A - Dermal Filler(ETI-101)
Dermal fillers have become very popular products in the cosmetic surgery arena with a current US market rapidly growing to the several hundred million dollar range. Current products utilize either collagen, hylauronic acid or polymer particles . The collagen and hylauronic acid products have relatively short duration of action and many are derived from animal sources (e.g. bovine or human) which is not optimal. The solid particle fillers generally come in the dry powder form and need to be mix with a vehicle such as a saline solution before injection (i.e. reconstituted). The reconstitution step is inconvenient and particles may not distribute evenly in saline.
ETI-101 addresses many of the shortcomings associated with currently marketed dermal fillers in that it is free of animal products and offers a adaptable clinical half life that can range up to as long as 6-12 months depending on the nature of the formulation. ETI-101 utilizes a novel phospholipid gel in combination with PLA microspheres. This proprietary formulation has attractive rheological properties which permit injection through needles as fine as 28-31 gauge. The formulation can be custom tailored to achieve a 6-12 month tissue bulking time as well as a variety of rheological characteristics which plastic surgeons view as important. The phospholipid gel is composed of naturally occurring or generally regarded as safe components which are not animal derived and which provide a clinically desirable vehicle for the PLA microspheres.
ETI-101 is expected to have a favorable competitive profile with regard to the collagen and hylauronic acid based products currently on the market and therefore may achieve rapid market penetration. The use of two filler components with different degradation kinetics coupled with the ease of manufacture, room temperature stability and desirable clinical properties should facilitate market penetration.
ETI has exclusive rights to a patent application (US and Europe) filed in July of 2004 which covers the novel phospholipids PLA mixture and is seeking a development and marketing partner to promote the product.
B-Long-acting Local Anesthetic Depot Injection (ETI 211)
It is highly desirable to reduce the need for systemic opiate based analgesia post surgery. Systemic post surgery analgesic therapy extends hospital stays, can result in significant post-surgical complications, and cause the patient to be substantially compromised as regards gastrointestinal and respiratory function as well as cognitively. The market for such an extended release local anesthetic will likely exceed several hundred million dollars annually in the US and may result in substantial reductions in hospital stays and costs to the healthcare system.
ETI 211 utilizes a variation of the proprietary PG employed in ETI-101 which serves to provide a sub-dermal depot for a long acting local anesthetic that is currently approved for human use. The product is formulated with a unique non-liposomal phospholipid mixture that produces a release profile of the local anesthetic proximate to the surgical wound for a period of 3-4 days thereby providing pain relief sufficient to reduce or eliminate the need for systemic patient controlled analgesia. Proof of concept data in pre-clinical models has shown superiority of ET-211 to a liposomal bupivicaine formulation developed by others.
As with the ETI-101 product, ETI-211 utilizes no new chemical entities and employs naturally occurring or generally regarded as safe phospholipids and excipients. This should reduce the regulatory requirements for approval of the product.