Antares Pharma, Inc. (NASDAQ:ATRS) today announced the approval by
the U.S. Food and Drug Administration (FDA) of three new dosage
strengths of OTREXUP™ (methotrexate) injection. The new
dosage strengths of 12.5 mg/0.4 ml, 17.5 mg/0.4 ml and 22.5 mg/0.4
ml will complement the already approved and marketed strengths of
7.5 mg/0.4 ml, 10 mg/0.4 ml, 15 mg/0.4 ml, 20 mg/0.4 ml, and 25
mg/0.4 ml. New, interim dose-strength options will enable
physicians to select more specific, optimal doses to help achieve
patient treatment goals.
“OTREXUP™ has always been available in the most
commonly prescribed strengths of methotrexate, but our new interim
dose options may provide physicians even more opportunity to give
their patients precisely what is needed to achieve disease
control,” said Robert Apple, President and Chief Executive Officer
of Antares Pharma. “Each and every patient treatment regimen is
different, so providing a step approach to therapy may extend and
optimize the use of OTREXUP™ for patients. New interim strengths
are also covered by OTREXUP™ TotalCare so all eight dosing options
are eligible for up to $125 of patient co-pay assistance.”
OTREXUP™ was the first FDA-approved subcutaneous
methotrexate for once weekly self-administration with an
easy-to-use, single dose, disposable auto injector. OTREXUP™ is
indicated for adults with severe active rheumatoid arthritis who
have had an insufficient therapeutic response to or are intolerant
of an adequate trial of first line therapy including full dose
non-steroidal anti-inflammatory agents. In addition, OTREXUP™
is also approved for use in children with active polyarticular
juvenile idiopathic arthritis as well as for use in adults for
symptomatic control of severe recalcitrant, disabling psoriasis
that is not adequately responsive to other forms of therapy.
For full prescribing information please
visit WWW.OTREXUP.COM
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.
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 Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, systemic
autoimmune disease characterized by pain and inflammation of the
joints. In people with RA, the immune system attacks healthy
tissue, specifically the thin membrane that lines the joints,
causing swelling that leads to pain and inflammation throughout the
body. Over long periods of time, RA can cause damage to cartilage,
tendons, or ligaments, leading to joint deformity or disability.
Additionally, research shows that people with RA, mainly those
whose disease is not well controlled, have a higher risk for heart
disease and stroke.
About Polyarticular Juvenile Idiopathic
Arthritis
Polyarticular juvenile idiopathic arthritis is a
subgroup of juvenile idiopathic arthritis (JIA)[i] in which five or
more joints are impacted in children within the first six months
after disease onset. JIA occurs in people under the age of 18.
In patients with JIA, the immune system attacks
healthy tissue, specifically the thin membrane that lines the
joints, causing swelling that leads to pain and inflammation
throughout the body. Over long periods of time, arthritis can cause
damage to cartilage, tendons or ligaments, leading to joint
deformity or disability.
Treatments are available that may help relieve
symptoms and reduce inflammation. In addition, disease-modifying
antirheumatic drugs (DMARDs) and new biologic agents can modify the
disease or slow its progression.
About Psoriasis
Psoriasis is a chronic autoimmune skin disease
that most commonly appears as raised, red patches with a white
buildup of dead skin cells. Psoriasis can affect skin on any part
of the body and occurs when the immune system sends out faulty
signals that speed the growth cycle of skin cells. Psoriasis is
considered recalcitrant psoriasis when it does not respond to
therapy, and can be disabling.
Psoriasis is generally considered to be severe
if it covers more than 5%-10% of body surface, recalcitrant when it
does not adequately respond to treatment and disabling when it
interferes with basic functions such as self-care, walking, sleep,
etc.
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 approval for VIBEX® Sumatriptan USP for the acute
treatment of migraine and cluster headache in the U.S. 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 license
and development deal with Teva Pharmaceutical Industries, Ltd. that
includes VIBEX® epinephrine, exenatide multi-dose pen, and another
undisclosed multi-dose pen, which have not been approved. 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: the utilization of
the new dosage strengths of 12.5 mg/0.4ml, 17.5
mg/0.4 ml and 22.5 mg/0.4 ml of Otrexup™ and
continued growth of prescriptions and sales of OTREXUP™,
the timing and results of the phase 3 studies for QuickShot®
Testosterone (QS T) and acceptance of the data by the U.S. Food and
Drug Administration (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 of the launch of Vibex
Sumatriptan Injection USP and the amount of revenue from the same;
Teva’s ability to adequately and timely respond to the FDA’s
complete response letter (CRL) related to their epinephrine auto
injector ANDA and FDA approval of the same, the timing and
therapeutic equivalence rating thereof, and any revenue pre or post
FDA approval; FDA action with respect to Teva’s ANDA for the
Exenatide pen; the timing and results of research projects,
clinical trials, and product candidates in development including
the development project with AMAG Pharmaceuticals
for a subcutaneous auto injector for their product Makena and
Teva’s undisclosed Pen 1 project; 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.
Contacts:
Jack Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com
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