FDA approves Glaxo's breast cancer drug

NEW YORK (CNNMoney.com) -- The Food and Drug Administration approved GlaxoSmithKline's breast cancer drug Tykerb, the drug company said Tuesday.

Glaxo's (down $0.95 to $55.05, Charts) pill was approved for patients who were previously and unsuccessfully treated with Genentech's (up $0.03 to $81.53, Charts) Herceptin, an intravenous cancer blockbuster that totaled $1.2 billion in the 2006 sales. Tykerb would be used in conjunction with Xeloda, a form of chemotherapy from the Swiss drug giant Roche.

Tykerb and Herceptin are both for patients with HER-2 positive breast cancer, which accounts for 20 to 30 percent of all breast cancer patients. Analysts believe that the two drugs could be used as a combination therapy.

Tykerb is years away from blockbuster-level sales, analysts say. To expand the use of Tykerb to billion-dollar levels, GlaxoSmithKline is studying the drug for additional types of treatment, which it would eventually file to the FDA for approval.

Christ Schott, analyst for Bank of America, projects that annual Tykerb sales will reach nearly $1 billion by 2011. Gbola Amusa, analyst for Sanford C. Bernstein, believes that sales will peak at $1.5 billion in 2012.

Analysts consider GlaxoSmithKline's pipeline to be one of the best in Big Pharma. The British drugmaker is awaiting a regulatory decision from European authorities regarding its cancer vaccine Cervarix, and Glaxo is expected to file an application for that vaccine to the FDA this year.

Cervarix, a vaccine for the sexually-transmitted human papillomavirus that causes cervical cancer, is considered a potential blockbuster and an up-and-coming rival to Merck's (down $0.84 to $43.45, Charts) Gardasil.

The analysts quoted in this story do not own shares of stock in the companies mentioned here. Bank of America Securities has provided banking services for Glaxo in the last 12 months.

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