Healthcare Industry News: TYSABRI
News Release - October 3, 2006
Long-Term Data Demonstrated Significantly Better Patient Adherence to COPAXONE(R) versus Interferons in Multiple Sclerosis TreatmentCOPAXONE(R) Patients Also Demonstrated Robust Response at Six Years
KANSAS CITY, Mo.--(HSMN NewsFeed)--A retrospective follow-up analysis of an ongoing prospective study of relapsing-remitting multiple sclerosis (RRMS) patients (n=285) taking immunomodulatory therapies (IMTs), found that after six years more than half of the patients (41/79) taking COPAXONE® (glatiramer acetate injection) had remained on treatment continuously, whereas less than thirty percent of patients (55/206) taking one of the interferon beta (IFN-(beta)) class of drugs remained in the study (pless than 0.0001). The study, which included patients receiving either COPAXONE®, Avonex® (IFN-(beta)-1a IM), Betaseron® (IFN-(beta)-1b SC), or Rebif® (IFN-(beta)-1a SC), was presented last week at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), in Madrid, Spain.
The results of this follow-up analysis reinforced and extended the four-year results presented at the 15th Meeting of the European Neurological Society (ENS) in 2005, which demonstrated better adherence in COPAXONE® patients versus those taking interferon therapies.
"The significantly higher treatment adherence rate demonstrated by COPAXONE® patients in this study, coupled with a robust response to treatment, may be meaningful to clinicians when it comes to recommending an initial IMT to patients," said Dr. Judith Haas, Head of the Department of Neurology, Jewish Hospital, Berlin, Germany and lead investigator of this study. "Drop-out rates are an excellent surrogate marker of the long-term efficacy of IMTs, and an important consideration in treating RRMS."
In addition to measuring patient adherence to IMTs, the study compared the efficacy of the various treatments, using relapse rate as primary efficacy parameter and the Kurtzke Expanded Disability Status Scale (EDSS) score as a secondary parameter. Data showed that patients taking COPAXONE® (n=41) had a significantly reduced relapse rate in comparison with Avonex® (n=20) (p=0.047). There were no significant differences between therapies in any other primary or secondary endpoints.
About the Study
Researchers in this study conducted a retrospective analysis of an ongoing prospective study of patients (n=285), and compared patients who remained continuously on their original treatments (completers, n=96) to those who switched to another therapy or dropped out of the study (n=189). Within the database, 33 percent of all patients were completers. By treatment, the rate of completers was 52 percent of COPAXONE® patients (41/79), 29 percent of Rebif® patients (14/49), 27 percent of Betaseron® patients (21/77), and 25 percent of patients taking Avonex® (20/80).
In order to make efficacy comparison from study baseline, only completers were included in the study's efficacy analysis.
Current data suggest COPAXONE® (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE® is now approved in 44 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.
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 80% of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
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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 rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the reintroduction of TYSABRI® into the market, 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, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results 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 publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Source: Teva Neuroscience
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