-- LEO Pharma: A Global Leader In
Dermatology And Topical Treatments For Psoriasis --
Antares Pharma, Inc. (NASDAQ: ATRS) today announced LEO Pharma’s
launch of OTREXUP to Dermatologists, the first U.S. Food and Drug
Administration (FDA) approved subcutaneous (SC) methotrexate (MTX)
product for once weekly self-administration with an easy-to-use,
single dose, disposable auto injector.
“We are very pleased that OTREXUP is now available for adult
patients with severe recalcitrant psoriasis,” said Paul K. Wotton,
Ph.D., President and Chief Executive Officer. “Collaborating with
LEO Pharma on the launch of OTREXUP gives Antares an opportunity to
team up with a proven and successful commercial organization while
LEO expands their portfolio with a new product in their field of
expertise. With a dedicated sales force focused solely on the
treatment of psoriasis and approximately 50,000 psoriasis patients
enrolled in their QualityCare program, we believe LEO Pharma will
be able to introduce and establish OTREXUP as an important new
treatment option with significant growth potential in
dermatology.”
OTREXUP is indicated for use in adults who need symptomatic
control of severe recalcitrant, disabling psoriasis that is not
adequately responsive to other forms of therapy. OTREXUP is also
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, or children with active
polyarticular juvenile idiopathic arthritis. OTREXUP was approved
by the FDA in October 2013.
"We are very excited to be working with Antares to bring OTREXUP
to psoriasis patients in the US. The addition of the novel OTREXUP
auto injector to the LEO Psoriasis Portfolio allows us to expand
our offering in Dermatology and will help dermatologists and their
patients manage a severe and debilitating condition," said John
Koconis, President and Chief Executive Officer LEO Pharma Inc.
Psoriasis is a chronic autoimmune skin disease that most
commonly appears as raised, red patches with a white build-up 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.
“As many as 7.5 million patients have psoriasis in the United
States and many of them have severe, disabling recalcitrant
disease. Methotrexate can be an important treatment option to
consider when treating these patients. The greater bioavailability
of subcutaneous methotrexate may provide benefits for many of these
patients who have had an inadequate response to oral methotrexate
due to either tolerability or efficacy,” said Robert E Kalb, M.D.,
Buffalo Medical Group, PC; Clinical Professor of Dermatology, State
University of New York at Buffalo.
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 LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care
solutions to patients in more than 100 countries globally, LEO
Pharma supports people in managing their skin conditions. Founded
in 1908 and owned by the LEO Foundation, the healthcare company has
devoted decades of research and development to delivering products
and solutions to people with skin conditions. LEO Pharma is
headquartered in Denmark and employs 4,800 people worldwide. For
more information, visit www.leo-pharma.com.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral
pharmaceutical products. The Company has received marketing
approval from the U.S. Food and Drug Administration for OTREXUP
(methotrexate) injection 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 VIBEX QS T for
testosterone replacement therapy. The Company's technology
platforms include VIBEX disposable Medi-Jet, disposable multi-use
pen injectors and reusable needle-free injectors marketed as Tjet
and Zomajet by Teva Pharmaceutical Industries, Ltd (Teva) and
Ferring Pharmaceuticals (Ferring), respectively. Antares Pharma has
a multi-product deal with Teva that includes Tev-Tropin [somatropin
(rDNA origin) for injection] human growth hormone (hGH), VIBEX
epinephrine and several other products. Antares Pharma’s
partnership with Ferring includes Zomacton hGH (somatropin)
injection. In the U.S. Antares has received FDA approval for
Gelnique 3% (oxybutynin) gel, a treatment for overactive bladder
that is marketed by Actavis. Elestrin® (estradiol gel) is FDA
approved for the treatment of moderate-to-severe vasomotor symptoms
associated with menopause, and is marketed in the U.S. by Meda
Pharma. Antares Pharma has two facilities in the U.S. The
Parenteral Products Group located in Minneapolis, Minnesota directs
the manufacturing and marketing of the Company’s reusable
needle-free injection devices and related disposables, and develops
its disposable pressure-assisted Medi-Jet and pen injector systems.
The Company’s corporate office and Product Development and
Commercial Groups are located in Ewing, New Jersey.
Forward-Looking Statement
This press release contains forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These statements are indicated by
the words “may,” “will,” “plans,” “intends,” “believes,” “expects,”
“anticipates,” “potential,” “could,” “would,” “should,” and similar
expressions and include statements regarding our expectations
regarding the launch of OTREXUP. Such forward-looking statements
are not guarantees of future performance and are subject to risks
and uncertainties that may cause actual results to differ
materially from those anticipated by the forward-looking
statements. These risks and uncertainties include, among others,
difficulties or delays in the commercial launch of OTREXUP, market
acceptance by physicians and patients of new products, delays in
product development and changes or delays in the regulatory process
for existing or new product candidates. 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, 2012, 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.
Antares Pharma, Inc.Jack HowarthVice President, Corporate
Affairs609-359-3016jhowarth@antarespharma.com
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