NO USE OF AVASTIN FOR PROSTATE CANCER

UPDATE 3-Roche's Avastin fails in prostate cancer study

Fri, Mar 12 2010

* Treatment doesn't prolong life in late stage patients

* Some adverse effects seen, already noted in other trials

* Follows recent ovarian cancer success and gastric failure * Roche shares fall 2.2 percent (Updates with latest shares, background on Pfizer's Sutent)

By Martin de Sa'Pinto and Ben Hirschler

ZURICH/LONDON, March 12 (Reuters) - Roche Holding AG's Avastin did not help men with late stage prostate cancer live longer in a clinical trial, marking another setback for the Swiss group as it tries to extend use of the blockbuster drug into new areas.

The miss in prostrate cancer, announced on Friday, follows similar disappointment last month with Avastin in gastric cancer but success in ovarian cancer.

Shares in Roche fell 2.2 percent by 1130 GMT as investors revised down expectations for Avastin, a closely watched drug which many analysts believe could be the world's biggest-selling pharmaceutical in a few years' time.

With the company having suggested prostate cancer could boost potential annual peak sales by between 500 million Swiss francs ($464.3 million) and 1 billion, Deutsche Bank analysts said the setback meant 0.5 to 2 percent might need to be come off consensus sales estimates for Roche and 1 to 4 percent from core earnings.

Oliver Kaemmerer, an analyst at WestLB, said he was likely to revise down his 2014 sales forecast for Avastin of 9.8 billion francs to nearer 9 billion, given that ovarian cancer was the only new opportunity now left available.

Avastin, which works by starving tumours of blood, is already used to treat colon, breast, lung and kidney cancers, and had 2009 annual global sales of 6.2 billion Swiss francs.

It is a flagship product for Roche, the world's largest maker of cancer drugs, given its potential to expand in these markets and move into treating new types of cancer.

The new uses of the drug, however, are seen as higher risk than existing ones and Roche had already warned at the time of full-year results that it was quite likely not all of the three new trials for Avastin would be successful.

It is not alone in finding that modern targeted cancer treatments do not seem to work for all tumours. Pfizer Inc reported on Thursday that its cancer drug Sutent had failed tests in breast cancer. [ID:nN11252225]

WATCHING ASCO

Roche plans to give further details on recent clinical trials with Avastin at the 2010 American Society of Clinical Oncology (ASCO) annual meeting later this year.

"The ASCO conference in June will be important to understand if the positive news in ovarian cancer can outweigh the disappointments in gastric and now prostate cancer," said Deutsche analyst Tim Race.

Before that, investors are hoping to get more insight into the company's pipeline potential when it holds an investor day in New York on March 18 -- its first major investor meeting since it bought out U.S. biotech company Genentech last year.

Avastin was being tested in combination with Sanofi-Aventis's chemotherapy drug Taxotere, or docetaxel, and prednisone in men with late stage prostate cancer in the Phase III sponsored by the U.S. National Cancer Institute.

Roche said in a statement it did not meet its primary objective of extending overall survival compared with chemotherapy and prednisone alone, and a preliminary safety assessment showed adverse events that have been previously observed in Avastin trials.

Prostate cancer is the second most commonly diagnosed cancer in men worldwide after lung cancer, with over 679,000 men receiving a diagnosis of the disease each year, the group said.

One third of men diagnosed will die from their disease.

"Patients with hormone-refractory prostate cancer are in urgent need of new treatment options. It is unfortunate that the study did not meet its primary objective," said Roche Chief Medical Officer Hal Barron.

The findings do not impact Avastin's approved indications and Roche said Avastin's broad development programme in other tumour types would continue as planned. (Editing by Mike Nesbit and David Holmes) ($1 = 1.077 Swiss francs)