Aclaris Therapeutics Announces Issuance of Additional Orange Book Listable Patent Covering RHOFADE® (Oxymetazoline Hydrochlo...
July 09 2019 - 7:00AM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory and
dermatological diseases, today announced that the United States
Patent and Trademark Office (USPTO) has issued U.S. Patent No.
10,335,391 covering methods of treating facial erythema associated
with rosacea using a 1.0% w/w oxymetazoline hydrochloride
composition. This issued U.S. Patent will be listed in the
Orange Book for RHOFADE and is set to expire in June 2035.
RHOFADE is the first α1A adrenoceptor agonist approved for the
topical treatment of persistent facial erythema (redness)
associated with rosacea in adults, which is estimated to affect
nearly 16 million people in the U.S.
The patent contains 37 claims directed to methods of treating
facial erythema associated with rosacea. The claimed methods
include topically administering once daily on the face of the
patient a composition comprising 1.0% w/w oxymetazoline
hydrochloride as the sole active ingredient.
The RHOFADE patent estate includes five other Orange Book listed
U.S. patents expiring between January 2024 and June 2035, as well
as several pending U.S. patent applications. Internationally,
RHOFADE is covered by several issued European patents, including
European Patent No. EP2675449, granted on April 24, 2019, which is
directed to the use of oxymetazoline cream for the topical
treatment of inflammatory lesions associated with rosacea.
RHOFADE is also covered by issued patents in Japan, South Korea,
Australia, and several other major foreign countries.
“Aclaris continues to expand its intellectual property estate
and we are pleased to add a 6th Orange Book listable patent to the
intellectual property portfolio covering RHOFADE. This U.S.
patent, together with the recently granted European patent, augment
our strong worldwide intellectual property portfolio covering
RHOFADE,” said Dr. Neal Walker, President and Chief Executive
Officer of Aclaris.
INDICATION RHOFADE cream
1% is indicated for the topical treatment of persistent facial
erythema associated with rosacea in adults.
IMPORTANT SAFETY INFORMATION AND WARNINGS
WARNINGS AND PRECAUTIONS Potential
Impacts on Cardiovascular Disease Alpha-adrenergic
agonists may impact blood
pressure. RHOFADE cream should be used
with caution in patients with severe or unstable or uncontrolled
cardiovascular disease, orthostatic hypotension, and uncontrolled
hypertension or hypotension. Advise patients with cardiovascular
disease, orthostatic hypotension, and/or uncontrolled
hypertension/hypotension to seek immediate medical care if their
condition worsens.
Potentiation of Vascular Insufficiency
RHOFADE cream should be used with caution in
patients with cerebral or coronary insufficiency, Raynaud’s
phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren’s
syndrome. Advise patients to seek immediate medical care if signs
and symptoms of potentiation of vascular insufficiency develop.
Risk of Angle Closure Glaucoma
RHOFADE cream may increase the risk of angle
closure glaucoma in patients with narrow-angle glaucoma. Advise
patients to seek immediate medical care if signs and symptoms of
acute angle closure glaucoma develop.
CONTRAINDICATIONS There are no
contraindications for RHOFADE cream.
ADVERSE REACTIONS The most common adverse
reactions ≥1% for RHOFADE cream were:
application-site dermatitis 2%, worsening inflammatory lesions of
rosacea 1%, application-site pruritus 1%, application-site erythema
1%, and application-site pain 1%.
For topical use only. Not for oral, ophthalmic, or intravaginal
use.
Please see RHOFADE cream full Prescribing Information
at www.aclaristx.com/uploads/ACRS-Rhofade-PI.pdf.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical
company committed to addressing the needs of people with
immuno-inflammatory and dermatological diseases who lack
satisfactory treatment options. The company’s diverse and
multi-stage portfolio includes two FDA-approved medicines, one
late-stage investigational medicine, and a pipeline powered by a
robust R&D engine exploring protein kinase regulation. Aclaris
Therapeutics’ active development programs focus on areas where
significant treatment gaps exist, such as common warts, alopecia
areata, and vitiligo. For additional information, please visit
www.aclaristx.com and follow Aclaris on LinkedIn or Twitter
@aclaristx.
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 beliefs
about Aclaris’ intellectual property portfolio. 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 for the year ended December 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 "SEC filings” 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.
Contact:Aclaris ContactMichael Tung, M.D.Senior
Vice President Corporate Strategy/Investor
Relations484-329-2140mtung@aclaristx.com
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