utilized in cryosurgery operations, and also provide cryosurgery treatments. The Company's prostate treatment services are provided principally by the Company using equipment that the Company leases from limited partnerships and other entities that the Company manages. The Company also provides services relating to operating the equipment, including scheduling, staffing, training, quality assurance, regulatory compliance, and contracting.
The Company provides anatomical pathology services primarily to the urology community. The Company has one pathology lab located in Georgia, HealthTronics Laboratory Solutions, that provides laboratory detection and diagnosis services to urologists throughout the United States. In addition, the Company manages pathology laboratories for physician practices groups located in Texas, Florida and Pennsylvania. Through HealthTronics Laboratory Solutions, the Company also provides administrative services to in-office pathology labs for practices groups and provides pathology services to physicians and practice groups with its lab equipment and personnel at its HealthTronics Laboratory Solutions laboratory sites. The Company manufactures and sells medical devices focused on minimally invasive technologies for tissue and tumor ablation through cryoablation, which is the use of lethal ices to destroy tissue, such as tumors, for therapeutic purposes. The Company develops and manufactures these devices for the treatment of prostate and renal cancers. The Company also manufactures the related spare parts and consumables for these devices. The Company also sells and maintains lithotripters and related spare parts and consumables.
The Company’s Lidoderm (lidocaine patch 5%) is a topical patch product containing lidocaine, Lidoderm is a product 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). During the year ended December 31, 2012, Lidoderm accounted for approximately 31% of its total revenues. Opana ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. Opana ER is designed to be crush-resistant, which is called Opana ER (oxymorphone hydrochloride) Extended-Release Tablets with INTAC technology. This formulation of Opana ER with INTAC technology has the same dosage strengths, color and packaging and similar tablet size as original Opana ER. Opana ER accounted for approximately 10% of its 2012 total revenues. Voltaren Gel (diclofenac sodium topical gel 1%) delivers effective pain relief with a safety profile as its systemic absorption is 94% less than the comparable oral diclofenac treatment. Voltaren Gel accounted for approximately 4% of its 2012, total revenues.
The Company’s Percocet (oxycodone hydrochloride and acetaminophen USP) Tablets CII is the treatment of severe pain. The Percocet franchise accounted for approximately 3% of its 2012, total revenues. Supprelin LA (histrelin acetate) is a soft, flexible 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. It markets Supprelin LA in the United States through a specialty sales force primarily to pediatric endocrinologists. Vantas (histrelin acetate) 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.
The Company’s Fortesta Gel is a patented 2% testosterone transdermal gel and is a treatment for men suffering from hypogonadism, also known as low testosterone (Low T). The precision-metered dose delivery system can be accurately customized and adjusted to meet individual patient needs with the appropriate dose. The hydrogel polymer implant is a subcutaneous, retrievable, non-biodegradable, hydrogel reservoir drug delivery device designed to provide sustained release of a spectrum of drugs continuously, at constant, predetermined rates. The hydrogel polymer implant delivers drugs at zero-order kinetics and the duration of delivery can be predetermined over a range of times. The Company’s other branded portfolio consists of a number of products, each of which accounted for 1% or less of its total revenues in 2012.
The Company’s Aveed is a novel, long-acting injectable testosterone preparation for the treatment of male hypogonadism. BEMA Buprenorphine is a transmucosal form of buprenorphine, a partial mu-opiate receptor agonist, which incorporates a bioerodible mucoadhesive (BEMA) technology. ODM-201, is an androgen receptor antagonist being developed for the treatment of castrate resistant prostate cancer. EN3342 is a soft, flexible six-month polyurethane implant designed to deliver risperidone for the maintenance treatment of schizophrenia in adults. It also has other products, including certain undisclosed products in its therapeutic areas of interest in early stages of development.
The Company’s products in the Qualitest portfolio includes Endocet, Morphine Sulfate ER, Hydrocodone and acetaminophen, Oxycodone and acetaminophen, Carisoprodol, Hydrocortisone, Promethazine, Multi Vitamins, Acetaminophen and codeine, Spironolactone, Isosorbide Mononitrate ER, Triamcinolone, Phenobarbital, Methylprednisolone, and Lisinopril. Its generic products are sold across multiple therapeutic categories, in various dosage forms, including solids, semi-solids and liquids. The Company’s generics pharmaceuticals pipeline portfolio contains products and product candidates for multiple therapeutic areas, including pain, urology, oncology, and endocrinology. Its Qualitest business has a number of products at various stages of development, including approximately 40 abbreviated new drug applications (ANDAs) under active Food and Drug Administration (FDA) review.
The Company’s 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 service contains a range of more naturally functioning inflatable prostheses than earlier generations of the product. InhibiZone is intended to reduce the rate of revision surgery due to surgical infections. 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 GreenLight XPS laser system is used to relieve restrictions on the normal flow of urine from the bladder caused by bladder obstructions, generally the result of BPH or bulbar urethral strictures. This therapy offers men experiencing a physical obstruction of the prostatic urethra an alternative to 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 provides shorter treatment times with similar long-term results compared to other laser systems. 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 compared to other laser systems. The GreenLight laser and fiber system revenue accounted for approximately 3% of its total revenues in 2012.
The Company’s AMS 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 safe, simple and precise mesh placement through a single vaginal incision, avoiding an external incision. Elevate revenue accounted for approximately 1% of its total revenues in 2012. The Company’s Monarc subfascial hammock is a 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. Monarc revenue accounted for approximately 1% of its total revenues in 2012. The Company’s AMS segment maintains a portfolio of products and product candidates in development, with focus in pelvic health.
The Company competes with Abbott Laboratories, Johnson & Johnson, Pfizer, Inc., Purdue Pharma, L.P., Allergan, Inc., Watson Pharmaceuticals, Inc., Watson, Teva Pharmaceuticals Industries Ltd., Mylan Technologies Inc., and Sandoz, Inc.,
Endo Health Solutions Inc
1400 Atwater Drive
MALVERN PA 19355