DUBLIN, Sept. 30, 2019
/CNW/ -- Endo International plc ("Endo") (NASDAQ: ENDP) today
announced the successful culmination of two litigation matters
before the U.S. District Court for the District of Columbia regarding the unlawful
compounding of vasopressin from bulk drug substances.
In October 2017, Endo initiated a
lawsuit against the U.S. Food and Drug Administration ("FDA")
challenging the FDA's interim policy authorizing the bulk
compounding of drugs. That policy relied on "enforcement
discretion" to allow bulk compounding of vasopressin, the active
ingredient in Vasostrict®, which is manufactured by
Endo's subsidiary Par Sterile Products, LLC. Endo's lawsuit
alleged that the FDA's interim policy violated Section 503B of the Drug Quality and Security Act
("DQSA") and other provisions of the Federal Food, Drug, and
Cosmetic Act which allow bulk compounding only if FDA first makes a
determination that there is a genuine "clinical need" for
compounding from a particular bulk drug substance.
Shortly after Endo filed its lawsuit, the FDA began to take
significant steps to implement the requirements of the DQSA, and in
particular issued proposed guidance regarding the statutory
"clinical need" requirement which was consistent with the claims in
Endo's Complaint. At FDA's and the Department of Justice's
request, Endo stayed its lawsuit to allow FDA time to complete this
process. FDA ultimately finalized its new guidance and issued
a thorough, well-reasoned administrative decision that bulk
compounders of vasopressin competing with Vasostrict®
could not satisfy the statutory "clinical need" requirement.
Soon thereafter, a bulk compounder of vasopressin, Athenex,
Inc., and two related entities (collectively, "Athenex"), sued the
FDA—also in the U.S. District Court in the District of
Columbia—seeking to invalidate the FDA's decision regarding
vasopressin. Endo intervened in the Athenex lawsuit to defend
the case alongside the FDA and the Department of Justice. The
defense was successful, with the Court concluding on August 1, 2019 that the "FDA's exclusion of
vasopressin from the 'clinical need' list was not arbitrary and
capricious," a decision that "forecloses [Athenex] from selling
their product." The Court also denied Athenex's subsequent
motion for a stay of its ruling pending appeal. Although
Athenex initially appealed the Court's ruling, it recently filed a
motion to withdraw that appeal.
Given FDA's determination removing bulk compounded vasopressin
from the market, and FDA's and Endo's success in the Athenex
litigation, Endo has agreed with the FDA and the Department of
Justice to voluntarily dismiss without prejudice its initial
lawsuit against the FDA. That case has been stayed since
February 2019, and Endo has now filed
with the Court a stipulation to voluntarily dismiss the suit.
"Endo congratulates FDA on the successful and well-reasoned
implementation of Section 503B of the
DQSA, and was very pleased to assist in the subsequent defense of
separate litigation regarding those actions," said Matthew J. Maletta, Executive Vice President and
Chief Legal Officer of Endo. "In light of FDA's determination
that bulk compounding of vasopressin is impermissible under Section
503B and the Court's decision to
uphold that determination, we have agreed with the Department of
Justice and the FDA to voluntarily dismiss Endo's
lawsuit."
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused
generics and specialty branded pharmaceutical company delivering
quality medicines to patients in need through excellence in
development, manufacturing and commercialization. Endo has
global headquarters in Dublin,
Ireland, and U.S. headquarters in Malvern, PA. Learn
more at www.endo.com.
Cautionary Note Regarding Forward-Looking Statements
Certain information in this press release may be considered
"forward-looking statements," within the meaning of the Private
Securities Litigation Reform Act of 1995 and any applicable
Canadian securities legislation including, but not limited to, the
statements by Mr. Maletta and other statements relating to the
status and outcome of litigation and the potential impact of the
FDA's clinical need determination for vasopressin. All
forward-looking statements in this press release reflect Endo's
current expectations of future events based on information
available to Endo as of the date of this press release. If
underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially
from Endo's expectations and projections. Risks and
uncertainties include, among other things, general industry and
market conditions; technological advances and patents attained by
competitors; challenges inherent in the research and development
and regulatory processes, including regulatory decisions, product
recalls, withdrawals and other unusual items; challenges related to
product marketing, such as the unpredictability of market
acceptance for new products and/or the acceptance of new
indications for such products; inconsistency of treatment results
among patients; potential difficulties in manufacturing; the
outcome of litigation, settlement discussions or other adverse
proceedings; general economic conditions; and governmental laws and
regulations affecting domestic and foreign operations. Endo
expressly disclaims any intent or obligation to update these
forward-looking statements except as required by law.
Additional information concerning these and other risk
factors can be found in Endo's periodic reports filed with the U.S.
Securities and Exchange Commission and in Canada on the System for Electronic Data
Analysis and Retrieval, including current reports on Form 8-K,
quarterly reports on Form 10-Q and annual reports on Form
10-K.
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SOURCE Endo International plc