Antares Pharma Announces FDA Approval of Generic EpiPen Utilizing VIBEX Auto Injector
August 16 2018 - 3:54PM
Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) today announced
that the U.S. Food and Drug Administration (FDA) has approved Teva
Pharmaceutical Industries, Ltd.’s (“Teva”) epinephrine auto
injector drug-device combination product indicated for emergency
treatment of severe allergic reactions including those that are
life threatening (anaphylaxis) in adults and certain pediatric
patients. Our partner Teva filed an Abbreviated New Drug
Application (ANDA) seeking FDA approval of the product as a generic
substitute of Mylan’s branded product EpiPen®. Teva’s
drug-device combination product utilizes the Antares Pharma VIBEX®
device and has been approved with an AP rating, defined as a
therapeutically equivalent injectable aqueous solution and
therefore fully substitutable to the EpiPen at the pharmacy.
“We are extremely pleased with the FDA’s
decision to approve Teva’s ANDA for the first and only fully
substitutable generic version of Mylan’s branded EpiPen, the most
widely used epinephrine auto injector on the market,” said Robert
F. Apple, President and Chief Executive Officer of Antares
Pharma. “This approval means patients living with severe,
sometimes life-threatening allergic reactions, (anaphylaxis), who
require immediate access to life-sparing epinephrine should have
access to a generic alternative. We and our partner Teva worked
diligently together to obtain the approval of this very complex
drug/device rescue pen combination product utilizing our VIBEX auto
injector platform and we look forward to Teva making it
commercially available to patients.”
Antares previously entered into an exclusive
License, Development and Supply Agreement with Teva for an
epinephrine auto injector product to be marketed in the U.S.
Pursuant to the agreement, Antares is responsible for supply of the
device which will be sold to Teva at cost plus margin. Teva
is responsible for commercialization and distribution of the final
product for which Antares will receive royalties on net sales.
About Antares Pharma
Antares Pharma, Inc. is a specialty
pharmaceutical company focused on the development and
commercialization of self-administered parenteral pharmaceutical
products using advanced drug delivery auto injection
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) and AMAG
Pharmaceuticals, Inc. Antares Pharma’s proprietary products
include OTREXUP® (methotrexate) injection for subcutaneous use and
Sumatriptan Injection USP, which is distributed by Teva. The
Company has developed an investigational new drug for testosterone
replacement therapy called XYOSTED™, currently under active review
at the FDA with a PDUFA date of September 29, 2018.
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: market acceptance of
Teva’s generic epinephrine auto-injector product and future revenue
from the same; timing and successful development of the
rescue pen with Pfizer and FDA approval and future revenue from the
same; successful completion of the transaction with Ferring
International Center, S.A.; the Company’s ability to resolve the
deficiencies identified by the FDA in the Complete Response Letter
for XYOSTED™, FDA approval of the Company’s NDA
for XYOSTED™ and future market
acceptance and revenue for XYOSTED™; 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; 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 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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