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

In order to develop Avastin into a safe and effective drug for wet macular degeneration, Genentech says that they would have to start at the pre-clinical trial stage. Considering the involvement of time (5-7 years), they maintain that such an effort would be fruitless when Lucentis is already in place and proving its value as a macular degeneration treatment.  GenenTech has indicated that it does not plan on entering into a clinical trial to test Avastin as a treatment for macular degeneration.

Regarding the large cost difference between the two drugs, the company holds that it should not be a serious concern, as treatment is fully-accepted by insurance and Medicare. Genentech also has in place their “Access to Care” foundation to provide financial assistance to patients if needed. Genentech strongly states that their decision to not pursue Avastin as a macular degeneration treatment option is not financially-based. The cost of such research would be high, they say, but to invest so much time and money trying to prove the dubious theory that Avastin is as good as Lucentis would be counterproductive when there are more important areas that need attention.  However, there have been threats by the United States Senate to investigate the company’s practices and pricing of the drug, especially after the company stated it would limit the availability of Avastin for retinal uses.

Despite concerns about Avastin, small studies and clinical observations have recently shown that intravitreal treatment with Avastin is showing no systemic adverse events and that the drug is showing success in inhibiting neovascularization and improving visual acuity in those patients with macular degeneration.  Small studies have shown no difference in eyes treated with Avastin and eyes treated with the more expensive drug Lucentis.

Avastin works by inhibiting growth of abnormal blood vessels in the back inner part of the eye (retina), a condition that occurs in wet macular degeneration. Researchers at the University of Miami’s Bascom Palmer Eye Institute said Avastin substantially reduced blood vessel leakage contributing to vision loss. A larger study is needed to determine if benefits of Avastin as a macular degeneration therapy outweigh risks, said Philip J. Rosenfeld, MD, PhD, associate professor of ophthalmology at the Institute.

“A potential advantage of Avastin over other therapies for wet AMD is that vision improvement can occur within one week of treatment,” said Dr. Rosenfeld, the principal investigator of the Bascom Palmer clinical trial. “In addition to the improved vision, Avastin causes a reduction in leakage from the abnormal blood vessels, and we observed a restoration of normal macular anatomy.”

Dr. Rosenfeld went on to emphasize that Avastin therapy isn’t a cure and it’s not the right treatment for everyone with wet macular degeneration. Avastin is only for patients in the early stages of the disease and should be used within 6 months to 12 months from the time of onset, said Dr. Rosenfeld. Some people would rather have an injection in the eye than worry about the risks of a systemic drug. What this offers us is a new potential option for patients with wet AMD. It also provides us with additional evidence that VEGF is the major factor for blood vessel growth and vision loss in wet macular degeneration.

“We don’t know how many treatments will be needed,” Rosenfeld said. “In this study patients were treated two or three times over a twelve week period. As most patients commonly get wet macular degeneration in both eyes, an added advantage of this therapy is that both eyes can be treated with a single infusion into the arm. [Avastin is now delivered as an intraocular injection.] A larger clinical trial is needed to determine if the benefits of Avastin outweigh the risks.

Avastin will continue to be used as a treatment for macular degeneration until the cost of Lucentis become reasonable.

Off-label drug use is the practice of prescribing a drug for outside the use they were approved for.  Any approved drug may be used by a licensed practioner for uses other than those stated on the label.  The physician must make decisions based on best judgement and what they have learned about the drugs through medical journals and their colleagues.

With Avastin and Lucentis, the practice of off-label prescribing has a totally different meaning and has fueled the debate.

In 2006, Lucentis (ranibizamab) was approved by the U.S. Food and Drug Adminstration (FDA) as a treatment for wet macular degeneration.  Many doctors have argued however, that Avastin (bevacizumab) is as effective as a treatment of wet macular degeneration and it costs considerably less than Lucentis.  Avastin is only approved as a cancer drug and not as an FDA approved treatment for wet macular degeneration.  Those physicians prescribing this as a treatment for macular degeneration have been prescribing Avastin as an off-label use.

With Avastin and Lucentis, things are not always as they appear.  This is more than a simple case of off-label prescribing.  Both Avastin and Lucentis are produced by the same pharmaceutical company, Genentech.  Lucentis is a direct derivative from the original drug Avastin, with both being almost identical in molecular makeup.

In October 2007, Genentech announced it would limit the supply of Avastin for ocular uses starting January 1, 2008.  This announcement led to many outcries from the ophthalmology community, especially since it was felt that Genentech was putting profits ahead of patient care largely because Lucentis costs approximately $2,000 per treatment and Avastin costs appproximately $100 – $150 per treatment.  This is compounded by the fact that experts cannot determine the difference in eyes treated with Avastin and eyes treated with Lucentis when both drugs are used to treat macular degeneration.

This has placed many governments in a situation where they must either decide to provide coverage for the more costly drugs or allow the less expensive drug to be used to treat wet macular degeneration.  Add  to this the pressures that regulating bodies such as the Common Drug Review committee in Canada places on governments by recommending that the provincial health care systems in Canada should provide coverage for Lucentis.  Now countries with publicly funded health care systems such as Canada and the UK must make a decision as to whether they will provide the expensive drug Lucentis or balance their costs by allowing physicians to continue to use the off-label Avastin.  Governments are concerned with the liabilities that this may pose on them and the physicians, but must strike a fine balance between being fiscally responsible or meeting legally mandated requirements to provide free health care.

The fact that Lucentis costs much more than Avastin has not gone unnoticed.  In the United States the Senate Special Committee on Aging had contemplated holding hearings surrounding this controversy of Genentech’s pricing for Lucentis.  While this did not occur, Wisconsin Democrat Herb Kohl did call for an investigation into Genentech’s decision to limt the supply of Avastin if it was to be used in treating macular degeneration.

Genentech did lift the restrictions on the supply of Avastin when faced with the threat of hearings and an investigation, and promised to provide free Lucentis for an NIH/National Eye Institute sponsored head-to-head study designed to evaluate Avastin and Lucentis.

This entire controversy will continue for some time until trials and studies into these two closely related drugs continue and the findings are presented and reviewed by experts.  Until then, the controversy will continue and it is the patients and governments who pay the ultimate price, one with their vision, their other with their bottom line.

Avastin and Lucentis, two drugs to treat macular degeneration, steeped in controversy and politics.