COPAXONE® Pre-Filled Syringe Can Now Be Stored for up to One Month at Room Temperature
Extended Storage Provides Enhanced Convenience for Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
JERUSALEM & PARIS--(BUSINESS WIRE)--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.
“For the past fifteen years, COPAXONE® has allowed me to control my disease and has granted me the ability to maintain an active lifestyle”
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.”
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.
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.
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.