We are a specialty pharmaceutical company that is exploiting our licensed and proprietary patented drug delivery technologies to develop and commercialize, either on our own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics.
Our development strategy focuses on the utilization of the FDA’s 505(b)(2) approval process to obtain more timely and efficient approval of new formulations of previously approved therapeutics which incorporate our licensed drug delivery technologies. Because the 505(b)(2) approval process is designed to address new formulations of previously approved drugs, we believe it has the potential to be more cost efficient and less time consuming than other FDA approval methods.
Our patented drug delivery technologies include:
the BEMA™ (transmucosal, or applied to the inner cheek membrane) drug delivery technology; and
the Bioral® nanocochleate drug delivery technology, which is designed to encapsulate active pharmaceutical ingredients and protect them from the environment and the body
Utilizing our proprietary delivery technologies, we are currently developing formulations of pharmaceuticals aimed principally at acute (i.e., short term) treatment opportunities in the areas of:
- fungal infections
As a general matter, we are focused on treatments for cancer patients and patients who have recently undergone surgical procedures, although we believe our drug delivery technologies have the potential to be applied to other types of pharmaceuticals as well.
In addition to our Bioral® and BEMA™ platforms, we are also the exclusive U.S. licensee for Emezine®, a rapid-onset treatment of nausea and vomiting. In early 2006, we received a non-approvable norification from FDA on Emezine® and are currently evaluating this program.