Antares Pharma, Inc. (NASDAQ:ATRS) today announced that the
Company’s OTREXUP.COM website has been awarded a 2015 Bronze
Horizon Interactive Award in the category of Consumer Information
Websites. The Horizon Interactive Awards are among the most
prestigious awards in the field of interactive and creative
media. The annual international competition, now in its 14th
season, recognizes, promotes and awards the best web sites, videos,
online advertising, print media and mobile applications. In
2015 alone, Horizon received over 1,100 competition submissions
from more than 40 countries. A volunteer panel of industry
professionals review the entries to determine the recognition and
shed a spotlight on the winners and the people who made it
happen.
“Antares believes that providing educational and
easy to understand content on disease condition and treatment
options is essential for patients,” said Robert Apple, President
and Chief Executive Officer. “The website was designed
specifically for patients, physicians and caregivers each with
distinct sections for easy navigation. Please visit
www.Otrexup.com.”
This is the second award received in 2015 which
recognizes the OTREXUP.COM website; the first was an honorable
mention from the MarCom Awards. The MarCom competition is the
largest of its kind in the world with about 6,000 entries per
year.
IMPORTANT SAFETY
INFORMATION
OTREXUP™ is a single-dose auto-injector
containing a prescription medicine, methotrexate. Methotrexate is
used to:
- treat certain adults with severe, active rheumatoid arthritis
(RA), and children with active polyarticular juvenile idiopathic
arthritis (pJIA), after treatment with other medicines including
non-steroidal anti-inflammatory (NSAIDS) have been used and did not
work well.
- control the symptoms of severe, resistant, disabling psoriasis
in adults when other types of treatment have been used and did not
work well.
OTREXUP should not be used for the treatment of
cancer.
OTREXUP should not be used for the treatment of
children with psoriasis.
Methotrexate includes the following
boxed warning:OTREXUP can cause serious side
effects that can lead to death, including:
- Organ system toxicity. People who use
methotrexate for the treatment of cancer, psoriasis, or rheumatoid
arthritis, have an increased risk of death from organ toxicity.
Types of organ toxicity can include: gastrointestinal, bone marrow,
liver, immune system, nerve, lung, kidneys and skin.
Your doctor will do blood tests and
other types of tests before you take and while you are taking
OTREXUP to check for signs and symptoms of organ toxicity. Call
your doctor right away if you have any of the following symptoms of
organ toxicity: vomiting, diarrhea, mouth sores, fever, confusion,
weakness, temporary blindness, seizures, headache, back pain, neck
stiffness, paralysis, irritability, sleepiness, and problems with
coordination, dry cough, trouble breathing and severe skin
rash.
- Women who are pregnant are at increased risk for death
of the baby and birth defects. Women who are
pregnant or who plan to become pregnant must not take OTREXUP. A
pregnancy test should be performed before starting
OTREXUP.
Contraception should be used by both
females and males while taking OTREXUP. Pregnancy should be avoided
if either partner is receiving OTREXUP:
- For a minimum of 3 months after treatment with OTREXUP
for males.
- During and for at least 1 menstrual cycle after
treatment with OTREXUP for females.
What are the possible side effects
of OTREXUP?OTREXUP may cause serious side
effects, including:See “What is the most important information I
should know about OTREXUP?”
- Fertility problems. Methotrexate, the active
ingredient in OTREXUP, may affect your ability to have a baby.
Males may have a decreased sperm count, and females may have
changes to their menstrual cycle. This can happen while taking
OTREXUP and for a short period of time after you stop.
- Certain cancers. Some people who have taken
methotrexate have had a certain type of cancer called Non-Hodgkin’s
lymphoma and other tumors. Your doctor may tell you to stop taking
OTREXUP if this happens.
- Tissue and bone problems. Taking Methotrexate
while having radiation therapy may increase the risk of your tissue
or bone not receiving enough blood. This may lead to death of the
tissue or bone.
Common side effects of
OTREXUP include: nausea, stomach
pain, indigestion (dyspepsia), mouth sores, and rash.
Who should not take OTREXUP?Do
not take OTREXUP if you:
- Are pregnant or planning to become pregnant
- Have alcohol problems (alcoholism)
- Have liver problems
- Have problems fighting infection (immune deficiency
syndrome)
- Have been told you have (or think you have) a blood disorder
such as low levels of white blood cells, red blood cells (anemia),
or platelets
- Have an allergy to methotrexate or any of the ingredients
in OTREXUP
What should I tell my doctor before
taking OTREXUP?Before you take OTREXUP,
tell your doctor if you have any other medical conditions. Tell
your doctor about all of the medicines you take, including
prescription, over-the-counter medicines, vitamins, and herbal
supplements.
OTREXUP may affect how other medicines work, and
other medicines may affect how OTREXUP works causing side effects.
Ask your doctor or pharmacist for a list of medicines if you are
not sure.
Tell your doctor if you have any side effect
that bothers you or that does not go away. These are not all the
possible side effects of OTREXUP. For more information, ask your
doctor or pharmacist.
Call you doctor for medical advice about side
effects. You may report side effects to FDA at
1-800-FDA-1088. For more information, go to
www.OTREXUP.com or call 1-855-OTREXUP (1-855-687-3987).
About Antares Pharma
Antares Pharma focuses on self-administered
parenteral pharmaceutical products. The Company’s product, OTREXUP™
(methotrexate) injection for subcutaneous use, is approved in the
U.S. for the treatment of adults with severe active rheumatoid
arthritis, children with active polyarticular juvenile idiopathic
arthritis and adults with severe recalcitrant psoriasis. Antares
Pharma is also developing QuickShot® Testosterone for testosterone
replacement therapy, and has recently received a therapeutically
equivalent FDA approval for VIBEX® Sumatriptan USP for the acute
treatment of migraines. The Company's technology platforms
include VIBEX® disposable auto injectors, disposable multi-use pen
injectors and reusable needle-free injectors. Antares Pharma has a
multi-product deal with Teva Pharmaceutical Industries, Ltd. that
includes VIBEX® epinephrine, exenatide multi-dose pen, and
teriparatide multi-dose pen. Our reusable needle-free
injector for use with human growth hormone (hGH) is sold worldwide
by Ferring B.V. The Company is also working with AMAG
Pharmaceuticals on a subcutaneous method of administering Makena, a
progesterone product indicated for use in lowering the risk of
pre-term birth.
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: continued growth of
prescriptions and sales of OTREXUP™; the outcome of the pending
patent litigation between Teva Pharmaceutical
Industries, Ltd. (Teva) and Eli Lilly and Company
regarding the Teriparatide multi-dose pen; the
timing and approval, if any, by the U.S. Food and
Drug Administration (FDA) of Teva’s Abbreviated
New Drug Application (ANDA) for
Teriparatide multi-dose pen and any future
revenue resulting therefrom; Teva’s ability to
adequately and timely respond to the Complete Response Letter
received from the FDA for the VIBEX® epinephrine pen ANDA and
approval by the FDA of the same, the timing and therapeutic
equivalence rating thereof, and any revenue pre or post FDA
approval; FDA action with respect to the ANDA filed for the
exenatide pen; the timing of the launch of VIBEX® Sumatriptan
Injection USP and the amount of revenue from the same, the timing
and results of the phase 3 studies for QuickShot® Testosterone (QS
T) and acceptance of the data by the FDA; the Company’s ability to
successfully complete a New Drug Application for QS T and submit to
the FDA and approval of the same by the FDA;; the timing and
results of research projects, clinical trials, and product
candidates in development; actions by the FDA or other regulatory
agencies with the 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 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 for the year
ended December 31, 2015, 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 Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com
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