GlaxoSmithKline Delays Filing of New Drug

Monday, May 16th 2005, 8:41 am

By: News On 6

LONDON (AP) _ Drugmaker GlaxoSmithKline PLC said Monday that it will delay filing a new drug application with U.S. authorities for its breast cancer drug Lapatinib until late 2006 or early 2007, based on Phase III trials now in progress.

The company had previously said it would consider filing with the U.S. Food and Drug Administration later this year on the basis of Phase II studies in patients with late-stage disease.

Glaxo said that Lapatinib showed a 35 percent response rate in women with advanced breast cancer in initial trials. The drug is designed to block the growth of HER-2 positive cancer cells as well as another protein involved in cancer growth.

``In this trial, we are seeing the strongest demonstration yet of the activity of Lapatinib in solid tumors, and the first demonstration of such activity by an oral therapy directed at ErbB2,'' said Paolo Paoletti, senior vice president of the oncology medicine development center at Glaxo.

``These data further demonstrate the potential of Lapatinib in breast cancer and will help guide the expansion of our Phase III program to support regulatory filings,'' Paoletti added in a statement to the London Stock Exchange.

Shares in Glaxo were barely changed in early trading, down just 0.07 percent at 13.36 pounds ($24.59).

Glaxo last month reported that strong European sales growth of key drugs underpinned a 16 percent rise in quarterly net profits to 1.202 billion pounds, up from 1.037 billion pounds in the first quarter of 2004. Analysts said the quarterly results were supported by a strong pipeline, including the Allermist drug for rhinitis and the Cervarix treatment for cervical cancer.