The 70,000-square-foot site has process research and clinical manufacturing capabilities.
Gilead Sciences is purchasing a clinical biologics manufacturing facility and certain process development assets located in California from Genentech, a member of the Roche Group. Gilead says that it will offer employment to about 55 of Genentech’s current production specialists and development scientists.
The companies expect the transaction to close in the third quarter of this year. Genentech’s Oceanside Clinical Plant (OCP) is 70,000 square feet in size. It is currently designed and equipped to produce biologic compounds for toxicological, Phase I, and Phase II studies.
Genentech will continue to operate and maintain ownership of the Oceanside Commercial Manufacturing (OCN) facilities at One Antibody Way and other adjacent land. The company was bought by Roche in March 2009. Roche paid about $46.8 billion for the 44.2% of Genentech it didn’t already own.
Initially, Gilead will use the OCP facility for the process development and manufacture of two mAb candidates—one that is in preclinical testing, and GS 6624 for cancer and for fibrotic diseases. GS 6624 targets the human lysyl oxidase-like-2 (LOXL2) protein and is in Phase I for solid tumors and idiopathic pulmonary fibrosis.
The molecule was discovered by Arresto Biosciences, which was acquired by Gilead in December 2010 for $225 million. Arresto’s focus was on targeting enzymes involved in the synthesis of the extracellular matrix, which appear to play a role in the etiology of a variety of fibrotic diseases and cancer.
Two months later Gilead picked up Calistoga Pharmaceuticals, which also had expertise in oncology. The company paid $375 million up front and agreed to another $225 million in milestone fees. Calistoga, which also works on inflammatory diseases, is focused on developing compounds that selectively target isoforms of phosphoinositide-3 kinase (PI3K). This pathway has been shown to be a central signaling pathway for cellular proliferation, survival, and trafficking. Calistoga’s pipeline is largely at the preclinical stage, with applications in oncology and inflammation.