Roche Holding Ltd (RHHBY)

[SAE]

Data Shows Effectiveness Of Roche Breast Cancer Drug Pertuzumab

Roche Holding AG (ROG.VX) Wednesday said new research shows its prospective medicine pertuzumab is effective in fighting breast cancer, providing a welcome boost for the Swiss pharmaceutical giant after its blockbuster cancer drug Avastin lost its U.S. breast cancer label earlier this month.

The data, which will be presented at this year's Breast Cancer Symposium in San Antonio, 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. "Given the strong data, we also have started a full phase III trial," he said.

Pertuzumab, a drug that works by inhibiting growth of cancer-causing protein HER2, should help Roche protect sales of Herceptin, which is set to lose its patent in a few years time, analysts say. Herceptin is one of the Swiss firm's best-selling products, which together with cancer blockbusters Avastin and Rituxan generates the bulk of Roche's annual turnover.

The growth potential of Roche's cancer portfolio was recently questioned after U.S. regulators in November revoked the breast cancer label for Avastin in the U.S., criticizing the medicine's effectiveness and prompting Roche to cut its peak sales estimates for the therapy.

Some analysts expect pertuzumab to become a future sales driver and help Roche alleviate pressure from generic competitors once Herceptin loses its patent protection.

"Increased visibility on pertuzumab potential begins at the San Antonio Breast Cancer meeting in December 2011, and will increase during 2012," said Citigroup pharmaceutical analysts Andrew Baum.

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. Sector specialists expect more details to come at the upcoming breast cancer conference, which starts on Dec. 6.

HER2 breast cancer is a common form of breast cancer. Around 20% of all breast cancer patients--about 1.4 million new cases are registered world-wide every year--are affected by this form of cancer.

While some analysts remain skeptical about the drug's chances to win approval due to safety and efficiency concerns, 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, [phone]; [e-mail]