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Press release from Business Wire

Gilead and GlobeImmune Announce License and Collaboration Agreement to Develop Therapeutic Vaccine Products for Treatment of Chronic Hepatitis B Infection

Monday, October 24, 2011

Gilead and GlobeImmune Announce License and Collaboration Agreement to Develop Therapeutic Vaccine Products for Treatment of Chronic Hepatitis B Infection16:25 EDT Monday, October 24, 2011 FOSTER CITY, Calif. & LOUISVILLE, Colo. (Business Wire) -- Gilead Sciences, Inc. (Nasdaq:GILD) and GlobeImmune, Inc. today announced that the companies have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of therapeutic vaccine products for use in conjunction with Viread® (tenofovir disoproxil fumarate) and other oral therapies for the treatment of chronic hepatitis B virus (HBV) infection. Under the terms of the agreement, Gilead will pay GlobeImmune an upfront payment and provide support for GlobeImmune's continued development of its HBV therapeutic vaccine program through Phase 1a clinical trials. Gilead can assume full responsibility for clinical development following Phase 1a. GlobeImmune also could receive additional payments based upon achievement of certain development milestones, as well as royalties on future potential net sales. The goal of the research collaboration is to create and develop therapeutic vaccine products that have specific HBV DNA antigens cloned into S. cerevisiae (a species of yeast). The companies anticipate that the combination of a therapeutic vaccine with oral suppressive antiviral therapy could help increase surface antigen (HBsAg) loss with seroconversion – a marker of the resolution of chronic HBV infection. “This collaboration is a significant milestone in GlobeImmune's efforts to advance therapies for major unmet medical needs,” said David Apelian, MD, PhD, Senior Vice President Research & Development and Chief Medical Officer at GlobeImmune. “Based on the proof-of-concept studies in hepatitis C infection, we believe that the combination of GlobeImmune's Tarmogen immunotherapy products with oral suppressive antiviral therapy will help eliminate the cells harboring the hepatitis B virus, thus increasing seroconversion within a finite period.” “Finite therapy remains a significant unmet need for patients with chronic hepatitis B,” said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. “We are hopeful that this approach will allow us to explore whether adaptive immunomodulatory approaches to HBV will help us improve HBsAg seroconversion, thereby eliminating the need for life-long daily therapy.” About GlobeImmune GlobeImmune, Inc. is a private company developing therapeutic vaccines called Tarmogen® products for the treatment of cancer and infectious diseases. Tarmogens stimulate the natural production of T cells that are capable of locating and eliminating cancer cells and virally-infected cells. GlobeImmune has raised over $160 million to date in support of its programs. For additional information, please visit the company's website at www.globeimmune.com. About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific. For more information on Gilead, please visit www.gilead.com. Gilead Forward-Looking Statement This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to the development and commercialization of therapeutic vaccines for the treatment of chronic HBV infection. Further, there are risks related to clinical trials of therapeutic vaccines under the collaboration, including the ability to enroll sufficient patients, the possibility of unfavorable results, the need to modify or delay the studies or to perform additional trials and the risk of failing to obtain approvals from the regulatory authorities. As a result, therapeutic vaccines under the collaboration may never be successfully commercialized. In addition, Gilead and GlobeImmune may make a strategic decision to terminate the collaboration or discontinue development of certain therapeutic vaccines under the collaboration. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. Viread is a registered trademark of Gilead Sciences, Inc.Tarmogen is a registered trademark of GlobeImmune, Inc.Gilead Contacts:Susan Hubbard, 650-522-5715 (Investors)Cara Miller, 650-522-1616 (Media)orGlobeImmune Contacts:David Apelian, MD, PhD, MBA, 303-625-2820Chief Medical OfficerorRusso PartnersMatt Middleman, 917-734-0324 (Media)