AVEO regains global rights for development, commercialization of AV-299 anti-HGF antibody candidate

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that AVEO has regained worldwide rights from Merck (through its subsidiary, Schering Corporation) to develop and commercialize AV-299 (also known as SCH 900105), its anti-hepatocyte growth factor (HGF) antibody candidate.

“AVEO is very pleased to regain worldwide rights for the development and commercialization of AV-299”

AV-299 is a potent, functional anti-HGF antibody that was discovered by AVEO through its Human Response Platform™. Data from Phase 1 clinical trials of AV-299 indicate a favorable tolerability profile and good combinability with EGFR inhibitors, erlotinib (Tarceva®) and gefitinib (Iressa®). In June 2010, AVEO initiated a Phase 2 clinical trial evaluating AV-299 in combination with gefitinib versus gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). In conjunction with the Phase 2 trial initiation, AVEO received an $8.5 million milestone payment from Merck under the terms of the license agreement. Top-line efficacy data from the AV-299 Phase 2 trial are expected in late 2011.

"AVEO is very pleased to regain worldwide rights for the development and commercialization of AV-299," stated Tuan Ha-Ngoc, president and chief executive officer of AVEO Pharmaceuticals. "AVEO now holds significant commercialization rights to all oncology products in our pipeline, and we believe that we are well-positioned to move toward our goal of becoming a fully-integrated commercial organization. Our expected year-end 2010 cash balance remains unchanged, and we reaffirm that AVEO has sufficient capital to take us beyond data from TIVO-1, our ongoing Phase 3 clinical trial of tivozanib in patients with renal cell carcinoma. We look forward to sharing top-line TIVO-1 data in mid-2011."

"Merck is pleased with our history of collaborating with AVEO, and would welcome the opportunity to work with AVEO again in the future," said David Nicholson, Ph.D., senior vice president and head of worldwide licensing and knowledge management at Merck. "The decision to return this program to AVEO is a result of portfolio prioritization."