Antares Pharma Announces Submission of New Drug Application for Quickshot® Testosterone
December 21 2016 - 8:00AM
Antares Pharma, Inc. (NASDAQ:ATRS) today announced that it had
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for QuickShot® Testosterone (QST), a
drug-device combination product for the delivery of testosterone
enanthate using a subcutaneous auto injector. QST is intended
to treat adult men with low testosterone associated with a
condition known as hypogonadism.
“The submission of the QST New Drug Application
represents yet another significant accomplishment for the Company
in 2016. It is the first product designed for subcutaneous
delivery of testosterone through a fine gauge needle in patients
diagnosed with hypogonadism,” said Robert F. Apple, President and
Chief Executive Officer. “We believe QST could be an
excellent treatment option for men with hypogonadism. In
addition to virtually eliminating the risk of transference that
exists with topical gel products and the uncomfortable deep
intramuscular administration associated with current injectable
therapies, the study data demonstrated that the QuickShot auto
injector can provide patients with physiologically normal and
steady levels of testosterone over the course of therapy. A
potential added benefit to patients is a virtually painless
treatment experience as demonstrated by the pain data collected in
our phase 3 program. We will work closely with the FDA during the
regulatory review process towards a potential approval with the
goal of bringing this new treatment option to men diagnosed with
hypogonadism.”
Two hundred and eighty-three men participated in
the QST phase 3 program. The phase 3 program consisted of a
one year pivotal safety and efficacy study and a second 6-month
safety study. In the phase 3 program, patients received 75 mg
of testosterone enanthate (TE) administered via the QuickShot®
device once-weekly for 6 weeks. At week 7, blinded dose adjustments
were made if necessary based on week 6 pre-dose blood levels.
The patients continued to receive subcutaneous doses of 50 mg, 75
mg or 100 mg of testosterone weekly for up to 52 weeks. The
QuickShot® testosterone auto injector has not been approved by the
United States Food and Drug Administration.
About QuickShot®
Testosterone
The investigational subcutaneous testosterone
enanthate auto injector is a proprietary, self-administered
testosterone replacement option for men diagnosed with hypogonadism
that is designed to be injected at home, on a weekly basis. Results
from the previously reported Phase 3 pharmacokinetic study showed
that testosterone delivered subcutaneously using the QuickShot®
testosterone auto injector provided rapid, steady, and reliable
efficacy by restoring testosterone to pre-defined physiologic
levels.
About QuickShot® Auto
Injector
The proprietary QuickShot® auto injector is
designed to allow 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. The QuickShot® auto injector can also provide the
patient with the ease and speed of self-administration, comfort and
discretion.
About Hypogonadism
Hypogonadism, also known as testosterone
deficiency 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, and maintenance of
musculoskeletal, metabolic, and mental health in maturity.
Symptoms of male hypogonadism can be treated with testosterone
replacement therapy.
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. The
Company and Teva Pharmaceutical Industries, Ltd. (Teva) recently
announced the third quarter 2016 U.S. commercial launch of VIBEX®
Sumatriptan Injection USP for the acute treatment of migraine and
cluster headache. Antares Pharma is also developing
QuickShot® Testosterone for testosterone replacement therapy. 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 that includes VIBEX® epinephrine, exenatide multi-dose pen,
and teriparatide multi-dose pen. Our reusable needle-free
injector for use with human growth hormone (hGH) is sold worldwide
by Ferring B.V. The Company is also working with AMAG
Pharmaceuticals on a subcutaneous method of administering Makena, a
progesterone product indicated for use in lowering the risk of
pre-term birth. For more information, visit
www.antarespharma.com.
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. Forward-looking statements are subject to certain risks
and uncertainties that can cause actual results to differ
materially from those described. Factors that may cause such
differences include, but are not limited to: U.S. Food and Drug
Administration (“FDA”) acceptance of the Company’s NDA for QST and
any FDA actions with respect thereto; FDA approval of the QST NDA
and future market acceptance and revenue for QST; the outcome of
the pending patent litigation between Teva Pharmaceutical
Industries, Ltd. (Teva) and Eli Lilly and Company regarding the
Teriparatide multi-dose pen; FDA action with respect to Teva’s
Abbreviated New Drug Application (“ANDA”) for the Teriparatide
multi-dose pen and the timing and approval, if any, by the FDA of
the same; Teva’s ability to adequately and timely respond to the
Complete Response Letter received from the FDA for the VIBEX®
epinephrine pen ANDA and approval by the FDA of the same, the
timing and therapeutic equivalence rating thereof, and any future
purchase orders and revenue pre or post FDA approval; Teva’s
ability to successfully commercialize VIBEX® Sumatriptan Injection
USP and the amount of revenue from the same; FDA action with
respect to Teva’s ANDA filed for the Exenatide pen and future
revenue from the same; continued growth of prescriptions and sales
of OTREXUP®; the timing and results of the development project with
AMAG Pharmaceuticals for an auto injector for Makena; the timing
and results of research projects, clinical trials, and
product candidates in development; actions by the FDA or other
regulatory agencies with the respect to the Company’s products or
product candidates of its partners; continued growth in product,
development, licensing and royalty revenue; 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.
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, 2015, 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.
Contact:
Jack Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com
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