Healthcare Industry News:  glatiramer 

Biopharmaceuticals Neurology

 News Release - September 29, 2006

Very Active Multiple Sclerosis Patients Benefited from COPAXONE(R) Treatment Following Short-Term Induction with Mitoxantrone

Induction Regime Reduced MRI-Measured Disease Activity by 89% Which Was Sustained Throughout 15-Month Study

JERUSALEM, Israel--(HSMN NewsFeed)--A new study showed that very active patients who received COPAXONE® (glatiramer acetate injection) therapy alone following short-term induction treatment with mitoxantrone experienced an 89 percent greater reduction (Pless than0.0001) compared to those receiving COPAXONE® alone, in Magnetic Resonance Imaging (MRI)-disease activity as measured by Gadolinium (Gd) enhancing lesions of the brain. This initial benefit achieved early on in the study was maintained over the entire 15-month study period. In addition, no adverse events outside of those associated with either treatment when used as monotherapy were observed.

These data were presented today at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain.

"These new data represent a promising development in the scientific community's effort to identify additional effective treatment strategies for those patients who have particularly aggressive forms of RRMS, many of whom do not respond optimally to traditional disease modifying therapies," said Tim Vollmer, M.D., chairman, Division of Neurology, Barrow Neurological Institute at St. Joseph's Hospital and Medical Center and the primary investigator in this study. "By putting patients on COPAXONE® after a brief induction period with mitoxantrone, we were able to significantly reduce MRI-disease activity in the brain of active RRMS patients and to sustain this benefit throughout the study."

About the Study

This randomized, double-blind study looked at the safety, tolerability and efficacy of COPAXONE® (glatiramer acetate injection) used after short-term induction therapy with mitoxantrone versus COPAXONE® alone. Relapsing-remitting multiple sclerosis (RRMS) patients in this study (n=40) were randomized to receive either COPAXONE® for one year following three months of mitoxantrone (M-GA; n=21), or COPAXONE® alone for 15 months (GA; n=19). The study included patients aged 18-55, who had a Gd-enhancing lesion at the time of an initial screening MRI scan and an EDSS score of <=6.5. Patients entering the study were considered very active with a mean number of Gd-enhancing lesions of 3.75. Subsequent brain MRIs were performed at screening and months six, nine, 12 and 15.

Results showing a reduction of Gd-enhancing lesions in the M-GA patient cohort compared with the GA cohort were observed as early as six months into the trial (pless than 0.0001) and were maintained throughout the duration of the study (p = 0.0147). The efficacy demonstrated in the GA cohort increased over the entire 15-months trial; a 46 percent reduction in Gd-enhancing lesions was achieved at nine months and at month 15, patients demonstrated a 67 percent reduction compared to entry.

A relapse was experienced on average eight months prior to baseline in all study participants; after 15 months, the majority of these patients had not experienced a relapse. Patients who received COPAXONE® after mitoxantrone showed a trend in experiencing fewer relapses over the study period. Mean relapse rate during the study period was 0.16 in the M-GA group and 0.32 in the GA group, reflecting a 46 percent greater reduction in relapses in M-GA patients than of those that did not receive mitoxantrone (p=0.31). There was no difference in time to first relapse between the patient cohorts.

Within study participants, the most frequent adverse events (AEs) associated with the M-GA group were infection, nausea and vomiting, menstruation irregularities and alopecia, and were consistent with known effects of mitoxantrone therapy. Injection site erythema was the most common AE in the GA group.

"Mitoxantrone carries certain risks which limit its use to a maximum recommended lifetime dose. These difficulties make mitoxantrone an option that is generally reserved for only a small group of patients who have a poor disease prognosis or whose disease does not respond to first-line treatment," said Tim Vollmer, M.D., chairman, Division of Neurology, Barrow Neurological Institute at St. Joseph's Hospital and Medical Center and the primary investigator in this study. "When used after short-term induction with mitoxantrone, COPAXONE® minimized exposure to mitoxantrone while maintaining treatment effects ongoing, making it a viable treatment option for a broader proportion of the MS population."

Teva has also issued today a press release regarding additional data presented at ECTRIMS on the efficacy and safety of COPAXONE® treatment after short-term combination of COPAXONE® and intravenous steroids, which will be posted at www.tevapharm.com.

About COPAXONE®

Current data suggest COPAXONE® 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 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 percent 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.

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 Pharmaceutical

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