Insys Therapeutics Inc. (INSY), a commercial-stage specialty pharmaceutical company developing supportive care products, recently received orphan drug status for its pharmaceutical cannabidiol (“CBD”) for the treatment of Glioblastoma Multiforme (“GBM”). GBM is the most common and aggressive form of malignant primary brain tumor affecting thousands of patients worldwide.
Unlike many other CBD-focused companies in the space, the company specializes in producing synthetic forms of cannabidiol that are over 99% pure. Management believes that it is the only U.S.-based company with t he capacity to produce pharmaceutical CBDs in large quantities. In addition to its GBM program, the company intends to pursue numerous other areas of the CBD industry.
According to its last annual report:
“We believe there is an unmet patient need for a more reliable synthetic THC for treating CINV and anorexia associated with weight loss in patients with AIDS. In a pivotal bioequivalence study, our Dronabinol Oral Solution product candidate has demonstrated rapid and more reliable absorption, which we believe represents an attractive product profile relative to Marinol. We are also evaluating proprietary sublingual spray, inhaled and intravenous formulations of dronabinol in preclinical testing. We also have the capability to manufacture synthetic cannabidiol (CBD) and we intend to pursue clinical studies that could result in future commercial products containing CBD.”
Insys Therapeutics also differentiates itself from many other companies in the cannabis therapeutics industry with its existing revenue and profitability. During the quartered ended June 30, 2014, the company reported $55,696,000 in revenue, $49,141 in gross profit, and $9,465,000, or $0.26 per diluted share, in net income from the sale of its approved products and other revenue.
Over the past three months, the stock has been a strong performer, jumping 27.41% compared to a 3.52% decline in the SPDR S&P Biotech ETF (XBI).
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