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Biotech / Medical : Biogen -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (1549)	5/17/2004 8:42:10 AM
From: mopgcw	Respond to of 1686

ssb: Digestive Disease Week (DDW) -- May 15-20 Biogen Idec (BIIB): We expect a high level of interest in Antegren for Crohn's disease among physicians at this meeting as a potential novel new biologic therapy for a difficult to treat indication. Detailed data from the second phase of the pivotal Phase III study called the ENACT-2 study exploring maintenance therapy with Antegren in Crohn's disease will be presented at a late-breaker session on Wednesday, May 19th. In addition, a variety of subgroup analyses from the initial phase of the pivotal Phase III study called the ENACT-1 study, which assessed induction therapy with Antegren in Crohn's disease patients, will also be presented. We note that the ENACT-1 study failed to achieve the primary endpoint of clinical response in patients treated with Antegren, which was a 10-week time point, on a statistically significant basis due to a high placebo rate. However, a statistically significant outcome in clinical response and remission were observed at week 12 and later time points. Based on the abstracts, the post- hoc subgroup analyses of ENACT-1 will demonstrate that patients receiving prior Remicade therapy and demonstrating active inflammation as measured by high levels of C-reactive protein (CRP) achieve a clinical response. Although the primary endpoint of maintaining a clinical response and remission was achieved in the maintenance phase called ENACT-2, we remind investors that the patients enrolled in this portion of the study were the initial responders to Antegren in ENACT-1 and therefore, may have positively impacted the outcome of the study. As a result, it remains uncertain as to whether Biogen Idec and Elan can submit a regulatory filing for Antegren in Crohn's disease with these data and that a second pivotal study may be required. Biogen Idec and Elan have already initiated an additional Phase III study exploring Antegren as an induction therapy. This study is targeting to enroll 432 patients with moderately to severely active Crohn's disease with elevated C-reactive protein levels. We believe Antegren may be viewed as another option to Remicade or a follow- on therapy to patients who may have failed or become intolerant to Remicade. We note that a relatively high percentage of patients eventually fail Remicade therapy even with increased dosing. This may be associated with the development of neutralizing antibodies. In clinical studies conducted with Antegren, neutralizing antibody formation occurred in approximately 6-7% of patients. Biogen Idec and Elan will be holding an investor meeting and conference call on Wednesday, May 19th, at 12 noon EST. As a reminder, Biogen Idec and Elan plan to submit a regulatory application for Antegren in multiple sclerosis based on positive one-year interim results from two Phase III studies this quarter with a potential launch in early 2005. Our Antegren sales estimate is $138 million for fiscal 2005. Biogen Idec and Elan have agreed to equally share in the profits of this product.