Curis, Inc. (NASDAQ:CRIS) and Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY) Genentech unit have stopped a hedgehog — not a spiky little beast, but a signaling pathway that could be the key in developing next-generation network-targeted cancer therapies. The hedgehog signaling pathway transmits information to embryonic cells that help them properly develop, and the proteins that move along these pathways regulate cell growth, differentiation, and survival.
However, if the pathway is improperly activated, it can cause a variety of cancers, most notably basal cell carcinoma, a common type of skin cancer. BCC is not usually fatal, but it can cause disfigurement and tissue destruction. In the United States, 30% of Caucasians are at risk of developing BCC, with 80% of cases occurring on the head and the neck.
Stopping the hedgehog generates strong sales growth
Curis, Inc. (NASDAQ:CRIS) and Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY)’s hedgehog pathway inhibitor program’s greatest accomplishment, Erivedge, is an orally administered small molecule hedgehog pathway inhibitor. It attempts to interrupt the hedgehog pathway signal within the cells, disrupting the growth of advanced BCC. Erivedge was approved in January 2012, becoming the second skin cancer drug to be approved by the Food and Drug Administration following the approval of Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY)’s melanoma treatment Zelboraf in August 2011. Erivedge also gained Australian approval in May and a conditional EU approval in June.
During clinical trials, Erivedge had a 43% success rate at shrinking BCC for locally advanced patients (when BCC grows deeper into the skin), and a 30% success rate at shrinking BCC for metastatic patients (when BCC spreads to other parts of the body). The treatment costs $7,500 per month for an average treatment period of 10 months.
Last quarter, higher sales of Erivedge fueled Curis, Inc. (NASDAQ:CRIS)’ 24% year-on-year increase in revenue to $5.4 million, as its adjusted EPS loss narrowed from $0.04 to $0.02 per share. Those figures exceeded the consensus estimate for revenue of $4.43 million and a loss of $0.05.
Other hedgehogs are crawling through the pipeline
Although inhibiting the hedgehog signaling pathway is a new approach to treating BCC, other competitors are already emerging. Novartis AG (ADR) (NYSE:NVS)‘s LDE-225 is the most noteworthy one, a hedgehog pathway inhibitor that is currently in clinical trials for treating BCC. It is also currently recruiting participants to test LDE-225 against Temodar for the treatment of brain cancer. LDE-225 is also undergoing preclinical studies in possibly inhibiting the growth of prostate cancer stem cells.