Antares Pharma Announces Publication of QuickShot® Testosterone Data in Prestigious Health Journal
September 28 2015 - 7:00AM
- Results of the study showed rapid restoration
and consistent maintenance of steady blood levels was achieved with
once-weekly subcutaneous administration of testosterone using the
QuickShot® auto injector -
Antares Pharma, Inc. (NASDAQ:ATRS) today announced that the journal
Sexual Medicine has published the previously
disclosed positive results from a multi-center, phase II clinical
study evaluating the pharmacokinetic (PK) profile of testosterone
enanthate administered once-weekly by subcutaneous injection using
the VIBEX® QuickShot® auto injector in testosterone deficient
men. The publication is entitled “Pharmacokinetic
Profile of Subcutaneous Testosterone Enanthate Delivered via a
Novel, Prefilled Single-Use Autoinjector: A Phase II Study”
authored by Jed Kaminetsky, MD et al. Dr. Kaminetsky is 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. The study
has been published in the October, 2015 issue of
Sexual
Medicine and can be located using the following
link:
http://onlinelibrary.wiley.com/doi/10.1002/sm2.80/full.
Thirty-nine men with a mean age of 52.9 years
and a history of physician-diagnosed hypogonadism (low
testosterone), were enrolled in the study. Following a
washout period, 29 patients were randomized to receive either 50 mg
or 100 mg testosterone enanthate administered subcutaneously (SC)
with the QuickShot® auto injector once weekly. Full PK
profiles were collected for each patient in the subcutaneous
treatment arms at weeks 1, 5 and 6. Pre-dose trough and 24
hours post-dose samples were collected at each of the 6 weekly
treatment visits.
Rapid restoration, consistent maintenance of
normal testosterone levels and dose proportionality of the 50 mg
and 100 mg strengths was achieved. During week 6 of the
study, when patients were already at steady state pharmacokinetic
conditions, the 50 mg and 100 mg SC groups had average plasma
testosterone values within the normal range at 422.4 ng/dL and
895.5 ng/dL, respectively. The normal range for Testosterone
is generally defined as 300 ng/dL to 1100 ng/dL.
According to the authors, the once-weekly
injection was generally well tolerated. No injection site
pain was reported by 28 of 29 patients dosed subcutaneously and 17
of the patients reported mild to moderate unrelated adverse events.
There were no deaths, cardiovascular events, serious adverse
events, or discontinuations due to adverse events in the study.
Eamonn P. Hobbs, President and Chief Executive
Officer, stated, “We were very pleased that the results of our
phase II study were accepted for publication in such a prestigious
health journal and we continue to be optimistic about the potential
for a self-administered, once-weekly subcutaneous dose of
testosterone based on the outcome of this phase II study and the
12-week PK phase III data released earlier this year, which showed
consistent results.” He continued, “As the injectable
testosterone market continues to grow, we look forward to
potentially introducing a novel, subcutaneous option for treating
low testosterone which may reduce peak to trough fluctuations
associated with current intramuscular injections as well as the
increased risk of transference associated with topical
treatments.”
About QuickShot® Auto
Injector
The proprietary VIBEX® QuickShot® auto injector
platform emphasizes enhanced performance on the attributes
contributing most to patients successfully controlling 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. 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 Antares Pharma
Antares Pharma focuses on self-administered
parenteral pharmaceutical products. The Company’s product, OTREXUP™
(methotrexate) injection for subcutaneous use, is approved in the
U.S. 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 QuickShot® Testosterone for testosterone
replacement therapy, and VIBEX® Sumatriptan for the acute treatment
of migraines. The Company's technology platforms include
VIBEX® disposable auto injectors, disposable multi-use pen
injectors and reusable needle-free injectors. Antares Pharma has a
multi-product deal with Teva Pharmaceutical Industries, Ltd. that
includes VIBEX® epinephrine, exenatide multi-dose pen, and another
undisclosed multi-dose pen. Our reusable needle-free injector
for use with human growth hormone (hGH) is sold worldwide by
Ferring B.V.
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 future clinical trial results consistent with the phase
II QuickShot® Testosterone (QS T)
study referenced herein, the timing and results of the supplemental
phase 3 safety study for QS T; acceptance of the data from the
supplemental phase 3 safety study by the U.S. Food and Drug
Administration (FDA); FDA actions with respect to QS T including
modified or additional clinical trials; the Company’s ability to
successfully complete a New Drug Application for QS T to the FDA
and FDA approval of the same and future market acceptance and
revenue from QS T, the growth of sales of
OTREXUP™; the approval by the FDA of
VIBEX® Epinephrine Pen, the timing thereof, the therapeutic
equivalence rating therefor and future sales by Teva;
FDA action with respect to the ANDA filed for the exenatide
pen; the Company’s ability to adequately and timely respond to the
complete response letter with respect to its ANDA for
VIBEX® Sumatriptan and FDA action
with respect to the same; the timing and results of research
projects, clinical trials, and product candidates in development;
actions by the FDA and the Company’s ability to obtain financial
and other resources for its research, development, clinical, and
commercial activities 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, 2014, 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.
Contacts:
Jack Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com
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