Dallas, Texas 07/13/2015 (Financialstrend) – Opko Health Inc. (NYSE:OPK) has set the stage for a single pivotal Phase 3 trial of its human growth hormone (hGH-CTP) after completing enrollment. The clinical study seeks to evaluate the safety and efficacy of the hormone with a primary endpoint being its superiority compared to Placebo.
Commercialization Plans
Opko Health Inc. (NYSE:OPK) is to carry out the trial in two treatment periods made of a 26-week double blind placebo controlled period and 26-week open label extension. The company plans to carry out a regulatory submission upon completion of the study in the second half of 2016.
Commercialization of the drug upon approval by the FDA should not be a problem as the company already has a worldwide collaboration agreement with Pfizer for the drug. The company starts the phase 3 study awaiting the FDA decision on Rolapitant, a nausea and vomiting drug whose rights it purchased in 2009.
Should Rolapitant attain the much-needed FDA approval, then Opko Health Inc. (NYSE:OPK) will be on course to receive up to $121 million in milestone payment, as well as royalty payments from sales. In May, the biopharmaceutical company filed for FDA approval for Rayaldee a prohomorne for vitamin D.
Vitamin D Deficiency drug
The company hopes to use the drug to vie for the vitamin D deficiency marketplace valued at $12 billion. Opko Health Inc. (NYSE:OPK) has already initiated plans to hire 20 to 40 sales rep as it remains confident of receiving the FDA approval. Vitamin D deficiency is a major deficiency facing many people around the world especially those diagnosed with Chronic Kidney disease.
There is no doubt that the stock has a number of catalyst on the horizon that could act as a catalyst going forward. However caution should also be taken as some of the catalysts might already be factored into the stock price already
Separately Opko Health Inc. (NYSE:OPK) has opted for an early termination of the waiting period for the planned acquisition of Bio-Reference, granted under the HSR improvement act effectively on July 1, 2015.
