TOLEVAMER
The toxin binder tolevamer represents a novel approach to the widespread, life-threatening problem of Clostridium difficile-associated disease (CDAD). In 2007, we will have data from two phase 3 trials conducted in North America, Europe, and Australia. We plan to file for U.S. approval in the first half of 2008. Unlike the current primary treatments for CDAD, tolevamer is not an antibiotic - significant because antibiotic therapies can reduce the levels of healthy bacteria that provide natural protection against CDAD and because resistance to antibiotics is a growing health-care concern.
MOZOBIL
With the acquisition of AnorMED, Inc. in late 2006, we gained Mozobil, a late-stage product candidate that has the potential to change the current standard of care for stem cell transplantation by mobilizing stem cells from bone marrow to the blood stream. Enrollment is complete in two international pivotal phase 3 trials of Mozobil. We expect to have top-line data in mid-2007 and to file for regulatory approval early in 2008.
ALEMTUZUMAB
We are developing alemtuzumab as a new way to treat patients with multiple sclerosis (MS). Two-year interim results from our phase 2 clinical trial of alemtuzumab in MS demonstrated that patients receiving alemtuzumab experienced significant reduction in the risks of relapse and progression of disability when compared with patients treated with Rebif. Building on these data, we plan to begin two phase 3 trials during the year.