More MS news articles for July 2001

Teva Announces FDA Approval of Enhanced Label for Copaxone

July 19, 2001  9:51pm
Source: Business Wire

JERUSALEM, Jul 19, 2001 (BUSINESS WIRE) -- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today the FDA approval of enhanced labeling for its multiple sclerosis drug COPAXONE(R) (glatiramer acetate for injection).

The new label will reflect the positive result of a large multicenter, double-blind, placebo-controlled study that showed a significant reduction of MRI (magnetic resonance imaging) Gd-enhanced lesions in patients treated with COPAXONE(R).

The study followed 239 patients performing monthly MRI scans for nine months with additional nine-month follow-up in which all patients were treated with COPAXONE(R). The study looked at various MRI measures of disease activity and burden of disease. The study was presented in a number of international scientific meetings and was recently published in Neurology. Physicians increasingly use MRI for their diagnosis and treatment of MS.

The primary outcome measure was the total number of enhancing lesions on T1-weighted images over the nine months. Treatment with COPAXONE(R) showed a significant reduction in T1 lesions compared with placebo (the medians of the cumulative number of lesions was 17 for placebo and 11 for COPAXONE(R), p=0.003). T1 enhancing lesions correlate to perivascular inflammation and blood brain disruption.

"We are pleased to have the MRI research added to the COPAXONE(R) label because it gives physicians an additional tool to consider when selecting an MS drug therapy," said Dr. Lillian Pardo, Medical Director, Teva Neuroscience.

"At Teva Pharmaceutical Industries, we are dedicated to improving the lives of people with MS through continued research. The expanded labeling which includes information on the reduction of MRI Gd-enhanced lesions is another example of how our ongoing research is confirming how COPAXONE(R) is having a positive impact on patients with RRMS," said Teva Neuroscience CEO, Larry Downey. This new label data will add to the research information that has made COPAXONE(R) the fastest growing MS therapy in the United States(a).

COPAXONE(R) is indicated for the reduction of relapses in relapsing-remitting multiple sclerosis. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, or a lump at the site of injection, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. These reactions are usually mild and seldom require professional treatment. Be sure to tell your doctor about any side effects.

Some patients report a short-term reaction right after injecting COPAXONE(R)(glatiramer acetate for injection). This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.

Teva Pharmaceutical Industries, Ltd. was granted approval by the U.S. Food and Drug Administration (FDA) in December 1996, to market COPAXONE(R). The drug was launched in April 1997. COPAXONE(R)is marketed in the United States by Teva Neuroscience, based in Kansas City, Mo., a subsidiary of Teva Pharmaceutical Industries, Ltd.

For more information about multiple sclerosis please visit Teva Neuroscience web site at: HTTP://WWW.COPAXONE.COM.

To receive prescribing information, call 800-887-8100, or visit the COPAXONE(R) web site at HTTP://WWW.COPAXONE.COM.

COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries, Ltd.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 40 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 85% of Teva's sales are outside Israel, mainly in North America and Europe. The Company develops, manufactures and markets generic branded human pharmaceuticals and active pharmaceutical ingredients.

Safe Harbor Statement:This report contains forward-looking statements, which express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company'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 the impact of pharmaceutical industry regulation, the difficulty of predicting FDA and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, fluctuations in currency, exchange and interest rates, operating results, and other factors that are discussed in the Company's Annual Report on Form 20-F and the Company's other filings with the U.S.Securities and Exchange Commission.

(a) Based on percent growth in total prescriptions, January-April 2000 vs. January-April 2001; IMS May 2001.

CONTACT:    Press:
                  Fleishman-Hillard, Inc.
                  Holly Gibson, 816/512-2349
                  Thomson Financial/Carson
                  Kevin Mannix, 212/701-1802

Copyright (C) 2001 Business Wire