I guess this isn't a big deal, but it's never nice to have a trial fail...
BEYOND study: Results do not support regulatory filing for Betaferon 500 mcg
October 29, 2007 – Bayer Schering Pharma today announced top line results from the BEYOND (Betaferon Efficacy Yielding Outcomes of a New Dose) study, a large randomized trial of patients with relapsing-remitting multiple sclerosis (MS) to investigate the efficacy, tolerability and safety of a 500 mcg dose of Betaferon (interferon beta-1b) compared to the standard 250 mcg Betaferon dose and Copaxone (glatiramer acetate). The overall outcome of the trial did not show a statistically significant superiority of the 500 mcg Betaferon dose compared to the 250 mcg Betaferon dose and Copaxone. The risk for relapses, which was the primary end point of the trial, was similar in all three study arms. In this study, there was a very low relapse rate in the entire study population, unlike in previous trials.
Results of the BEYOND study do not support the regulatory filing for the 500 mcg dose of Betaferon. Consequently, the intangible assets from the BEYOND project, capitalized in the course of the Schering acquisition, will be depreciated. Therefore, an impairment of -152 million Euro will be recognized in the third quarter financial reporting. Bayer Schering Pharma expects sales of Betaferon to grow in the range of 7-9 percent in 2007 and 2008. The company’s continued investment in lifecycle management programs, including enhancing the Betaferon application system as well as ongoing long term follow-up programs will further enhance the product. The data from the Betaferon clinical studies combined with development supporting potential new therapies, such as alemtuzumab, demonstrate Bayer Schering Pharma’s long-standing commitment to advancing the treatment of MS patients with new highly effective and safe therapies.
Patients in the study were required to exhibit clinical signs of the disease in the past year before entering the trial. When compared to the relapse rate during the year prior to study enrollment, Betaferon 250 mcg reduced the relapse rate by 78 percent during the observational period which was up to 3.5 years (Betaferon 500 mcg: 79 percent, Copaxone 79 percent).
The study also provides some interesting insights into the tolerability and patient acceptance of the treatments. The drop out rate for Betaferon 250 mcg was the lowest of the three study arms, with 13 percent for Betaferon 250 mcg compared to 19 percent for Betaferon 500 mcg and 17 percent for Copaxone. Clinical experience with Betaferon has shown that implementing dose titration, using an auto-injector and co-medication with an analgesic result in excellent patient tolerability. These methods were also used in the BEYOND study, which may have resulted in the very good tolerability seen in patients treated with Betaferon 250 mcg.
“Results of the BEYOND study confirm the high efficacy, excellent tolerability and low drop-out rate for Betaferon. The standard Betaferon® 250 mcg dose is the optimal Betaferon dose for treatment-naïve patients,” said Dr. Douglas S Goodin, Professor of Neurology at the University of California, San Francisco (UCSF) and member of the Steering Committee of the BEYOND study. “BEYOND is a well-conducted, comprehensive study with a wealth of data that is still to be analyzed. I look forward to identifying how additional data that will come over time might help answer some of our remaining questions about MS and its treatment.“
“Betaferon is the MS drug with the longest clinical experience of more than 16 years. The product offers both unsurpassed efficacy and long-term reliable safety in relapsing-remitting multiple sclerosis,” said Darlene Jody, M.D., Senior Vice President and President of Bayer HealthCare’s Specialized Therapeutics Global Business Unit. “The results from the BENEFIT study have already demonstrated that early treatment with Betaferon reduces patients’ risk of permanent disability due to MS events by 40 percent over three years compared to delayed treatment. BEYOND adds support to the BENEFIT findings in that it demonstrated that Betaferon 250mcg is the optimal dose for the treatment-naïve patient population due to high efficacy and excellent tolerability.”