Antares Pharma Announces Update to QuickShot Testosterone Clinical Program
June 01 2016 - 7:00AM
Antares Pharma, Inc. (NASDAQ:ATRS) today announced that the last
patient has completed treatment in a dose-blinded, multiple-dose,
concentration controlled 26-week safety and pharmacokinetic phase 3
study of QuickShot® Testosterone (QS T) administered subcutaneously
once each week to adult males with hypogonadism. The study,
QST-15-005 included a screening phase, a titration phase and a
treatment phase for evaluation of safety and tolerability
assessments, including laboratory assessments, adverse events and
injection site assessments. The study was conducted to help
ensure that we satisfy the U.S. Food and Drug Administration’s
recommendation that we have a safety database of approximately 350
subjects exposed to QS T in total with approximately 200 subjects
exposed for six months and approximately 100 subjects exposed for a
year.
“We are very excited to announce that the last
patient has completed treatment in our phase 3 supplemental safety
study of QuickShot testosterone,” stated Robert F. Apple, President
and Chief Executive Officer. “With this study now concluded, we
will combine these data with the previously announced positive
pharmacokinetic and safety data from the QST-13-003 study for
inclusion into our New Drug Application, with a filing goal of
later this year or in early 2017. We plan to work closely
with the Food and Drug Administration on the potential approval of
this novel approach to treating hypogonadism.”
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 has recently received a therapeutically
equivalent approval from the U.S. Food and Drug Administration for
VIBEX® Sumatriptan USP for the acute treatment of migraine and
cluster headache. 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
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.
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 results
of the phase 3 studies for QuickShot® Testosterone (QS T) and
acceptance of the data by the U.S. Food and Drug Administration
(“FDA”); the timing and Company’s ability to successfully complete
a New Drug Application (“NDA”) for QS T, acceptance of the
NDA for QS T by the FDA and approval of the same by the FDA; Teva’s
ability to adequately and timely respond to the Complete Response
Letter received from the FDA for the VIBEX® epinephrine pen
Abbreviated New Drug Application (“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; the timing of the launch of VIBEX® Sumatriptan Injection
USP and the amount of revenue from the same; the outcome of the
pending patent litigation between Teva Pharmaceutical Industries,
Ltd. (Teva) and Eli Lilly and Company regarding the Teriparatide
multi-dose pen; the timing and approval, if any, by the FDA of
Teva’s ANDA for the Teriparatide multi-dose pen and any future
revenue resulting therefrom; the outcome of the pending patent
litigation between Teva and AstraZeneca regarding the
Exenatide multi-dose pen; 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.
Contacts:
Jack Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Jul 2023 to Jul 2024