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News Breaks
February 21, 2014
07:01 EDTINSYInsys Therapeutics reports dismissal of stockholder class action lawsuit
Insys Therapeutics announced that the previously reported stockholder class action lawsuit that had been filed against the company and certain of its officers and directors in U.S. District Court for the District of Arizona was on February 20, voluntarily dismissed by the plaintiff and thereafter terminated by the court. No payment or consideration of any kind was made by any of the defendants in connection with the dismissal.
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August 12, 2014
09:21 EDTINSYOn The Fly: Pre-market Movers
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07:48 EDTINSYInsys Therapeutics submits NDA for new formula of Dronabinol Oral Solution
Insys Therapeutics announced it has submitted a New Drug Application to the FDA for its proprietary Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol, or THC. Upon completion of the Phase III trial: Insys' Dronabinol Oral Solution demonstrated bioequivalence by using 4.25 mg of oral solution versus 5 mg of Marinol, suggesting patients may achieve similar clinical benefits with a lower dose of THC. All patients who took the oral solution achieved detectable plasma levels at 15 minutes, while less than 25% of Marinol patients achieved detectable plasma levels over the same duration. It took four hours for all Marinol subjects to achieve detectable plasma levels. The dronabinol oral solution compared to the Marinol arm also showed less intra patient variability by over 60 percent when measuring total patient exposure to THC. Insys conducts cannabinoid research and production in the United States at its advanced pharmaceutical-grade manufacturing facility, which is approved by the DEA and inspected by the FDA. The company is expanding its production capabilities to include an additional facility to meet anticipated demand once the FDA approves its pipeline products.
06:56 EDTINSYInsys Therapeutics on track to submit NDA for Dronabinol Oral Solution during Q3
The company is also on track to submit at least four IND applications with the FDA in the second half of 2014. Michael L. Babich, president and CEO, stated, "We remain on track to submit the NDA for our proprietary Dronabinol Oral Solution, in Q3. Assuming FDA approval, we believe our formulation will provide cancer and AIDS patients with several advantages over the currently available gelatin capsules and a GMP alternative to medical marijuana. Currently, the market for generic Marinol is estimated at $150M and our product would be the only branded one competing in this market. With 70% of generic dronabinol prescriptions written by approximately 8,000 healthcare providers, and prescriptions growing organically at a rate of four percent annually, the approval of this novel formulation would create an opportunity to satisfy a growing unmet medical need. Once launched, we believe we have the potential to capture a significant share in a manner similar with what we've been able to achieve with Subsys."
06:53 EDTINSYInsys Therapeutics reports Q2 adjusted EPS 58c, consensus 30c
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