Additional information about clinical studies of idelalisib and Gilead’s other investigational cancer agents can be found at www.clinicaltrials.gov. Idelalisib and GS-9973 are investigational products and their safety and efficacy have not yet been established.
About Indolent Non-Hodgkin’s Lymphoma
Indolent non-Hodgkin’s Lymphoma (iNHL) refers to a group of slow-growing lymphomas that can lead to life-threatening complications such as serious infections and anemia and includes follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma / Waldenström macroglobulinemia and marginal zone lymphoma. Patients typically experience enlarged lymph nodes, and other organs such as the spleen and liver may also be involved. Patients may develop symptoms such as fever, night sweats, weight loss and fatigue. Most iNHL patients are diagnosed at an advanced stage of disease, which is usually not curable, and median survival from time of initial diagnosis for patients with the most common form of iNHL, follicular lymphoma, is 8 to 10 years. By contrast, the outlook for patients who are unresponsive to rituximab and chemotherapy, such as those included in this study, is less encouraging.
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.
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 the possibility of unfavorable results from clinical trials involving idelalisib, including in combination with GS-9973 or other product candidates. Gilead also faces risks related to its ability to enroll patients in Phase 3 studies and may need to modify or delay these studies. As a result, idelalisib may never be successfully commercialized. Further, Gilead may make a strategic decision to discontinue development of idelalisib if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. 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 March 31, 2013, 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.