Antares Pharma Provides XYOSTED™ Regulatory Update
March 27 2018 - 7:00AM
Antares Pharma, Inc. (NASDAQ:ATRS) (the Company)
today announced that the official minutes from the Type A
meeting with the U.S. Food and Drug Administration (FDA or the
Agency) held on February 21, 2018 have been received. The
Company had previously attended the in-person Type A meeting with
the FDA to discuss the Complete Response Letter (CRL) received in
connection with the XYOSTED™ New Drug Application (NDA).
Based upon this meeting and the FDA minutes, Antares believes
that it does not need to conduct any new clinical studies to
support the resubmission. The Company anticipates that the
resubmission will include re-analyses of existing data, and address
labeling and potential post-approval risk mitigation
strategies. The Company anticipates submitting the complete
response in the second quarter of this year. Under FDA’s policies,
thirty days after FDA’s receipt of the resubmission, the Agency
will determine whether the filing constitutes a complete response
that addresses all deficiencies in the CRL and, if so, assign a
target action date which the Company expects will be within six
months of FDA’s receipt of the resubmission.
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 an investigational new drug,
XYOSTED™, for the treatment of testosterone deficiency
(hypogonadism). The Company filed a New Drug Application for
XYOSTED™ and received a Complete Response Letter. The
Company's technology platforms include VIBEX® disposable auto
injectors and disposable multi-use pen injectors. Antares Pharma
has license, development and supply agreements with Teva that
include VIBEX® epinephrine, exenatide multi-dose pen, and
teriparatide multi-dose pen. The Company also provides AMAG
Pharmaceuticals with a subcutaneous QuickShot® auto injector for
administering Makena® (hydroxyprogesterone
caproate injection). 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 Company’s ability
to resolve the deficiencies identified by the FDA in the Complete
Response Letter for XYOSTED™, the
timeframe associated with such resolution and
whether any such response will be accepted by the
FDA, FDA approval of the Company’s NDA
for XYOSTED™ and future
market acceptance and revenue for
XYOSTED™; the timing of
the commercial launch of the Makena subcutaneous auto injector
product in the U.S. and future market acceptance and revenue from
the same; successful completion of the transaction with Ferring
International Center, S.A. and satisfaction of the various
conditions in the Ferring asset purchase agreement and payment of
the full purchase price; Teva’s ability to successfully
commercialize VIBEX® Sumatriptan Injection USP and the amount of
revenue from the same; continued growth of prescriptions and sales
of OTREXUP®; the timing and results of the Company’s or its
partners’ research projects or clinical trials of product
candidates in development; actions by the FDA or other regulatory
agencies with the respect to the Company’s products or product
candidates or product 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, 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 HowarthVice President, Corporate Affairs of
Antares Pharma609-359-3016jhowarth@antarespharma.com
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