* Rates of death, heart attack and stroke similar
* People who took Avastin had more hospitalizations
* Roche shares up 1.5 pct, Novartis up 1 pct
(Adds comments from researchers, conference call)
By Julie Steenhuysen
CHICAGO, April 28 Roche Holding AG's ROG.VX
cancer drug Avastin works just as well as its far more
expensive eye drug Lucentis in treating vision loss from
macular degeneration, but has more side effects, U.S.
researchers said on Thursday.
Avastin's effect was equivalent to Lucentis after a year
when given monthly to treat wet age-related macular
degeneration, according to researchers in the National Eye
Institute study. Rates of death, heart attack and stroke were
similar, they said.
The results could pose a threat to the billions of dollars
Roche hopes to reap from Lucentis sales, should more doctors
prefer the far-cheaper Avastin. Avastin costs about $50 per
injection compared with nearly $2,000 for Lucentis.
Dr. Daniel Martin of the Cole Eye Institute at the
Cleveland Clinic led the study and said it shows "both are
viable options and clinicians may choose one or another."
Roche and its partner Novartis AG NOVN.VX each generated
around $1.5 billion in Lucentis sales last year. Some analysts
see it becoming a $10 billion-plus drug.
But doctors may still hesitate to prescribe Avastin after
the study showed higher rates of serious systemic side effects
that required hospitalization, with 24.1 percent of patients in
the Avastin group experiencing these side effects compared with
19 percent in the Lucentis group.
"It means that the Lucentis franchise won't be threatened,"
Vontobel analyst Andrew Weiss said. "If Lucentis is the safer
drug, then it is the better drug. Whether or not it is worth
such a big price tag is another issue."
Deutsche Bank analyst Tim Race said in a note to clients
that "slight wrinkles in the data suggest that (for now) the
status quo in sales will prevail."
Roche and Novartis also were quick to point out the
remaining safety debate after the results were released online
in the New England Journal of Medicine. Roche noted Lucentis
was specifically designed to be cleared more quickly from the
bloodstream to minimize side effects.
"People who are really evangelical Avastin users will
probably continue on their way, but I think when people really
think about the article, they will have a lot of unanswered
safety concerns," Trevor Mundel, global head of development at
Novartis, told Reuters.
Roche shares rose about 1.5 percent and Novartis rose 1
percent, both in Zurich.
NO CLEAR LINK BETWEEN DRUG, SIDE EFFECTS
Age-related macular degeneration is the leading cause of
blindness in people over 60. Some 13 million Americans have
signs of AMD and more than 1 million Americans have the wet
form, the most severe type.
In the wet form of the disease, abnormal blood vessels grow
beneath the retina and leak blood and fluid. Both Lucentis and
Avastin are vascular endothelial growth factor, or VEGF,
inhibitors what work by blocking the growth of blood vessels.
Eye specialists have been treating patients with Avastin
for years on an off-label basis, using contract pharmacies to
split up doses of the cancer drug into smaller portions.
Roche's Genentech unit has always discouraged the process,
saying Avastin was never tested for such uses. The NEI study
was designed to prove Avastin was just as effective as
Lucentis, which the team said it accomplished.
But the study also showed both drugs worked well when used
on an as-needed basis, rather than on a monthly schedule, which
could save patients four or five shots a year.
The average age in the 1,200 patient trial was 80. A high
rate of hospitalizations might stem from chronic or acute
medical conditions more common to older populations.
Researchers said the side effects were distributed across
many different conditions, most of which were not previously
associated with Avastin in cancer clinical trials where the
drug was used at a much higher dose.
They also noted that the number of deaths, heart attacks,
and strokes were low and similar for both drugs. And there were
more systemic side effects among people who got lower doses of
Avastin, suggesting the issue was not related to dose.
Dr. Philip Rosenberg of the University of Miami wrote in an
editorial that the study answers the question of effectiveness,
but was not big enough to address the issue of side effects.
Overall, he said the study results, combined with doctors'
experiences, support the use of either drug.
The study is important not only for the two Swiss
drugmakers, but also Germany's Bayer AG (BAYGn.DE), which is
developing a rival eye drug with Regeneron Pharmaceuticals Inc(REGN.O).
Analysts are also awaiting an analysis of more than 77,000
Medicare claims to be presented at a medical meeting next week
that found an 11 percent increased risk of death and a 57
percent increased risk of stroke with Avastin versus Lucentis.
Martin told reporters on a conference call he was aware of
the analysis and said it is not a peer-reviewed randomized
clinical trial, which bears far greater scientific weight.
"On the important severe adverse events that we are
primarily concerned about -- death, (heart attack) and stroke
-- there is no difference between drugs," Martin added.
(Additional reporting by Ben Hirschler in London and Katie
Reid in Zurich and Bill Berkrot in New York; editing by Michele
Gershberg, Dave Zimmerman, Tim Dobbyn and Andre Grenon)