In April of 2012 alone, Dr. Phillip Frost, Chairman and CEO of Opko Health, Inc. (NYSE:OPK), purchased 585.000 shares with prices ranging from $4.40 to $4.81 per share, a total investment of $2,658.286 - quite a vote of confidence in your own company with open market share purchases. This continues a pattern that the CEO has undertaken for months, his total shares owned now at 110,985,854. With the recent flurry of developments surrounding the company, this level of confidence in the stock, and the company, is understandable.
A target remedy for Chemotherapy Induced Nausea and Vomiting (CINV)
The severe problem of nausea and vomiting as a result of chemotherapy treatment is well known. Reportedly up to 90% of cancer patients are inflicted, depending on the type of chemo administered, dosing and other factors such as age. Over an extended period of time, nausea and vomiting generally result in weight loss, dehydration and malnutrition, sometimes resulting in hospitalization. If not prevented, CINV may result in a delay or even discontinuation of chemotherapy treatment.
NK-1 receptors are highly concentrated in the brain and bind the neurokinin substance P. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by emetogenic stimuli, including certain cancer chemotherapies. NK-1 receptor antagonists have been demonstrated to improve the management of nausea and vomiting experienced by cancer patients undergoing chemotherapy.
Rolapitant as the potential solution
Every investor in this space perks up when the mention of a Phase 3 Trial is mentioned. Opko announced that the Phase 3 clinical program for Rolapitant is currently enrolling patients. Rolapitant is a neurokinin-1 (NK-1) receptor antagonist with an extended plasma half-life. It is currently in Phase 3 clinical testing for prevention of CINV. In Phase 2 testing of Rolapitant, cancer patients treated with highly emetogenic chemotherapy demonstrated promising five-day activity in CINV prevention, following the administration of a single dose. The safety and tolerability of single and repeat doses of rolapitant has been assessed in over 1,000 subjects. Rolapitant is an investigational agent and has not been approved by regulatory agencies.
The Phase 3 program consists of two randomized, double-blind and placebo controlled clinical trials designed to evaluate the efficacy of a single 200mg oral dose of Rolapitant in patients receiving highly emetogenic chemotherapy, or HEC, in addition to one clinical trial evaluating the efficacy of a single 200mg oral dose of Rolapitant in patients receiving moderately emetogenic chemotherapy, or MEC. The study will involve approximately 2,400 cancer patients.
Each of the HEC clinical trials consist of approximately 530 patients and is focused on evaluating Rolapitant plus the standard of care compared with placebo plus the standard of care. The MEC clinical trial consists of approximately 1,350 patients and is focused on evaluating Rolapitant plus the standard of care compared with placebo plus the standard of care. In each of the Phase 3 clinical trials the standard of care consists of a 5-HT3 receptor antagonist in combination with the corticosteroid dexamethasone.
The patients in these clinical trials are being evaluated for evidence of an improvement in control of nausea and vomiting during the acute (0 - 24 hours), delayed (24 - 120 hours) and overall (0 - 120 hours) time periods post administration of chemotherapy. The primary outcome of each trial will be based on complete response (defined as no emetic episodes and no use of rescue medication) in the delayed phase. Additional outcome measures include complete response for other time points, the incidence and severity of nausea, and safety and tolerability. The company expects to report tabulated results from each of the clinical trials in the second half of 2013.
Continued path of key acquisitions
Opko has also completed the acquisition of ALS Distribuidora Limitada ("ALS"), a privately-held Chilean pharmaceutical company. ALS imports, commercializes and distributes pharmaceutical based products for private markets. The company, in operation since 2009, is the exclusive product distributor of Arama Laboratorios y Compañía Limitada ("Arama"), a 20 year-old entity in the pharmaceutical products market.
Key to this transaction, and typical of prior transactions of this type, Opko acquired all of the product registrations and trademarks previously owned by Arama, as well as the Arama name.
Dr. Frost's efforts also extended to a deal granting exclusive license to Laboratory Corporation of America Holdings (LabCorp) (NYSE:LH) to use its technology for detecting Alzeimer's disease in North America and the United Arab Emirates. LabCorp is a supplier of diagnostic services, associated with patient disease management.
Opko had previously acquired the license to a blood test, designed to detect elevated levels of antibodies that appear to be unique to Alzheimer's disease. This technology was rooted in the Scripps Research Institute where Dr. Thomas Kodadek developed the technology at Scripps' Jupiter campus. As noted prior in public disclosures, Dr. Frost is a board member of Scripps.
Opko had previously signed a deal with pharmaceutical company Bristol-Myers Squibb Co. (BMY) to collaborate on the development of the Alzheimer's disease test. According to The Alzheimer's Association, 5.4 million Americans are living with Alzheimer's disease, One in eight older Americans has Alzheimer's disease, and the disease is the sixth-leading cause of death in the United States and the only cause of death among the top 10 in the United States that cannot be prevented, cured or even slowed. No financial terms of its deal with LabCorp (NYSE: ) were released.
Opko Health, Inc. NYSE is currently trading $4.76 with a 1YR Target Estimate of $8.25 and a 52wk Range of 3.15 - 5.85. Its Market Cap is 1.4B.