OTREXUP™ (methotrexate) Injection Approved By FDA a New Treatment for Adults with Rheumatoid Arthritis, Children with Polyarticular Idiopathic Arthritis, and Adults with Psoriasis

EWING, N.J.--(BUSINESS WIRE)--
Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of
OTREXUP (methotrexate) injection by the U.S. Food and Drug
Administration (FDA). OTREXUP is the first FDA approved
subcutaneous (SC) methotrexate (MTX) 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 (RA) 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 (NSAIDs), or children with active polyarticular
juvenile idiopathic arthritis (pJIA). The FDA also approved adult use of
OTREXUP for symptomatic control of severe recalcitrant,
disabling psoriasis that is not adequately responsive to other forms of
therapy.

In 2012, approximately six million prescriptions were written across all
dosage forms of MTX in the U.S. to treat patients for RA, pJIA and
psoriasis, the same indications for which OTREXUP has been
approved. MTX treatment is usually initiated with oral tablets, however;
many patients experience an inadequate response for reasons of efficacy
or tolerability.

“This new delivery system for methotrexate provides a welcome option for
physicians and their patients to continue effective use of methotrexate.
OTREXUP can be used when a response is inadequate or there
are tolerability issues with oral methotrexate, before adding or
switching to costlier therapies,” said Dr. Michael Schiff, Clinical
Professor of Medicine in the Rheumatology Division at the University Of
Colorado School Of Medicine in Denver. “The availability of an easy and
safe way to administer subcutaneous methotrexate may overcome some of
the current barriers to parenteral administration which could enable
more patients to realize the possibility of continued disease control
and therefore benefit from subcutaneous methotrexate.”

Human study data submitted to the FDA demonstrated increased
bioavailability of SC MTX compared to oral MTX at every dose. These
results confirm and strengthen the findings of previously published
bioavailability data, and highlight the saturable limitations of oral
MTX that result in a bioavailability plateau at 15mg. These important
data are included in the approved OTREXUP label and have
been selected for a prestigious oral presentation this month at the
American College of Rheumatology Scientific Meeting.

There has been substantial literature published that documents the
potential benefits of SC MTX after an inadequate response to oral MTX.
In the United States, however, use of parenteral MTX is often overlooked
for the treatment of RA or psoriasis, primarily due to the challenges of
self-administration associated with compromised manual dexterity, needle
phobia, or patients’ lack of confidence to accurately and safely
self-inject with a vial, needle and syringe.

“We are very pleased to receive approval from the FDA for OTREXUP
because we believe it is an important step up in the standard of care
for people living with RA, pJIA and psoriasis,” said Paul Wotton, Ph.D.,
President and Chief Executive Officer of Antares Pharma. “This approval
represents a strategic milestone for Antares because we believe it
validates our proprietary VIBEX Medi-Jet
technology which provides a significant advance in improving health
outcomes with high tech but easy self-administration of SC medications.
Antares has several other products in development, where this
auto-injector technology could provide substantial benefits if the
product candidates are approved.” He went on to say: “Our VIBEX
proprietary technology is protected by numerous granted patents and
OTREXUP is protected by several patents through at least
2030.”

“We expect the commercial launch of OTREXUP in early 2014
will make a meaningful difference in the lives of people living with RA,
pJIA and psoriasis and we believe also introduces the potential for a
cost effective treatment option for physicians,” said LeRoux Jooste,
Senior Vice President Sales & Marketing. “I have been fortunate in my
career to lead and play a major role in several successful product
launches and I am excited to introduce OTREXUP with an
experienced team of sales and marketing professionals.”

For full prescribing information please visit

OTREXUP is a single-dose auto-injector containing a
prescription medicine, methotrexate. Methotrexate is used to:

OTREXUP should not be used for the treatment of cancer.

OTREXUP should not be used for the treatment of children with psoriasis.

OTREXUP may cause serious side effects, including:

See “What is the most important information I should know about OTREXUP?”

nausea,
stomach pain, indigestion (dyspepsia), mouth sores, and rash.

Before you take OTREXUP, tell your doctor if youhave 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).

VIBEX disposable Medi-Jet is a
proprietary parenteral drug delivery system protected by several issued
and pending patents. Medi-Jet is designed to enable patients
to quickly and easily, reliably, and comfortably self-administer a drug
subcutaneously or intramuscularly, Medi-Jet technology also enhances
safety with an integrated, shielded needle that protects against
accidental needle stick and drug exposure. Medi-Jet is a
trademark of Antares Pharma.

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.

Polyarticular juvenile idiopathic arthritis is a subgroup of juvenile
idiopathic arthritis (JIA) 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.

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.

Antares Pharma focuses on self-administered parenteral pharmaceutical
products and topical gel-based medicines. The Company is developing VIBEX
QS T for testosterone replacement therapy. The Company's technology
platforms include VIBEX disposable Medi-Jet,
disposable multi-use pen injectors and Vision 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 OTREXUPand the application of the auto
injector technology in other product candidates. 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.comorElaine AndrecovichMakovsky212-508-9675

Source: Antares Pharma, Inc.