DORVAL, QC, Nov. 16 /CNW Telbec/ – New Brunswickers with wet age-related macular degeneration (AMD) now have access to the new treatment Lucentis* (ranibizumab injection) through the New Brunswick Prescription Drug Program (NBPDP) – an important development that demonstrates the government’s commitment to ensuring New Brunswick residents diagnosed with the leading cause of adult-onset vision loss receive optimal treatment.

New Brunswick now joins Newfoundland and Labrador as the only second Atlantic province to reimburse Lucentis*, giving patients for whom the diagnosis of wet age-related macular degeneration could previously have meant rapidly deteriorating central vision loss and possibly even blindness , real hope to preserve and even improve vision and to maintain their independence.  New Brunswick now joins public drug plans in Newfoundland, Labrador, Quebec, Ontario, British Columbia, Saskatchewan, the Yukon and Alberta in reimbursing Lucentis*.

Lucentis* sets a new treatment standard for people suffering from the wet form of age-related macular degeneration as the only approved therapy for wet age-related macular degeneration 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 function and can increase their ability to perform activities requiring central vision such as seeing faces, reading and driving and independence.

The decision to reimburse Lucentis* is testament to the important clinical benefits of this treatment. 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.

Novartis Pharmaceuticals Canada Inc. continues to work with officials in the remaining provinces to ensure all Canadians with wet macular degeneration who rely on provincial drug plans will equally have access to Lucentis*.

About Age Related Macular Degeneration
Nearly 300,000 Canadians suffer from wet age-related macular degeneration.  It is anticipated that 20,000 new cases of wet age-related macular degeneration will be diagnosed in Canada this year alone, a number expected to double within the next 25 years.  Age-related macular degeneration 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.  Age-related macular degeneration can lead to vision loss and blindness.  Wet age-related macular degeneration is responsible for 90% of vision loss associated with age-related macular degeneration.

About Lucentis*

Lucentis* is recommended to be administered by intravitreal (in the eye) 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.

Close to 1,500 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, 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.

About Novartis Pharmaceuticals Canada Inc.

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.  In 2008, the Company invested over $96 million in research and development.  Novartis Pharmaceuticals Canada Inc. employs approximately 800 people in Canada and its headquarters are located in Dorval, Quebec.  It has been named one of the “50 Best Employers in Canada” for the last three years.  For further information, please consult www.novartis.ca.

About Novartis

Novartis AG 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 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 98,000 full-time associates and operate in over 140 countries around the world.  For more information, please visit http://www.novartis.com.

Forward-Looking Statement

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.

* Lucentis is a trademark of Genentech, Inc., used under permission by Novartis Pharmaceuticals Canada Inc.

For further information: Julie Holroyde, Hill and Knowlton, Mobile: (416) 254-5300, julie.holroyde@hillandknowlton.ca; Sabrina Tremblay, Novartis Pharmaceuticals Canada Inc., Mobile: (514) 880-9766, sabrina.tremblay@novartis.com

New Brunswick joins Newfoundland and Labrador as only the second Atlantic Canadian province to provide coverage for Lucentis treatments.  With the annoucement, New Brunswick joins Newfoundland and Labrador, Quebec, Ontario, British Columbia, Saskatchewan, the Yukon and Alberta in providing treatments for patients diagnosed with wet macular degeneration.

People diagnosed with wet macular degeneration generally experience a rapid deterioration of their central vision that eventually leads to blindless.  Lucentis has become the treatment standard for wet macular degeneration and has been shown to dramatically improve the vision in the majority of the patients receiving the injections.  In clinical trials, Lucentis was shown to improve the vision of approximately 40 percent of patients to a visual acuity of 20/40 or better.

In March 2008, the Common Drug Review (CDR), Canada’s national drug review panel recommended that Lucentis be covered under provincial drug plans.  Ontario and Quebec were the first provinces to provide coverage of Lucentis for macular degeneration.

Lucentis is designed specifically for use in teh eye and is administered through injections.  Wet macular degeneration is characterized by the formation of abnormal blood vessels and leakages behind the retina that results in the loss of central vision.  Lucentis treatments targets these abnormal blood vessels and prevents further leakages from occurring.

With New Brunswick being the latest Canadian province to provide coverage for Lucentis, one can only hope that the remaining provinces will follow suit.

In March 2008, the Common Drug Review committee made a recommendation that ranibizumab (Lucentis) be included as part of the drug plan formulaires across Canada.  Currently, only Ontario and Quebec has included coverage for this drug as a treatment of wet macular degeneration.

On April 27, 2008, all provincial government health departments in Canada were contacted through the mechanisms identified on their website.

Macular Degeneration Support Canada asked the following questions:

• Given that the Common Drug Review Committee has recommended provincial health care systems provide coverage for the drug Lucentis as a treatment of macular degeneration, does your province provide coverage for this drug?
• If coverage for Lucentis is not provided, what treatment options do you pay for and provide for patients suffering from Macular Degeneration

The province of New Brunwick had the following response.

The Canadian Expert Drug Advisory Committee’s (CEDAC) recommendation that ranibizumab (Lucentis) be listed on Federal/Provincial/Territorial drug plan formularies has been received.  However, the listing decision for the New Brunswick Prescription Drug Program has not yet been finalized.   Verteporfin (Visudyne) is covered for age-related macular degeneration (AMD) for New Brunswick residents. Some ophthalmologists may opt to use bevacizumab (Avastin®) as their drug of choice for AMD and charge the patient for the drug.

The only Canadian provinces to reply indicating that Lucentis was covered as a treatment for the wet macular degeneartion have been Ontario and Quebec.

Nova Scotia and Newfoundland have not yet provided a response.