Aclaris Therapeutics Files Patent Infringement Lawsuit Against Taro Pharmaceuticals, Inc. for Filing an ANDA for a Generic Ve...
October 08 2019 - 5:01PM
Aclaris Therapeutics, Inc. (Nasdaq: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory diseases,
announced today that the company, together with Allergan, Inc., has
filed a patent infringement lawsuit in the United States District
Court for the District of Delaware against Taro Pharmaceuticals,
Inc. ("Taro"), related to an Abbreviated New Drug Application
("ANDA") that Taro filed with the U.S. Food and Drug Administration
("FDA") to market a generic version of RHOFADE® (oxymetazoline
hydrochloride) cream, 1% ("RHOFADE").
The lawsuit claims infringement of U.S. Patent Nos. 7,812,049,
8,420,688, 8,815,929, 9,974,773 and 10,335,391, which are listed in
the FDA's Approved Drug Products with Therapeutic Equivalence
Evaluations, commonly known as the Orange Book, for RHOFADE.
Aclaris Therapeutics received a Paragraph IV Notice Letter from
Taro dated August 28, 2019, advising that Taro had submitted an
ANDA to the FDA seeking approval from the FDA to manufacture and
market a generic version of RHOFADE prior to the expiration of the
Orange Book-listed patents.
Aclaris intends to vigorously enforce its intellectual property
rights relating to RHOFADE.
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 Aclaris’ intent to vigorously defend its intellectual
property. 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
related to the ability of the company to protect its intellectual
property and defend its patents and the possible introduction of
generic products, 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, Aclaris’ Quarterly
Report on Form 10-Q for the quarter ended June 30, 2019, 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.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical
company committed to addressing the needs of people with
immuno-inflammatory diseases who lack satisfactory treatment
options. The company’s diverse portfolio includes 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. For additional information, please visit
www.aclaristx.com and follow Aclaris on LinkedIn or Twitter
@aclaristx.
Aclaris Contact:
Michael Tung, M.D.Senior Vice President Corporate
Strategy/Investor Relations484-329-2140mtung@aclaristx.com
Source: Aclaris Therapeutics, Inc.
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