Egalet Ltd.

Egalet Ltd. is a specialty pharma company focusing on pain management.

 

Egalet® technology is used for a series of controlled release products developed by Egalet Ltd. Egalet® technology works by incorporating the active ingredient into a polymeric matrix that is eroded by body fluids at a constant rate. The tablet is made by way of injection molding techniques involving only few steps. Egalet® technique breaks new ground because it can be used for virtually any type of medicine and because it provides controlled release with unusual precision and reliability. In addition, the products do not show food effect or dose dumping when administered with alcohol and has best in class tamper resistance properties. This is especially important for drugs that can be abused such as opioids or stimulants.

Egalet additionally holds various proprietary drug delivery technologies that enable it to develop products for special populations and controlled release formulations with extreme precision for chronotherapy.

Egalet® Technology
Egalet has several opioid compounds in development, but currently the development focus is Egalet® oxycodone. Egalet® oxycodone has initiated phase 1 development and the regulatory path towards an NDA has been clarified with an estimated development time to an NDA of about 3 years.

Oxycodone is a growing $2+ billion market. Our product has a superior PK profile for the potential benefit of patients and also provides strong tamper-resistance properties. Egalet is protecting the technology with an IP portfolio of various patents and patent applications that will provide a patent life reaching into 2030.

Egalet has also been able to formulate a number of other compounds (both opioid and non-opioid) with superior pharmacokinetic and tamper-resistance properties.

Egalet® Chrono Technology
Egalet® Chrono technology is facilitating dispensing of drugs when a certain timing of release is wanted. The principle behind delayed release, applying Egalet® Chrono technology, is that the release is controlled from the welldefined fixed surface erosion area at both ends of the cylindrical tablet. The tablet consists of end-plugs and a middle-plug in which the active ingredient is incorporated. Furthermore, each plug comprises one or more polymeric carriers as well as physico-chemical stabilizers, which determine the dissolution rate.

Before the drug is released from the core of the tablet, the end-plugs must dissolve. Thus, the first layer exposed to gastric fluids are the end-plugs, thereby allowing a tightly controlled, extended release as well as the possibility to formulate delayed release preparations.

EgaletSchematic overview of product design

Egalet schematic overview of product design
A: Finished product
B: Erosion of delay matrix
C: Erosion of active matrix.

Parvulet® Technology
Parvulet® technology is facilitating dispensing of drugs to infants and elderly.

Egalet created Parvulet® technology to address the growing need of better pediatric therapeutics. Although children and adolescents (0–19 years) comprise approximately 22% of the total population, very few medicines have been tested on them.

Governments around the world are now putting considerable pressure on the pharmaceutical industry to improve this situation by developing more and improved medicines especially for children. From a physician’s point of view, better delivery systems for children are also needed because compliance is a major issue.

With Parvulet® technology, Egalet has created a universal formulation that is acceptable for all children. Drugs contained in Parvulet® technology are dispersed as a special dry powder or tablet that on exposure to a small amount of water turn into a pleasant tasting, soft textured, dosage form. The formulated drug can also be incorporated into a familiar carrier, such as a spoon, with the water being added just before administration.

Egalet Ltd.
+45 44 47 80 80
+45 44 47 24 25
http://www.egalet.com