**** $INSY Insys Therapeutics - its proprietary intranasal formulation of epinephrine to treat anaphylaxis achieved plasma absorption similar to that of Mylan's (MYL) Epipen.
Janney analyst Ken Trbovich said in a note to clients on Friday morning that Insys management told him the formulation achieved plasma levels in excess of 100 picograms per milliliter in less than five minutes.
"This is important because the FDA sees this as a critical threshold to establish a therapeutic benefit," Trbovich said. "Others who have attempted to deliver epinephrine via the intranasal route have failed to reach the 100 pg/ml level in less than 5 minutes. The company also noted its study ensured absorption was not significantly impaired by those suffering from nasal congestion and it did so by showing similar results."
Insys shares jumped 15% in pre-bell trading.
Epinephrine has been around for more than 100 years, but the current market is dominated by autoinjectors because they can deliver the drug rapidly.
Insys management told Janney that it plans to meet with the Food & Drug Administration to discuss the results and find a path forward before the end of the year. That likely indicates that a new drug application will be filed no later than the first half of 2019, with a potential for a priority review. If that happens, the drug could be approved by the first quarter of 2020.
Insys has filed a patent application for its proprietary intranasal spray formulation, which relies on caprylic acid and a second permeation enhancer to enable rapid plasma absorption intranasally. Based on the patent application date, if issued, the patent would be in effect at least through 2035 and perhaps as along as 2037.
"Insys also believes its formulation can offer longer shelf-life, which is another potential advantage easily overlooked by investors," Trbovich said. "Epinephrine degrades at room temperatures resulting in lower potency of the product over time."
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