Antares Pharma Receives Complete Response Letter From the FDA for XYOSTED™
October 20 2017 - 6:49PM
Antares Pharma, Inc. (NASDAQ:ATRS) announced that today it has
received a Complete Response Letter (CRL) from the U.S. Food and
Drug Administration (FDA) regarding the New Drug Application (NDA)
for XYOSTED™ (testosterone enanthate) injection. The CRL indicates
that the FDA cannot approve the NDA in its present form.
The CRL identified two deficiencies related to
clinical data. Based on findings in studies QST-13-003 and
QST-15-005, the FDA is concerned that XYOSTED™ could cause a
clinically meaningful increase in blood pressure. In addition, the
letter also raised a concern regarding the occurrence of depression
and suicidality. The CRL did not cite any Chemistry, Manufacturing
and Controls (CMC), device or efficacy issues with regard to
XYOSTED™. The next step will be to request a meeting with the FDA
to further evaluate the deficiencies raised and to agree upon a
path forward for a potential approval of XYOSTED™.
“We are disappointed with the outcome of the
review and are assessing the content of the Complete Response
Letter, including the information that may be needed to resolve the
deficiencies,” said Robert F. Apple, President and Chief Executive
Officer. “The Company remains committed to bringing XYOSTED to
market and will work closely with the FDA to determine the
appropriate responses to the deficiencies noted in the letter.”
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
adequately and timely respond to the deficiencies in the XYOSTED™
CRL issued by the FDA, whether any such response will be accepted
by the FDA, the Company’s ability and timing to
resubmit the NDA for XYOSTED™, and FDA acceptance of the
resubmitted NDA and any approval of the Company’s NDA 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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