Antares Pharma Announces FDA Acceptance of IND Application for ATRS-1902 for Adrenal Crisis Rescue
July 22 2021 - 7:30AM
Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty
pharmaceutical company, today announced that the U.S. Food and Drug
Administration (FDA) has accepted the Investigational New Drug
Application (IND) for ATRS-1902 for adrenal crisis rescue. The
active IND enables Antares to initiate a Phase 1 clinical study for
ATRS-1902 for the treatment of acute adrenal insufficiency, known
as adrenal crisis, in adults and adolescents, using a novel
proprietary auto-injector platform to deliver hydrocortisone.
“The FDA acceptance of this IND is an important
milestone in the development of a novel formulation and delivery of
hydrocortisone in a crisis situation. We believe acute adrenal
insufficiency is a medical emergency which would benefit from a
simplified and readily-available way to administer an essential
treatment during a possibly life-threatening situation,” commented
Dr. Peter Richardson, MRCP (UK), EVP, Research and Development and
Chief Medical Officer of Antares Pharma.
Adrenal crisis is a potentially fatal condition
associated mainly with an acute deficiency of cortisol, which is a
hormone produced and released by the adrenal gland, and commonly
occurs in patients with long-term adrenal insufficiency. Current
standard of care for the management of acute adrenal crises
includes Solu-Cortef®, which is an anti-inflammatory
glucocorticoid. With hydrocortisone sodium succinate as the active
ingredient, Solu-Cortef® is provided as a sterile powder that needs
to be reconstituted for intravenous or intramuscular injection and
can represent a potentially time-consuming and cumbersome injection
process, particularly challenging in a crisis situation.
Robert F. Apple, President and Chief Executive
Officer of Antares Pharma, added, “We are pleased to be able to
advance the development of our proprietary pipeline with the FDA
acceptance of this IND. With a novel expansion to our device
technology platform, we hope to enhance the clinical benefit and
offer key advantages to this important patient population at a
critical time. We also look forward to the opportunity to leverage
the success that our commercial team continues to garner with
XYOSTED to ATRS-1902, as both products have an endocrinology call
point. We are excited to continue to invest in our proprietary
pipeline to support our potential future growth.”
The IND application for ATRS-1902 includes a
protocol for an initial clinical study to compare the
pharmacokinetic (PK) profile of the Company’s novel formulation of
hydrocortisone versus Solu-Cortef®, which is expected to initiate
in 2H 2021. Assuming this study is completed successfully, a second
study will then be conducted utilizing Antares’ proprietary
auto-injector technology which has been developed to provide
reliability and ease-of-use in emergency situations by the patient
or caregiver. We believe these two studies will be the basis of our
anticipated 505(b)(2) NDA filing with the FDA expected towards the
end of 2022.
About Antares Pharma
Antares Pharma, Inc. is a specialty
pharmaceutical company focused primarily on the development and
commercialization of pharmaceutical products and technologies that
address unmet needs in targeted therapeutic areas such as urology
and endocrinology. The Company has a portfolio of proprietary and
partnered commercial products with several product candidates in
various stages of development, as well as significant strategic
alliances with industry leading pharmaceutical companies including
Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals
(AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd.
(Idorsia). Antares Pharma’s FDA-approved products include XYOSTED®
(testosterone enanthate) injection, OTREXUP® (methotrexate)
injection for subcutaneous use and Sumatriptan Injection USP, which
is distributed by Teva. The Company also markets NOCDURNA®
(desmopressin acetate) in the U.S., which was licensed from Ferring
Pharmaceuticals.
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
clinical development program for ATRS-1901 adrenal crisis rescue
auto-injector, future NDA submission and FDA approval of the same,
and if approved, future market acceptance and revenue for the same,
the Company’s ability to achieve the 2021 full-year revenue
guidance; the uncertainty regarding the ongoing COVID-19 pandemic,
including new strains of the virus, and the mitigation measures and
other restrictions implemented in response to the same and the
impact on demand for our products, new patients and prescriptions,
future revenue, product supply, clinical trials, and our overall
business, operating results and financial condition;
commercial success of
XYOSTED® and future
revenue from the same; market acceptance of Teva’s
generic epinephrine auto-injector product and future revenue from
the same; future prescriptions and sales of
OTREXUP®; successful
commercialization of NOCDURNA® in
the U.S. and market acceptance and future revenue from the
same; whether the FDA will withdraw marketing
approval for AMAG Pharmaceuticals’
Makena® subcutaneous auto
injector following the FDA letter seeking withdrawal, whether AMAG
will be granted an appeal hearing and if granted, whether
Makena® will be successful
and future prescriptions, market acceptance and
revenue from the same; Teva’s ability to successfully commercialize
VIBEX® Sumatriptan Injection USP
and the amount of revenue from the same; Teva’s ability to
successfully commercialize generic teriparatide in Europe, Canada
and Israel and future revenue from the same, successful development
including the timing and results of the Phase 3 trial of the drug
device combination product for selatogrel with Idorsia
Pharmaceuticals and FDA and global regulatory approvals and future
revenue from the same; FDA approval of Teva’s ANDAs for both
generic Forteo® and
Byetta® and future revenue from
the same; the timing and results of the Company’s or its partners’
research projects or clinical trials of product candidates in
development including the Company’s urology
assets in development as well as Pfizer’s
undisclosed development product; actions by the FDA or other
regulatory agencies with 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 repay the debt obligation to Hercules Capital; 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:Tram BuiVice President,
Corporate Communications and Investor
Relations609-359-3016tbui@antarespharma.com
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