Antares Pharma and Lunatus Enter Into an Exclusive Distribution Agreement for XYOSTED® in Saudi Arabia and the United Arab E...
August 03 2020 - 7:00AM
Antares Pharma, Inc. (NASDAQ: ATRS), a pharmaceutical technology
company, today announced they have entered into an exclusive
distribution agreement with Lunatus Global Medical Supplies
(“Lunatus”) to distribute and promote the sale of XYOSTED® in
Saudi Arabia and the United Arab Emirates (“UAE”).
Under the agreement, Antares will be responsible
for the supply of fully packaged product to Lunatus and Lunatus
will be responsible for submitting and obtaining regulatory
approval for XYOSTED® in Saudi Arabia and the UAE as well as
marketing, promotion and distribution of XYOSTED® in these two
countries.
“We believe today’s announcement represents the
first step in creating increased brand awareness for XYOSTED in the
rest of the world, and look forward to working with our partner
Lunatus in that endeavour. XYOSTED is currently the fastest
growing branded testosterone replacement therapy in the U.S.,” said
Robert F. Apple, President and Chief Executive Officer of the
Company.” He continued, “Current treatment options in these
two countries include a painful hospital administered testosterone
injection given every three months or a topical gel.
Alternatively, XYOSTED would be an attractive new treatment option
for physicians and patients given its unique product profile
featuring a virtually painless, once-weekly, at-home subcutaneous
self-injection. Lunatus, a Dubai based company, has a proven
track record of introducing, building and maintaining profitable
brands in the Arabian Gulf and Middle East regions. We
believe this agreement will help lay the groundwork for expanding
our global footprint for XYOSTED and represents the first of
potentially multiple international distribution agreements.”
“We are excited to bring XYOSTED to Saudi Arabia
and the UAE. XYOSTED is a U.S. FDA approved treatment option
for adult men diagnosed with testosterone deficiency,” said Dr.
Lina Kouatly, President and Chief Executive Officer of
Lunatus. “Assuming regulatory approval in these two
countries, we believe our partnership can achieve significant share
and expand the market using this novel treatment approach.”
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 proprietary products include
XYOSTED® (testosterone enanthate) injection, OTREXUP®
(methotrexate) injection for subcutaneous use and Sumatriptan
Injection USP, which is distributed by Teva.
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: Lunatus’ ability to
obtain regulatory approval and successfully commercialize XYOSTED
in Saudi Arabia and the United Arab Emirates and the amount of
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 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.
Contacts:
Jack HowarthVice President, Corporate
Affairs609-359-3016jhowarth@antarespharma.com
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