Biotech company Genentech Inc. and Swiss drug maker Roche Holding AG said that an interim analysis of clinical trial data showed that cancer treatment Avastin met its primary endpoint of increasing survival rates in breast cancer patients.
Genentech shares rose $9.63, or 16.4 percent, to $68.26 in midday trading on the New York Stock Exchange on the news and subsequent analyst upgrades.
The 722-patient, late-stage clinical trial pitted using Avastin with chemotherapy against chemotherapy alone in patients with breast cancer that had spread to other areas of the body.
The companies said they plan to file the data with the Food and Drug Administration and discuss having Avastin’s indication expanded to treating breast cancer. The FDA approved Avastin in February 2004 as a first-line treatment for colorectal cancer that has spread.
Avastin is an antibody designed to block a growth factor in the body that allows blood vessels to grow and maintain tumors.
Analysts jumped on the news and issued a flurry of upgrades on Genentech’s stock.
JPMorgan upgraded Genentech to “Overweight” from “Neutral,” and increased its Avastin sales projections on the basis of the new indication.
“We think that Genentech will move expeditiously to get this information to the FDA,” said JPMorgan analyst Ronald Renaud, Jr., in a note to investors. “In our view, Genentech could get an approval for treating front-line metastatic breast cancer from the FDA by mid-2006 at the latest.”
The analyst said that the clinical trial was powered to identify an improvement in the median time to progression of the disease from 6 months in patients taking chemotherapy alone to 8 months for those patients taking Avastin and chemotherapy. While specific data has yet to be released, JPMorgan said it believes survival rates were longer than 8 months in the Avastin group.
The firm raised its earnings per share estimates to $1.49 from $1.39 for 2006, and to $1.94 from $1.69 for 2007. JPMorgan raised sales estimates of the drug to $1.6 billion from previous forecasts of $1.3 billion for 2006 and to $2.6 billion from $1.7 billion in 2007.
Prudential Equity also upgraded the stock to “Overweight” from “Neutral,” on the preliminary data and boosted sales projections.
The firm increased its Avastin sales estimates to $1.2 billion from $1 billion for 2006 and to $2.6 billion to $1.6 billion in 2007. Prudential also raised its 12 to 18 month price target to $80 from $63. The firm also reminded investors that the treatment is also in clinical trials for ovarian, prostate, kidney and pancreatic cancer.
In a research note, Prudential raised its earnings per share estimates to $1.13 from $1.08 for 2006, and to $1.68 from $1.35 for 2007.
On the preliminary data, Deutsche Securities upgraded Genentech to “Buy” from “Hold.”
Analysts surveyed by Thomson Financial estimate Genentech’s earnings per share at $1.48 for 2006 and $1.90 for 2007.