Egalet Enters Into Development Collaboration and License Agreement With Shionogi Limited for Abuse-Deterrent Oral Hydrocodone Opioid Product Candidates

Egalet Licenses Rights to Preclinical Hydrocodone-Based Product Candidates to Be Developed Using Egalet's Proprietary Abuse-Deterrent Delivery Technology; Egalet to Receive Upfront and Milestone Payments Plus Potential Royalties on Net Sales

MALVERN, Pa., Nov. 26, 2013 (GLOBE NEWSWIRE) -- Egalet Corporation ("Egalet") announced today that it has entered into a definitive collaboration and license agreement with Shionogi Limited ("Shionogi") for the development and potential commercialization of multiple oral abuse-deterrent hydrocodone opioid product candidates using Egalet's proprietary technology.

Egalet will receive a $10 million upfront payment from Shionogi and Shionogi has agreed to purchase up to approximately $15 million in common stock in a private placement to close concurrently with Egalet's recently filed initial public offering. Egalet is eligible to receive milestone payments upon development and approval of products under the agreement, which may exceed $300 million if multiple products are approved. Shionogi will fund all costs associated with the development of these products. Shionogi will also have exclusive global rights to commercialize the resulting products. If any products developed under the collaboration are approved for marketing, Egalet is eligible to receive tiered royalties, ranging from the mid-single digits to the low double digits based on the net sales of such products, as well as sales-based milestone payments that could exceed $100 million based on the attainment of specified sales thresholds.

"With their commitment to pain therapeutics and their strong sales and marketing capabilities, we are pleased to be collaborating with Shionogi for the development and potential commercialization of abuse-deterrent hydrocodone products using our proprietary technology," said Bob Radie, Egalet's President and Chief Executive Officer. "We believe this collaboration provides validation for our proprietary abuse-deterrent drug delivery platform and positions us to capitalize on our technology, both through the products to be developed under the collaboration and by enabling us to develop additional opioid candidates utilizing our platform technology."

Stifel acted as exclusive financial advisor to Egalet in this transaction.

About Hydrocodone

Hydrocodone is an opioid agonist used in the treatment of mild to moderate pain.  It is currently available as a single agent or in combination with other analgesics, such as acetaminophen (e.g., Vicodin).  Abuse of prescription opioids has become a national epidemic in the United States. A study funded by the National Institutes of Health estimates that approximately 8% of the nation's 12th-graders abused hydrocodone in 2010. There are no abuse-deterrent hydrocodone single-agent or combination products currently on the market.

About Shionogi 

Shionogi & Co., Ltd., headquartered in Osaka, Japan, has subsidiaries in Europe (Shionogi Limited), US (Shionogi Inc.), and Asia.  Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to placing the highest value on meeting the medical needs of patients.  In addition, Shionogi & Co., Ltd. is engaged in new research in areas such as pain and infectious diseases.  Contributing to the health of patients around the world through innovative research and development is Shionogi & Co., Ltd.'s primary goal.  For more details on Shionogi Limited, please visit For more details on Shionogi Inc, please visit For more information on Shionogi & Co., Ltd., please visit

About Egalet Corporation

Egalet Corporation 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 manipulation, while also providing tailored release of the active pharmaceutical ingredient.  Our lead product candidate, Egalet-001, is an abuse-deterrent, extended-release, oral morphine formulation in development for the treatment of moderate to severe pain.  There are currently no commercially available abuse-deterrent formulations of morphine, and we believe that Egalet-001, if approved, would fill a significant unmet need in the marketplace. Our second product candidate, Egalet-002, is an abuse-deterrent, extended-release, oral oxycodone formulation in development for the treatment of moderate to severe pain.  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.

Safe Harbor Statement

Certain statements in this news release regarding future expectations and plans for future activities may be regarded as "forward-looking statements."  These statements are indicated by the words "may," "will," "plans," "believes," "expects," "anticipates," "potential," "should," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements.  Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release.  Factors that might cause future results to differ include, but are not limited to, the following: timely and successful discovery and development by Egalet of abuse-deterrent hydrocodone-based products; the ability to successfully commercialize any approved abuse-deterred hydrocodone-based products;  the availability and pricing of third-party sourced products and materials; the ability to obtain and enforce patents and other intellectual property rights; the strength of the United States dollar relative to international currencies, particularly the Japanese yen; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties described in Egalet's Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on October 16, 2013, and the amendments thereto, including those factors discussed under the caption "Risk Factors" in such filings.  Egalet does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of securities of Egalet, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. 


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