WAYNE, Pa., May 11, 2017 /PRNewswire/ -- Egalet Corporation
(Nasdaq: EGLT) ("Egalet"), a fully integrated specialty
pharmaceutical company focused on developing, manufacturing and
commercializing innovative treatments for pain and other
conditions, hosted a panel discussion as part of its investor event
on May 10, 2017, featuring three
leading pain management specialists. The panelists discussed the
challenges of treating patients with pain, the expected/potential
advantages of prescribing abuse-deterrent formulations (ADFs) of
opioids, and the role ADFs and non-narcotic treatment options could
play in helping to curb the epidemic of opioid misuse and
abuse.
"There are so many patients that you don't even know how [opioid]
abuse is going to manifest itself," said Richard Rauck, M.D., founder of the Carolinas
Pain Institute. "Whether they are selling their home and
somebody comes to the open house and gets into their medicine
cabinet, or kids steal opioids out of a medicine cabinet or
maybe out of a car, there are so many ways these
drugs can end up in the wrong hands. So we can change that
discussion to get all, in particular the long-acting [opioids], in
abuse-deterrent formulations."
The panel, which was moderated by Egalet medical director
Colville Brown, M.D. and included
Jeffrey Fudin, Pharm D., adjunct
associate professor, Albany College of
Pharmacy and Health Sciences; Jeffrey Goldstein, D.O., founder and director of
Fountain Medical Group; and Dr. Rauck, discussed a range of topics
from how to treat individuals living with pain to where Egalet's
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, can play a role.
As part of the investor event, Egalet's management team provided
an overview of the company's commercial business, regulatory and
clinical updates, and reported first quarter 2017 earnings.
Highlights from investor day include:
- Established commercial foundation and have grown demand for
SPRIX Nasal Spray and OXAYDO over last eight quarters;
- To maximize the commercial opportunity for all three products,
deployed 82 territory managers in two teams at the end of the first
quarter in conjunction with ARYMO ER launch;
- Initial positive feedback from target healthcare providers on
profile of ARYMO ER, which was approved by the U.S. Food and Drug
Administration (FDA) on January 9, 2017 and launched at the end of
the first quarter;
- Market access team is targeting select commercial insurers to
overcome barriers and laying the ground work for Medicare and
Medicaid access in the future;
- Potential to expand commercial opportunity for OXAYDO with
prior approval supplement for OXAYDO 10 and 15 mg dosage strengths,
which was filed in February of 2017, and supplemental NDA to
strengthen the label with abuse-deterrent label that shows OXAYDO
resists syringeability;
- Focused on commercial execution in 2017 and making necessary
tradeoffs to maximize resources;
-
- Egalet-002 phase 3 program to be completed in the fourth
quarter of 2017, but additional expense postponed; and
- To continue to grow, Egalet continues to evaluate in-licensing
opportunities, contemplate partnerships to co-promote SPRIX and
consider opportunities to leverage Guardian Technology.
To listen to a replay of the webcast of the event, please visit:
http://egalet.investorroom.com/eventsandwebcasts.egalet.com
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, including
the boxed warning and medication guide, please visit oxaydo.com.
For additional information on Egalet, please visit
egalet.com.
Safe Harbor
Statements included in this press release 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," "focused on" and
other similar expressions are "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. These forward-looking statements, which include plans to
target commercial insurers and to seek Medicare and Medicaid
access, the potential addition of new OXAYDO dosage strengths and a
strengthened OXAYDO label, the execution of Egalet's
commercialization plan in 2017 and taking steps to maximize
Egalet's resources, 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: Egalet's
ability to obtain regulatory approval of its product candidates,
its regulatory filings 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 its 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 which compete with Egalet's that
are or become available; the success of Egalet's clinical trials,
including the timely recruitment of trial subjects and meeting the
timelines therefor; general market conditions; and the 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. In addition, the forward-looking
statements included in this press release represent Egalet's views
only as of the date hereof. Egalet anticipates that subsequent
events and developments may cause its views to change. 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.
Investor and Media Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com
Tel: 917-432-9275
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SOURCE Egalet Corporation