Egalet Announces Financing to Fund Abuse-Deterrent Medications Two lead programs to enter pivotal trials

MALVERN, Pa., Sept. 12, 2013 /PRNewswire/ -- Egalet Ltd., a specialty pharmaceutical company developing and planning to commercialize abuse-deterrent oral products for the treatment of pain and other indications, announced today that it has closed a financing of up to $20 million led by Index Ventures with participation from other existing investors.  Egalet has received $10 million initially, with an option for an additional $10 million investment under pre-specified conditions.

Prescription drug abuse became the leading cause of accidental death in the United States in 2008 surpassing deaths caused by automobile accidents.  A 2011 research report prepared by the Substance Abuse and Mental Health Services Administration of the U.S. Department of Health and Human Services, or SAMHSA, estimated that nearly 35 million Americans have used prescription pain relievers, including opioid-containing drugs, for non-prescription purposes at least once in their lifetime.  As of 2007, the total costs of prescription drug abuse were estimated to be up to $72.5 billion annually for public and private healthcare payors in the United States according to the North American Journal of Managed Care. 

Egalet has created two distinct drug delivery systems, each with novel abuse-deterrent features and the ability to control the release profile of the active pharmaceutical ingredient, or API. Using the Company's proprietary platform, Egalet has developed a pipeline of clinical-stage, opioid-based product candidates in tablet form that are specifically designed to deter abuse by physical and chemical tampering while also providing tailored release of the API.  Egalet's lead product candidates, Egalet-001 and Egalet 002, are abuse-deterrent, extended-release, oral formulations of commonly prescribed opioids in development for the treatment of moderate to severe pain.  Egalet-001 and Egalet 002, if approved, could fill significant unmet needs in the marketplace.

"With these funds we will be able to begin our pivotal studies for Egalet 001 in the first quarter of 2014," said Bob Radie, Egalet's president and chief executive officer.  "We plan to submit a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, in the fourth quarter of 2014."

About Egalet Ltd.

Egalet Ltd. is a specialty pharmaceutical company developing and planning to commercialize proprietary, abuse-deterrent oral products for the treatment of pain and other indications.  The company has created two distinct drug delivery systems, each with novel abuse-deterrent features and the ability to control the release profile of the active pharmaceutical ingredient.  Using its proprietary platform, Egalet  has developed a pipeline of clinical-stage, opioid-based product candidates in tablet form that are specifically designed to deter abuse by physical and chemical tampering while also providing tailored release of the active pharmaceutical ingredient.  The Egalet technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple APIs with similar or different release profiles.   The company's goal is to be a leading specialty pharmaceutical company focused on the development, manufacture and commercialization of abuse-deterrent pharmaceutical products.  Please visit www.egalet.com for more information.

Contact:
E. Blair Clark-Schoeb
Tel.: 917-432-9275
Email: blair@biotechcomm.com

SOURCE Egalet Ltd.



RELATED LINKS
http://www.egalet.com

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