|[March 10, 2014]
Antares Pharma Announces LEO Pharma's Launch of OTREXUP (Methotrexate) Injection to Dermatologists for Adults with Psoriasis
EWING, N.J. --(Business Wire)--
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
"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
OTREXUP should not be use for the treatment of cancer.
OTREXUP should not be used for the treatment of children with psoriasis.
Methotrexate includes the following boxed warning:
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
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
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
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.
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.
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