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<u>UPDATE</u>: Roche Gets Boost On Breast Cancer Drug Expectation

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SAE   Monday, 12/05/11 12:26:58 PM
Re: SAE post# 80
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UPDATE: Roche Gets Boost On Breast Cancer Drug Expectation

Roche Holding AG (ROG.VX) Wednesday said new data shows its experimental medicine pertuzumab is effective in treating breast cancer, providing a welcome boost for the Swiss drug giant after its key oncology product Avastin lost its U.S. breast cancer label earlier this month.

The detailed research, which will be presented at this year's Breast Cancer Symposium in San Antonio that starts December 6, includes results from a late-stage study of pertuzumab used in combination with Roche's cancer medicine Herceptin and chemotherapy docetaxel.

"The data shows that pertuzumab is effective and we plan to file the drug for health authority review this year," Stefan Frings, Head Medical Affairs Oncology at Roche, told Dow Jones Newswires. Roche will file the drug, which works by blocking cancer-causing protein HER2, as a first line treatment in HER2-positive metastatic breast cancer.

"Given the strong data, we also have started a full phase III trial in the adjuvant setting," he said. In medical trials, the term adjuvant refers to treatments that are undertaken after surgery.

The potential approval of pertuzumab should help Roche protect its strong cancer franchise. The growth potential of Roche's core business was questioned after U.S. regulators in November revoked the breast cancer label for Avastin, Roche's best-selling cancer drug besides Herceptin and Rituxan.

Some analysts also expect pertuzumab to help Roche alleviate generic pressure once Herceptin loses its patent. "The market is materially undervaluing pertuzumab in HER2 breast cancer, which will help negate the potential negative impact of Herceptin biosimilars," said Citigroup analyst Andrew Baum.

Investors widely shunned Roche stock during 2010 due to several development setbacks. But Roche's shares pushed higher Wednesday and at 1203 GMT stood 0.9% higher at CHF142.9 in an unchanged overall market.

Roche has so far only said that late stage data has shown that pertuzumab, in combination with other treatments, helped some breast cancer patients live "significantly" longer without their disease worsening. Because of the dearth of detailed data, some analysts remain skeptical about the drug's chances to win approval. But some, like Bank Vontobel, expect the medicine to reach sales of close to $2 billion.

Another issue for analysts is the quality of the data, as Roche is using progression-free survival, or PFS, data to highlight the drug's effectiveness. Unlike overall survival rate, which denotes a percentage of patients who still live after taking a drug within a pre-defined period, PFS is the length of time during and after medication when the disease being treated doesn't get worse. Regulators have become wary of PFS, especially for first-line treatments.

"Progression free survival is a meaningful primary endpoint and a direct measure of the drug's effect," said Roche's Frings. "The data is quicker to measure, the drugs can potentially reach patients faster, and the outcome is not confounded by subsequent treatment lines," he said.

-By Goran Mijuk, Dow Jones Newswires, +41 43 443 80 47; goran.mijuk@dowjones.com

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