- Lucentis(*) now available to treat leading cause of severe
age-related vision loss in Canadians over 50
DORVAL, QC, Sept. 5 /CNW/ - Novartis Pharmaceuticals Canada Inc.
announced today availability of Lucentis(*) (ranibizumab) for the treatment of
neovascular (wet) age-related macular degeneration (AMD), following a Health
Canada Priority Review. The accelerated review and approval is a testament to
the fact that there is an unmet medical need and that Lucentis(*) has
significant clinical advantages over existing therapies for wet AMD.
In addition to a priority review from Health Canada, the innovative
benefits of Lucentis(*) have also been recognized by the Ontario Drug Benefit
Plan which has granted Lucentis(*) a rapid review under its new system to speed
reimbursement decisions for important new medicines.
Wet AMD, the leading cause of severe vision loss in Canadians over
50 years of age, is a debilitating eye condition that can rapidly diminish
central vision and lead to blindness. Lucentis(*) is the first and only approved
treatment clinically proven to offer wet AMD patients significant vision
gains. Designed specifically for use in the eye and administered by injection
into the eye, Lucentis(*) may help to restore patients' independence by
increasing their ability to perform activities requiring central vision such
as seeing faces, reading and driving.
"People with wet AMD have until now been faced with the harsh reality of
progressive, and sometimes very quick vision loss, leaving them unable to see
loved ones, drive or enjoy other activities," said Dr. Keith Gordon, Head of
Research for CNIB, a nationwide, community-based charity committed to
research, public education and the vision health of all Canadians. "With
Lucentis(*), many people now can have some hope of actually having improvement
in vision, promising a great increase in their quality of life."
Lucentis(*) sets a new treatment standard for people suffering from the wet
form of AMD. While earlier therapies have been able to slow the progression of
vision loss, Lucentis(*) offers patients - for the first time - a real
opportunity for statistically and clinically significant visual improvement
with a proven therapy. In clinical trials, up to 40% of Lucentis(*)-treated
patients achieved visual acuity of 20/40 or better, which is greater than the
level of vision required to drive.
Lorna Rosenstein, a Director at The Foundation Fighting Blindness (FFB),
Canada's leading charity for vision research, welcomes this new treatment for
wet AMD patients. "This new treatment is significant because until now, vision
loss was irreversible for patients who live with wet AMD. Previous therapies
only slowed the decline in vision. As a director with The Foundation Fighting
Blindness, and someone who is visually impaired, I'm excited that thousands of
patients with wet AMD now have a new treatment that is scientifically proven
to be safe and effective. This is a major advance in the fight against
Lucentis(*) is specifically designed for use in the eye to bind and inhibit
VEGF-A, a protein that plays a critical role in the formation of new blood
vessels under the macula which lead to disease progression and central vision
loss. It has undergone an extensive 10-year clinical development program and
has a large body of documented medical evidence conducted in a controlled
clinical trial setting. This data reinforces the medication's efficacy and
safety - evidence needed by clinicians to make appropriate prescribing
"The clinical trial results with Lucentis(*) are the most impressive we
have ever seen in AMD. Data from pivotal trials have shown that on therapy
more than 90% of patients maintain their vision and even more impressive, is
that 40% actually had significant improvement in vision", said Dr. David R.
Chow, Assistant Professor, University of Toronto. "This marks a major advance
in our ability to treat patients with wet AMD because this drug virtually
eliminates the risk of disease progression and associated visual loss while
offering them for the first time some realistic hope of visual improvement."
The Health Canada approval of Lucentis(*) was based on the results of two
Phase III, multi-centre, randomized, double-masked studies in 1,139 wet AMD
patients that compared Lucentis(*) treatment to sham control (the MARINA trial)
or active control (the ANCHOR trial). In these two pivotal Phase III clinical
trials, up to 96 per cent of Lucentis(*)-treated patients maintained visual
acuity. The MARINA results in particular, demonstrated that vision benefits
gained in the first year of the study were sustained with continued treatment
in the trial's second year.
More than 290,000 Canadians suffer from wet AMD. It is anticipated that
30,000 new cases of wet AMD will be diagnosed in Canada this year alone, a
number expected to double within the next 25 years. Age-related macular
degeneration (AMD) is a degenerative eye disease that affects the macula - the
central part of the retina at the back of the eye that is responsible for the
"straight ahead" vision necessary for identifying faces and everyday
activities like reading, driving and telling time. There are two types of AMD:
wet and dry. Neovascular or wet AMD is a fast, progressive disease that,
without treatment, leads to severe vision loss and can severely compromise a
person's ability to function independently. While the dry form is more common,
wet AMD accounts for 90% of vision loss associated with the disease.
Lucentis(*) is recommended to be administered by intravitreal injection
once a month. Treatment may be reduced to one injection every 3 months after
the first three injections if monthly dosing is not feasible. Compared to
monthly dosing, dosing every 3 months will lead to an approximate 5-letter
(1 line) loss of visual acuity benefit, on average, over the following
9 months. Patients should be evaluated regularly.
Of the close to 1500 patients who were followed through clinical trials,
most reported side effects were mild to moderate and generally reversible.
Serious ocular adverse events related to the injection procedure are rare.
They could include inflammation of the interior of the eye, tear or detachment
of the retina or traumatic cataract. In the MARINA trial, the rate of
inflammation of the interior of the eye (endopthalmitis), one of the more
serious potential adverse events with Lucentis(*) administration, was 0.05%, or
5 cases out of 10,443 total injections.
Lucentis(*) was developed by Genentech and Novartis. Genentech has the
commercial rights to Lucentis(*) in the United States, while Novartis has
exclusive rights in the rest of the world.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "significant clinical advantages", "the
first and only", "significant opportunity", or similar expressions, or by
express or implied discussions regarding potential additional marketing
approvals or future sales of Lucentis(*). Such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may
cause actual results with Lucentis(*) to be materially different from any future
results, performance or achievements expressed or implied by such statements.
There can be no guarantee that Lucentis(*) will receive any additional marketing
approvals in any other countries, or that it will reach any particular sales
levels. In particular, management's expectations regarding commercialization
of Lucentis(*) could be affected by, among other things, additional analysis of
Lucentis(*) clinical data, new clinical data, unexpected clinical trial results,
unexpected regulatory actions or delays or government regulation generally,
the company's ability to obtain or maintain patent or other proprietary
intellectual property protection, competition in general, increased
government, industry, and general public pricing pressures, and other risks
and factors referred to in the Company's current Form 20-F on file with the US
Securities and Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those anticipated, believed, estimated
or expected. Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new information,
future events or otherwise.
CNIB is a nationwide, community-based, registered charity committed to
research, public education and the vision health of all Canadians. CNIB
provides the services and support necessary to enjoy a good quality of life
while living with vision loss. Founded in 1918, CNIB reaches out to
communities across the country, offering access to rehabilitation training,
innovative consumer products and peer support programs, as well as alternative
format newspapers and magazines, and braille and talking books from its
library. To find out more visit www.cnib.ca or call 1-800-563-2642.
About Foundation Fighting Blindness (FFB)
The Foundation Fighting Blindness is a Canadian health charity that was
founded in 1974 by a small group of families intent on finding a cure for the
disease robbing their children of sight. Its mission is to find the causes,
treatments and ultimately the cures for retinitis pigmentosa, macular
degeneration and related retinal diseases by the support and promotion of
research and the development of public awareness. For more information, go to
About Novartis Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. Novartis Pharmaceuticals
Canada Inc. conducts hundreds of clinical trials across the country seeking
new treatments for cardiovascular disease, diabetes, cancer, ophthalmology and
organ transplantation. In 2006, the Company invested over $69 million in
research and development. Novartis Pharmaceuticals Canada Inc. employs more
than 850 people in Canada and its headquarters are located in Dorval, Quebec.
In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in
Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer
Health Canada Inc., CIBA Vision Canada Inc. and Sandoz Canada Inc. For further
information about Novartis Canada, please consult http://www.novartis.ca.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to
protect health, cure disease and improve well-being. Our goal is to discover,
develop and successfully market innovative products to treat patients, ease
suffering and enhance the quality of life. We are strengthening our
medicine-based portfolio, which is focused on strategic growth platforms in
innovation-driven pharmaceuticals, high-quality and low-cost generics, human
vaccines and leading self-medication OTC brands. Novartis is the only company
with leadership positions in these areas. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2 billion.
Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel,
Switzerland, Novartis Group companies employ approximately 101,000 associates
and operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.
(*) Lucentis is a trademark of Genentech, Inc., used under permission by
Novartis Pharmaceuticals Canada Inc.
Satellite Feed Coordinates:
Wednesday September 5, 2007
11:00 to 11:30 and 14:00 to 14:30 EST
Anik F2C/7B @ 111.1 West
Vertical Polarization, D/L Freq. 3980 MHz.
Audio subcarriers 6.8 left, 6.2 right
Also available at Toronto T.O.C.
SDI Router Position No. 42
For further information:
For further information: Julie Holroyde, Hill and Knowlton, Tel (416)
413-4625, Mobile (416) 805-7942, firstname.lastname@example.org; Sabrina
Tremblay, Novartis Pharmaceuticals Canada Inc., Tel: (514) 633-7880 ext. 2254,
Mobile: (514) 880-9766, email@example.com