Antares Pharma Announces Positive Results from Final MTX Medi-Jet™ Clinical Study

  Antares Pharma Announces Positive Results from Final MTX Medi-Jet™ Clinical
  Study

     MTX Medi-Jet™ Shown to Increase and Provide Consistent MTX Systemic
                      Availability Compared to Oral MTX

Business Wire

EWING, N.J. -- November 13, 2012

Antares Pharma, Inc. (NASDAQ: ATRS) today announced positive results from an
open-label, randomized, crossover study comparing the systemic availability of
MTX Medi-Jet to oral methotrexate (MTX) in adult patients with rheumatoid
arthritis (RA).

This study was designed to compare the relative systemic availability of MTX
following oral administration to subcutaneous (SC) self-administered MTX using
the Medi-Jet device. Patients were assigned to one of four dose levels of MTX,
10 mg, 15 mg, 20 mg, and 25 mg. Results showed that the systemic availability
of methotrexate following oral dosing plateaus above 15 mg. Following
administration of MTX with Medi-Jet, the systemic availability increased
proportionally at every dose, which will extend the range of exposure compared
to patients receiving oral therapy.

Historically, parenteral MTX use has been limited in clinical practice for
several reasons including the inconvenience of weekly injections by a
healthcare professional, and/or the challenges associated with teaching
patients with impaired hand function, safe and sterile self-injection
techniques. To address these issues, the easy to use, single-use MTX Medi-Jet
auto injector was developed to optimize the clinical benefit of MTX, leading
to cost effective treatment outcomes.

Dr. Lee S. Simon, Co-managing Director SDG LLC, stated, “Methotrexate has
become the gold standard for first line disease modifying drugs used in the
treatment of rheumatoid arthritis. Understanding how to optimize methotrexate
therapy for better patient outcomes has become increasingly important.” Dr.
Simon continued, “Treating to target in relation to biologic therapies, so
that patients can achieve a low activity state of disease is optimal, and it
is now time to address this same idea with methotrexate taking advantage of
the MTX Medi-Jet to improve patient care.”

“Greater exposure to MTX when administered with MTX Medi-Jet could enhance the
efficacy with improved response to disease control,” said Kaushik J. Dave
R.Ph., Ph.D., Executive Vice President Product Development.

About VIBEX Medi-Jet and Methotrexate

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

Methotrexate is a commonly prescribed disease-modifying anti-rheumatic drug
(DMARD), used in an estimated 70% of rheumatoid arthritis patients either on
its own or in combination with biological therapies. Methotrexate is started
at a low dose, generally 7.5mg given orally, once-a-week, and titrated up for
greater therapeutic effect, or until the patient incurs side effects. The
maximum oral dose given is generally 20mg to 25mg per week. Published studies
have reported that 30% to 60% of patients experience gastrointestinal side
effects with oral methotrexate, preventing further dose escalation or
requiring discontinuation in some patients. Oral absorption of methotrexate
varies considerably between patients and between doses in the same patient and
has been shown to decline with increasing doses, which may also contribute to
insufficient therapeutic response even after dose escalation. Switching
patients from oral to parenteral methotrexate improves absorption and has been
associated with improved therapeutic response. Additionally, some studies have
shown a lower incidence of gastrointestinal side effects in patients that were
switched from oral to parenteral methotrexate.

About Antares Pharma

Antares Pharma focuses on self-administered parenteral pharmaceutical products
and topical gel-based medicines. 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^® human growth hormone (hGH), VIBEX epinephrine and several other
products. Antares Pharma’s partnership with Ferring includes Zomacton^® hGH.
In the U.S. Antares has received FDA approval for Gelnique 3%™, a treatment
for overactive bladder that is marketed by Watson Pharmaceuticals, Inc.
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
head office and Product Development Group 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. 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, changes in revenue growth and difficulties or delays in
the initiation, progress, or completion of product development. 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, 2011, 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:

Antares Pharma, Inc.
Jack Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com
 
Press spacebar to pause and continue. Press esc to stop.