National drug review process recommends funding of the first ever
medication to improve vision and restore quality of life
DORVAL, QC, March 28 /CNW Telbec/ - Canadians diagnosed with the leading
cause of age-related vision loss, neovascular (wet) age-related macular
degeneration (AMD), are one step closer today to real hope for vision
improvement. The Common Drug Review (CDR), Canada's national drug review
process, has recommended today that provincial drug plans list the innovative
treatment Lucentis(*) (ranibizumab). The positive CDR recommendation for
Lucentis(*) is a critical step forward. It is now up to each province to follow
in the footsteps of Quebec and Ontario to recognize the innovative benefits of
Lucentis(*) and make it available to those who can benefit from it.
Ontario and Québec have shown leadership in the fight against blindness
by recognizing the need for this important treatment and fast-tracking the
review process and decision to add Lucentis(*) to their provincial drug plans.
The CDR decision to recommend Lucentis(*) for listing on provincial
formularies through this national advisory process is testament to its
significant clinical merits and will give real hope for vision improvement to
many Canadian patients for whom the diagnosis of wet age-related macular
degeneration (AMD) has too often meant rapid and severe central vision loss
and even blindness.
Novartis Pharmaceuticals Canada Inc. will continue to work with officials
in the remaining provinces to ensure all patients with wet AMD who rely on
provincial drug plans will have access to Lucentis(*).
"We hope that the drug plans in each province adopt the CDR
recommendations and reach timely decisions to provide patients who have wet
AMD with access to Lucentis(*)," says Dr. Alan Cruess, Professor and Head of the
Department of Ophthalmology and Visual Sciences at Dalhousie University and
President of the Canadian Ophthalmological Society. "We hope that all patients
suffering from wet AMD will be able to benefit from this unique treatment as
soon as possible before the disease has progressed and has a major impact on
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(*) helps to
stabilize or improve patients' vision loss which, in turn, can increase their
independence and ability to perform activities requiring central vision such
as seeing faces, reading and driving.
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.
About the Common Drug Review (CDR)
The Common Drug Review (CDR) conducts objective, rigorous reviews of the
clinical and cost effectiveness of drugs, and provides formulary listing
recommendations to the publicly funded drug plans in Canada (except Québec).
For further information, please consult www.cadth.ca.
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 1,500 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 "innovative", "the first and only",
"significant", 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.
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, oncology, diabetes, cancer,
ophthalmology and organ transplantation. In 2007, the Company invested close
to $86 million in research and development. Novartis Pharmaceuticals Canada
Inc. employs more than 800 people in Canada and its headquarters are located
in Dorval, Québec. 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
Novartis AG provides healthcare solutions that address the evolving needs
of patients and societies. Focused solely on growth areas in healthcare,
Novartis offers a diversified portfolio to best meet these needs: innovative
medicines, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, and consumer health products. Novartis is the only company
with leading positions in these areas. In 2007, the Group's continuing
operations (excluding divestments in 2007) achieved net sales of
USD 38.1 billion and net income of USD 6.5 billion. Approximately
USD 6.4 billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 98,200 full-time associates and operate in over 140 countries
around the world. For more information, please visit www.novartis.com.
(*) Lucentis is a trademark of Genentech, Inc., used under permission by
Novartis Pharmaceuticals Canada Inc.
For further information:
For further information: Sylvie Lafrance, HKDP Communications and public
affairs, (418) 523-3352 ext. 243, Mobile: (418) 956-9833,
firstname.lastname@example.org; Sabrina Tremblay, Novartis Pharmaceuticals Canada Inc.,
(514) 633-7880 ext. 2254, Mobile: (514) 880-9766,