Athenex Provides an Update Regarding the Vasopressin Case
02 August 2019 - 10:00PM
Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company
dedicated to the discovery, development and commercialization of
novel therapies for the treatment of cancer, today announced that
the U.S. District Court for the District of Columbia issued a
decision in Athenex’s litigation against the U.S. Food and Drug
Administration (FDA) denying Athenex’s motion for summary judgment
and granting the FDA’s cross-motion for summary judgment. Athenex
plans to appeal the ruling and seek a stay of ruling pending its
appeal. Athenex will cease producing and marketing its compounded
vasopressin product until it is permitted to recommence production
by the Court and FDA.
The latest court decision follows an FDA decision on March 4,
2019 not to list vasopressin on the list of bulk drug substances
permitted to be compounded under Section 503B of the Federal Food,
Drug and Cosmetic Act. Subsequent to the FDA decision, the company
commenced a lawsuit against the FDA in the U.S. District Court for
the District of Columbia contesting the FDA’s decision not to
include vasopressin on the bulk drug substances list. In its
decision, the court found in favor of the FDA, upholding the
agency’s determination that vasopressin is not a bulk drug
substance for which there is a clinical need for outsourcing
facility compounding under Section 503B.
Jeffrey Yordon, Chief Operating Officer of Athenex, stated,
“While we are disappointed by the court’s decision, it does not
come unexpected. We believe our vasopressin product helps to meet
an important clinical need, so while we will comply with the
court’s and FDA’s decision, we may explore additional actions,
including an appeal. Vasopressin is part of a portfolio of
specialty pharmaceutical and 503B products sold by Athenex, and we
will continue to seek opportunities to add to this portfolio, in
order to drive further growth and leverage the brand recognition
and relationships we have built in oncology. In parallel, we remain
focused on the progress of our proprietary oncology pipeline.”
About Athenex, Inc.Founded in
2003, Athenex, Inc. is a global clinical stage
biopharmaceutical company dedicated to becoming a leader in the
discovery, development and commercialization of next generation
drugs for the treatment of cancer. Athenex is organized
around three platforms, including an Oncology Innovation Platform,
a Commercial Platform and a Global Supply Chain Platform. The
Company’s current clinical pipeline is derived from four different
platform technologies: (1) Orascovery, based on non-absorbed
P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell
receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation
therapy. Athenex’s employees worldwide are dedicated to improving
the lives of cancer patients by creating more active and tolerable
treatments. Athenex has offices
in Buffalo and Clarence, New York; Cranford,
New Jersey; Houston, Texas; Chicago, Illinois; Hong
Kong; Taipei, Taiwan; and multiple locations
in Chongqing, China. For more information, please
visit www.athenex.com.
Forward-Looking Statements Except for
historical information, all of the statements, expectations, and
assumptions contained in this press release are forward-looking
statements. These forward-looking statements are typically
identified by terms such as “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “foresee,” “guidance,” “intend,”
“likely,” “may,” “plan,” “potential,” “predict,” “preliminary,”
“probable,” “project,” “promising,” “seek,” “should,” “will,”
“would,” and similar expressions. Actual results might differ
materially from those explicit or implicit in the forward-looking
statements. Important factors that could cause actual results to
differ materially include: the development stage of our primary
clinical candidates and related risks involved in drug development,
clinical trials, regulation, manufacturing and commercialization;
our reliance on third parties for success in certain areas of
Athenex’s business; our history of operating losses and need to
raise additional capital to continue as a going concern;
competition; intellectual property risks; risks relating to doing
business in China; the uncertain impact of inspections to be
performed by the Department of Emergency Management of Chongqing on
the production of API in our Chongqing plant and our business
generally; and the other risk factors set forth from time to time
in our SEC filings, copies of which are available for
free in the Investor Relations section of our website
at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or
upon request from our Investor Relations Department. All
information provided in this release is as of the date hereof and
we assume no obligation and do not intend to update these
forward-looking statements, except as required by law.
CONTACTS Investor Relations: Tim McCarthy
Managing Director, LifeSci Advisors, LLC Tel: +1
716-427-2952 Direct: +1 212-915-2564
Athenex, Inc.: Randoll Sze Chief Financial Officer
Email: randollsze@athenex.comJacqueline Li Corporate
Development and Investor Relations
Email: jacquelineli@athenex.com
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