Egalet to Co-Host Category 1 Focus Group
--Attendees to discuss best practices in Category 1 abuse-deterrent studies--
Jan 24, 2018
WAYNE, Pa., Jan. 24, 2018 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today announced it will be co-hosting the 3rd Category 1 Focus Group meeting (part of the Cross Company Abuse Liability Council Non-profit Organization) on January 30 and 31 in Alexandria, VA. The meeting is designed to bring together industry, researchers, the Food and Drug Administration (FDA) and other interested parties to discuss best practices in in vitro (Category 1) studies of abuse-deterrent formulations.
"This meeting continues to help advance the field of Category 1 abuse-deterrent studies which is a crucial step in the development of safer opioids," said Karsten Lindhardt, founder of the Category 1 Focus Group and chief scientific officer of Egalet. "We look forward to the discussions with individuals involved in research and development of abuse-deterrent products as well as representatives from the FDA. The meeting will have a focus on the new FDA guidance for developing generic abuse-deterrent opioids."
The objectives of the meetings are to:
- share experiences and best practices in Category 1 assessments of abuse-deterrent formulations;
- discuss standardization of Category 1 studies and the limits associated with established standard practices;
- provide an open forum and a society enabling discussion on the FDA Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling; and
- provide an opportunity for presentations by academia, regulatory and industry experts focused in the Category 1 field.
The meeting will be held at the Embassy Suites Hotel in Alexandria, VA. For more information about the meeting, please visit cat1focusgroup.com.
Statements included in this press release (including but not limited to upcoming milestones) that are not historical in nature and contain the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "look forward to" and other similar expressions are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations, and are subject to known and unknown uncertainties and risks. Actual results could differ materially from those discussed due to a number of factors, including, but not limited to: the success of Egalet's clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefor; Egalet's ability to obtain regulatory approval of Egalet's product candidates and the labeling claims that Egalet believes are necessary or desirable for successful commercialization of its products and product candidates; Egalet's ability to maintain the intellectual property position of Egalet's products and product candidates; Egalet's ability to identify and reliance upon qualified third parties to manufacture its products; Egalet's ability to commercialize its products, and to do so successfully; the costs of commercialization activities, including marketing, sales and distribution; the size and growth potential of the markets for Egalet's products and product candidates, and Egalet's ability to service those markets; Egalet's ability to obtain reimbursement and third-party payor contracts for its products; Egalet's ability to service its debt obligations; Egalet's ability to raise additional funds to execute its business plan and growth strategy on terms acceptable to Egalet, if at all; Egalet's ability to find and hire qualified sales professionals; the rate and degree of receptivity in the marketplace and among physicians to Egalet's products; the success of products that compete with Egalet's that are or become available; general market conditions; and other risk factors set forth in Egalet's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in other filings Egalet makes with the SEC from time to time. While Egalet may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by law.
Media and Investor Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
SOURCE Egalet Corporation