Genentech Submits Biologics License Application for FDA Review of
Lucentis(TM) in Wet Age-Related Macular Degeneration


BLA Includes Request for Priority Six-Month Review

SOUTH SAN FRANCISCO, Calif., Dec. 30 /PRNewswire-FirstCall/ --
Genentech,
Inc. (NYSE: DNA) announced today that it has submitted a Biologics
License
Application (BLA) to the U.S. Food and Drug Administration (FDA) for
the use
of Lucentis(TM) (ranibizumab) in the treatment of neovascular wet
age-related
macular degeneration (AMD). Lucentis is the first therapy for wet
AMD to have
shown improved vision in two pivotal Phase III trials and
demonstrated a
clinical benefit over verteporfin (Visudyne(R)) photodynamic therapy
(PDT) in
a head-to-head clinical trial. As part of the Lucentis BLA
submission,
Genentech has requested a Priority Review designation from the FDA,
which, if
granted, would give the FDA six months from the Agency's receipt of
the
submission to take action on the application.
The BLA submission is based on one-year clinical data on the
efficacy and
safety of Lucentis from two pivotal Phase III trials, ANCHOR and
MARINA, as
well as one-year clinical data from the Phase I/II FOCUS trial. In
addition
to these registrational studies, Genentech is currently enrolling
patients
with wet AMD in a Phase IIIb safety study called SAILOR. Data from
the Phase
IIIb PIER study evaluating a less frequent dosing regimen for
Lucentis are
anticipated in the first half of 2006.
"This application represents a summary of data from more than
six years of
rigorous clinical study and the dedication of thousands of patients
and
physicians hoping to improve outcomes for those with this devastating
disease," said Hal Barron, M.D., Genentech's senior vice president of
Development and chief medical officer. "We look forward to working
with the
FDA in our efforts to bring this potential therapy to patients
quickly as it
may offer benefit to patients with all types of wet AMD."

ANCHOR
In November 2005, Genentech announced positive preliminary data
from the
pivotal Phase III ANCHOR study (ANti-VEGF Antibody for the Treatment
of
Predominantly Classic CHORoidal Neovascularization in AMD), a
randomized,
two-year, multi-center, double-masked, active-treatment controlled
study
comparing two different doses of Lucentis to PDT in 423 patients with
predominantly classic wet AMD. Approximately 94 percent of patients
treated
with 0.3 mg of Lucentis and 96 percent of those treated with 0.5 mg
of
Lucentis maintained (defined as a loss of less than 15 letters in
visual
acuity) or improved vision (defined as a gain of 15 letters or more)
compared
to approximately 64 percent of those treated with PDT alone
[p<0.0001] during
the first year of the two-year study. The Lucentis treatment groups
further
showed a statistically significant difference from the control arm
in an
important secondary endpoint: mean change in visual acuity (VA) from
baseline
to month 12. On average, VA among patients treated with Lucentis
improved,
while VA among patients treated with PDT declined. Based on these
results,
patients in the PDT-alone arm of the study will have access to
Lucentis for
the remainder of the study. One-year data from the ANCHOR study
will be
presented at the Macula 2006 meeting in New York in January.

MARINA
In July 2005, Genentech presented positive preliminary one-year
results
from the pivotal Phase III MARINA study (Minimally classic/occult
trial of the
Anti-VEGF antibody Ranibizumab In the treatment of Neovascular AMD),
a
randomized, two-year, multi-center, double-masked, sham-injection
controlled
study evaluating the safety and efficacy of two different doses of
Lucentis in
716 patients with minimally classic or occult wet AMD. Nearly 95
percent of
patients treated with Lucentis maintained or improved vision at 12
months.
Additional one-year results include:

-- Twenty five percent (59/238) of patients treated with 0.3
mg of
Lucentis and 34 percent (81/240) treated with 0.5 mg of
Lucentis
improved vision by a gain of 15 letters or more compared to
approximately 5 percent (11/238) of patients in the control
group as
measured by the ETDRS eye chart.
-- Nearly 40 percent (188/478) of Lucentis-treated patients
(38.7 percent in the 0.3 mg group and 40 percent in the 0.5
mg group)
achieved a visual acuity score of 20/40 or better compared
to
11 percent (26/238) in the control group.
-- Patients treated with Lucentis gained an average of
approximately
seven letters in visual acuity (6.5 letters in the 0.3 mg
group and
7.2 letters in the 0.5 mg group) compared to study entry,
while those
in the control group lost an average of 10.5 letters.
-- The majority of patients treated with Lucentis (349/478)
(74.8 percent in the 0.3 mg group and 71.3 percent in the
0.5 mg
group) experienced a letter improvement of zero or more
compared to
28.6 percent (68/238) in the sham group.

In October 2005, Genentech announced that patients still in the
sham arm
of the MARINA study would be crossed over to active treatment with
Lucentis.

FOCUS
The FOCUS trial (RhuFab V2 Ocular Treatment Combining the Use of
Visudyne(R) to Evaluate Safety) is a randomized, two-year, multi-
center,
single-masked study evaluating the safety, tolerability and efficacy
of
Lucentis in combination with PDT compared to PDT alone in 162
patients with
predominantly classic subfoveal wet AMD. Preliminary one-year data
were
presented in July 2005 and showed that approximately 90 percent of
patients
maintained or improved vision when treated with the combination of
Lucentis
and PDT compared to approximately 68 percent of those treated with
PDT alone
(p = 0.0003).

Lucentis Safety Profile
In clinical trials to date, the most common side effects that
occurred
more frequently in the Lucentis arms (0.3 mg and 0.5 mg) than in the
control
arms were mild to moderate and included: conjunctival hemorrhage,
eye pain,
increased intraocular pressure and vitreous floaters.
Serious ocular adverse events that occurred more frequently in
the
Lucentis-treated arms were uncommon and included endophthalmitis and
intraocular inflammation (less than 1 percent for each). Among non-
ocular
serious adverse events, cerebral vascular events and myocardial
infarctions
were observed in all three arms of both the Phase III MARINA and
ANCHOR
studies; in each study the combined rate of these events was similar
in the
control and the 0.3 mg Lucentis arms and slightly higher in the 0.5
mg
Lucentis arm. Cerebral vascular events and myocardial infarctions
were also
seen in the Phase I/II study of Lucentis 0.5 mg in combination with
Visudyne
PDT (FOCUS), although the combined frequency of these events was
approximately
equal in both treatment arms.

Additional Phase III Studies

SAILOR
In November 2005, Genentech began enrollment in a Phase IIIb
study,
SAILOR, to make Lucentis available to eligible patients. SAILOR
(Safety
Assessment of Intravitreal Lucentis fOR AMD) is a Phase IIIb
clinical study of
Lucentis for patients with all types of new or recurrent active
subfoveal wet
AMD. It is a one-year study designed to evaluate the safety of two
different
doses (0.3 mg and 0.5 mg) of Lucentis administered once a month for
three
months and thereafter as needed based on retreatment criteria. The
study will
be conducted at more than 100 sites in the United States and will
enroll up to
5,000 patients. Those interested in additional information about the
study can
call toll-free 1-888-662-6728.

PIER
Genentech is also conducting PIER (A Phase IIIb, Multi-center,
Randomized,
Double-Masked, Sham Injection-Controlled Study of the Efficacy and
Safety of
Ranibizumab in Subjects with Subfoveal Choroidal Neovascularization
with or
without Classic CNV Secondary to Age-Related Macular Degeneration)
with
184 patients in the United States. In this trial, Lucentis is
administered
once per month for the first three months followed thereafter by
doses once
every three months for a total of 24 months. Enrollment in this
study is
complete and preliminary results are expected in the first half of
2006.

About AMD
AMD is a major cause of painless central visual loss and is the
leading
cause of blindness for people over the age of 60. The National Eye
Institute
estimates that there are 1.6 million people with AMD in the United
States
alone and that this prevalence will grow to 2.95 million by 2020.
AMD occurs
in two forms: dry and wet.
The dry form is associated with atrophic cell death of the
central retina
or macula, which is required for fine vision used for activities
such as
reading, driving or recognizing faces. The wet form is caused by
growth of
abnormal blood vessels also known as choroidal neovascularization
(CNV) or
ocular angiogenesis under the macula. These vessels leak fluid and
blood and
cause scar tissue that destroys the central retina. This results in
a
deterioration of sight over a period of months to years.

About Lucentis
Lucentis(TM) (ranibizumab) is a humanized therapeutic antibody
fragment
developed at Genentech and designed to bind and inhibit VEGF-A, a
protein that
is believed to play a critical role in angiogenesis (the formation
of new
blood vessels). Lucentis is designed to block new blood vessel
growth and
leakiness, which lead to wet AMD disease progression and vision loss.
Lucentis is being developed by Genentech and the Novartis
Ophthalmics
Business Unit. Genentech retains commercial rights for Lucentis in
North
America. Novartis has exclusive commercialization rights for the
rest of the
world.

About Angiogenesis
Genentech is a leader in research and product development in the
area of
angiogenesis, the process by which new blood vessels are formed. In
1989
Napoleone Ferrara, M.D., and a team of scientists at Genentech
conducted
seminal work in the field, which resulted in the identification and
cloning of
a gene termed Vascular Endothelial Growth Factor (VEGF), now known
as VEGF-A.
The VEGF-A protein is believed to play a critical role in
angiogenesis and
serves as one of the key contributors to physiological or
pathological
conditions that can stimulate the formation of new blood vessels.
The process
of angiogenesis is normally regulated throughout development and
adult life,
and the uncontrolled growth of new blood vessels is an important
contributor
to a number of pathologic conditions, including wet AMD.

About Genentech
Genentech is a leading biotechnology company that discovers,
develops,
manufactures and commercializes biotherapeutics for significant
unmet medical
needs. A considerable number of the currently approved
biotechnology products
originated from, or are based on, Genentech science. Genentech
manufactures
and commercializes multiple biotechnology products directly in the
United
States and licenses several additional products to other companies.
The
company has headquarters in South San Francisco, Calif., and is
traded on the
New York Stock Exchange under the symbol DNA. For additional
information
about the company, please visit http://www.gene.com .

This press release contains forward-looking statements regarding
Lucentis
as a potential therapy and the expected time frame for the PIER
trial results.
Actual results could differ materially. Among other things, the
time frame
for the PIER results could be affected by unexpected safety or
efficacy
issues, additional time requirements to achieve study endpoints or
for data
analysis, or discussions with the FDA or FDA actions; and Lucentis
as a
potential therapy could be affected by certain of the forgoing and
the failure
to receive FDA approval, competition, pricing and the ability to
supply
product or a product withdrawal. Genentech disclaims any obligation
and does
not undertake to update or revise the forward-looking statements in
this press
release.

Media Contact: Dawn Kalmar 650-225-5873
Investor Contact: Kathee Littrell 650-225-1034
Patient Inquiries: 1-888-662-6728

SOURCE Genentech, Inc.
Web Site: http://www.gene.com

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