GlaxoSmithKline provides pipeline update for oncology drugs

In an update to investors on Monday, GlaxoSmithKline announced that it plans to launch up to five new cancer treatments by 2010. The products include cervical cancer vaccine Cervarix, pazopanib for kidney cancer, Promacta (eltrombopag) to treat thrombocytopenia, Rezonic (casopitant) for nausea and vomiting related to chemotherapy and surgery, and HuMax-CD20 (ofatumumab) for certain lymphomas and leukaemias. The drugmaker also plans to start enrolling patients in a late-stage study of experimental non-small-cell lung cancer vaccine, MAGE-A3, in September.

GlaxoSmithKline's chairman of R&D, Moncef Slaoui, confirmed that the drugmaker expects to start selling Cervarix in Europe in the second half of 2007, if approved, although analysts don't expect the product to be launched in the US before 2008. Additionally, the company plans to seek regulatory approval for Promacta by early 2008, and for Rezonic in the first half of next year.

Regarding pazopanib, the company announced that a late-stage trial of drug in patients with renal cell carcinoma is fully enrolled. "The response rate in our Phase II trial was so high that the independent data monitoring committee decided that we should stop the study for ethical reasons,'' and that all the patients should receive the treatment, Slaoui stated. The company added that it is considering pazopanib as a treatment for a dozen different types of cancer, and trials have also been conducted on the medicine in ovarian cancer and soft tissue sarcoma.

Slaoui also stated that GlaxoSmithKline plans to launch a head-to-head trial of HuMax-CD20 and Roche's MabThera (rituximab), sold in the US as Rituxan by Genentech. HuMax-CD20, which was discovered by GlaxoSmithKline's partner Genmab, is currently in late-stage trials for non-Hodgkin's lymphoma and chronic lymphocytic leukaemia, and the Danish company said the drug could be launched for the oncology indications in 2008, if approved.

Furthermore, the company indicated that initial results of the Phase III study of MAGE-A3 are expected in 2012. A GlaxoSmithKline scientist, Patrick Therasse, remarked that the vaccine is useful in tumours with MAGE-A3, which accounts for about between 35 percent to 50 percent of non-small-cell lung cancers, as well as about 70 percent of skin cancers. Kepler Equities analyst Denise Anderson noted that drugmakers "don't engage in such large Phase III trials unless they have some level of confidence that this is an attractive product."

In related news, Slaoui revealed that breast cancer drug Tykerb (lapatinib) has had "a good start'' in the US, where more than 3000 patients have received the treatment since it was approved in March. Slaoui remarked that the company expects to launch the drug in Europe, where it would be marketed as Tyverb if it garners regulatory approval, in the second half of this year. GlaxoSmithKline said that data regarding combination treatment with Tykerb and Roche's Herceptin (trastuzumab) in breast cancer will be available at the end of the year, while findings on Tykerb as a first-line treatment are anticipated early in 2008. The company's director of oncology, Paolo Paoletti, also disclosed that the company is in discussions with regulators over Tykerb's potential use to prevent the spread of breast cancer to the brain.

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