KANSAS CITY, Mo.--(BUSINESS WIRE)--New data from a randomized, double-blind study showed that a combination of COPAXONE® (glatiramer acetate injection) along with the oral antibiotic minocycline reduced T1 Gadolinium (Gd)-enhancing lesions of the brain by 63 percent (p=0.08) in patients with active relapsing-remitting multiple sclerosis (RRMS), as measured by magnetic resonance imaging (MRI), compared to those receiving COPAXONE® alone. Additionally, the nine-month study demonstrated that treatment with COPAXONE® in combination with minocycline reduced the number of new T2 lesions in patients by 65 percent (p=0.06). These results trended toward but did not reach statistical significance.
These data were presented at the 59th Annual Meeting of the American Academy of Neurology (AAN) in Boston, MA, April 28 – May 5, 2007.
“The results of this study indicated that further exploration of this combination is warranted, as the established effect of COPAXONE® on disease activity may be boosted when used in combination with minocycline for the treatment of active relapsing-remitting patients,” said Luanne Metz, M.D., professor at the Department of Clinical Neuroscience of the University of Calgary, and principal investigator. “In these patients, the combination was safe and well tolerated,” she added.
Minocycline is a broad-spectrum antibiotic, which is used to treat pneumonia, acne, and infections of the skin, genital and urinary systems, and the central nervous system. In a small proof-of-concept trial of 10 RRMS patients, minocycline demonstrated an 84 percent relative reduction in mean total Gd-enhancing lesions and was well tolerated, and data published in the Journal of Neuroimmunology indicated that the combination of minocycline and COPAXONE® decreased neuron-inflammation, axonal loss and demyelination in an animal model of MS.
“COPAXONE® is one of the most frequently used RRMS therapies due to its proven efficacy and safety and unique presumed mechanism of action,” said Metz. “In previous studies, COPAXONE® has shown efficacy and safety both in combination with intravenous steroids and after induction with the immunosuppressant mitoxantrone; its compatibility with other compounds may make it unique among the disease modifying class of drugs and a treatment of interest for the future study of combination therapies for MS,” Metz added.
About the Study
This double-blind, randomized study evaluated the safety, tolerability and efficacy of the combination of COPAXONE® plus oral minocycline in the treatment of RRMS patients with active disease.
Patients in this study (n=44) with one or more T1-enhancing lesions on their screening MRI were randomized to receive either COPAXONE® 20 mg daily plus minocycline 100 mg twice daily or COPAXONE® plus placebo for nine months. Patients were assessed clinically and by MRI scans at screening and months 1, 3, 8 and 9. The primary outcome was the total number of T1-enhancing lesions at months 8 and 9.
Forty patients completed the study. Groups were balanced at baseline except for greater T1-enhancing lesion number in the COPAXONE® plus minocycline group (median 3 versus 2; mean 7.62 versus 2.43 (p=0.07)). Despite this imbalance, treatment trended toward significance in the COPAXONE® plus minocycline group. At months 8 and 9, the number of T1-enhancing lesions was reduced by 63 percent (mean 1.47 versus 2.95; p=0.08) and the number of new T2 lesions was reduced by 65 percent (mean 1.84 versus 5.14; p=0.06), compared to COPAXONE® alone. Relapse risk rate was also non-significantly reduced in the COPAXONE® plus minocycline group (0.19 versus 0.41; p=NS).
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, 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 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. Close to 90 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.
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.
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.