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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