Biogen Idec announces positive results for the first phase 3 study for oral administration against multiple sclerosis

The primary objective and all secondary objectives were achieved in the DEFINE study at the two doses tested - the full data will be presented at a medical conference to be held in the future

Biogen today announced positive results in the DEFINE study, the first of two pivotal Phase 3 clinical trials evaluating the experimental oral drug BG-12 (dimethyl fumarate) for people with relapsing-remitting multiple sclerosis (RRMS). The results show that taking 240 mg of BG-12 two or three times a day answers the main goal of the study, at a high level of statistical significance (p<0.0001), among RRMS patients with a two-year relapse rate compared to a placebo. In both doses, BG-12 also met all the secondary objectives with a significant improvement in the annual recurrence rate, at a high level of statistical significance, in the number of new or increased injuries and in the rate of disability progression over two years in the EDSS (Expanded Disability Severity Scale) index.
DEFINE was a global, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of BG-12 in RRMS patients. In addition to meeting the primary goal and all the secondary goals, the initial data from the trial indicate an excellent profile of safety and tolerability. The number of injury events and serious events was similar to that recorded in the control group that took a placebo drug, in both groups treated with BG-12. The safety profile was consistent with that recorded in the BG-12 phase 2 trial. The analysis of the findings of the DEFINE study is still ongoing and the company intends to present the results at a future medical conference.
"The significant clinical results of the DEFINE study represent an important step forward in the development of BG-12 for those suffering from multiple sclerosis (MS)," said Dr. Douglas Williams, Senior Vice President of Research and Development at Biogen Idec. "We are very satisfied with these results and believe that the drug BG-12 offers patients with multiple sclerosis a very effective option for oral treatment, with a high safety profile."
Data from scientific studies indicate that the drug BG-12 can significantly reduce the penetration of inflammatory cells into the central nervous system (CNS) and their action, as well as protect the cells of the central nervous system and prevent their death.
In 12, the drug BG-2008 received Fast Track approval from the American Food and Drug Administration (FDA). Besides the DEFINE study, another phase 3 study is currently underway among patients with relapsing-remitting multiple sclerosis, which is called CONFIRM. In the study, the drug BG-12 is tested in comparison to a dummy drug, in terms of the relapse rate, MRI tests, disease progression and safety. The results from the CONFIRM study should be published in the second half of 2011.

DEFINE (Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS) was a global, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of BG-12 in more than 1,200 RRMS patients. Two doses of BG-12 were tested in the study: 240 mg twice a day and 240 mg 3 times a day. The primary objective was to determine whether BG-12 effectively reduces the proportion of patients who have a relapse over 12 years. The secondary objectives included reducing the number of new or enlarged lesions (according to MRI tests), reducing the annual recurrence rate, and slowing the progression of disability according to the EDSS index. Additional objectives included the safety of BG-XNUMX and the tolerability of the drug.
About Biogen Idec
Biogen Idec uses advanced scientific methods to discover, develop, manufacture and market drugs for the treatment of serious diseases, focusing on neurological disorders. Biogen Idec was established in 1978 and is the oldest independent biotechnology company in the world. Patients around the world benefit from Biogen Idec's leading drugs for the treatment of multiple sclerosis and the company's annual revenues reach more than 4 billion dollars. Details about the products, press releases and additional information about the company can be found at www.biogenidec.com.