Antares Pharma Announces the Successful Completion of Teva’s Decentralized Procedure for Teriparatide Injection in Europe
December 19 2016 - 7:00AM
Antares Pharma, Inc. (NASDAQ:ATRS) today announced that Teva
Pharmaceutical Industries, Ltd. (Teva) has successfully concluded a
decentralized procedure registration process in Europe for its
teriparatide injection product, a treatment for osteoporosis in
postmenopausal women and men at increased risk of fracture and for
glucocorticoid induced osteoporosis in men and women.
Applications for marketing authorizations in Europe are ongoing in
each of the countries of application.
“We are extremely pleased with the outcome of
Teva’s teriparatide decentralized procedure in Europe and look
forward to the issuance of the marketing authorizations in each
country of application,” said Robert F. Apple, President and Chief
Executive Officer of Antares Pharma. He continued, “While our
collaboration partner Teva awaits final marketing authorizations
and the clearance of the intellectual property of the original
product, we will continue to monitor progress on their Abbreviated
New Drug Application for a U.S. generic equivalent of Forteo®[1],
which is currently under active review at the Food and Drug
Administration.”
Antares is responsible for manufacturing and the
supply of the multi-dose pen that Teva will use for
teriparatide. The scope of the teriparatide license and
supply agreement with Teva is worldwide and provides for a margin
on device sales and a royalty on end sales of the product.
About Teriparatide
Teriparatide is used for the treatment of
osteoporosis as it reduces the risk of bone fracture in various
patient groups. Osteoporosis is more common in women after
menopause, and it can also occur in both men and women as a side
effect of glucocorticoid treatment.
About Antares PharmaAntares 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.
The Company and Teva Pharmaceutical Industries, Ltd. (Teva)
recently announced the third quarter 2016 U.S. commercial launch of
VIBEX® Sumatriptan Injection USP for the acute treatment of
migraine and cluster headache. Antares Pharma is also
developing QuickShot® Testosterone for testosterone replacement
therapy. 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 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. For more information, visit
www.antarespharma.com.
[1] FORTEO® is a registered trademark of Eli Lilly and
Company.
SAFE HARBOR STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995This 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 issuance of the marketing authorizations for Teriparatide
multi-dose pen in the various European Member States of
application, the timing and clearance of patents related to Forteo
or the expiration of patents related to Forteo, whichever is
longer, and Teva Pharmaceutical Industries, Ltd. (Teva) ability to
successfully commercialize the Teriparatide multi-dose pen in
Europe and any future revenue therefrom; the outcome of the pending
patent litigation between Teva and Eli Lilly and Company regarding
the Teriparatide multi-dose pen; U.S. Food and Drug Administration
(“FDA”) action with respect to Teva’s Abbreviated New Drug
Application (“ANDA”) for the Teriparatide multi-dose pen and the
timing and approval, if any, by the FDA of the same; the results of
the phase 3 studies for QuickShot® Testosterone (QST) and
acceptance of the data by the FDA; the timing and Company’s ability
to successfully complete a New Drug Application (“NDA”) for
QST, acceptance of the NDA for QST by the FDA and approval of
the same by the FDA; 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 future purchase orders and revenue pre or post FDA approval;
Teva’s ability to successfully commercialize VIBEX® Sumatriptan
Injection USP and the amount of revenue from the same; FDA action
with respect to Teva’s ANDA filed for the Exenatide pen and future
revenue from the same; continued growth of prescriptions and sales
of OTREXUP®; the timing and results of the development
project with AMAG Pharmaceuticals for an auto injector for Makena;
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, 2015, 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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