We believe that our Hypermatrix™ technology is a novel and robust controlled-release drug delivery platform. This unique technology allows us to provide life-cycle management or new chemical entity delivery system solutions for virtually any small molecule. The flexibility of this technology allows us to quickly develop complex drug delivery solutions.
We operate in the niche market created by the expiration of drug product patents and drug product exclusivity periods. There are two ways that we employ our controlled-release technologies, which represent substantial opportunities for us to license our technologies and products:
For branded immediate-release (multiple-times-per-day) drugs, we formulate improved replacement products, typically by developing a new, patentable, controlled-release once-a-day drug. These drugs can be licensed to and sold by the pharmaceutical company that made the original immediate-release product. This protects against revenue erosion in the brand by providing a clinically attractive patented product that competes favorably with the generic immediate-release competition which arises on expiry of the original patent(s). The regulatory pathway for this approach requires new drug applications ("NDA") via a 505 (b)(2) pathway. This accelerates development timelines and reduces costs in comparision to new drug applications for new chemical entities.
For existing controlled-release (once-a-day) products covered by patents about to expire or already expired, we can formulate generic products, which are bioequivalent to the branded products. Such products can be licensed to and sold by distributors of generic products. Our scientists have previously demonstrated a successful track record with such products, having developed several drugs on a private contract basis. The regulatory pathway for this approach requires an abbreviated new drug application ("ANDA").