Antares Pharma Discloses “Pen 1” Development Project as Teriparatide
April 05 2016 - 7:00AM
Antares Pharma, Inc. (NASDAQ:ATRS) today disclosed that the “Pen 1”
development project with Teva Pharmaceutical Industries, Ltd.
(Teva) relates to a generic form of Forteo® (teriparatide [rDNA
origin] injection) (Teriparatide), marketed by Eli Lilly and
Company (Lilly). Forteo is an injectable treatment for
osteoporosis in postmenopausal women and men at high risk for
fracture and for glucocorticoid induced osteoporosis in men and
postmenopausal women. On March 16, 2016 Lilly filed a lawsuit
against Teva in response to Teva’s Paragraph IV notice and filing
contained in their Abbreviated New Drug Application (ANDA) for
Teriparatide filed with, and accepted by, the U.S. Food and Drug
Administration (FDA). Based on available information, Antares
believes that Teva may be the "first applicant" to file an ANDA for
a generic equivalent of Forteo and, should Teva’s ANDA be approved,
may be entitled to 180 days of generic market exclusivity.
“Today’s announcement represents an important
step forward in the process of providing U.S. patients with a
generic alternative to Forteo,” said Robert F. Apple, President and
Chief Executive Officer of Antares Pharma. He continued, “The
ANDA for Teriparatide represents the fourth ANDA for which Antares
is the device developer and the third drug device combination
product with first-to-file status using an Antares device. Teva is
an extremely valuable partner and we look forward to working with
them towards an approval of this important product.”
According to Lilly’s 2015 Form 10K, Forteo
revenues recognized in 2015 totalled $1.3 billion, including U.S.
revenues of $0.6 billion. Antares is responsible for
developing and manufacturing the multi-dose pen that Teva will use
for the Teriparatide product, if approved. The scope of the
Teriparatide agreement with Teva is worldwide.
About Antares Pharma
Antares Pharma focuses on self-administered
parenteral pharmaceutical products. The Company’s product, OTREXUP™
(methotrexate) injection for subcutaneous use, is approved in the
U.S. for the treatment of adults with severe active rheumatoid
arthritis, children with active polyarticular juvenile idiopathic
arthritis and adults with severe recalcitrant psoriasis. Antares
Pharma is also developing QuickShot® Testosterone for testosterone
replacement therapy, and has recently received a therapeutically
equivalent approval for VIBEX® Sumatriptan USP for the acute
treatment of migraines. The Company's technology platforms
include VIBEX® disposable auto injectors, disposable multi-use pen
injectors and reusable needle-free injectors. Antares Pharma has a
multi-product deal with Teva Pharmaceutical Industries, Ltd. that
includes VIBEX® epinephrine, exenatide multi-dose pen, and
teriparatide multi-dose pen. Our reusable needle-free
injector for use with human growth hormone (hGH) is sold worldwide
by Ferring B.V. The Company is also working with AMAG
Pharmaceuticals on a subcutaneous method of administering Makena, a
progesterone product indicated for use in lowering the risk of
pre-term birth.
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 outcome of the
pending patent litigation between Teva
Pharmaceutical Industries, Ltd. (Teva) and
Eli Lilly and Company regarding the Teriparatide
multi-dose pen; the timing and approval, if any, by the
U.S. Food and Drug Administration (FDA) of Teva’s
Abbreviated New Drug Application (ANDA) for
Teriparatide multi-dose pen and any future
revenue resulting therefrom; Teva’s ability to
adequately and timely respond to the Complete Response Letter
received from the FDA for the VIBEX® epinephrine pen ANDA and
approval by the FDA of the same, the timing and therapeutic
equivalence rating thereof, and any revenue pre or post FDA
approval; FDA action with respect to the ANDA filed for the
exenatide pen; the timing of the launch of VIBEX® Sumatriptan
Injection USP and the amount of revenue from the same, the timing
and results of the phase 3 studies for QuickShot® Testosterone (QS
T) and acceptance of the data by the FDA; the Company’s ability to
successfully complete a New Drug Application for QS T and submit to
the FDA and approval of the same by the FDA; continued growth of
prescriptions and sales of OTREXUP™; the timing and results
of research projects, clinical trials, and product candidates
in development; actions by the FDA or other regulatory agencies
with the 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 for the year ended December 31, 2014, 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 Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com
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