Strategic Focus

Providing Life-Cycle Management or New Chemical Entity Delivery System Solutions

Our Hypermatrix™ technologies are central to the development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Hypermatrix™ technologies are a multidimensional controlled-release drug delivery platform that we believe can be applied to the efficient development of a wide range of existing and new pharmaceuticals. We believe that the flexibility of these technologies allows us to develop complex drug delivery solutions within an industry-competitive timeframe. Based on this technology platform, we have developed several drug delivery systems and a pipeline of products (some of which have received final FDA approval) and product candidates in various stages of development, including ANDAs filed with the FDA and one NDA filing.

The technology that is central to our abuse deterrent formulation of Oxycodone hydrochloride ER is the novel Point of Divergence Drug Delivery System ("nPODDDS™"). nPODDDS™ is designed to provide for certain unique drug delivery features in a product. Our PODRAS™ delivery technology platform was designed to prevent overdose when more pills than prescribed are swallowed intact

The flexibility of our technologies allows us to quickly develop complex drug delivery solutions and focus our development activities in three niche markets:

• Improved current therapies through controlled-release (NDA regulatory path)
  • 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 comparison to new drug applications for new chemical entities.
  • Regabatin™ is one of our non-generic controlled-release products that is developed in extended-release capsules.
• Abuse deterrence
  • Some of our technologies are also focused on the development of abuse-deterrent and overdose preventative pain medications. The growing abuse and diversion of prescription "painkillers", specifically opioid analgesics, is well documented and is a major health and social concern. We believe that our technologies and know-how are aptly suited to developing abuse deterrent pain medications. The regulatory pathway for this approach requires NDAs via a 505(b)(2) application for the U.S. or corresponding pathways for other jurisdictions where applicable.
  • Oxycodone hydrochloride ER, an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation, is one of our key non-generic development products.
• Difficult-to-produce controlled-release generic drugs (ANDA regulatory path)
  • 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").