WAYNE, Pa., Feb. 20, 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 has received a U.S. patent for its proprietary
Guardian™ Technology.
"The newly issued patent covers our proprietary Guardian
Technology which has successfully been tested in clinical studies,"
said Karsten Lindhardt, Ph.D., chief
scientific officer of Egalet. "This issuance adds to our growing
patent portfolio around our Guardian Technology which was the basis
for our FDA approved product, ARYMO ER."
The patent covers the Guardian Technology two-component tablet
architecture which provides precise drug delivery and can confer
abuse-deterrent properties. The United States Patent and Trademark
Office (USPTO) has issued patent number 9,884,029 covering
Egalet-002. The patent offers protection through March 2024.
Egalet has been granted a total of 20 U.S. patents and 59
patents outside of the U.S. that cover Guardian Technology and its
product candidates.
About Egalet
Egalet, a fully integrated specialty
pharmaceutical company, is focused on developing, manufacturing and
commercializing innovative treatments for pain and other
conditions. Egalet has three approved products: ARYMO®
ER (morphine sulfate) extended-release tablets for oral use —CII,
developed using Egalet's proprietary Guardian™ Technology,
OXAYDO® (oxycodone HCI, USP) tablets for oral use only
—CII and SPRIX® (ketorolac tromethamine) Nasal Spray.
Using Guardian Technology, Egalet is developing a pipeline of
clinical-stage, product candidates for which we are seeking
partners including Egalet-002, an abuse-deterrent,
extended-release, oral oxycodone formulation for the management of
pain severe enough to require daily, around-the-clock, long-term
opioid treatment and for which alternative treatment options are
inadequate. Guardian Technology can be applied broadly across
different classes of pharmaceutical products and can be used to
develop combination products that include multiple active
pharmaceutical ingredients with similar or different release
profiles.
For full prescribing information on ARYMO ER, including the
boxed warning and medication guide, please visit arymoer.com. For
full prescribing information on SPRIX, including the boxed warning
and medication guide, please visit sprix.com. For full prescribing
information on OXAYDO, including the boxed warning and medication
guide, please visit oxaydo.com.
Safe Harbor
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
Email: ir@egalet.com
Tel: 484-259-7370
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SOURCE Egalet