AMG 151 (Amgen Inc.)—Glucokinase activator for type 2 diabetes
During fiscal 2011, we completed two Phase 1 studies of AMG 151 under our collaboration and license agreement with Amgen: a multiple ascending dose trial in patients with Type 2 diabetes to evaluate safety, exposure and glucose control over a 10-day period, and a relative bioavailability study assessing the effect of food and formulation on exposure. Amgen is responsible for future clinical development and commercialization for AMG 151 and any resulting back-up compounds. In addition, Amgen is funding a research program at Array to identify and advance second-generation glucokinase activators.
GDC-0068 (RG7440) (Genentech Inc.)—AKT inhibitor for cancer
In May 2011, Genentech and their clinical investigators reported interim results on a Phase 1a trial with GDC-0068. The drug was well tolerated with a favorable safety profile. Pharmacodynamics and efficacy data showed GDC-0068 was active in patients, with greater than 60% pathway inhibition in tumors and surrogate tissue. In addition, Genentech advanced GDC-0068 into a Phase 1b dose-escalation study to evaluate the safety and pharmacology of GDC-0068 in combination with either Taxotere or fluoropyrimidine plus oxaliplatin in patients with advanced solid tumors.
ARRY-382 (Celgene Corporation)—cFMS inhibitor for cancer
In November 2010, we received a $10 million milestone payment from Celgene upon filing an IND application for ARRY-382, which is currently in a Phase 1 clinical trial. Array is responsible for the continued development of ARRY-382 through Phase 1, and Celgene has an option to obtain exclusive rights to ARRY-382.
In addition, Array continues to work with Celgene on two other collaborative research programs: TYK2 for inflammation and PDGFR for fibrosis. Under the terms of Array’s agreement with Celgene, Celgene has an option to select two of the programs and Array would retain rights to the third. If Celgene exercises any of its options, Celgene would be responsible for additional development and commercialization of the drug, and Array would be entitled to receive additional milestones as well as royalties on sales of the drug.
ARRY-575 and GDC-0425 (RG7602) (Genentech)—Chk-1 inhibitor for cancer
Array entered into an oncology agreement with Genentech in August 2011 for the development of each company’s small-molecule Chk-1 program. The programs include Genentech’s compound GDC-0425 (RG7602), currently in Phase 1, and Array’s compound ARRY-575, which is being prepared for an IND application to initiate a Phase 1 trial in patients with cancer. Under the terms of the agreement, Genentech is responsible for all clinical development and commercialization activities. Array received an upfront payment of $28 million and is eligible to receive clinical and commercial milestone payments up to $685 million and up to double-digit royalties on sales of any resulting drugs.