Antares Pharma Announces First Patient Dosed in Phase 3 QuickShot Study Evaluating Testosterone-Deficient Adult Males
July 22 2014 - 7:00AM
Business Wire
Antares Pharma, Inc. (NASDAQ: ATRS) today announced that the
first patient has been dosed in a double-blind, multiple-dose,
phase 3 study to evaluate the efficacy and safety of QuickShot®
Testosterone (QS T) administered subcutaneously once each week to
testosterone-deficient adult males. Patients enrolled in this study
must have a documented diagnosis of hypogonadism, or testosterone
deficiency defined as having testosterone levels below 300 ng/dL.
The study will include a screening phase, a treatment titration and
efficacy phase and an extended treatment phase.
Eamonn P. Hobbs, President and Chief Executive Officer, stated,
“We are very excited to announce that the first patient has been
dosed in the phase 3 QS T study of testosterone-deficient adult
males. The QS T delivery system could potentially fill a patient
need for a more precise and convenient dosing regimen in the
growing testosterone replacement market.” Mr. Hobbs continued, “Our
proprietary QuickShot system is designed for pain-free subcutaneous
administration of a weekly fixed dose of testosterone through a
fine gauge needle in a matter of seconds. We look forward to
working closely with the U.S. Food and Drug Administration to bring
this novel product to an expanding market.”
Approximately 150 patients will be enrolled in this study.
Patients meeting all eligibility criteria will be assigned to
receive a starting dose of QS T once weekly for six weeks.
Adjustments to dose may be made at week seven based upon the week
six pre-dose blood level. The efficacy of QS T and dose adjustment
to regulate testosterone levels will be evaluated after 12 weeks of
treatment. Upon completion of this phase, patients may remain on
their optimized QS T dose and will be followed for an additional 40
weeks. Approximately 100 patients will be needed to complete
collection of 26 weeks of safety data, and approximately 50
patients will be needed to complete collection of 52 weeks of
safety data.
About Testosterone Deficiency
Testosterone deficiency, also known as male hypogonadism or Low
T, is a condition in which the body does not produce enough
testosterone, the hormone that plays a key role in masculine growth
and development during puberty. In most instances, male
hypogonadism responds to testosterone replacement therapy.
According to published data, 2012 U.S. sales of testosterone
replacement therapies exceeded $2.5 billion dollars with
prescriptions on average growing more than 20% annually.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral
pharmaceutical products. The Company markets OTREXUP™
(methotrexate) injection for the treatment of adults with severe
active rheumatoid arthritis and children with active polyarticular
juvenile idiopathic arthritis. LEO Pharma markets OTREXUP™ to
dermatologists for adults with severe recalcitrant psoriasis.
Antares Pharma is also developing QuickShot® 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. 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.
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, including statements made with
respect to the potential for the QuickShot® testosterone delivery
system to fill patient need, the design, methodology, endpoints and
timing of the Company’s phase 3 study of testosterone-deficient
males; the Company’s ability to obtain approval of the QuickShot®
testosterone product by the U.S. Food and Drug Administration; the
rate of growth of U.S. prescriptions for testosterone replacement
therapies; 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. 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.
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, 2013, 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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