Antares Pharma Announces Positive Results from the VIBEX QuickShot Pharmacokinetic Study in Testosterone Deficient Men
February 20 2014 - 7:00AM
Business Wire
Rapid Restoration and Consistent Maintenance
of Steady Testosterone Blood Levels Achieved with Once-Weekly
Subcutaneous Administration Using the QuickShot Auto
Injector
Antares Pharma, Inc. (NASDAQ: ATRS) today announced positive
results from a multi-center phase 2 clinical study evaluating the
pharmacokinetic profile of testosterone enanthate administered
once-weekly by subcutaneous injection at doses of 50 mg and 100 mg
using the VIBEX QuickShot auto injector in testosterone deficient
adult males.
Twenty nine adult males with hypogonadism (low testosterone) and
testosterone blood levels less than 300 ng/dL were randomized into
two groups. The first group received 50 mg testosterone enanthate
administered subcutaneously with the QuickShot auto injector once
weekly for six weeks and the second group received 100 mg of
testosterone enanthate using the same device and time sequence. The
clinical study followed patients for four weeks after the last
dose.
The mean testosterone baseline for the 50 mg group was 214.6
ng/dL and 201.5 ng/dL in the 100 mg group. At week one, both doses
produced normal mean total testosterone concentrations at 24 hours
post-dose, 434 ng/dL in the 50 mg group and 572 ng/dL in the 100 mg
group. During week six of the study when patients were already at
steady state pharmacokinetic conditions, the 50 mg and 100 mg
groups had average plasma testosterone values within the normal
range at 422.4 ng/dL and 895.5 ng/dL, respectively. The study
demonstrated rapid restoration, consistent maintenance of normal
testosterone levels and dose proportionality of the 50 mg and 100
mg strengths. The once-weekly injection was generally well
tolerated. No injection site pain was reported by 28 of 29 patients
and seventeen patients reported mild to moderate adverse events
which according to the investigators were unrelated to the drug or
device. There were no deaths, serious adverse events or
discontinuations due to adverse events in the study.
Paul K. Wotton, Ph.D., President and Chief Executive Officer,
stated, “We are very optimistic about the potential for a
self-administered, once weekly subcutaneous dose of testosterone
based on the outcome of this study.” Dr. Wotton continued, “The
administration of testosterone using our proprietary QuickShot
device showed that normal testosterone levels can be rapidly
restored and then reliably maintained with reduced peak to trough
fluctuations relative to those associated with intramuscular
injections. Unlike topical treatments for males with hypogonadism,
currently approved injectable forms of testosterone do not carry a
black box warning for risk of transference, which has been reported
to lead to abnormal development of male sexual characteristics in
women and children.”
About QuickShot Auto Injector
The proprietary VIBEX QuickShot auto injector emphasizes
enhanced performance on the attributes contributing most to
patients successfully controlling their testosterone deficiency –
reliable and consistent blood levels, ease and speed of
self-administration, comfort and discretion. The State-of-the-Art
precision engineering of the QuickShot device allows rapid
subcutaneous self-administration of highly viscous drugs such as
testosterone and biologics using high spring pressure through a
fine gauge needle. Conventional auto injectors or even a vial,
needle and syringe could not inject these drugs efficiently or as
fast and easy as the QuickShot device.
About Testosterone Deficiency
Testosterone deficiency, also known as male hypogonadism or Low
T, is a condition in which the body doesn’t produce enough
testosterone – the hormone that plays a key role in masculine
growth and development during puberty, and maintenance of
musculoskeletal and mental health in maturity. Symptoms of male
hypogonadism can be treated with testosterone replacement therapy.
According to published data, 2013 U.S. sales of testosterone
replacement therapies were approximately $2.8 billion dollars with
prescriptions on average growing more than 20% annually.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral
pharmaceutical products and topical gel-based medicines. 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 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.
Safe Harbor 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. In addition, the QuickShot testosterone
product referred to in this press release has not yet been approved
by the FDA, and the commercialization of QuickShot testosterone is
dependent on the Company receiving FDA approval of this product.
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.com
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