Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) today announced
that it has entered into a global agreement with Idorsia
Pharmaceuticals Ltd. (“Idorsia”) (SIX: IDIA) to develop a novel,
drug-device product combining selatogrel, Idorsia’s potent,
fast-acting and highly selective P2Y12 receptor antagonist under
development, with the Antares subcutaneous QuickShot® auto
injector. Selatogrel, a new chemical entity (NCE), is being
developed for the treatment of a suspected acute myocardial
infarction (AMI) in adult patients with a history of AMI. Idorsia’s
Phase 2 clinical data demonstrated that subcutaneous administration
of selatogrel resulted in a potent and rapid platelet inhibition
effect in patients with a history of coronary artery disease and
AMI. According to Idorsia, the product was safe and well tolerated.
Idorsia is now preparing for a clinical bridging study to be
followed by a global Phase 3 study of a self-administered
QuickShot® auto injector containing selatogrel for the pre-hospital
treatment of a suspected acute myocardial infarction.
“Today, we are extremely pleased to announce a
new and important global development agreement with Idorsia
Pharmaceuticals, one of Europe’s premier biopharmaceutical
companies. Idorsia is developing a novel approach to treating
patients with a suspected AMI on an emergency basis using a new
chemical entity, selatogrel, with our proven QuickShot device.
Idorsia hopes to improve upon outcomes for those patients
experiencing a recurrent heart attack by providing a rapid and
sustained platelet inhibition thus potentially providing for early
treatment of AMI,” said Robert F. Apple, President and Chief
Executive Officer of Antares. “This is one of the most exciting and
innovative partner product opportunities we have ever worked on in
the Company’s history. The development agreement between Antares
and Idorsia further expands our portfolio of pipeline partnered
products and represents our first opportunity to develop a
combination product utilizing a partner’s NCE. We believe our track
record of drug-device combination product approvals is impressive,
speaks to the reliability of our device platforms and we believe is
why Idorsia chose to work with Antares on this exciting product. We
look forward to working closely with Idorsia throughout the
development phase of this novel product and assisting them in
pursuing FDA drug device and global regulatory approval assuming
successful completion of their Phase 3 study.”
Idorsia will pay for the development of the
combination product and will be responsible for applying for and
obtaining global regulatory approvals for the product. The parties
intend to enter into a separate commercial license and supply
agreement pursuant to which Antares will provide fully assembled
and labelled product to Idorsia at cost plus margin. Idorsia will
then be responsible for global commercialization of the product,
pending FDA or foreign approval. Antares will be entitled to
receive royalties on net sales of the commercial product.
Jean-Paul Clozel, MD and Chief Executive Officer
of Idorsia, commented, “For patients suffering an AMI, the time
from onset of symptoms to first medical contact is critical to
preserving muscle and heart function. Our concept of
self-administration of a potent, fast-acting P2Y12 receptor
antagonist at onset of symptoms could have significant potential.
This potential can only be unlocked when our compound is brought
together with the right device. Hence finding a safe and reliable
device which is easy for patients to use under stressful conditions
was a key part for the further development. I'm confident that with
Antares we have found the right partner to deliver on this
mission.” He added, “The team at Idorsia is also preparing a
comprehensive program to train patients on when to inject and
instruct them on how to self-administer treatment. It is a
challenging but incredibly exciting project, and as a cardiologist,
I know how important early treatment at the very onset of symptoms
of an AMI is. Based on our current plans, the usability and
reliability studies, and ongoing discussions with health
authorities, I hope that we can initiate the Phase 3 in the first
half of 2021."
About Selatogrel
Idorsia is developing selatogrel, a potent,
fast-acting, reversible, and highly-selective P2Y12 receptor
antagonist, for single subcutaneous self-administration for the
treatment of a suspected AMI in patients with a history of AMI.
Idorsia has previously announced that two Phase 2 studies in
patients with stable coronary artery disease and acute myocardial
infarction, respectively, have met their pharmacodynamic objectives
of significantly inhibiting platelet aggregation. According to the
studies, subcutaneous administration of selatogrel 8 mg and 16 mg
has demonstrated a rapid onset of action, within 15 minutes, with
the height of its effect extending over 4-8 hours, depending on the
dose. Selatogrel was safe and well tolerated in both studies and
there were no treatment-emergent serious bleeds. In consultation
with health authorities, Idorsia is preparing a large,
international, multi-center, Phase 3 study to investigate the
efficacy and safety of subcutaneous self-administration of
selatogrel for the treatment of a suspected AMI in patients with an
history of AMI. Participating patients will be trained on when to
inject and instructed on how to self-administer treatment.
Selatogrel has not been approved by the FDA in the United States or
any foreign country.
Both studies were presented at the European
Society of Cardiology 2019:
"Selatogrel, a novel P2Y12 inhibitor for
emergency use, achieves rapid, consistent and sustained platelet
inhibition following single-dose subcutaneous administration in
stable CAD patients”, Professor Robert Storey, BM, Professor of
Cardiology, University of Sheffield, UK. The abstract can be found
online.
"Inhibition of platelet aggregation after
subcutaneous administration of a single-dose of selatogrel, a novel
P2Y12 antagonist, in acute myocardial infarction: A randomised
open-label phase 2 study”, Professor Peter Sinnaeve, MD, Department
of Cardiology, University Hospitals Leuven, Faculty of Medicine,
University of Leuven, Belgium. The abstract can be found
online.
A manuscript for the study of selatogrel in
stable CAD patients is also now available: Storey RF, et al,
Pharmacodynamics, pharmacokinetics, and safety of single-dose
subcutaneous administration of selatogrel, a novel P2Y12 receptor
antagonist, in patients with chronic coronary syndromes. European
Heart Journal (2019) 0, 1–9 doi:10.1093/eurheartj/ehz807
About Acute Myocardial
Infarction
An AMI, or heart attack, is a life-threatening
condition that occurs when blood flow to the heart muscle 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. The American
Heart Association estimates that each year more than 600,000
persons living in the US will suffer their first heart attack and
around 200,000 will suffer a recurring heart attack.
AMI is associated with a 30% mortality rate and
about half of these deaths occur prior to arrival at the hospital.
As a result, early action is crucial for survival, however there
are no treatment options available for the critical time from onset
of AMI symptoms to first medical contact. The need for an early
intervention has been highlighted by the guidelines of the European
Society of Cardiology and the American College of Cardiology /
American Heart Association, which identified the prehospital phase
as the most critical and reiterated that efforts must be made to
reduce the delay for treatment initiation to reduce death.
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
one of Europe’s leading biopharmaceutical companies, with a strong
scientific core.
Headquartered in Switzerland - a biotech-hub of
Europe - Idorsia is specialized in the discovery and development of
small molecules, to transform the horizon of therapeutic options.
Idorsia has a broad portfolio of innovative drugs in the pipeline,
an experienced team, a fully-functional research center, and a
strong balance sheet – the ideal constellation to bringing R&D
efforts to business success.
Idorsia was listed on the SIX Swiss Exchange
(ticker symbol: IDIA) in June 2017 and has over 750 highly
qualified specialists dedicated to realizing our ambitious
targets.
About Antares Pharma
Antares Pharma, Inc. is a combination drug
device company focused primarily on the development and
commercialization of self-administered parenteral 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, Inc.
and Pfizer Inc. (Pfizer). Antares Pharma’s proprietary products
include XYOSTED® (testosterone enanthate) injection, OTREXUP®
(methotrexate) injection for subcutaneous use and Sumatriptan
Injection USP, which is distributed by Teva.
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 clinical bridging and Phase 3
clinical trial of the drug device combination product for
Selatogrel with Idorsia Pharmaceuticals and FDA and global
regulatory approvals and future revenue from the same; market
acceptance, adequate reimbursement coverage and 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; our expectations regarding whether the FDA will
pursue withdrawal of approval for AMAG Pharmaceuticals Inc.’s
Makena® subcutaneous auto injector following the recent FDA
advisory committee meeting and future prescriptions, market
acceptance and revenue from Makena® subcutaneous auto injector;
Teva’s ability to successfully commercialize VIBEX® Sumatriptan
Injection USP and the amount of revenue from the same; continued
growth of prescriptions and sales of OTREXUP®; 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; achievement of
the 2019 revised revenue guidance; the Company’s ability to meet
loan extension and interest only payment milestones and the 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:
Jack HowarthVice President, Corporate Affairs of
Antares609-359-3016jhowarth@antarespharma.com
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