GlaxoSmithKline PLC (GSK) Monday said it's filing its promising breast cancer drug Tykerb with European regulators, following a similar move with the U.S. Food and Drug Administration last month.
The world's third largest pharmaceutical company by prescription drug sales is applying to market the pill in combination with Roche Holding AG's (RHHBY) chemotherapy treatment Xeloda, to treat advanced breast cancer in women who have received other therapies.
A spokeswoman said the company is hopeful it will launch Tykerb both in the European and U.S. markets next year, but declined to comment on its sales prospects, which some analysts say may top $1 billion a year.
Mike Ward, an analyst at Nomura Code, said he concurs with these forecasts.
"A few people have been skeptical about Tykerb because they saw a limited market, but oncologists will vote with their prescribing pen when they see good data," he said.
Ward added that Tykerb's initial indication will be for late-stage cancer, but its use will likely widen to earlier stages of the disease, increasing its sales prospects.
At 0906 GMT, GlaxoSmithKline shares were up 0.7% or 10 pence at 1,454p, in a higher broader London market.
Tykerb, whose generic name is lapatinib, targets a type of metastatic breast cancer associated with high levels of two types of genes. A metastatic cancer is one that spreads to other parts of the body.
An over-abundance of one of the genes, HER2, is thought to be present in about one-fourth of women with breast cancer. This is the same gene targeted by Roche's breast cancer Herceptin.
But while Herceptin has advanced the treatment of breast cancer since its launch in 1998, some women fail to respond to this therapy once their tumor spreads to other parts of the body.
The combination of Tykerb with Xeloda, if approved, would be used in these cases.
The E.U. and U.S. regulatory filings follow the release of positive data on Tykerb, which were presented in June at the American Society of Clinical Oncology in Atlanta.
The clinical trial - which studied 321 women with HER2-positive advanced breast cancer that had persisted despite prior therapy, including chemotherapy and Herceptin - was stopped early because the results exceeded expectations.
Tykerb is also in clinical trials for the treatment of a number of solid tumors, including renal as well as head and neck cancer.
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