Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) (“the Company”)
today announced that the Company’s social media campaign for
XYOSTED®, has been honored with a 2019 MarCom Platinum Award.
The award is the highest level achievable in the international
marketing competition.
The social media campaign for XYOSTED® featured
a series of Facebook and Instagram ads to prime existing
testosterone deficient patients for the launch of a new
testosterone replacement therapy. The ads used humor and arresting
imagery which focused on the challenges of other testosterone
therapies such as messy application of testosterone gels and
painful intramuscular injections. XYOSTED® is a once weekly,
virtually painless subcutaneous injection of testosterone which can
restore men’s testosterone levels into the normal range. The
social media campaign competed with other lifestyle content on the
social platforms, with results that exceeded initial
expectations.
“We are honored to be recognized by the
Association of Marketing and Communication Professionals with such
a prestigious award for our XYOSTED social media campaign.
Extensive market research with testosterone deficient patients
helped us understand the compromises they were making with their
current treatment options. We wanted to potentially help these
patients, by making them aware of a new treatment option,” said
Robert F. Apple, President and Chief Executive Officer of the
Company. “We believe that many of our prescribers and
patients see the benefits of XYOSTED, a once weekly subcutaneous,
virtually pain-free treatment option.”
For complete prescribing information, please
visit
http://www.xyosted.com
XYOSTED®IMPORTANT SAFETY
INFORMATION
What is the most important safety information I should
know about XYOSTED?
Blood Pressure Increases – XYOSTED can increase
your blood pressure, which can increase your risk of having a heart
attack or stroke and can increase your risk of death due to a heart
attack or stroke. Your risk may be greater if you have
already had a heart attack or stroke or if you have other risk
factors for heart attack or stroke. If your blood pressure
increases while you are on XYOSTED, blood pressure medicines may
need to be started or new medicines may need to be added. If your
blood pressure cannot be controlled, XYOSTED may need to be
stopped. Your healthcare provider should monitor your blood
pressure while you are being treated with XYOSTED.
What is XYOSTED?
XYOSTED is a prescription medicine that contains testosterone.
XYOSTED is used to treat adult men who have low or no testosterone
due to certain medical conditions.
It is not known if XYOSTED is safe and effective to treat men
who have low testosterone due to aging.
It is not known if XYOSTED is safe and effective for use in
children younger than 18 years old. Improper use of XYOSTED may
effect bone growth in children.
XYOSTED is a controlled substance (CIII) because it contains
testosterone that can be a target for people who abuse prescription
medicines. Keep your XYOSTED in a safe place to protect it.
Never give your XYOSTED to anyone else. Selling or giving away this
medicine may harm others and it is against the law.
XYOSTED is not meant for use by women.
Do not use XYOSTED if you:
- Are a man who has breast cancer.
- Have or might have prostate cancer.
- Are a woman who is pregnant. XYOSTED may harm your unborn
baby.
- Are allergic to XYOSTED or to any ingredients in XYOSTED
including testosterone or sesame oil.
- Have low testosterone without certain medical conditions.
For example, do not take XYOSTED if you have low testosterone due
to age.
What should I tell my healthcare provider before using
XYOSTED?
Before you use XYOSTED, tell your healthcare provider
about all of your medical conditions, including, if you have any of
the following: high blood pressure or heart problems, high
red blood cell count, urinary problems due to an enlarged prostate,
kidney or liver problems, a history of mental health illness
including suicidal thoughts or actions, depression, anxiety or mood
disorder, or problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take,
including prescription and nonprescription medicines, vitamins,
and herbal supplements.
Using XYOSTED with other medicines can affect each other.
Especially, tell your healthcare provider if you take insulin,
medicines that decrease blood clotting (blood thinners),
corticosteroids or medicines for pain and cold. Know the
medicines you take. Ask your pharmacist for a list of all your
medicines if you are not sure. Show your list to your
healthcare provider and pharmacist when you get a new medicine.
How should I use XYOSTED?
- See the detailed Instructions for Use for Information
about how to use XYOSTED.
- Use XYOSTED exactly as your healthcare provider tells you to
take it.
- Your healthcare provider will show you or your caregiver how to
inject XYOSTED. You should not inject XYOSTED until you have been
trained on the proper way to use it.
What are the possible side effects of
XYOSTED?
XYOSTED can cause serious side effects
including:
- See “What is the most important information I should
know about XYOSTED?” above.
- Increase in blood pressure.
XYOSTED can increase your blood pressure, which can increase your
risk of having a heart attack or stroke and can increase your risk
of death due to heart attack or stroke. Your risk may be greater if
you have already had a heart attack or stroke or if you have other
risk factors for heart attack or stroke.
- Increase in red blood cell count, hematocrit or
hemoglobin. High red blood cell counts increase the
risk of clots, strokes, and heart attacks. You may need to
stop XYOSTED if your red blood cell count increases. Your
healthcare provider should check your red blood cell count,
hematocrit and hemoglobin while you use XYOSTED.
- Cardiovascular Risk. Possible Increase risk of
heart attack, death, or stroke.
- If you already have an enlarged prostate, your signs
and symptoms may get worse while using XYOSTED. This can
include: increased nighttime urination, trouble starting
urination, more frequent urination, feeling an urge to urinate,
having a urine accident, and being unable to pass urine or weak
urine flow.
- Increased risk of prostate cancer. Your
healthcare provider should check you for prostate cancer or any
other prostate problems before you start and while you use
XYOSTED.
- Blood clots in the legs or lungs. Signs and
symptoms of a blood clot in your leg can include leg pain, swelling
or redness. Signs and symptoms of a blood clot in your lungs can
include difficulty breathing or chest pain.
- Abuse. Testosterone can be abused, when
taken at higher than prescribed doses and when used with other
anabolic androgenic steroids. Abuse can cause serious heart and
psychological side effects.
- In large doses XYOSTED may lower your sperm
count.
-
Liver
problems. Symptoms of liver problems may include nausea or
vomiting, yellowing of your skin or whites of your eyes, dark urine
or pain on the right side of your stomach area (abdominal
pain).
- Swelling of your ankles, feet, or body, with or without
heart failure. This may cause serious problems for
people who have heart, kidney or liver disease.
- Enlarged or painful breasts.
- Problems breathing while you sleep (sleep
apnea).
- Change in mood. Talk to your healthcare
provide if you have changes in mood or behavior including, new or
worsening depression, or suicidal thoughts.
Call your healthcare provider right away if you have any
of the serious side effects listed above.
The most common side effects of XYOSTED
include: red blood cell increase, prostatic specific
antigen (PSA) increase (a blood test for prostate cancer),
increased blood pressure, and injection site reactions including
bruising, bleeding, redness and headache.
Other side effects include more erections than
are normal for you or erections that last a long time. Tell your
healthcare provider if you have any side effect that bothers you or
that does not go away. These are not all the possible side effects
of XYOSTED. For more information, ask your healthcare provider or
pharmacist.
For more information, go to www.XYOSTED.com or call
1-844-XYOSTED (1-844-996-7833).
To report side effects to the FDA, visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Please see the full Prescribing Information, including
Boxed Warning, and Medication Guide.© 2019 Antares Pharma,
Inc. All rights reserved.
About Hypogonadism
Hypogonadism, also known as testosterone
deficiency or Low T, is a condition in which the body does not
produce enough testosterone – the hormone that plays a key role in
masculine growth and development during puberty, and maintenance of
musculoskeletal, metabolic, and mental health in maturity.
Symptoms of male hypogonadism can be treated with testosterone
replacement therapy. (see Indications and Usage above)
About Antares Pharma
Antares Pharma, Inc. is a combination drug
device company focused primarily on the development and
commercialization of self-administered parenteral 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: impact of the social
media campaign on future XYOSTED® prescriptions, 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;
achievement of the 2019 revised revenue guidance; 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:
Jack HowarthVice President, Corporate Affairs of
Antares609-359-3016jhowarth@antarespharma.com
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