WAYNE, Pa., March 23, 2017 /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 the issuance of new U.S. and international patents
for Egalet's proprietary Guardian™ Technology.
The United States Patent and Trademark Office (USPTO) has issued
patent number 9,549,899 covering ARYMO™ ER (morphine sulfate)
extended-release tablets for oral use only –CII developed using
Egalet's proprietary Guardian Technology. It is the second U.S.
patent covering ARYMO ER. The patent offers protection through 2033
and is listed in the Orange Book.
European patent number 2393487 has been issued to Egalet and
offers protection of products developed using Guardian Technology.
Also issued is Australian patent number 2015200243. It is the third
in a patent family. Both the European and Australian patents offer
protection through 2030.
Canadian patent number 2,751,667 also was issued and covers
Guardian Technology's immediate-release system designed to slow the
release of the active pharmaceutical ingredient in the presence of
alcohol. The patent offers protection through 2030.
"The newly issued patents further strengthen our ability to grow
our business through the development of immediate- and
extended-release products using our Guardian Technology," said
Mark Strobeck, Ph.D., executive vice
president and chief operating officer at Egalet.
Egalet has been granted a total of 18 U.S. patents and 95
patents outside of the U.S. that cover Guardian Technology and its
product candidates.
Guardian™ Technology
Egalet's Guardian Technology has many applications and has been
used to develop abuse-deterrent forms of commonly abused
prescription medications. Egalet's proprietary Guardian Technology
is a polymer matrix tablet technology that utilizes a novel
application of the well characterized manufacturing process of
injection molding, which results in tablets that are hard and
difficult to manipulate for misuse and abuse. This approach offers
the ability to design tablets with controlled-release profiles as
well as physical and chemical properties that have been
demonstrated to resist both common and rigorous methods of
manipulation. Tablets manufactured with Guardian Technology have
been shown to have increased resistance to physical methods of
manipulation, such as cutting, crushing, grinding or breaking,
using a variety of mechanical and electrical tools. They are also
resistant to chemical manipulation and attempts at extraction and
turn into a viscous hydrogel on contact with liquid, making
syringeability very difficult.
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 only –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 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, please visit
oxaydo.com. For additional information on Egalet, please visit
egalet.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: bcs@egalet.com
Tel: 917-432-9275
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SOURCE Egalet Corporation