About the GDC-0449 Advanced Basal Cell Carcinoma Pivotal Phase II Clinical Trial

In   February 2009, Genentech initiated this pivotal Phase II clinical trial   of GDC-0449 as a single-agent therapy for patients with metastatic   or locally advanced basal cell carcinoma (BCC).  Genentech expects to   evaluate GDC-0449 in approximately 100 patients with metastatic or   locally advanced BCC in a global single-arm, two-cohort clinical trial.    One cohort includes all patients with histologically-confirmed, RECIST   measurable metastatic BCC.  RECIST provides standard parameters to be   used when documenting patient response for solid tumors.  The second   cohort includes histologically-confirmed, locally advanced BCC that is   considered inoperable by the treating physician.  All patients will   receive a daily oral dose of GDC-0449.  This Phase II pivotal study   builds upon the Phase I safety and efficacy data demonstrated by   GDC-0449, which showed clinical benefit in a substantial proportion of   advanced BCC patients.  There is currently no standard of care for   patients with these types of BCC and Genentech has indicated that it   designed this pivotal trial so that the data, if positive, may serve as   the basis for NDA submission by Genentech.  Roche has projected that   data results will be available in the first half of 2011 and that,   assuming favorable results, a potential regulatory submission for   GDC-0449 in advanced BCC could also occur in 2011.

Additional details for this clinical trial are available at www.clinicaltrials.gov.

About the Genentech Collaboration

Under   the ongoing collaboration agreement between Genentech, a member of the   Roche Group, and Curis, GDC-0449 was discovered by Genentech and was   jointly validated through a series of preclinical studies.  Through   this collaboration, Genentech and Roche are responsible for clinical   development, and Genentech (U.S.), Roche (Ex-U.S. excluding Japan) and Chugai Pharmaceuticals (Japan) are responsible for commercialization of GDC-0449.  Curis   is eligible to receive cash payments assuming successful achievement of   specified clinical development and regulatory approval milestones, and   is also eligible to receive royalties assuming successful   commercialization of GDC-0449 by Genentech and its sublicensees, which   include Roche and Chugai.

In   addition to the advanced BCC study, GDC-0449 is currently being   developed by Genentech and Roche in a Phase II clinical trial in   advanced ovarian cancer, and Genentech and Roche have indicated that   they also plan to initiate a Phase II clinical trial in operable basal   cell carcinoma during the second half of 2010.  Through   a collaborative relationship with the National Cancer Institute (NCI),   the molecule is also being tested in several additional NCI-sponsored   trials.  Details for all GDC-0449 clinical trials are available at ClinicalTrials.gov.

About the Hedgehog Signaling Pathway

The   Hedgehog pathway is normally active during embryonic development and   plays a central role in cell differentiation and proliferation.  Inappropriate   activation or dysregulation of the Hedgehog pathway is believed to play   a critical role in the proliferation and survival of certain cancer   cells, including in basal cell carcinoma and medulloblastoma as well as   in colorectal, ovarian, pancreatic, small cell lung and breast cancers,   among others. The Hedgehog pathway is also thought to be a potential   regulator of cancer stem cells, which are discrete tumor cell   populations that display self-renewal and tumorigenic properties.

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