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Five Major New Medicines for Oncology in Next Three Years


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GlaxoSmithKline Expects to Launch Up to Five Major New Medicines for Oncology in Next Three Years

LONDON, June 18, 2007-GlaxoSmithKline plc (GSK) today presented an overview on its expanding and innovative oncology portfolio, with clinical updates on several important new medicines, to investors and analysts at a meeting in London.


· GSK expects to launch up to five major new compounds from 2007 — 2010 in cancer prevention, treatment and supportive care across a broad range of cancer types:

­ Cervarix, for prevention of cervical cancer

­ Pazopanib, for renal cell carcinoma

­ Promacta, for thrombocytopenia (initially ITP)

­ Rezonic, for emesis

­ Ofatumumab (HuMax-CD20®), for NHL/CLL.

· Tykerb, GSK’s new oral treatment for breast cancer, off to a strong start in USA with approximately 3,000 patients treated since launch in March.

· Together, these 6 significant opportunities will enter fast-growing, new markets:

­ Current oncology market valued at >£20 billion and growing annually at 20%.

­ Pioneering products in cervical cancer and ITP meet significant unmet medical need.

Seminar highlights

· Latest phase II/III clinical data confirms innovative, competitive product profiles:

­ Tykerb: Significant efficacy seen in the treatment of HER2-positive breast cancer in relapsed and first-line metastatic settings. Large-scale clinical programme underway in the adjuvant setting with rapid enrolment in the landmark trial, TEACH. Promising activity also demonstrated in the treatment and prevention of breast cancer related brain metastases.

­ Pazopanib: Data demonstrate positive activity in renal cell carcinoma, soft tissue sarcoma and ovarian cancer; and suggest encouraging tolerability profile. Registration studies in renal cell carcinoma are now fully recruited and development programmes for combination therapy and monotherapy in 11 other cancer types are underway.

­ Promacta: Phase III data confirms increased platelet count and significantly lower incidence of bleeding in patients with ITP. Filing for use in treatment of short-term ITP expected by the end of 2007/early 2008.

­ Rezonic: New phase III data, presented for the first time today, demonstrate superiority of Rezonic in combination with Zofran, over Zofran alone. Planned filing for PONV & CINV in first half of 2008.

­ Ofatumumab: a fully human high-affinity antibody is in late-stage development for the treatment of follicular NHL and CLL.

­ MAGE-A3 ASCI: a novel vaccine to treat NSCLC is entering phase III in 2007. The phase III registration trial, involving over 2,200 patients, will be the largest clinical trial ever conducted for the treatment of lung cancer.

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