This excerpt taken from the ELN 6-K filed Jul 18, 2005.
Cambridge, MA and Dublin, Ireland July 18, 2005 Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that SENTINEL, the Phase III TYSABRI( (natalizumab) add-on trial with AVONEX® (Interferon beta-1a), achieved the two-year primary endpoint of slowing the progression of disability in patients with relapsing forms of multiple sclerosis (MS). The addition of TYSABRI to AVONEX resulted in a 24 percent reduction in the risk of disability progression compared to the effect provided by AVONEX alone. Data from SENTINEL also demonstrated that the addition of TYSABRI to AVONEX led to a 56 percent relative reduction in the rate of clinical relapses compared to that provided by AVONEX alone. The reduction in relapse rate was statistically significant and sustained over the entire two-year study period.
Other efficacy data from SENTINEL at two years, including MRI measures and immunogenicity, were similar to previously reported one-year results.
Common adverse events included headache, nasopharyngitis, limb pain, depression, flu-like symptoms, diarrhea, insomnia, sinusitis, influenza, nausea, muscle pain, anxiety and cough. The rate of infection was 1.6 per patient-year in both AVONEX plus TYSABRI-treated patients and AVONEX plus placebo-treated patients. Serious infections occurred in 2.9 percent of AVONEX plus placebo-treated patients and 2.7 percent of AVONEX plus TYSABRI-treated patients. TYSABRI has been associated with hypersensitivity reactions, including serious systemic reactions which occurred at an incidence of less than 1 percent of patients.
On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. The companies have previously reported three confirmed cases of PML, two of which were fatal. Two of the patients with confirmed PML had received AVONEX plus TYSABRI for over two years as part of the SENTINEL trial. Biogen Idec and Elans comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. The results of this safety evaluation will be discussed with regulatory agencies to determine the appropriate path forward for TYSABRI.
These data demonstrate the effect of TYSABRI on disability progression and clinical relapses. We continue to believe in the therapeutic benefit of TYSABRI in MS, a disease with significant unmet medical need, said Burt Adelman, MD, executive vice president, Development, Biogen Idec. Our extensive safety evaluation, in collaboration with leading experts and regulatory agencies, is on track and we hope to have findings by the end of the summer. As always, our primary commitment is to improving the lives of people with MS.
TYSABRI continues to show benefit in the treatment of immune-mediated diseases, said Lars Ekman, MD, PhD, executive vice president and president, Research and Development, Elan. Patient safety is our top priority. We remain strongly committed to defining TYSABRIs benefit-risk profile and determining the appropriate path forward.
SENTINEL is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX-treated patients in 123 clinical trial sites worldwide. In the trial, AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen.
The companies anticipate that two-year data from SENTINEL will be presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Thessaloniki, Greece, which begins September 28, 2005.