Significantly Reduced Brain Atrophy and Tissue Loss over Five Years in Treatment-Naive Relapsing-Remitting Multiple Sclerosis Patients

COPAXONE(R) Significantly Reduced Brain Atrophy and Tissue Loss over Five Years in Treatment-Naive Relapsing-Remitting Multiple Sclerosis Patients

News source: Business Wire

Final results from a five-year comparative imaging study examining the long-term effect of disease-modifying therapies (DMTs) in treatment-naive, early relapsing-remitting multiple sclerosis (RRMS) patients, demonstrated that COPAXONE(R)-(glatiramer acetate injection) treated patients experienced significantly less brain tissue loss, as measured by percent change in brain volume, compared with patients on other DMTs. In the study, patients receiving COPAXONE(R) experienced a reduced mean annualized rate of brain atrophy (ARBA) of -0.46 percent over five years, while patients receiving Avonex(R) or Betaseron(R)/Rebif(R) experienced mean ARBA of -0.52 percent and -0.64 percent, respectively. Patients in the untreated control group with an average follow-up of 15.2 months experienced the highest rate of brain atrophy (-0.95 percent). These data were presented at the 60th Annual Meeting of the American Academy of Neurology (AAN).

"Brain atrophy is a clinically relevant tool to measure disease progression and subsequent neurological disability in RRMS patients," said Omar Khan, M.D., Professor of Neurology, Director, Multiple Sclerosis Center, Wayne State University and lead investigator of the study. "Long-term brain volume measurements may be more appropriate than short-term examination to assess the ability of DMTs to affect brain tissue loss in RRMS. Although patients showed a significantly lower ARBA in all three treatment groups compared with the untreated group, COPAXONE(R)-treated patients demonstrated significantly reduced brain atrophy versus patients treated with either low-dose or high-dose interferon-beta."

About the Study

The study analyzed 309 treatment-naive RRMS patients who began and remained on the same DMT for five years. Patients included were those with disease duration of five years or less and an Expanded Disability Status Scale (EDSS) score of 3.0 or less at baseline. All patients had brain magnetic resonance imaging (MRI) scans (at onset of DMT and five years later) on the same 1.5T scanner. Untreated RRMS patients with follow-up ranging from 8 to 24 months were enrolled as controls. A fully automated technique known as SIENA was used to measure brain volume change. Image analysis was performed blinded to treatment allocation.

There were 121 patients on COPAXONE(R), 101 on high-dose interferon beta (Betaseron(R) or Rebif(R)) and 53 on Avonex(R). All treatment groups were well-matched at baseline. The mean ARBA over five years was -0.46 percent, -0.52 percent, and -0.64 percent in the COPAXONE(R), Avonex(R) and Betaseron(R)/Rebif(R) groups, respectively. The untreated control group with an average follow-up of 15.2 months had a mean ARBA of -0.95 percent. The ARBA was lower in all three treatment groups compared to the untreated group (p less than 0.0001).

COPAXONE(R)-treated patients demonstrated significantly reduced ARBA than patients treated with either Avonex(R) or Betaseron(R)/Rebif(R) (p=0.0336 and p less than 0.0001).

"This study also demonstrated that brain atrophy is a dynamic process that can be detected in mildly affected early MS patients. Therefore, in accordance with National MS Society recommendations, it is important to initiate therapy soon after the diagnosis of MS is confirmed," said Omar Khan, M.D.

The study was supported by Wayne State University Neuroscience Program.

About COPAXONE(R)

COPAXONE(R) (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in RRMS.
The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE(R) is now approved in 51 countries worldwide, including the United States, all European countries, Canada, Mexico, Australia, and Israel. In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE(R) is marketed by Teva Neuroscience, Inc.

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 Teva Neuroscience

Teva Neuroscience is dedicated to investigating, developing and marketing ground-breaking products and technologies, with emphasis on cutting-edge treatments for patients who are living with neurological conditions, including multiple sclerosis (MS) and Parkinson's disease (PD). Therapies developed by Teva Neuroscience include COPAXONE(R) (glatiramer acetate injection) for relapsing-remitting multiple sclerosis (RRMS) and AZILECT(R) (rasagiline tablets) for the treatment of PD.
Teva Neuroscience's suite of innovative products continues to demonstrate the company's commitment to fulfilling unmet medical needs and has helped the company evolve into a global leader in RRMS. Teva Neuroscience is a North American division of Teva Pharmaceutical Industries Ltd., the world's largest generic drug company. Teva Neuroscience is proud of the role it plays in providing effective treatment options to patients worldwide. For more information, please visit www.tevaneuro.com or www.tevaclinicaltrials.com.

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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: when and whether the proposed acquisition will be consummated, Teva's ability to rapidly integrate Bentley's' operations with its own operations and achieve expected synergies, the diversion of management time on merger-related issues, Teva's ability to accurately predict future market conditions, 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(R), Neurontin(R), Lotrel(R), Famvir(R) and Protonix(R), 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, the effects of competition on our innovative products, especially Copaxone(R) 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.