Insys Therapeutics ($INSY), a combination drug developer and delivery specialist, won an orphan designation from the FDA for a gastric cancer treatment that delivers paclitaxel trapped in liposomes to make the common cancer drug more soluble and less toxic.
Insys acquired the Liposome Entrapped Paclitaxel from NeoPharm during the two companies' merger in 2010. LEP-ETU (the ETU stands for "Easy To Use") is designed as a formulation for the anti-cancer agent paclitaxel, which is used for a broad range of cancers to prevent cell division and growth, and "trap" the drug within liposomes made from fats. By putting a lipid barrier between the paclitaxel and healthy cells, the formulation is intended to more safely deliver the drug to tumors.
Paclitaxel is currently sold as Taxol by Bristol-Myers Squibb ($BMY) and Abraxane by Celgene ($CELG). Because of its poor solubility, it must be either part of a formula (as with Taxol) or bound to a delivery vehicle (as with Abraxane).
Although currently unapproved by the FDA, the orphan designation for LEP-ETU represents a step forward for Insys in bringing the new formulation to market.
"We are pleased to have received orphan drug designation for LEP-ETU to treat gastric cancer, a devastating and difficult-to-treat disease," said Insys CEO Michael L. Babich. "By entrapping the paclitaxel with liposomes, we believe our LEP-ETU formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy of the cancer-fighting paclitaxel. We are currently evaluating next steps with respect to this drug product candidate."
Insys is facing the fire on another drug, Subsys, a sublingual narcotic painkiller limited by the FDA for use in cancer patients. Even with these limits in place, the drug brought in $96 million in sales last year and sent Insys' stock skyrocketing. It had The New York Times wondering whether these numbers were fueled by off-label marketing.
With LEP-ETU, though, Insys stands to gain a foothold in gastric cancer, which is the fifth most common in the world and the third-leading cause of death.
Chandler, AZ-based Insys raised $37 million in its IPO last October.
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