Antares Pharma Provides XYOSTED™ Regulatory Update
October 12 2017 - 5:00PM
Antares Pharma, Inc. (NASDAQ:ATRS) today announced that, on October
11, 2017, the Company received a letter from the U.S. Food and Drug
Administration (FDA) stating that, as part of their ongoing review
of the Company’s New Drug Application (NDA) for XYOSTED™
(testosterone enanthate) injection, they have identified
deficiencies that preclude the continuation of the discussion of
labeling and postmarketing requirements/commitments at this
time. The letter does not specify the deficiencies identified
by the FDA and there has been no further clarification of the
deficiencies by the FDA at this time. We anticipate receiving
further clarification from the FDA on or before the Prescription
Drug User Fee Act (PDUFA) date of October 20, 2017. The
Company intends to work with the FDA to understand the nature of
the deficiencies once identified and resolve them as quickly as
possible.
On December 20, 2016, the Company submitted to
the U.S. Food and Drug Administration a New Drug Application
pursuant to section 505(b)(2) of the Federal Food, Drug and
Cosmetic Act (FDCA), for testosterone enanthate subcutaneous
injection. On February 24, 2017, the Company received a
letter from the FDA notifying the Company that the FDA assigned a
PDUFA target date for completion of its review by October 20, 2017.
On September 22, 2017, the Company received labeling comments
from the FDA which the Company responded to on September 29,
2017.
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 XYOSTED™ for testosterone
replacement therapy and has filed a New Drug Application with the
U.S. Food and Drug Administration. 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 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 Company’s ability
to resolve the deficiencies once identified by the FDA in the
Company’s NDA for XYOSTED and the timeframe associated with such
resolution, whether the Company will be able to respond to the
deficiencies 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,
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, FDA approval of the sNDA submitted by AMAG
Pharmaceuticals for an auto injector for Makena and future market
acceptance and revenue of the same; the outcome of the pending
patent litigation between Teva Pharmaceutical Industries, Ltd.
(Teva) and Eli Lilly and the 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
expectations about timing and approval of the VIBEX® epinephrine
pen ANDA by the FDA and potential product launch of the same, the
therapeutic equivalence rating thereof, and any future revenue from
the same; 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 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, 2016, 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
Antares609-359-3016jhowarth@antarespharma.com
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