LEAD program

Long Acting IFN beta

Allozyne’s lead program is PEGylated IFN beta for the treatment of multiple sclerosis (MS), a chronic disease characterized by demyelination of nerve fibers, which leads to severe nerve damage. MS symptoms include fatigue as well as cognitive and visual impairment. Six drugs currently are approved for treating MS, including three brands of IFN-β. These three IFN brands and Copaxone comprise a large and growing market for MS therapies. Annual sales for these drugs increased nearly 15% from 2005 to 2006, reaching $4.6 billion in 2006. Despite their commercial success these drugs have significant limitations. While all four can reduce relapses, only two can slow disease progression and only one is effective after a patient’s first MS attack. Additionally, dosing for these drugs is at least once weekly and can require up to 7 injections per week, depending on the drug.

Leading MS clinicians believe that there is significant need for new therapies that offer improved efficacy and side-effect profiles, can be used in MS of different severity types and offer more patient-friendly delivery and dosing.

We are currently evaluating PEG IFN for the treatment of relapsing-remitting MS, which comprises approximately 80% of the MS population. In preclinical studies, PEG IFN beta has shown superior safety and efficacy profiles compared with approved IFN beta products. Data suggest that this results from an improved pharmacokinetic profile. The data also suggest that PEG IFN beta could have superior tolerability compared with approved IFN beta products, leading to improved patient compliance. Based on these preclinical data, we believe that PEG IFN beta could be dosed as infrequently as two to four times per month.

Although other companies are evaluating long-acting formulations of IFN beta, we believe that Allozyne has several competitive advantages, including: