Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty
pharmaceutical company, today announced that its partner Idorsia
Ltd (“Idorsia”) initiated its Phase 3 registration study to
evaluate the efficacy and safety of self-administered subcutaneous
selatogrel, Idorsia’s P2Y12 receptor antagonist, in suspected acute
myocardial infarction (“AMI”) utilizing Antares’ Quickshot®
auto-injector.
Robert F. Apple, President and Chief Executive
Officer of Antares Pharma, commented, “We are excited to play an
important role in Idorsia’s development of selatogrel with our
autoinjector technology. The strong collaboration between our teams
has allowed Idorsia to achieve this important milestone of
initiating the Phase 3 study of this novel combination product in
approximately eighteen months from the signing of our development
agreement. The opportunity to self-inject selatogrel at the onset
of symptoms from a suspected heart attack represents a compelling
proposition for patients and we believe Idorsia’s commitment to
that innovation could prove revolutionary. We look forward to
continuing to support Idorsia’s clinical advancement of
selatogrel.”
Idorsia is initiating an international,
multi-center, double-blind, randomized, placebo-controlled,
parallel-group, Phase 3 study to assess the clinical efficacy and
safety of 16 mg selatogrel when self-administered (on top of
standard-of-care) upon occurrence of symptoms suggestive of an
acute myocardial infarction. The primary efficacy endpoint is the
occurrence of death from any cause, or non-fatal AMI after any
study treatment self-administration. The study will enroll
approximately 14,000 patients who are at high risk of recurrent
AMI, at approximately 250 sites in approximately 30 countries.
A Special Protocol Assessment has been agreed
with the U.S. Food and Drug Administration (“FDA”) for Idorsia’s
selatogrel. This indicates the FDA is in agreement with the
adequacy and acceptability of specific critical elements of overall
protocol design (e.g., entry criteria, dose selection, endpoints
and planned analyses) for a study intended to support a future
marketing application.
In December 2020, the FDA designated Idorsia’s
investigation of selatogrel for the treatment of a suspected AMI in
adult patients with a history of AMI as a “fast-track” development
program. This designation is intended to promote communication and
collaboration between the FDA and pharmaceutical companies for
drugs that treat serious conditions and fill an unmet medical
need.
Idorsia selected Antares’ Quickshot®
autoinjector for the development of selatogrel due to the
robustness, reliability, ease-of-use and emergency-ready
capabilities of our technology. Idorsia has confirmed the usability
of the Quickshot® autoinjector in the clinical development program
through human factor validation studies.
Antares entered into a global development
agreement with Idorsia in November 2019. Under the terms of the
agreement, Antares will provide clinical supply to Idorsia during
clinical development in addition to fully packaged product upon FDA
or foreign regulatory approval. Idorsia is responsible for the
clinical development and regulatory approvals of the combination
product. Idorsia will be responsible for global commercialization
of the product, pending regulatory approvals, and Antares will be
entitled to receive royalties on net sales of the commercial
product.
About Acute Myocardial Infarction
(AMI)
An AMI, or heart attack, is a life-threatening
condition that occurs when blood flow to the heart muscle
(myocardium) is suddenly decreased or completely cut off. It is
usually caused by a blood clot or blockage in one or more of the
coronary vessels supplying blood to the heart muscle. An AMI
requires immediate treatment and medical attention, as any delay in
intervention can result in irreversible damage to the heart muscle.
According to the U.S. Centers for Disease Control and Prevention,
each year more than 800,000 persons living in the US will suffer a
heart attack.[1]
1. Benjamin EJ, et al. Heart Disease and Stroke
Statistics—2019 Update: A Report From the American Heart
Association. Circulation 2019;139(10):e56-e528.
About Idorsia
Idorsia Ltd is reaching out for more – We have
more ideas, we see more opportunities and we want to help more
patients. In order to achieve this, we will develop Idorsia into a
leading biopharmaceutical company, with a strong scientific
core.
Headquartered near Basel, Switzerland – a
European biotech-hub – Idorsia is specialized in the discovery,
development and commercialization of small molecules to transform
the horizon of therapeutic options. Idorsia has a broad portfolio
of innovative drugs in the pipeline, an experienced team of
professionals covering all disciplines from bench to bedside,
state-of-the-art facilities, and a strong balance sheet – the ideal
constellation to translate R&D efforts into business
success.
Idorsia was listed on the SIX Swiss Exchange
(ticker symbol: IDIA) in June 2017 and has over 900 highly
qualified specialists dedicated to realizing our ambitious
targets.
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: successful development including
the timing and results of the Phase 3 trial of the drug device
combination product for selatogrel with Idorsia Ltd and FDA and
global regulatory approvals and future revenue from 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; 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; 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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