Pipeline

We are developing drug candidates in several important medical fields where there are substantial unmet therapeutic needs.  The  Hedgehog antagonist program in collaboration with Genentech is our most  advanced program with our lead small molecule candidate, GDC-0449,  currently being tested in a Phase I expansion cohort for the study of  locally advanced, multi-focal or metastatic basal cell carcinoma.  Phase  II clinical testing of GDC-0449 in combination with bevacizumab and  chemotherapy in first line metastatic colorectal cancer was initiated  in May of 2008 and patient treatment has begun.  Genentech has  indicated that it expects to initiate two additional Phase II clinical  trials of GDC-0449 in advanced basal cell carcinoma and advanced  ovarian cancer in the second half of 2008. 

We  have focused our internal resources on developing additional candidates  through our proprietary Targeted Cancer Drug Development Platform. This  platform has generated small molecules that target networks of  disregulated cell signaling that we believe underlie cancer biology.  In addition to our U.S.  based operations, we have advanced these programs by increasing our  preclinical capacities and productivity through strategic relationships  with third party providers in Shanghai and Beijing, China. 

We  have selected CUDC-101, an inhibitor of Her2, EGFR and HDAC, as our  first developmental candidate and the Phase I clinical trial was  initiated in May 2008. Our second candidate selected for development is  CUDC-305, a Hsp90 inhibitor.

Except  for our systemically administered Hedgehog antagonist program, our  programs are in various stages of preclinical drug development.  Because  of the early stages of development of these programs, our ability and  that of our collaborators and licensors to successfully complete  preclinical and clinical studies of these product candidates, and the  timing of completion of such programs, is highly uncertain.