95 per cent of Canadians who rely on public drug plans have access to Lucentis* while Nova Scotians with wet AMD are denied
DORVAL, QC, April 15 /CNW Telbec/ - Despite critical patient need and the significant scientific evidence to support the clinical merits of Lucentis* (ranibizumab) for the treatment of wet age-related macular degeneration (AMD), the Nova Scotia government has decided against funding the treatment. The decision to not reimburse Lucentis* is devastating for Nova Scotians who have been waiting for the treatment since last fall when the government publicly stated it would consider reimbursement.
Eight of Canada's ten provinces currently reimburse Lucentis* and this decision makes Nova Scotia the only province to not list the treatment after evaluation of the file. While currently 95 per cent of Canadians who rely on public drug plans and need Lucentis* have access to it, Nova Scotians are being denied an equal chance to change the outcome of their disease.
Lucentis* is reimbursed under public drug plans in New Brunswick, Newfoundland, Labrador, Quebec, Ontario, British Columbia, Alberta, Saskatchewan, the Yukon, Nunavut and Northwest Territories. Manitoba will reimburse Lucentis* under the province's public drug plan starting on June 1st 2010. Novartis continues to work with officials in Prince Edward Island to ensure people in this province have access to Lucentis* as soon as possible.
Lucentis* was approved for use in Canada in June 2007 and in March 2008 the Common Drug Review (CDR), Canada's national drug review process, recommended that it be listed by provincial drug plans.
Lucentis* sets a new treatment standard for people suffering from the wet form of AMD as the only approved therapy by Health Canada to demonstrate statistically and clinically significant improvement in vision in the majority of patients. While earlier therapies were able to slow the progression of vision loss, 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.
Designed specifically for use in the eye and administered by injection into the eye, Lucentis* helps to stabilize or improve patients' vision and vision-related functions. Lucentis* can increase their ability to perform activities requiring central vision such as seeing faces, reading and driving and to maintain their independence.
Nearly 300,000 Canadians suffer from wet AMD. It is anticipated that 20,000 new cases of wet AMD will be diagnosed in Canada this year alone, a number expected to double within the next 25 years. AMD is a progressive disease that causes rapid and severe central vision loss in a matter of a few weeks to months and can severely compromise a person's ability to function independently. AMD can lead to vision loss and blindness. Wet AMD is responsible for 90% of vision loss associated with AMD.
Lucentis* is administered by intravitreal (in the eye) injection. The treatment is initiated with a loading phase of one injection per month for three consecutive months, followed by a maintenance phase in which patients should be monitored monthly for visual acuity. If the patient experiences a loss of greater than 5 letters in visual acuity, or clinical or diagnostic evidence of disease activity, Lucentis* should be administered.
Close to 7,500 wet AMD patients were followed through clinical trials. Of the reported side effects, most 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, tearing 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.
About Novartis Pharmaceuticals 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 clinical trials across the country seeking new treatments in the area of cardiovascular, vision health, cancer, organ transplantation, multiple sclerosis, respiratory diseases and many others. In 2009, the Company invested close to $110 million in research and development. Headquartered in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs more than 750 people in Canada.
In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada includes Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc., Novartis Animal Health Canada Inc. and Sandoz Canada Inc. For further information, please consult www.novartis.ca.
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group invested USD 7.5 billion globally in R&D activities. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit www.novartis.com.
The foregoing release contains forward-looking statements that can be identified by terminology such as "the first and only", "significant", "optimal", or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Lucentis* or regarding potential future revenues from Lucentis*. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and 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 be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Lucentis* will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Lucentis* could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG'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.
* Lucentis is a registered trademark of Genentech, Inc., used under
permission by Novartis Pharmaceuticals Canada Inc.
SOURCE Novartis Pharmaceuticals Canada Inc.
For further information: For further information: Sabrina Tremblay, External Communications, Novartis Pharmaceuticals Canada Inc., Mobile: (514) 880-9766, email@example.com