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Tarceva - Improves Survival

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Roche: Our Cancer Drug Improves Survival

ZURICH (AP) - In a result few had expected, Swiss drug-maker Roche Holding AG Monday said its novel cancer drug Tarceva "significantly" improved survival for certain lung cancer patients who failed to respond to standard chemotherapy.

The drug was discovered by OSI Pharmaceuticals Inc. and in-licensed by Genentech Inc. for the United States and Roche for other markets. Roche owns a majority stake in Genentech, which is based in South San Francisco, Calif.

Shares of Melville, N.Y.-based OSI Pharmaceuticals surged 106 percent, or $40.57, to trade at $78.71 Monday morning on the Nasdaq Stock Market.

Shares of Genentech jumped $15.88, or 13 percent, to $134.10 on the New York Stock Exchange.

The drug is the first of its kind to show in a major study that the approach can extend survival in patients in non-small cell lung cancer. This is the most common form of lung cancer, accounting for almost 80 percent of all lung cancer, a disease that results in 1.1 million deaths a year.

Tarceva is one of a new generation of cancer medications designed to take direct aim at cancer cells. Traditional chemotherapy drugs are toxins that kill many normal cells as well as tumors, one reason they often result in serious side effects such as nausea, hair loss and susceptibility to infection.

By contrast, Tarceva blocks a protein known as "epidermal growth factor receptor," or EGFR, that is common in cancer cells, and which is thought to play a key role in helping them divide uncontrollably. The drug is similar in many respects to Astra Zeneca's Iressa, which was launched in 2002.

"Tarceva is the first EGFR-inhibitor that has been shown to extend survival in patients with relapsed non-small cell lung cancer, for whom there are very limited treatments possible," said Nick Thatcher, lung-cancer group chairman at Britain's Christie and Wythenshawe Hospitals.

Tarceva is the fifth cancer medicine with a proven survival benefit, joining breast cancer drugs Herceptin and Xeloda, blood cancer treatment Mabthera, and colorectal cancer drug Avastin.

"We will be striving to make Tarceva available as quickly as possible to patients," said William M. Burns, Head of Roche's Pharmaceuticals Division.

Analysts raised their estimates for Tarceva's potential revenue to between $700 million and $1 billion on the positive trial data.

The findings of the study came as somewhat of a surprise after Tarceva in earlier studies failed to prolong survival in patients with metastatic lung cancer when used as first line treatment, meaning the patients hadn't yet been treated with other medicines. At the time, two studies in which Tarceva was used with traditional chemotherapy showed no sign of helping lung-cancer patients live longer.

This latest study of more than 700 patients looked at the benefits of using Tarceva alone, without chemotherapy, in patients who had already had chemotherapy treatment. The study met its primary endpoint of improving overall survival, with patients on Tarceva living longer than those in the placebo arm.

The international study was conducted by the National Cancer Institute of Canada, Clinical Trials Group at Queens University in collaboration with OSI.

Roche and its partners hope to submit data from this trial for presentation at the upcoming 2004 Annual Meeting of the American Society of Clinical Oncology, known as ASCO, in New Orleans from June 5-8.

Analysts said they expect Roche to launch Tarceva late next year, or early in 2006.

04/26/04 10:53 EDT

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