Teva Neuroscience Announces New Data Demonstrated Significant Impact of Access to Neutralizing Antibody Testing on MS Treatment Management.
* Significant proportion of IFN-treated patients who are regularly tested for NAbs have changed therapy (p<0.0069)
* Results accepted for oral presentation at the 62(nd )American Academy of Neurology Annual Meeting
KANSAS CITY, Mo. -- Teva Neuroscience today announced results at the 62nd American Academy of Neurology Annual Meeting which demonstrated that eliminating barriers to neutralizing antibodies (NAbs) testing significantly impacted multiple sclerosis (MS) treatment choices in patients receiving interferon beta (IFN) therapies.
"One of the most common barriers for NAbs testing is the current lack of reimbursement for the tests," said lead study investigator, Dr. Barbara Green, Director West County MS Center, St. John's Mercy Medical Center. "Our results indicate that access to NAbs testing may be an important consideration surrounding MS therapy decisions."
IFN therapies for MS are associated with the development of NAbs in some patients. NAbs are antibodies produced by the body, which react with a foreign agent and destroy it or inhibit its effect1. This study explored whether removing barriers to antibody testing impacted treatment decisions for MS patients receiving IFN therapies (1-4 years).
Currently, only Europe has guidelines recommending that IFN patients be tested at 12 and 24 months for NAbs. The guidelines also recommend that testing should be repeated in patients who test positive for NAbs, and therapy with IFN should be discontinued in patients with high titers of NAbs sustained at repeated measurements at three to six month intervals.2
Patients randomized to both arms (regularly scheduled antibody testing, n=651 and usual care, n=565) of this 12-month, open-label study had a mean disease duration of 8.5 years and mean interferon treatment duration of two years. The proportion of therapy change was significantly different between the two arms (p<0.0069). There was also a significant difference between arms on the number of patients starting one or more courses of corticosteroids for relapses (p=0.0022) and starting glatiramer acetate (p=0.0028). While clinical worsening was the most frequent reason for therapy change in both arms, positive NAbs results represented the second most frequent indicated reason in the NAbs testing arm.
This study was sponsored by Teva Neuroscience.
About the Study
MS patients on IFNs (1-4 years) were enrolled in a 12-month, open-label study. Patients were randomized into either Regularly Scheduled Antibody Testing arm (3 binding antibodies [BAbs] and NAb tests within 9 months) or Usual Care arm (blinded BAbs and NAbs testing at baseline and usual patient care). Both arms had optional testing at 12 months. BAb and NAb levels were measured by ELISA and viral cytopathic effect (CPE) assays, respectively.
Patients in the Antibody Testing arm (n=651) and Usual Care arm (n=565) had a mean disease duration of 8.5 years, and a mean of 2 years on interferons; 71% on IFN 1a SC, 28% on IFN 1b. At baseline, 37% of IFN-1a SC patients and 47% of IFN-1b were BAb +; 19% and 22% were NAb+, respectively. Proportion of therapy change was significantly different between the two arms; 19.5% of patients in Antibody Testing arm and 14.2% of patients in Usual Care arm had a therapy change (p<0.0069).
Copaxone([R]) (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
Additional Safety Information about Copaxone([R])
The most common side effects of Copaxone([R]) are injection site reactions, such as redness, pain, swelling, itching, or a lump at the site of injection. A permanent indentation under the skin at the injection site may occur, due to a local destruction of fatty tissue. Be sure to follow proper injection technique and inform your doctor of any skin changes. Some people report a short-term reaction right after injecting Copaxone([R]). This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety and trouble breathing. Keep in mind that these symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems. If symptoms become severe, call the emergency phone number in your area. Do not give yourself any more injections until your doctor tells you to begin again.
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Please see enclosed additional important information.
Teva Pharmaceutical Industries Ltd., (NASDAQ: TEVA) headquartered in Israel, is among the top 15 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.
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 marketed 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 our 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: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin([R]), Lotrel([R]) and Protonix([R]), the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone([R]) (including potential generic and oral competition for Copaxone([R])), the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of our patents and other protections for innovative products, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered by insurance, the termination or expiration of governmental programs or tax benefits, current economic conditions, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").
1 Stachowiak, Julie (August 15 2008). Julia Stachowiak "Neutralizing Antibodies and Disease-Modifying Therapies for Multiple Sclerosis". About.com. http://ms.about.com/od/treatments/a/cmp_nabs.htm Julia Stachowiak. Retrieved March 9, 2010.
2 Sorensen PS, Deisenhammer F, Duda P, Hohlfeld R, Myhr KM, Palace J, Polman C, Pozzilli C, Ross C, EFNS Task Force on Anti-IFN-beta Antibodies in Multiple Sclerosis. Guidelines on use of anti-IFN-beta antibody measurements in multiple sclerosis: report of an EFNS Task Force on IFN-beta antibodies in multiple sclerosis. Eur J Neurol 2005 Nov;12(11):817-27.
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|Date:||Apr 14, 2010|
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