United States

Profile: OPKO Health Inc (OPK.O)

OPK.O on Nasdaq

19 Jul 2019
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OPKO Health, Inc., incorporated on November 18, 1991, is a diversified healthcare company. The Company's segments include Pharmaceutical, Diagnostics and Corporate. The pharmaceutical segment consists of the pharmaceutical operations in Chile, Mexico, Ireland, Israel and Spain and its pharmaceutical research and development operations. The diagnostics segment primarily consists of the clinical laboratory operations in Bio-Reference Laboratories (Bio-Reference) and its point-of-care operations.

Diagnostics Segment

Through Bio-Reference, which is a full service clinical laboratory in the United States, the Company offers laboratory testing services utilized by healthcare providers in the detection, diagnosis, evaluation, monitoring, and treatment of diseases, including esoteric testing, molecular diagnostics, anatomical pathology, genetics, women's health and correctional healthcare. It markets and sells these services to physician offices, clinics, hospitals, employers and governmental units nationally. As of December 31, 2016, Bio-Reference operated a network of approximately 275 patient service centers or in-office phlebotomy stations for collection of patient specimens. Its Bio-Reference laboratory testing business consists of routine testing and esoteric testing. Routine tests measure various health parameters, such as the functions of the heart, kidney, liver, thyroid and other organs, including such tests as blood cell counts, cholesterol levels, pregnancy, substance abuse and urinalysis. Through Bio-Reference, it operates in the specialized laboratory divisions, such as Bio-Reference Laboratories, GenPath (Oncology), GenPath (Women's Health), GeneDx and Laboratorio Bueno Salud.

The Company's Bio-Reference division constitutes its clinical testing laboratory offering automated, routine testing services, special tertiary admissions test (STAT) testing, informatics, human immunodeficiency virus (HIV), Hepatitis C (Hep C) and other molecular tests. GenPath (Oncology) has national oncology presence with expertise in cancer pathology and diagnostics, as well as molecular diagnostics. Its tests include FLOW, Immunohistochemistry (IHC), MicroArray, fluorescence in situ hybridization (FISH), in situ hybridization (ISH), Morphology, and full service oncology. GenPath (Women's Health), a technology platform for sexually transmitted infections, has enabled expansion nationally with specimens coming from 41 states, including Image Directed Paps analysis, HPV Plus, and STI Testing. GeneDx is a national laboratory for testing rare and ultra-rare genetic diseases with international reach, performing testing on specimens from over 50 countries. Laboratorio Bueno Salud is a national testing laboratory serving the Spanish-speaking population in the United States, where all business is conducted in Spanish, including patient and physician interaction.

The Company offers 4Kscore test, a laboratory developed blood test that provides a personalized risk score for aggressive prostate cancer, through its Bio-Reference laboratory located in Elmwood Park, New Jersey. It offers the 4Kscore test through its Bio-Reference laboratory located in Elmwood Park, New Jersey. The 4Kscore test measures the blood plasma levels of four different prostate derived kallikrein proteins: Total prostate-specific antigen (PSA), Free PSA, Intact PSA and Human Kallikrein-2 (hK2). These biomarkers are then combined with a patient's age, digital rectal exam (DRE) status (nodule/no nodule), and prior negative biopsy status (yes/no) using an algorithm to calculate the risk (probability) of finding a Gleason Score 7 or higher prostate cancer.

OPKO Diagnostics, LLC (OPKO Diagnostics), a subsidiary of the Company, is developing a diagnostic instrument system to provide blood test results and enable tests to be run in point-of-care settings. The instrument, a microfluidics-based diagnostic test system consisting of a credit card-sized disposable test cassette that works with a small desktop analyzer, provides quantitative blood test results within minutes and permits the transition of immunoassays from the centralized reference laboratory to the physician's office, hospital nurses station, or other decentralized location. The technology requires a finger stick drop of blood introduced into the test cassette, which can then run a quantitative test. It is working to add additional tests for its point-of-care system, including vitamin D.

Pharmaceutical Segment

As of December 31, 2016, the Company had one commercial stage pharmaceutical product and several pharmaceutical compounds and technologies in various stages of research and development for a range of indications and conditions, including Renal Products, selective androgen receptor modulator (SARM), Biologics, hGH-CTP, Factor VII, Oxyntomodulin, active pharmaceutical ingredients (APIs), Oligonucleotide Therapeutics, NK-1 Program, Asthma and chronic obstructive pulmonary disease (COPD). It offers Rayaldee, its lead renal product, in the United States market. Rayaldee extended release capsules is a treatment of secondary hyperparathyroidism (SHPT) in adults with stage III or IV chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D. Rayaldee is an extended release product of a prohormone called calcifediol (25-hydroxyvitamin D3). Its second renal product, Alpharen (Fermagate Tablets), is a potent non-absorbed phosphate binder to treat hyperphosphatemia in Stage V CKD patients requiring regular hemodialysis. Alpharen (Fermagate Tablets) has been shown to be safe and effective in treating hyperphosphatemia in phase II and III trials in stage V CKD patients undergoing chronic hemodialysis. TT701 is an orally administered SARM, which the Company is developing for the treatment of patients benefiting from its effects on increasing muscle and bone strength and decreasing body fat mass. The selective and antagonistic properties of TT701 appear to be well suited to provide anabolic therapeutic benefits to specific patient populations, while potentially avoiding, or even reducing, prostate hypertrophy. TT701 is being studied in a Phase II study in prostate cancer patients undergoing radical prostatectomy, and a Phase IIb study is planned to determine the optimal dose to treat patients with Benign Prostatic Hypertrophy (BPH).

The Company's biologics business focuses on developing and commercializing longer acting versions of already approved therapeutic proteins. One of its platform technologies uses a short, naturally-occurring amino acid sequence (carboxl terminal peptide or CTP) that has the effect of slowing the removal from the body of the therapeutic protein to which it is attached. Its lead product candidate utilizing CTP, hGH-CTP, is a recombinant human growth hormone product under development for the treatment of growth hormone deficiency (GHD), which is a pituitary disorder resulting in short stature in children and other physical ailments in both children and adults. In addition to hGH-CTP, it is developing a product to extend the life span of Factor VIIa (hemophilia) using the CTP technology. It offers longer-acting version of clotting Factor VIIa, Factor VIIa-CTP, for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VIII or Factor IX. Factor VIIa therapy is available only as an intravenous (IV) formulation which, due to Factor VIIa's short half-life, requires multiple infusions to treat a bleeding episode. In addition to hGH-CTP and Factor VII-CTP, its internal product development program is focused on developing a once weekly administered oxyntomodulin for type II diabetes and obesity. Its oxyntomodulin product candidate, TT401, a once-weekly administered peptide for the treatment of type II diabetes and associated obesity, is a dual agonist of the GLP-1 (Glucagon-Like Peptide-1) and glucagon receptors. Its MOD-6031 is in a phase I study, is a once weekly oxyntomodulin with a delivery system to slowly release the natural oxyntomodulin, which allows the molecule to penetrate the blood brain barrier.

FineTech Pharmaceutical, Ltd. (FineTech) is the Company's Israel-based subsidiary that develops and produces high potency specialty APIs. FineTech manufactures commercial APIs for sale or license to pharmaceutical companies in the United States, Canada, Europe and Israel. OPKO CURNA, LLC (CURNA) is engaged in the discovery of new drugs for the treatment of a range of illnesses, including cancer, heart disease, metabolic disorders and a range of genetic anomalies. CURNA's platform technology utilizes a short, single strand oligonucleotide and is based on the up-regulation of protein production through interference with non-coding RNA's, or natural antisense. It out-licensed the development, manufacture and commercialization of its NK-1 candidate, VARUBI (rolapitant), to TESARO. VARUBI, a potent and selective competitive antagonist of the NK-1 receptor, had completed phase II clinical testing for prevention of chemotherapy induced nausea and vomiting, or CINV, and post-operative induced nausea and vomiting. It provides heparin-derived oligosaccharide, a treatment for asthma and COPD.

Other businesses in the pharmaceutical segment include EirGen, OPKO Health Europe, OPKO Mexico, OPKO Chile and ALS Distribuidora Limitada. EirGen is a specialty pharmaceutical company based in Ireland. EirGen is focused on the development and commercial supply of high potency, high barrier to entry, pharmaceutical products. OPKO Health Europe operates primarily in Spain and is engaged in the development, manufacture, marketing, and sale of pharmaceutical, nutraceutical, and veterinary products in Europe. OPKO Mexico is engaged in the manufacture, marketing, sale, and distribution of ophthalmic and other pharmaceutical products to private and public customers in Mexico. OPKO Mexico manufacturers and sells products primarily in the generics market in Mexico, although it also has some proprietary products as well. OPKO Chile markets, sells and distributes pharmaceutical and natural products to the private, hospital, pharmacy and public institutional markets in Chile for a range of indications, including, cardiovascular products, vaccines, antibiotics, gastro-intestinal products, and hormones, among others. ALS Distribuidora Limitada (ALS) is engaged in the business of importation, commercialization and distribution of pharmaceutical products for private markets in Chile.

The Company competes with Quest Diagnostics and Laboratory Corporation of America.

Company Address

OPKO Health Inc

4400 Biscayne Blvd
MIAMI   FL   33137-3212
P: +1305.5754138

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