* Now approved in US for 5 different cancer types
* Kidney cancer is US's 8th most commonly diagnosed cancer
* Shares down 2.1 pct, weaker than index
(Adds background, updates stock)
By Katie Reid
ZURICH, Aug 3 Roche Holding AG's ROG.VX cancer
drug Avastin has won approval from the U.S. Food and Drug
Administration (FDA) for the treatment of the most common type
of kidney cancer, the Swiss drugmaker said on Monday.
The FDA approval gives the green light to treat metastatic
renal cell carcinoma using Avastin plus interferon alpha, based
on data from a Phase III study in patients with the advanced,
previously untreated condition, Roche said.
The study showed that patients who were treated with Avastin
plus interferon alpha lived nearly twice as long without their
disease getting worse than those who received interferon alpha
alone, the group said.
"The approval was expected, and we estimate that it could
increase revenues by 300-500 million francs. We have already
factored 400 million francs into our Avastin assumptions," said
Vontobel analyst Silvia Schanz in a note.
By 1256 GMT, Roche stock, which has rallied in recent weeks
after it raised its outlook, was trading 2.1 percent lower at
164.90 Swiss francs, compared with a flat European
pharmaceuticals sector .SXDP.
Avastin, which works by starving tumours of blood supply and
is made by Roche's recently acquired Genentech unit, is also
used to treat lung, colon and breast cancers, and had annual
global sales of 5.2 billion Swiss francs ($4.86 billion) in
In the new kidney cancer setting Avastin will face "intense"
competition from Pfizer's (PFE.N) Sutent, Bayer BAYG.DE and
Onyx's ONXX.O Nexavar, and Wyeth's WYE.N Torisel, Helvea
analysts said in a note.
"(These drugs) have carved out a large share of the market
on strong data as single-agent therapies, i.e. without the use
of toxic interferon. Nevertheless, Avastin is believed capable
of making inroads into the market," they said.
Kidney cancer is the eighth most commonly diagnosed cancer
in the U.S., according to the American Cancer Society. Around
13,000 Americans will die from the disease in 2009.
Avastin has been available in Europe since the end of 2007
for the first-line treatment of patients with advanced and/or
metastatic renal cell cancer in combination with interferon
"Avastin has now been approved for five different types of
cancer in the USA," William Burns, chief executive of Roche's
Pharmaceuticals Division, said in a statement.
"This underscores our belief in the important clinical
benefits that Avastin delivers as we push forward with our
ongoing research programs in more than 30 tumour types."
Swiss brokerage Kepler Capital Markets raised its price
target to 186 francs from 173 francs and confirmed its buy
rating in the wake of Roche's first-half results and recent drug
"With recent supportive drug news... the innovation engine
is fully running, with more momentum to come in the second half,
(such as) Avastin in ovarian cancer, taspoglutide in
diabetes," analyst Daniel Daetwyler said in a note.
Last month Roche gave a bullish forecast for the next two
years, raising its earning guidance as a result of the Genentech
($1=1.070 Swiss Franc)
(Editing by Will Waterman and Mike Nesbit)