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|  |  GlaxoSmithKline Presents Rapidly Expanding Pipeline of Oncology and Supportive Care CompoundsPress Release November 30, 2005 PHILADELPHIA and LONDON, Nov. 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline plc (NYSE: GSK - News) today updated investors and financial analysts in New York on the Company's rapidly expanding pipeline feat uring innovative science that addresses a broad range of patient needs for cancer prevention, treatment and supportive care. Seminar Highlights * GSK's substantial oncology and supportive care portfolio includes New Chemical Entities (NCEs), product line extensions (PLEs) and oncology- related vaccines. Four NCEs highlighted in this seminar are expected to be in phase III development in 2006: Tykerb (lapatinib), eltrombopag ('115), casopitant ('769), and pazopanib ('034). * Tykerb - A targeted oral therapy with the potential to become an essential component in the treatment of breast cancer: - Latest data demonstrate promise as first-line treatment for advanced breast cancer, with 40% of patients experiencing clinical benefit including tumor reduction or stable disease for at least 24 weeks. - Tykerb's clinical program has been expanded: * three new phase III trials are being initiated by January 2006, two in first-line therapy and one in refractory breast cancer * large phase II trial in the treatment of brain metastases associated with breast cancer started in November 2005 * in mid-November, the Breast International Group and GSK agreed to collaborate on a large global clinical trial to evaluate Tykerb as adjuvant therapy in early-stage breast cancer. * Eltrombopag - New clinical data demonstrate the potential for eltrombopag to become the first oral platelet growth factor for patients suffering from thrombocytopenia, a condition which can lead to uncontrolled bleeding, significantly reduced life expectancy and compromised treatment for cancer or liver disease. * Casopitant - New clinical data demonstrate the potential for casopitant when combined with Zofran as a new and improved therapy for the prevention of nausea and vomiting associated with chemotherapy and after surgery. * Pazopanib - Latest clinical data demonstrate prevention of tumor growth. Consequently an aggressive clinical development program is expected to begin shortly in multiple cancer types including phase III trials in renal cancer. * Other GSK oncology assets highlighted at the seminar include Arranon for T-cell acute lymphoblastic leukemia and lymphoma (launch in Q106), new indications for Hycamtin in relapsed cervical and relapsed small cell lung cancer (filing Q405/2006), Avodart for reducing the risk of prostate cancer (phase III) and relacatib ('795) a cathepsin-K inhibitor for the prevention and treatment of bone metastases (entering phase II in 2006). "Today's seminar clearly shows the progress GSK has made in building its oncology pipeline," said Tachi Yamada, GSK's Chairman of Research & Development. "From modest beginnings, we now have a pipeline which is one of the largest in our industry with seven major assets expected to be in phase III development in the coming months, including the four NCEs highlighted today." "Cancer remains an area of substantial unmet medical need. Our strategy is focused on meeting all aspects of a cancer patient's treatment -- from control, reduction and prevention of tumors to novel medicines that will improve supportive care for patients undergoing chemotherapy." Paolo Paoletti, Senior Vice President of GSK's Oncology Medicine Development Center, commented: "GSK is pursuing therapies targeting cancer at a molecular level in order to block biochemical pathways that transform normal, healthy human cells into cancer cells. We are particularly excited that the promising efficacy of Tykerb, our targeted dual-kinase inhibitor, has led to support among leading cancer experts for the initiation next year of a large study of Tykerb in the treatment of early stage breast cancer." Allen Oliff, Senior Vice President of GSK's Oncology Center for Excellence in Drug Discovery, said: "We are very encouraged by the recent clinical data on eltrombopag. This product clearly has the potential to be a significant advance in the treatment of thrombocytopenia, a condition which has few therapeutic options and can lead to sub-optimal treatment for patients suffering from a number of conditions including cancer and liver disease." Compounds reviewed at today's seminar include: * Tykerb - a targeted oral therapy with the potential to become an essential component in the treatment of breast cancer World-wide, 400,000 women die each year as a result of breast cancer, and its prevalence is increasing with approximately 1.5 million new cases diagnosed every year. Tykerb, a dual-kinase inhibitor, is an oral once-daily treatment currently being developed for breast cancer and other tumors. It works by inhibiting two well-validated targets in oncology, the kinase components of ErbB1 (EGFR) and ErbB2 receptors, which are associated with cancer-cell proliferation and tumor growth. Data presented at today's seminar, and at the recent European Cancer Conference (ECCO) in Paris, illustrate the promising efficacy and safety profile of Tykerb. Interim results from an international phase II trial of Tykerb as first-line therapy in 40 patients with advanced or metastatic breast cancer (with ErbB2 overexpression) showed that 33% of patients had tumor reductions, with 40% of patients experiencing clinical benefit (tumor reduction or stable disease for at least 24 weeks). A further update will be presented at the San Antonio Breast Cancer Symposium on 8th December. Tykerb has also shown preliminary activity in the treatment of brain metastases, which represents a significant unmet medical need for breast cancer patients. Results were recently analyzed from a 416 patient phase II/III clinical trial in the treatment of renal cancer. While the primary end-point was not met in the full population, a preliminary analysis of the sub-group of 241 patients with over-expression of EGFR demonstrated a statistically significant survival benefit for patients receiving Tykerb. This data is expected to be presented at ASCO in 2006. In the 3,500 patients who are part of its clinical development program, Tykerb to date has shown a low incidence of cardiotoxicity, a condition associated with some breast cancer treatments. The most frequently reported adverse events associated with Tykerb have been mild to moderate itching, rash, diarrhea, acne, and dry skin. Tykerb's clinical program has been expanded, with three new phase III trials being initiated by January 2006, two in first-line therapy and one in refractory breast cancer. A large phase II trial in the treatment of brain metastases associated with breast cancer started in November 2005. In mid-November, GSK and the Breast International Group -- one of the world's premier cancer research groups -- agreed to collaborate on a large-scale global clinical trial to evaluate Tykerb as adjuvant therapy in early-stage breast cancer. GSK expects to file Tykerb for US Food and Drug Administration (FDA) approval at the end of 2006 or in the first half of 2007. * Eltrombopag ('115) demonstrates potential to become the first oral blood platelet growth factor for patients suffering from thrombocytopenia For a complete release, go here: http://biz.yahoo.com/prnews/051130/nyw040.html?.v=32
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