Shares of Opko Health Inc. (NASDAQ: OPK), a pharmaceutical and diagnostics company, plunged more than 15 percent on Friday after the company reported disappointing results to a clinical trial.
In a press release, Opko Health announced data analysis from a Phase 3 trial which evaluated its long-acting human growth hormone product (hGH-CTP) in adults with growth hormone deficiency (GHD).
Opko Health has a global collaboration and license agreement with Pfizer Inc. (NYSE: PFE) for the development and commercialization of hGH-CTP. The agreement calls for Opko Health to handle the clinical program while Pfizer will handle registration and commercialization of the product.
The study was a double blond, placebo-controlled and enrolled 203 subjects, 198 of which received at least on dose of the weekly injection treatment.
Opko Health said its study found no statistical difference between hGH-CTP and a placebo. However, the company did add that after unblinding the study, it has identified one or more outliers that may have affected the primary outcome. Accordingly, management is now undertaking a further review of the study population as quickly as possible.
Opko Health also said it has now initiated a pivotal Phase 3 study this month in pre-pubertal growth hormone deficient children to evaluate weekly treatment with hGH-CTP versus daily injections of Genotropin.
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