Opko Health
Opko Health (OPK) is a diversified healthcare company that seeks to establish industry-leading positions in large and rapidly growing medical markets. Its diagnostics business includes BioReference Laboratories (“BioReference”), the nation’s third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore prostate cancer test and the Claros 1 in-office immunoassay platform (in development). Opko Health's pharmaceutical business features Rayaldee , an FDA-approved treatment for secondary hyperparathyroidism (“SHPT”) in adults with stage 3 or 4 chronic kidney disease (“CKD”) and vitamin D insufficiency (launched in November 2016), and VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO in November 2015 and pending approval for IV formulation), OPK88003, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists (Phase 2b), and OPK88004, an androgen receptor modulator for androgen deficiency indications. Its pharmaceutical business also features hGH-CTP, a once-weekly human growth hormone injection (in Phase 3 and partnered with Pfizer), and a once-daily Factor VIIa drug for hemophilia (Phase 2a).1
Opko Health operate established pharmaceutical platforms in Spain, Ireland, Chile and Mexico, which are generating revenue and from which the company expect to generate positive cash flow and facilitate future market entry for its products currently in development. EirGen, its specialty pharmaceutical manufacturing and development site in Ireland, is focused on the development and commercial supply of high potency, high barrier to entry pharmaceutical products. In addition, the company operate a specialty active pharmaceutical ingredients (“APIs”) manufacturer in Israel, which the company expect will facilitate the development of its pipeline of molecules and compounds for its proprietary products.
Recent developments
In June 2017, Opko Health announced the completion of its post-hoc sensitivity analyses to evaluate the influence of outliers on the primary endpoint results for its Phase 3, double-blind, placebo-controlled study of hGH-CTP in adults with GHD. Opko Health used multiple statistical approaches, and analyses that excluded outliers showed a statistically significant difference between hGH-CTP and placebo on the change in trunk fat mass. Additional analyses that did not exclude outliers showed mixed results. Post-hoc analyses do not carry the same weight of evidence as a pre-specified primary analysis.
