First trial patient - Exelixis discovered GDC-0973 internally
Item 8.01 Other Events.
On January 14, 2013, Exelixis, Inc. (the "Company") received notice from Genentech, Exelixis' collaborator and a member of the Roche Group, that the first patient was dosed in a phase 3 pivotal trial evaluating the BRAF inhibitor Zelboraf� (vemurafenib) alone and in combination with GDC-0973 (XL518, RG7421) in previously untreated patients with malignant melanoma and the BRAF V600 mutation (the "Dosing Notice"). The trial is being conducted by Roche and Genentech. Exelixis discovered GDC-0973 internally and advanced the compound to investigational new drug (IND) status before entering into a worldwide co-development agreement with Genentech in late 2006. Exelixis was responsible for the development of GDC-0973 through the end of phase 1, at which point Genentech exercised its option to further develop the compound.
Exelixis' receipt of the Dosing Notice triggers the beginning of the 12 month period in which Exelixis can exercise its option to co-promote GDC-0973 in the United States under the terms of Exelixis' agreement with Genentech.