Antares Pharma Announces Receipt of Orphan Drug Designation for the Treatment of Ectopic Pregnancy With Methotrexate
March 28 2019 - 7:30AM
Antares Pharma, Inc. (NASDAQ: ATRS) today announced receipt of
orphan drug designation to evaluate the use of subcutaneous
methotrexate (“MTX”) for the treatment of ectopic pregnancy that
meets predefined criteria for medical management. Antares
plans to initiate a development program utilizing a proprietary
auto injector device with doses of methotrexate not commercially
approved or available in an auto injector in order to provide
potential benefits for both patients and healthcare professionals.
Ectopic pregnancy is simply defined as a
pregnancy that occurs outside of the uterine cavity. Due to several
potential causes, the nonviable pregnancy tissue grows in the
abnormal location with the most common site being the fallopian
tube. If untreated, the pregnancy may continue to grow, rupture the
tube and create catastrophic bleeding with subsequent death of the
patient. Most cases of unruptured ectopic pregnancy can be
successfully treated with either minimally invasive surgical
techniques (laparoscopy) or with medical management using
intramuscular methotrexate in an "off-label" fashion.
Dr. James P. Tursi, Executive Vice President,
Head of Research & Development, Chief Medical Officer, stated,
“The use of subcutaneous methotrexate has the potential to
effectively medically treat an ectopic pregnancy resolving the risk
of rupture, hemorrhage and subsequent death without the need for
laparoscopic surgery or emergency surgical intervention.” He
continued, “We believe the potential avoidance of surgical
intervention and associated risks of surgery and anesthesia may
reduce patient morbidity and costs to the healthcare system.
Medical treatment with methotrexate may also help to preserve
future fertility and may obviate the need for surgical intervention
or future infertility intervention. This is potentially both
life-saving and cost-saving. The subcutaneous approach
utilizing our proprietary auto injector technology may reduce
patient discomfort when compared to traditional intramuscular
injections. We are not aware of any sponsor that has
conducted well-designed clinical studies to fully characterize the
appropriate dosing, safety and efficacy of MTX for the treatment of
unruptured ectopic pregnancy.”
Ectopic pregnancy accounts for approximately 2%
of all reported pregnancies in the United States. Approximately
128,000 ectopic pregnancies occur annually. Despite improvements in
diagnosis and management, ectopic pregnancy continues to be a
significant cause of pregnancy-related morbidity and mortality.
Hemorrhage from ectopic pregnancy is the leading cause of
pregnancy-related maternal death in the first trimester and
accounts for 4% to 10% of all pregnancy related deaths in the
U.S.
The Orphan Drug Designation program is overseen
by the U.S. Food and Drug Administration (FDA) and provides orphan
designation status to drugs and biologics for rare
diseases/conditions, defined as diseases/conditions that affect
fewer than 200,000 people in the U.S. The purpose of the
designation was to create incentives for companies to develop new
drugs and biologics for rare diseases. These incentives may include
a partial tax credit for certain clinical trial expenditures, the
waiver of certain FDA user fees, and potential eligibility for 7
years of orphan drug marketing exclusivity if approved. The
granting of an orphan designation request does not alter the
standard regulatory requirements or the approval standard and
process for obtaining marketing approval.
About Antares PharmaAntares
Pharma, Inc. is a combination drug device company focused 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
advanced 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:
the timing and results of the clinical development program with
orphan designation to evaluate the use of subcutaneous methotrexate
for the treatment of ectopic pregnancy that meets predefined
criteria for medical management; the ability to
maintain orphan drug designation, receive ultimate product
approval, and receive the advantages of orphan drug designation;
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; successful completion of the
transaction with Ferring International Center, S.A.; future 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 including
projects with Teva and Pfizer; 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
revenue guidance; 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
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''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
Affairs609-359-3016jhowarth@antarespharma.com
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