Glaxo Gets U.S. Approval for Tykerb, a Breast-Cancer Medication

GlaxoSmithKline plc has won FDA approval for Tykerb, a dual-kinase inhibitor designed to combat breast-cancer tumors. The FDA has approved the drug's use in combination with Roche's Xeloda for treatment of advanced breast cancer in women who carry the HER-2 gene and don't respond to Genentech's Herceptin. A clinical trial involving about 400 women indicated that Tykerb plus Xeloda delayed tumor growth for an average of eight and a half months, or about twice as long as Xeloda alone. Tykerb, an oral medication, might ultimately compete directly with intravenously administered Herceptin if it is approved to treat earlier-stage breast cancer. Glaxo hopes that in addition to providing a solid footing in the $35 billion global cancer market, Tykerb will counter slowing sales of Advair, the company's bestselling asthma medication, and compensate for the pending loss of several patents, including depression blockbuster Wellbutrin XR, bipolar disorder medication Lamictal and migraine drug Imitrex. Tykerb, which is projected to reach $1 billion in sales by 2010, will be available to the public in about two weeks. Although it will cost approximately $2,900 a month, the drug will be part of a program that will dispense it free to those without health insurance.

Sources: Bloomberg, Business Week, MSNBC, MarketWatch, Wall Street Journal
Commentary: GlaxoSmithKline Grabs HuMax-CD20, Genmab's Promising New Cancer Drug • Glaxo and the Making of a Blockbuster Drug • Top Six Socially Responsible Healthcare and Pharmaceutical Firms
Stocks/ETFs to watch: GlaxoSmithKline plc [ADR] (GSK). Competitors: Novartis AG (NVS), Pfizer Inc. (PFE), Sanofi-Aventis (SNY). ETFs: Europe 2001 HOLDRs (EKH), BLDRS Europe 100 ADR Index (ADRU), BLDRS Developed Markets 100 ADR Index (ADRD)

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