Rapid Restoration & Consistent Maintenance of Steady Blood Levels Achieved with Once-Weekly Subcutaneous Administration of Te...
June 25 2014 - 7:00AM
Business Wire
Antares Pharma Announces The Presentation of
a Scientific Poster At The 16TH International
Congress Of Endocrinology And The Endocrine Society’s
96TH Annual Meeting & Expo
Antares Pharma, Inc. (NASDAQ: ATRS) today announced the
presentation of a scientific poster at the 16th International
Congress of Endocrinology and the Endocrine Society’s 96th Annual
Meeting & Expo held in Chicago, Illinois. The poster presents
the final pharmacokinetic and safety results from 29 randomized
patients treated with a once-weekly injection of testosterone
administered subcutaneously with the Company’s VIBEX® QuickShot®
auto injector. The Company’s previously reported interim results
from this multi-center phase 2 clinical study were also presented
as a scientific abstract at the same meeting.
Results from 29 adult males ages 31 to 69 with hypogonadism
symptoms and screening testosterone blood levels less than 300
ng/dl were reported. These patients were randomized into two groups
and followed for 10 weeks. The first group received weekly 50 mg
testosterone administered subcutaneously with a novel auto
injector, and the second group received 100 mg of testosterone
using the same device and time sequence.
The mean testosterone baseline was 244 ng/dL in the 50 mg group
and 243.7ng/dL in the 100 mg group. Testosterone levels normalized
within hours of the first dose. At week six of the study when
patients were at steady state pharmacokinetic conditions, the 50 mg
and 100 mg groups had average plasma testosterone values within the
normal range at 422ng/dL and 896 ng/dL, respectively. Rapid
restoration, consistent maintenance of normal testosterone levels
and dose proportionality of the 50 mg and 100 mg strengths were
thereby demonstrated. The once-weekly, virtually pain-free
administration took three to four seconds and consistently provided
a precise dose of 0.5 ml.
“Current topical treatments for hypogonadal men require daily
administration and risk transfer to women and children.
Intramuscular injections do not carry this risk but may be painful,
difficult to administer, and can be associated with wide variation
between testosterone level peaks and troughs potentially leading to
side effects, including mood swings,” said Antares Pharma President
and Chief Executive Officer, Eamonn P. Hobbs. “We believe this
study suggests that weekly subcutaneous administration of
testosterone using the Company’s VIBEX QuickShot auto injector
achieves consistent testosterone levels within the normal
physiologic range, reduces the peak-and-trough variation and
prevents transfer by contact.”
Antares Pharma plans to initiate a Phase 3 study in 150
testosterone-deficient adult males during the third quarter of
2014.
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 in 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. 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 VIBEX® 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. 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 data to be presented from research sponsored by the
Company at the 16th International Congress of Endocrinology &
the Endocrine Society’s 96th Annual Meeting & Expo, the timing
of initiation of the Company’s phase 3 study in 150
testosterone-deficient males, the approval of the VIBEX® QuickShot®
testosterone product by the U.S. Food and Drug Administration and
the timing thereof; the efficacy of the QuickShot® device; 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.Investor Contact:Jack HowarthVice
President, Corporate
Affairs609-359-3016jhowarth@antarespharma.com
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