Technology and Business Model

Technology

The Encore proprietary Phospholipid Gel (PL Gel) is a unique formulation designed to delivery drugs intradermally or intramuscularly for prolonged action (i.e. a depot formulation). The PL Gel is a non-liposomal preparation comprising mainly phospholipids along with other injectable ingredients. All components are biocompatible and biodegradable and are selected from the GRAS (Generally Regarded as Safe) list or have been used in other injectable products approved by the FDA. PL Gel does not contain any new or unproven raw materials

The PL Gel is capable of delivering a high load (10-20%) and sustained release drug profile (3-7 days) for hydrophilic or lipophilic drugs. This unique formulation is robust with low risk of initial drug burst release. ETI believes that this high-load and 3-4 day duration depot system represents a substantial opportunity to improve therapeutic benefits and patient compliance for many injectable drugs.

In addition to the PL Gel, Encore also has a proprietary nano-emulsion formulation technology (NE) that is designed for intravenous drug formulations. The ETI-411 product candidate employs this formulation. This formulation has been used for a variety of drugs and has proven to be effective in delivering difficult APIs. It is also compatible with both lipophilic and hydrophilic drug products and contains only GRAS constituents.

Business Strategy

Encore uses these two proprietary phospholipid based formulation technologies to improve the safety and efficacy of EXISTING drugs. We identify existing drugs that can be enhanced in a clinically relevant manner and use them to design new products and extend their patent life through our novel formulation technology. This greatly reduces the development risk, time and cost. The regulatory path to FDA approval is simplified and generally involves a 505b2 registration approach.

The Company seeks development and marketing partners after generating pre-clinical Proof of Concept of the re-engineered drug product. Encore has already licensed its ETI-211 product candidate to a development partner and is in discussions on some of its other product candidates.