Aclaris Therapeutics Announces Issuance of Additional Orange Book Listable Patent Covering ESKATA
May 30 2018 - 7:00AM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company committed to identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in aesthetic and medical dermatology and immunology,
announced today the United States Patent and Trademark Office
(USPTO) has issued U.S. Patent No. 9,980,983 covering methods of
treating seborrheic keratosis using a stabilized hydrogen peroxide
composition. This issued U.S. patent will be listed in the
Orange Book for ESKATA and is set to expire in April 2035, subject
to any patent term adjustment or extension.
The patent contains 25 claims directed to methods
of treating seborrheic keratosis by administering a 40% w/w
stabilized hydrogen peroxide composition. Our current marketed
product, ESKATA, includes such stabilized hydrogen peroxide.
Aclaris’ ESKATA patent estate also includes two other Orange Book
listed patents as well as a patent application directed to
particular applicators used to administer high-concentration
hydrogen peroxide formulations, including 40% and 45% topical
solutions of hydrogen peroxide. Internationally, Aclaris has filed
applications in Europe and other major foreign countries directed
to high-concentration hydrogen peroxide formulations, including 40%
and 45% topical solutions of hydrogen peroxide, methods for using
such solutions, and applicators therefor.
“We are delighted to add another Orange Book
listable patent to our robust intellectual property portfolio
covering ESKATA. The steadily growing portfolio includes numerous
issued patents and pending patent applications in the U.S. and
major international markets. We are committed to working on
the expansion of our patent protection for ESKATA,” said Stuart
Shanler, M.D., Chief Scientific Officer of Aclaris.
About ESKATA™ ESKATA
(hydrogen peroxide) topical solution, 40% (w/w), is the first and
only FDA-approved medication for the treatment of raised
seborrheic keratoses (SKs).
Important Safety Information and Approved
Use
ESKATA can cause serious side effects,
including:
- Eye problems. Eye problems can
happen if ESKATA™ (hydrogen peroxide) topical solution, 40%
(w/w) gets into your eyes, including: ulcers or small holes in your
eyes, scarring, redness, irritation, eyelid swelling, severe eye
pain, and permanent eye injury, including blindness.
- If ESKATA accidentally gets into your eyes, your
healthcare provider will tell you to flush them well with water for
15 to 30 minutes. Your healthcare provider may send you
to another healthcare provider if needed.
- Local skin reactions. Skin
reactions have happened in and around the treatment area after
application of ESKATA. Severe skin reactions can include: breakdown
of the outer layer of the skin (erosion), ulcers, blisters and
scarring. Tell your healthcare provider if you have any skin
reactions during treatment with ESKATA.
The most common side effects of ESKATA
include: itching, stinging, crusting, swelling,
redness and scaling.
Your healthcare provider will not apply another
treatment of ESKATA if your treated area is still irritated from
the previous treatment.
Tell your healthcare provider right away if ESKATA
gets into your eyes, mouth or nose during application. ESKATA
is for topical use on the skin only, and is not for use in your
eyes, mouth or vagina.
These are not all the possible side effects of
ESKATA.
Approved Use for ESKATA
ESKATA is a prescription medicine used to treat
seborrheic keratoses that are raised.
ESKATA is for use as an in-office treatment. ESKATA
is applied by your healthcare provider and is not for use at
home.
You are encouraged to report negative side
effects of prescription drugs to the FDA. Contact Aclaris
Therapeutics, Inc. at 1-833-ACLARIS or 1-833-225-2747
or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
About Aclaris Therapeutics,
Inc.
Aclaris Therapeutics, Inc. is a
dermatologist-led biopharmaceutical company committed to
identifying, developing, and commercializing innovative therapies
to address significant unmet needs in dermatology, both aesthetic
and medical, and immunology. Aclaris’ focus on market segments with
no FDA-approved medications or where treatment gaps exist has
resulted in the first FDA-approved treatment for raised
seborrheic keratoses and several clinical programs to develop
medications for the potential treatment of common warts, alopecia
areata, androgenetic alopecia, and vitiligo. For additional
information, please visit www.aclaristx.com and follow
Aclaris on LinkedIn.
Cautionary Note Regarding Forward-Looking
Statements
Any statements contained in this press release that
do not describe historical facts may constitute forward-looking
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by words such as "believe", "expect", "may", "plan," "potential,"
"will," and similar expressions, and are based on Aclaris' current
beliefs and expectations. These forward-looking statements include
expectations regarding the commercial use of ESKATA and the
expansion of our intellectual property portfolio covering ESKATA.
These statements involve risks and uncertainties that could cause
actual results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the conduct
of clinical trials, Aclaris' reliance on third parties over which
it may not always have full control, and other risks and
uncertainties that are described in the Risk Factors section of
Aclaris' Annual Report on Form 10-K filed for the year
ended December 31, 2017, Aclaris’ Quarterly Report on Form
10-Q filed earlier for the quarter ended March 31,
2018 and other filings Aclaris makes with the U.S.
Securities and Exchange Commission from time to time. These
documents are available under the "Financial Information" section
of the Investors page of Aclaris' website
at http://www.aclaristx.com. Any forward-looking statements
speak only as of the date of this press release and are based on
information available to Aclaris as of the date of this release,
and Aclaris assumes no obligation to, and does not intend to,
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Aclaris ContactMichael Tung,
M.D.Senior Vice President Corporate Strategy/Investor
Relations484-329-2140mtung@aclaristx.com
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