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opko health inc (OPK) Details

Opko Health, Inc., a biopharmaceutical and diagnostics company, is engaged in the discovery, development, and commercialization of novel and proprietary technologies. It operates in two segments, Pharmaceuticals and Diagnostics. The company develops a range of solutions to diagnose, treat, and prevent various conditions, including point-of-care tests, laboratory developed tests, molecular diagnostics tests, and proprietary pharmaceuticals, and vaccines. Its product pipeline includes various pharmaceutical compounds and technologies in research and development for a range of indications and conditions. The company’s lead products comprise RayaldyTM, a vitamin D prohormone, which in phase III clinical development stage to treat secondary hyperparathyroidism in patients with stage III or IV chronic kidney disease and vitamin D insufficiency; and Alpharen, a new and potent non-absorbed phosphate binder to treat hyperphosphatemia in dialysis patients. It also manufactures, sells, and licenses specialty active pharmaceutical ingredients for pharmaceutical companies. In addition, the company is involved in the discovery of new drugs for the treatment of various illnesses, including cancer, heart disease, metabolic disorders, and genetic anomalies; and developing a protein-based influenza vaccine that would offer protection against influenza, as well as has various therapeutic agents for respiratory disorders in clinical development, including products for asthma, chronic obstructive pulmonary disease, and chronic cough. Further, it develops rolapitant, a potent and selective competitive antagonist that has completed phase II clinical testing for prevention of chemotherapy induced nausea and vomiting. It also operates OPKO Lab, a full-service medical laboratory specializing in urologic pathology. The company operates in the United States, Chile, Spain, Israel, Mexico, and Ireland. OPKO Health, Inc. is based in Miami, Florida.

625 Employees
Last Reported Date: 03/3/14

opko health inc (OPK) Top Compensated Officers

Chairman and Chief Executive Officer
Total Annual Compensation: $492.3K
Vice Chairman and Chief Technical Officer
Total Annual Compensation: $482.3K
Executive Vice President of Administration an...
Total Annual Compensation: $455.0K
Total Annual Compensation: $275.0K
Compensation as of Fiscal Year 2013.

opko health inc (OPK) Key Developments

Opko Health, Inc. Announces Six Months Results of A Phase 2 Dose-Finding Study

OPKO Health, Inc. announced six month results of a Phase 2 dose-finding study evaluating the safety and efficacy of its novel long-acting human growth hormone product (Lagova) to treat pediatric growth hormone deficiency disorder. All three Lagova once-weekly doses demonstrate strong catch-up growth during the six months treatment. The annualized growth rates are above 12 cm in all three doses. The results are supported by excellent dose dependent pharmacokinetics and pharmacodynamics profiles. Lagova shows a promising safety profile with no serious adverse events reported. Glucose and lipid metabolism markers are within the normal ranges. No lipoatrophy was observed in any patients dosed, and no clinically significant local tolerability issues were identified. The randomized, comparator-controlled Phase 2 study was conducted in up to 56 pre-pubertal, naïve GHD children receiving one of three Lagova doses as once-weekly regimen (0.25, 0.48, 0.66mg/Kg/week; equivalent of 0.18, 0.35, 0.48 mg/Kg/week of hGH) or daily hGH (34ug/Kg/day) subcutaneously. In order to introduce naïve patients to the allocated Lagova dose in a gradual manner, a stepwise dose increase approach was implemented. Once patients reached the targeted doses, Lagova, GH, IGF-1 and IGF-BP3 concentrations were measured and PK-PD analysis was conducted utilizing a population based approach. Study Results: An interim analysis of six months data demonstrated that all doses of Lagova used in the study provided strong catch-up growth response better than historical controls of daily growth hormone therapy. The baseline characteristics of all patients were comparable among all groups. Interim analysis of the PK profile following administration of Lagova demonstrates a significantly extended half-life as reflected by the T1/2 and AUC respectively. A dose dependent PD (IGF-1) response was observed between Lagova cohorts, reaching steady state with no accumulation or excessive levels. All cohorts demonstrated promising "catch-up" growth, in line with reported age and GHD severity-matched data. The annualized height velocities are more than 12 cm, which correlates with the PK/PD profile in those patients.

Opko Health, Inc. - Special Call

To discuss six month data from Phase 2 trial of hGH-CTP in growth hormone deficient pediatric subjects

Opko Health, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-03-2014 02:30 PM

Opko Health, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-03-2014 02:30 PM. Venue: Grand Hyatt, New York, New York, United States. Speakers: Charles W. Bishop, Chief Executive Officer of OPKO Renal, David Okrongly, President of Diagnostics Business Unit, Phillip Frost, Chairman and Chief Executive Officer.


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