Antares Pharma Announces Last Patient Enrolled in Phase 3 QuickShot® Study Evaluating Testosterone-Deficient Adult Males
November 03 2014 - 7:00AM
Business Wire
Antares Pharma, Inc. (NASDAQ: ATRS) today announced that the
last patient has been enrolled 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
had a documented diagnosis of hypogonadism or testosterone
deficiency defined as having testosterone levels below 300 ng/dL.
The study includes a screening phase, a treatment titration and
efficacy phase and an extended treatment phase.
Approximately 150 patients are enrolled in this study. Patients
meeting all eligibility criteria were assigned to receive a
starting dose of QS T once weekly for six weeks. Adjustments to
dose could be made at week 7 based upon the week 6 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.
Jed C. Kaminetsky, MD, a urologist at University Urology
Associates, Medical Director of Manhattan Medical Research and
clinical assistant professor of urology at New York University
School of Medicine, said, “A once-weekly, at-home, subcutaneously
administered testosterone product could be an exciting new
treatment option for men suffering from hypogonadism.” He
continued, “This precise dosing option removes transference
concerns commonly associated with gels, potentially eliminates
costly in-office procedures and may reduce the peaks and troughs in
testosterone levels associated with current intramuscular
injections.”
Eamonn P. Hobbs, President and Chief Executive Officer of
Antares Pharma, stated, “We are pleased to announce the last
patient has been enrolled in the QuickShot Testosterone study. The
enrollment was completed ahead of schedule in just three months.”
Mr. Hobbs continued, “Given the prevalence of testosterone
deficiency, also referred to as Low T, we intend to work closely
with the U.S. Food and Drug Administration toward approval of a
unique, at-home treatment for low testosterone that is designed to
provide steady maintenance of testosterone levels through
once-weekly, subcutaneous self-administration.”
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, a 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 subcutaneous use in 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 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. 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.
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 QuickShot® Testosterone to eliminate
in-office procedures and reduce peaks and troughs in testosterone
levels, 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 QuickShot® Testosterone 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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