Aclaris Therapeutics Announces Divestiture of RHOFADE®
October 10 2019 - 4:02PM
Aclaris Therapeutics, Inc. (Nasdaq: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory diseases,
today announced it has divested RHOFADE® (oxymetazoline
hydrochloride) cream, 1% (RHOFADE) and related intellectual
property assets to EPI Health, LLC (EPI Health). The divestiture of
RHOFADE is a key component of Aclaris’ recently announced strategic
plan to refocus resources on the development of its
immuno-inflammatory development programs.
“This transaction provides us with an
opportunity to refocus our resources on the development of our
immuno-inflammatory assets so that we may develop treatments for
patients with immuno-inflammatory diseases who lack satisfactory
treatment options.” said Dr. Neal Walker, Aclaris’ President and
Chief Executive Officer. “We also believe that EPI Health’s
extensive dermatology and commercial expertise will be instrumental
in their commercialization of RHOFADE."
Aclaris and EPI Health have entered into a
purchase agreement whereby Aclaris sold the worldwide rights to
RHOFADE, which includes the assignment of certain licenses for
related intellectual property assets. Pursuant to the terms of the
agreement, EPI Health has agreed to pay Aclaris total cash
consideration of up to $55.0 million, consisting of (i) an upfront
payment of $35.0 million and (ii) potential sales milestone
payments of up to $20.0 million in the aggregate upon the
achievement of specified levels of net sales of products covered by
the agreement. In addition, EPI Health has agreed to pay Aclaris,
(i) a specified high single-digit royalty calculated as a
percentage of net sales, on a product-by-product and
country-by-country basis, subject to specified reductions,
limitations and adjustments and (ii) 25% of any upfront, license,
milestone, maintenance or fixed payment received by EPI Health from
a licensee or sublicensee in any territory outside of the United
States, subject to specified exceptions.
SVB Leerink LLC acted as exclusive financial
advisor and DLA Piper LLP (US) served as legal counsel to
Aclaris.
Concurrently with the closing of this
transaction, Aclaris repaid in full its $30 million term loan (plus
fees and expenses) with Oxford Finance LLC. EPI Health has agreed
to assume the obligation to pay specified royalties and milestone
payments under Aclaris’ existing agreements with Allergan Sales,
LLC, Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc.
As a result of these changes, Aclaris
anticipates that its current cash, cash equivalents and marketable
securities on hand, including the upfront proceeds received from
EPI Health, and the repayment of the outstanding term loan, will be
sufficient to fund its operations into the third quarter of 2021,
without giving effect to any potential new business development
transactions or financing activities.
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 drug candidate 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.
About EPI Health, LLC
Headquartered in Charleston, South Carolina, EPI Health is a
specialty pharmaceutical company committed to delivering innovative
prescription therapies to dermatologists while improving the
quality of life of patients and providing outstanding medical
services to dermatology community. EPI Health is a wholly owned
subsidiary of EPI Group. For more information, visit the EPI Health
website at www.epihealth.com.
Cautionary Note Regarding
Forward-Looking StatementsAny 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 its belief that its
existing cash, cash equivalents and marketable securities will be
sufficient to fund its operations into the third quarter of 2021
and the commercialization of RHOFADE by EPI Health. 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 and in commercialization of products, 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, 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.
Aclaris ContactMichael Tung, M.D.Senior Vice
President Corporate Strategy/Investor
Relations484-329-2140mtung@aclaristx.com
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