Teva and Antares Announce FDA Approval of Needle-Free Injector Product for Administration of Tev-Tropin® (Human Growth Hormone)
* Reuters is not responsible for the content in this press release.
New patient-friendly option to be made available for Tev-Tropin
JERUSALEM & EWING, N.J.--(Business Wire)--
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and its partner,Antares
Pharma, Inc. (NYSE Amex: AIS) today announced the approval of a Supplemental New
Drug Application (sNDA), which added "needle-free injection" to its Tev-Tropin
[somatropin (rDNA) for injection] brand human growth hormone (hGH) drug label.
Teva will market the Antares needle-free device as the Tev-Tropin Tjet Injector
system.
"We are pleased to add this new technology to our growing portfolio through our
successful partnership with Antares, and to offer patients a less invasive
delivery system," stated Larry Downey, head of Teva`s North America Brand
Pharmaceuticals division. "This significant achievement demonstrates our ability
to leverage our leadership in the pharmaceutical industry, and our ongoing
commitment to utilize our global strengths in innovative activities."
"This is the first product approval stemming from our portfolio of product
collaborations with Teva and is a very exciting milestone for the Company" said
Paul K. Wotton, President and Chief Executive Officer of Antares Pharma.
"Importantly it is another example of delivering on our strong focus and
commitment to patients, together with our partners, to provide new ways to
administer drugs. We look forward to the launch of this product by Teva."
Human growth hormone is a protein given by injection that is commonly used to
treat children with growth hormone deficiency. Pediatric patients benefit both
from the avoidance of using needles as well as the rapid injection speed
associated with giving needle-free injections. According to industry estimates,
the market for human growth hormone in the United States is approximately $1
billion which is the largest market segment globally. Antares currently markets
its needle-free injection system for use in the treatment of growth hormone
deficient children through its partners in Europe, Japan and Asia.
About Tev-Tropin
TEV-TROPIN® is indicated only for the treatment of children who have growth
failure due to inadequate secretion of normal endogenous growth hormone (GH).
Important Safety Information for Tev-Tropin
TEV-TROPIN® stimulates linear growth in children lacking endogenous GH.
Treatment of growth hormone-deficient (GHD) children with TEV-TROPIN® produces
growth rate and IGF-1 levels similar to those seen after treatment with hGH of
pituitary origin.
Unless patients with Prader-Willi Syndrome (PWS) also have a diagnosis of GHD,
TEV-TROPIN® is not indicated for treatment of pediatric patients who have growth
failure due to genetically confirmed PWS. Because of reported fatalities,
patients with PWS who are severely obese, have severe respiratory impairment,
respiratory infections, or sleep apnea should interrupt use of GH.
Patients should be observed for evidence of glucose intolerance,
hypopituitarism, malignant transformation of skin lesions, hypothyroidism,
slipped capital femoral epiphysis, and intracranial hypertension. Funduscopic
examination of patients is recommended at the initiation and periodically during
the course of GH treatment. TEV-TROPIN® should not be initiated in patients with
acute critical illness as a complication of open heart surgery, abdominal
surgery, multiple accidental trauma, or those with acute respiratory failure.
TEV-TROPIN® should not be used in patients with evidence of an active
malignancy, progressive or recurrent underlying intracranial tumor, active
proliferative or severe nonproliferative diabetic retinopathy, or closed
epiphysis.
When somatropin is administered subcutaneously at the same site over a long
period of time, tissue atrophy may result. This can be avoided by rotating the
injection site.
Because somatropin increases growth rate, patients with a history of scoliosis
who are treated with somatropin should be monitored for progression of
scoliosis.
Somatropin may alter the clearance of drugs metabolized by the CP450 enzyme
system and careful monitoring is advisable.
Benzyl alcohol associated with toxicity in newborns is contained in the diluent
supplied with TEV-TROPIN®. Treatment of patients with coexisting ACTH deficiency
should have glucocorticoid replacement dose adjusted to avoid inhibition of
growth.
In studies of growth hormone-deficient children, headaches occurred
infrequently. Injection-site reactions (eg, pain, bruise) occurred in 8 of the
164 treated patients.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top
20 pharmaceutical companies in the world and is the world's leading generic
pharmaceutical company. The Company develops, manufactures and markets generic
and innovative human pharmaceuticals and active pharmaceutical ingredients, as
well as animal health pharmaceutical products. Over 80 percent of Teva's sales
are in North America and Europe.
About Antares Pharma (www.antarespharma.com)
Antares Pharma is a product development company committed to improving
pharmaceuticals through its patented drug delivery systems. Antares has multiple
development partnerships with leading pharmaceutical companies. The Company`s
products are designed to improve safety and efficacy profiles by minimizing
dosing and reducing side effects while enabling improved patient compliance.
Antares has three validated drug delivery systems: the ATDTM Advanced
Transdermal Gel Delivery system; subcutaneous injection technology platforms,
including VibexTM disposable pressure-assisted auto injectors, ValeoTM/Vision
reusable needle-free injectors, and disposable multi-use pen injectors; and Easy
TecTM oral disintegrating tablets (ODT). Two of the systems have generated
FDA-approved products. Antares Pharma has corporate headquarters in Ewing, New
Jersey, with subsidiaries performing research, development, manufacturing and
product commercialization activities in Minneapolis, Minnesota and Basel,
Switzerland.
Teva's Safe Harbor Statement under the U.S. Private Securities Litigation Reform
Act of 1995:
This release contains forward-looking statements, which express the current
beliefs and expectations of management. Such statements are based on
management's current beliefs and expectations and involve a number of known and
unknown risks and uncertainties that could cause our future results, performance
or achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include risks
relating to: our ability to successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic equivalents, the
extent to which we may obtain U.S. market exclusivity for certain of our new
generic products and regulatory changes that may prevent us from utilizing
exclusivity periods, potential liability for sales of generic products prior to
a final resolution of outstanding patent litigation, including that relating to
the generic versions of Neurontin®, Lotrel® and Protonix®,the current economic
conditions, competition from brand-name companies that are under increased
pressure to counter generic products, or competitors that seek to delay the
introduction of generic products, the effects of competition on our innovative
products, especially Copaxone® sales, dependence on the effectiveness of our
patents and other protections for innovative products, the impact of
consolidation of our distributors and customers, the impact of pharmaceutical
industry regulation and pending legislation that could affect the pharmaceutical
industry, our ability to achieve expected results though our innovative R&D
efforts, the difficulty of predicting U.S. Food and Drug Administration,
European Medicines Agency and other regulatory authority approvals, the
uncertainty surrounding the legislative and regulatory pathway for the
registration and approval of biotechnology-based products, the regulatory
environment and changes in the health policies and structures of various
countries, supply interruptions or delays that could result from the complex
manufacturing of our products and our global supply chain, our ability to
successfully identify, consummate and integrate acquisitions, including the
integration of Barr Pharmaceuticals, Inc., the potential exposure to product
liability claims to the extent not covered by insurance, our exposure to
fluctuations in currency, exchange and interest rates, significant operations
worldwide that may be adversely affected by terrorism, political or economical
instability or major hostilities, our ability to enter into patent litigation
settlements and the intensified scrutiny by the U.S. government, the termination
or expiration of governmental programs and tax benefits, impairment of
intangible assets and goodwill, environmental risks,and other factors that are
discussed in this report and in our other filings with the U.S. Securities and
Exchange Commission ("SEC").
Antares' Safe Harbor Statement under the U.S. 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.
Such forward-looking statements include statements related to the launch of the
T-Jet device and the related potential device sales and royalties, the Company`s
future financial performance, and other statements which are other than
statements of historical facts. In some cases, you can identify forward-looking
statements by terminology such as "may," "will," "should," "expects," "intends,"
"plans," anticipates," "believes," "estimates," "predicts," "projects,"
"potential," "continue," and other similar terminology or the negative of these
terms, but their absence does not mean that a particular statement is not
forward-looking. 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
Company may experience difficulties or delays in the initiation, progress, or
completion of its clinical trials, including the phase 3 trial ofAnturol,
whether caused by competition, adverse events, investigative site initiation
rates, patient enrollment rates, regulatory issues, or other factors; that
clinical trials may not demonstrate that Anturol is both safe and effective for
the treatment of patients with overactive bladder syndrome; that the safety
and/or efficacy results of the phase 3 trial of Anturol may not support an
application for marketing approval in the United States or any other country;
that an application for marketing approval may not be accepted for priority
review or at all by the FDA or any other regulatory authority; and that the
Company may lack the financial resources and access to capital to fund future
clinical trials. 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, 2008, 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.
Please see enclosed full prescribing information.
Tev-Tropin is a registered trademark of Teva Pharmaceuticals USA, Inc.
09839701/090980
Teva Pharmaceutical Industries Ltd.
Elana Holzman, 972 (3) 926-7554
or
Teva North America
Kevin Mannix, 215-591-5149
or
Antares Pharma
Robert Apple, 609-359-3020
Chief Financial Officer
or
In-Site Communications, Inc
Lisa Wilson, 917-355-3100
Copyright Business Wire 2009
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.



Follow Reuters