Antares Pharma Announces Epinephrine Auto-Injector Settlement Agreement Between Teva and Pfizer
26 April 2012 - 11:26PM
Business Wire
Antares Pharma, Inc. (NYSE Amex: AIS) today announced that
Meridian Medical Technologies, a Pfizer subsidiary, has entered
into a settlement agreement with Teva, Antares’ pharmaceutical
partner, that will resolve pending patent litigation related to its
abbreviated new drug application (ANDA) for a generic epinephrine
auto-injector. According to the terms of the settlement, Teva may
launch a generic epinephrine auto-injector covered by its ANDA on
June 22, 2015 or earlier under certain circumstances, subject to
receipt of approval from the U.S. Food and Drug Administration.
Additional terms of the agreement are confidential, and the
agreement itself is subject to review by the U.S. Department of
Justice and the Federal Trade Commission.
Under a separate agreement, Teva has agreed to provide Antares
with device orders of an undisclosed amount in the years 2013 and
2014, to make a milestone payment to Antares upon FDA approval of
epinephrine auto-injector, and to assume all litigation costs
related to the patent litigation between Teva and Meridian
Medical.
About Antares Pharma
Antares Pharma focuses on self-injection pharmaceutical products
and topical gel-based medicines. The Company's subcutaneous and
intramuscular injection technology platforms include Vibex™
disposable pressure-assisted auto injectors, disposable multi-use
pen injectors and Vision™ reusable needle-free injectors
distributed as Tjet® and Zomajet® by Teva Pharmaceutical
Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring),
respectively. In the injector area, Antares Pharma has a
multi-product deal with Teva that includes Tev-Tropin® human growth
hormone (hGH) and a partnership with Ferring that includes
Zomacton® hGH. In the gel-based area, the Company's FDA approved
product is oxybutynin gel 3% for the treatment of OAB (overactive
bladder) which has been licensed to Watson Pharmaceuticals, Inc.
for marketing in the U.S. and Canada. Antares’ portfolio includes
Elestrin® (estradiol gel) indicated for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause,
and marketed in the U.S. by Jazz Pharmaceuticals. Antares Pharma
has two facilities in the U.S. The Parenteral Products Division
located in Minneapolis, Minnesota directs the manufacturing and
marketing of the Company’s reusable needle-free injection devices
and related disposables, and develops its disposable
pressure-assisted auto injector and pen injector systems. The
Company’s corporate offices and Pharma Division are located in
Ewing, New Jersey, where pharmaceutical products are developed
utilizing both the Company’s transdermal systems and drug/device
combination products.
Forward-Looking Statement
This press release contains forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These statements are indicated by
the words “may,” “will,” “plans,” “ intends, ” “believes,”
“expects,” “anticipates,” “potential,” “could,” “would,” “should,”
and similar expressions. Such forward-looking statements are not
guarantees of future performance and are subject to risks and
uncertainties that may cause actual results to differ materially
from those anticipated by the forward-looking statements. These
risks and uncertainties include, among others, that the agreement
will be acceptable to the U.S. Department of Justice and the
Federal Trade Commission. 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 for the year ended December 31, 2011, 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.
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