Copaxone Pre-Filled Syringe Can Now Be Stored for up to One Monthat Room Temperature
JERUSALEM & PARIS--(BUSINESS WIRE)--Jun 6, 2007 - Teva Pharmaceutical Industries, Ltd. and sanofi-aventis today announced that the application for up to one month room temperature storage of Copaxone (glatiramer acetate injection) pre-filled syringe has been approved by the U.S. Food and Drug Administration (FDA) and in Europe under the Mutual Recognition Procedure (MRP). With this supplemental amendment, Copaxone may now be stored by patients at room temperature for up to one month. Prior to this approval, Copaxone was approved for storage at room temperature for up to seven days.
Christina A., Germany, an opera singer who has been using Copaxone for the past six years commented: "As a performer, I spend a lot of time on tour. Transporting and storing my Copaxone will now be much easier."
"For the past fifteen years, Copaxone has allowed me to control my disease and has granted me the ability to maintain an active lifestyle," said Laura K., a participant in the first pivotal trial evaluating the drug. "As a competitive equestrian, I spend a lot of time away from home, and now that Copaxone can remain at room temperature for a longer period of time, transporting and storing it will be much easier."
About Copaxone
Copaxone is indicated for the reduction of the frequency of relapses in ambulatory patients with RRMS characterized by at least two attacks of neurological dysfunction over the preceding two-year period. Copaxone 20 mg/ml should be administered as a subcutaneous injection once daily. The above mentioned information does not modify the knowledge in terms of efficacy and tolerability of Copaxone as indicated in the European SmPC.
Copaxone is approved in 47 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, Copaxone is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd (NASDAQ:TEVA). Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the 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 76 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs, primarily for diseases of the central nervous system.
See additional important information at http://www.Copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.
About sanofi-aventis
Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Teva Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
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
Teva's 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: Teva`s ability to successfully develop and
commercialize additional pharmaceutical products, the introduction
of competing generic equivalents, the extent to which Teva may
obtain U.S. market exclusivity for certain of its new generic
products and regulatory changes that may prevent Teva from
utilizing exclusivity periods, 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 impact of consolidation of our distributors
and customers, potential liability for sales of generic products
prior to a final resolution of outstanding patent litigation,
including that relating to the generic versions of Allegra and
Neurontin, the effects of competition on our innovative
products, especially Copaxone sales, the impact of
pharmaceutical industry regulation and pending legislation that
could affect the pharmaceutical industry, the difficulty of
predicting U.S. Food and Drug Administration, European Medicines
Agency and other regulatory authority approvals, the regulatory
environment and changes in the health policies and structures of
various countries, our ability to achieve expected results though
our innovative R&D efforts, Teva's ability to successfully
identify, consummate and integrate acquisitions, potential exposure
to product liability claims to the extent not covered by insurance,
dependence on the effectiveness of our patents and other
protections for innovative products, significant operations
worldwide that may be adversely affected by terrorism, political or
economical instability or major hostilities, supply interruptions
or delays that could result from the complex manufacturing of our
products and our global supply chain, environmental risks,
fluctuations in currency, exchange and interest rates, and other
factors that are discussed in Teva's Annual Report on Form 20-F and
its other filings with the U.S. Securities and Exchange Commission.
Forward-looking statements speak only as of the date on which they
are made and the Company undertakes no obligation to update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
Sanofi-aventis Forward Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include financial projections
and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with
respect to future events, operations, products and services, and
statements regarding future performance. Forward-looking statements
are generally identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans" and similar
expressions. Although sanofi-aventis' management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of sanofi-aventis, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include those discussed
or identified in the public filings with the SEC and the AMF made
by sanofi-aventis, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended
December 31, 2006. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or
revise any forward-looking information or statements.
Contact
Teva Pharmaceutical Industries Ltd.
Dan Suesskind, 972-2-589-2840
Chief Financial Officer
or
Teva Pharmaceutical Industries Ltd.
Teva North America
George Barrett, 215-591-3030
Executive V.P. - Global Pharmaceutical Markets
President and CEO
or
Investor Relations:
Teva Pharmaceutical Industries Ltd.
Teva North America
Kevin Mannix / Liraz Kalif,
972-3-926-7281 / 215-591-8912
or
sanofi-aventis
Salah Mahyaoui, + 33 6 3.68.78.88
salah.mahyaoui@sanofi-aventis.com
or
Richard Vento, + 33 6 78.79.93.26
richard.vento@sanofi-aventis.com
Posted: June 2007
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