Antares Pharma Announces Positive Results From Phase I Study For ATRS-1902 For Adrenal Crisis Rescue
11 Janvier 2022 - 1:30PM
Antares Pharma, Inc. (NASDAQ: ATRS) (the “Company”), a specialty
pharmaceutical company, today announced positive results from a
Phase I study for ATRS-1902 for adrenal crisis. The positive
results support the advancement of the ATRS-1902 development
program to a pivotal clinical study for the treatment of acute
adrenal insufficiency, known as adrenal crisis, in adults and
adolescents, using our Vai™ novel proprietary rescue pen
platform to deliver a liquid stable formulation of hydrocortisone.
The results of the Phase I cross-over study met
its primary objective showing ATRS-1902 (100 mg) delivered a
comparable pharmacokinetic profile to Solu-Cortef® (100 mg), the
reference-listed drug, in 32 healthy adults. The study also
demonstrated that ATRS-1902 was safe and well tolerated.
“We are pleased that the results from this Phase
I study support the advancement of ATRS-1902 to a pivotal clinical
study which we anticipate starting in the second quarter of 2022.
As we remain focused on strengthening our clinical development
pipeline, we expect to file the 505(b)(2) NDA with the FDA by the
end of 2022 assuming the successful completion of the pivotal study
and an additional human factor study. We look forward to the
opportunity to provide an essential treatment that can be easily
administered for a potentially life-threatening situation,”
commented Dr. Peter Richardson, MRCP (UK), EVP, Research and
Development and Chief Medical Officer of Antares Pharma.
Robert F. Apple, President and Chief Executive
Officer of Antares Pharma, added, “These positive results reinforce
our commitment to improving the current standard of care for
adrenal crisis patients and advancing our proprietary development
pipeline. As a leader in rescue pen technology, our recently
developed Vai device allows for a simple injection for patients in
crisis. With a clear development timeline, we expect ATRS-1902 to
support our future revenue growth and leverage our commercial
organization and one of our current therapeutic footprints in
endocrinology.”
About Antares Pharma
Antares Pharma, Inc. is a specialty
pharmaceutical company focused primarily on the development and
commercialization of self-administered injectable pharmaceutical
products using advanced drug delivery auto injector technology. 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 and Sumatriptan Injection USP,
which is distributed by Teva. The Company also markets NOCDURNA®
(desmopressin acetate) in the U.S. and expects to commercially
launch TLANDO® (testosterone undecanoate) in the U.S. pending final
FDA approval.
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-1902 adrenal crisis rescue
auto-injector including the pivotal study and human factors study,
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 updated 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;
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
respect to the Company’s products or product candidates of its
partners; commercial success of the Company’s products or partner
products and 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:Tram BuiVice President,
Corporate Communications and Investor
Relations609-359-3016tbui@antarespharma.com
Antares Pharma (NASDAQ:ATRS)
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