Antares Pharma Enters Exclusive License Agreement With Ferring Pharmaceuticals for Nocdurna® in U.S.
01 October 2020 - 10:46PM
Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a
pharmaceutical technology company, today announced that it entered
into an exclusive license agreement with Ferring Pharmaceuticals
(“Ferring”), a research-driven, specialty biopharmaceutical group,
for the marketed product NOCDURNA® (desmopressin acetate), which is
indicated for the treatment of nocturia due to nocturnal polyuria
in adults who awaken at least two times per night to urinate, in
the United States (U.S).
“This license agreement for NOCDURNA immediately
expands our urology portfolio, which already includes XYOSTED, the
best-selling branded testosterone replacement product in the United
States. With a launch expected later in the fourth quarter, we look
forward to leveraging the urology office call points of our
90-person national sales force and believe the significant overlap
enhances execution efficiency and may provide for similar success
in NOCDURNA as XYOSTED. Furthermore, we believe NOCDURNA supports
our commercial strategy to enhance our growth through the expansion
of our proprietary product portfolio,” said Robert F. Apple,
President and Chief Executive Officer of Antares Pharma. “We remain
committed to improving patient care and believe nocturnal polyuria
is a clinically underappreciated disease, which leaves a large
untreated patient population and significant unmet medical
need.”
Ferring commercially launched NOCDURNA® in late
2018 upon approval by the U.S. Food and Drug Administration (FDA)
in June 2018 as the first and only rapidly dissolving sublingual
tablet that treats adult patients with nocturia, who awaken at
least two times per night to urinate, due to nocturnal polyuria
(NP). More than 70 million people in the U.S. are affected by
nocturia. NP is present in up to 88% of nocturia patients. Patients
may already be taking medication for overactive bladder (OAB) or
benign prostatic hyperplasia (BPH); however, these medications may
not reduce night-time urination because they do not treat NP. In
patients diagnosed with NP, the kidneys produce too much
urine at night, which can lead to frequent night-time bathroom
visits and can be very disruptive to sleep.
Under the terms of the agreement, Ferring
received an upfront payment of $5.0 million upon execution and will
be paid an additional $2.5 million at one year from execution and
is eligible for tiered royalties and additional commercial
milestone payments potentially totalling up to $17.5 million based
on net sales of NOCDURNA® in the United States.
NOCDURNA® is patent-protected with Orange
Book-listed patents in the United States with varying expirations
through 2030.
About Antares Pharma
Antares Pharma, Inc. is a pharmaceutical
technology company focused primarily on the development and
commercialization of self-administered injectable pharmaceutical
products using advanced drug delivery auto injector technology. The
Company has a portfolio of proprietary and partnered commercial
products with several product candidates in various stages of
development, as well as significant strategic alliances with
industry leading pharmaceutical companies including Teva
Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc.
(AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd.
(Idorsia). Antares Pharma’s FDA approved products include XYOSTED®
(testosterone enanthate) injection, OTREXUP® (methotrexate)
injection for subcutaneous use and Sumatriptan Injection USP, which
is distributed by Teva.
About Ferring
Pharmaceuticals
Ferring Pharmaceuticals is a research-driven,
specialty biopharmaceutical group committed to helping people
around the world build families and live better lives. In the
United States, Ferring is a leader in reproductive medicine and
maternal health, and in specialty areas within gastroenterology and
orthopaedics. For more information, call 1-888-FERRING
(1-888-337-7464); visit www.FerringUSA.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains
forward-looking statements within the meaning of the safe
harbor provisions of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are subject to certain risks and uncertainties that can
cause actual results to differ materially from those described.
Factors that may cause such differences include, but are not
limited to: the Company’s ability to successfully
commercialize Nocdurna in the
United States and market acceptance and future revenue from the
same; the uncertainty regarding the duration,
scope and severity of the COVID-19 pandemic and the mitigation
measures and other restrictions implemented in response to the same
and the impact on reinstated 2020 full-year
revenue guidance, demand for our
products, new patients and prescriptions, future
revenue, product supply, and our overall business,
operating results and financial
condition; market acceptance,
adequate reimbursement coverage and commercial success of
XYOSTED® and future
revenue from the same; successful development
including the timing and results of the clinical bridging and Phase
3 clinical trial of the drug device combination product
for Selatogrel with Idorsia
Pharmaceuticals and FDA and global regulatory approvals and future
revenue from the same; market acceptance of Teva’s
generic epinephrine auto-injector product and future revenue from
the same; our expectations
regarding whether the FDA will pursue withdrawal of approval for
AMAG Pharmaceuticals Inc.’s Makena®
subcutaneous auto injector following the recent FDA
advisory committee meeting and future
prescriptions, market acceptance and revenue from
Makena® subcutaneous auto
injector; Teva’s ability to successfully commercialize
VIBEX® Sumatriptan Injection USP
and the amount of revenue from the same; continued growth of
prescriptions and sales of
OTREXUP®; the timing and results
of the Company’s or its partners’ research projects or clinical
trials of product candidates in development; actions by the FDA or
other regulatory agencies with respect to the Company’s products or
product candidates of its partners; continued growth in product,
development, licensing and royalty revenue; the Company’s ability
to meet loan extension and interest only payment milestones and the
ability to repay the debt obligation to Hercules Capital; the
Company’s ability to obtain financial and other resources for its
research, development, clinical, and commercial activities and
other statements regarding matters that are not historical facts,
and involve predictions. These statements involve known and unknown
risks, uncertainties and other factors that may cause actual
results, performance, achievements
or prospects to be materially different from any future
results, performance, achievements or prospects expressed in or
implied by such forward-looking statements. In some cases you can
identify forward-looking statements by terminology such as ''may'',
''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'',
''anticipate'', ''believe'', ''estimate'', ''predict'',
''potential'', ''seem'', ''seek'', ''future'', ''continue'', or
''appear'' or the negative of these terms or similar expressions,
although not all forward-looking statements contain these
identifying words. Additional information concerning these and
other factors that may cause actual results to
differ materially from those anticipated in the
forward-looking statements is contained in the "Risk Factors"
section of the Company's Annual Report on Form 10-K, and in the
Company's other periodic reports and filings with the Securities
and Exchange Commission. The Company cautions investors not to
place undue reliance on the forward-looking statements contained in
this press release. All forward-looking statements are based on
information currently available to the Company on the date hereof,
and the Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this press release, except as required by
law.
Contact:Tram
BuiVice President, Corporate Communications and Investor
Relations609-359-3016tbui@antarespharma.com
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