Antares Pharma Announces FDA Acceptance of New Drug Application for Quickshot® Testosterone
February 27 2017 - 7:00AM
Antares Pharma, Inc. (NASDAQ:ATRS) today announced that the New
Drug Application (NDA) for QuickShot® Testosterone (QST), a
drug-device combination product for the delivery of testosterone
enanthate using a subcutaneous auto injector, has been accepted for
standard review by the U.S Food and Drug Administration
(FDA). QST was developed to treat adult men with low
testosterone associated with a diagnosed condition known as
hypogonadism.
The FDA has assigned a Prescription Drug User
Fee Act (PDUFA) date of October 20, 2017, ten months from the
official NDA submission. The PDUFA date is the target date
for the FDA to complete its review of the NDA.
“The FDA’s acceptance of the QuickShot
testosterone NDA is an important start to the review process and
marks another significant milestone for our Company,” said Robert
F. Apple, President and Chief Executive Officer. “We continue
to believe QST could be an excellent treatment option for men with
hypogonadism based upon the positive pharmacokinetic and safety
data produced in the two phase three studies now on file with the
FDA. 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, we believe that the phase three
studies demonstrated that weekly subcutaneous administration of
testosterone using the QuickShot auto injector can provide patients
with physiologically normal and steady levels of testosterone over
the course of therapy. The study data also showed patients had a
virtually painless treatment experience using the device. We
will work closely with the FDA during the regulatory review process
toward a potential approval.”
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.
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. 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’s product Sumatriptan Injection USP, is approved in the
U.S. for the acute treatment of migraine and cluster headache and
is distributed by Teva Pharmaceutical Industries, Ltd. (Teva).
Antares Pharma is also developing QuickShot® Testosterone for
testosterone replacement therapy and has filed a New Drug
Application to the Food and Drug Administration. 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 for 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: the timing and outcome
of the U.S. Food and Drug Administration (“FDA”) review of the QST
NDA, 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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