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.

Avastin (bevacizumab) and Lucentis (ranibizumab) were compared in a double-masked, randomized controlled trial.  Lucentis is the preferred macular degeneration treatment and is approved by the FDA.  Avastin is an off-label macular degeneration treatment and was originally approved to treat colo-rectal cancer.

Until this recent study, there was no data supporting which macular degeneration drug was effective.

In this study, the Veterans Affairs Boston Healthcare System funded a study where patients were enrolled by a 2 to 1 randomization to either the Avastin or Lucentis treatment.  Patients were given intravitreal injections of either Avastin or Lucentis every month for the first three months of the trial and evaluated after the third injection to determine if subsequent macular degeneration treatments were required.

It was shown that at six months, there was no difference in those patients treated with Avastin or Lucentis.

This adds fuel to the debate over which of the two drugs should be used to treat macular degeneration.  Genentech refused to conduct any trials of Avastin as a macular degeneration treatment stating that Lucentis is the FDA approved treatment for the eye disease.

However, Avastin costs approximately $40 per treatment while Lucentis costs approximately $2000 per treatment.  With some patients requiring multiple injections to treat their macular degeneartion, the costs associated with Lucentis treatments can be enormous.

As the debate over whether Lucentis or Avastin is better for treating macular degeneration, new research recently reveals that making the choice will be much more difficult.

In a retrospective chart review published in the British Journal of Ophthalmology, it appears that Lucentis or Avastin are equally effective at decreasing macular thickness and volume.  Avastin appears to last longer than Lucentis.

Does this mean that Avastin is better than Lucentis when treating macular degeneration patients?  Not necessarily.

Another paper published in the Graefes Archive of Clinical and Experimental Ophthalmology reveals that Avastin accumulates within retinal pigment epithelial (RPE) cells.  Lucentis however, does not accumulate.  Thus, the study concluded that there are substantial differences in the pharmacokinetics of these two macular degeneration drugs.

A third study published in Investigative Ophthalmology and Vision Science reported that higher does of Avastin resulted in higher cell death of photoreceptors.  This study compared Avastin treatments with Macugen treatments.  Lucentis was not considered as part of this study.

Researchers concluded that the destruction of photoreceptors may be important for patients suffering from a variety of eye diseases, including macular degeneration and diabetic retinopathy, especially if Avastin treatments were continuing for a period of time.

Other studies in whether Lucentis or Avastin is better for treating macular degeneration are continuing.  The debate will continue especially since the cost of these two drugs is substantial.

VICTORIA, B.C. — The B.C. government will start funding two new drugs to treat people suffering from a disease that could cause blindness for seniors.

Health Minister George Abbott said Lucentis and Avastin will be available starting June 1 to patients dealing with age-related wet macular degeneration, with the recommendation of a retinal specialist.

B.C. currently funds only one drug – Visudyne – but it hasn’t proven effective for many seniors who’ve had to spend over $1,600 per treatment every six weeks for Lucentis.

Abbott said that besides slowing or stabilizing the disease, the newly funded drugs may even improve patients’ vision.

The announcement comes days before the B.C. election campaign officially begins April 14.

“The drugs have been under review for some time,” he said.

Ontario and Quebec already pay for the two drugs.

Abbott said Saskatchewan recently announced it would be funding only Lucentis while Manitoba will be footing the bill for Avastin.

Last December, public health authorities in Canada investigated a spike in eye inflammation among patients being treated for macular degeneration with the cancer drug Avastin.

The first cases were noticed in B.C. but Abbott said only one lot of the drug that was shipped worldwide – except to the United States – was responsible for the problem.

“It has not been a generalized problem with respect to Avastin,” he said.

Claude Dufour, 72, was thrilled to hear B.C. will be funding Lucentis. He said he has spent over $15,000 on it since last year.

The Kamloops, B.C., resident said his specialist tried the other two drugs but they didn’t work for him.

“Everybody that I talked to who’s taking Lucentis, it’s working,” said Dufour, who had already lost the sight in his right eye after macular degeneration struck over four years ago.

“In my right eye I was getting Avastin and I’m blind in my right eye,” he said.

Dufour said while he has been able to afford Lucentis up to now, he couldn’t have kept shelling out money for it.

He said he has been lobbying the government to fund the drugs to help seniors at risk of going blind.

“Last time I was at the hospital when I got an injection, there was a lady in her 80s and an older fellow and they couldn’t afford Lucentis,” he said. “She was getting the Avastin and she looked like she was going blind.”

Dufour said he’s angry the government waited until before an election to announce funding for the drugs.

“They’re hijacking seniors for their bloody election,” he said.

British Columbians go to the polls on May 12.

He said B.C. should have followed the lead of Ontario and Quebec to quickly approve vision-saving drugs.

Abbott said up to 3,500 British Columbians will receive one of the three treatment drugs each year to combat the disease that can quickly rob a senior of their eyesight.

The province expects to spend about $15 million a year on all three drugs.

With approximately 20,000 people in Newfoundland and Labrador suffering from Macular Degeneration, this announcement is major news.  With only 10 percent of the diagnosed cases of macular degeneration being the wet type of the eye disease, this means that approximately 2,000 people can benefit from this funding announcement.

Lucentis being covered for treating macular degeneration in Newfoundland and Labrador is a major announcement.  The CBC has a podcast on Macular Degeneration where it talks to the CNIB in St. John’s, Newfoundland.

Normally, patients would require between 3 and 15 injections of Lucentis.  What is not clear about the program announced by the Newfoundland and Labrador Government is how many treatments patients will qualify for.  What is clear is that the availability of Lucentis now means that seniors and the aging no longer have to worry about financing their treatments for wet macular degeneration.

Treatments of Lucentis are anticipated to cost approximately $2,000 per dosage and looking at the math, there is a potential to quickly consume the $2.8 million in funding announced.  However, being only the fourth province to step up to the plate and cover this drug is a major step.  It now means that those who need Lucentis to save their vision no longer have to worry about mortgaging their homes tao pay for treatments.

The findings were presented at the 2008 joint meeting of the American Academy of Ophthalmology and the European Society of Opthalmology.

The trials used evaluating the safety of Lucentis as a treatment of macular degeneration included the MARINA, ANCHOR, PIER and SAILOR trials, and included 3701 patients that had received a total of 28,547 injections of Lucentis.

Incidence of intraocular inflammation was somewhat higher in the MARINA and ANCHOR trials for Lucentis treated patients when compared to the sham treatment or the photodynamic thearapy for macular degeneration.  The rates of serious endophthalmitis per injection was very low for those treated with Lucentis when compared to those in the control group.

In the Lucentis vs the control group, the incidence of cataracts was comparable in the MARINA trial, but higher with Lucentis in the other trials.

The rate of stroke in the Lucentis group treated for macular degeneration was shown to be non significant.

The study showed that there were no safety concerns that should prevent physicians from using Lucentis to treat patients suffering from macular degeneration.

There was evidence to support that Avastin treatments for macular degeneration may be safe and effective, but there was no endorsement given.  Avastin has not been approved by the FDA for use in the eye.

The preliminary data reported at the American Society of Retina Specialists indicate that there is a difference between Avastin (bevacizumab) and Lucentis (ranibizumab) as a treatment for Macular Degeneration.  The difference is in the short-term biological effect and in the durability of activity.  This leads to differences in remission intervals in patients treated with Avastin or Lucentis for wet macular degeneration.

In a retrospective study of 52 patients that had been treated with Lucentis and 68 patients that had been treated for macular degeneration with Avastin, it was shown that the mean remission times were 6.6 months for Avastin and 3.8 months for Lucentis.

Using optical coherence tomography (OCT) to conduct qualitative analysis, the recurrence of choroidal neovascular activity in wet macular degeneration was found after treatments of either Avastin or Lucentis.

Dr. Chang and his colleagues who completed the study indicated that the advantage of Lucentis as a treatment for macular degeneration was in its short-term biological effect.  The advantage of Avastin as a treatment for macular degeneration is in its durability of activity.

Macular degeneration is a progressive eye disease that is the leading cause of blindness in people over 50. This disease attacks the macula which is the center portion of the retina, and ausese a loss of centra vision.

There are two types of macular degeneration: Dry and Wet. There is no macular degeneration cure for either type of the disease but there are treatments depended on the type of eye disease a person is diagnosed with.

Contrary to what some sites promote as a “macular degeneration cure” for those people suffering from the dry form of the eye disease, this information is not correct. Dry Macular degeneration has no cure, and no real treatment. However, in the Age Related Eye Disease (AREDS) study, it was found that a formula consisting of high levels of antioxidants could reduce the risk associated with developing an advanced form of dry macular degeneration.

With wet macular degeneration being the fastest progressing of the disease, accounting for 90 percent of the blindess caused by the eye disease, there are several treatments available for patients. The most promising treatments for macular degeneration are the anti-VEGF drugs such as avastin, macugen and lucentis.

Wet macular degeneration occurs when abnormal blood vessels leak and cause both scarring and a bulging of the macula. Macugen, Avastin and Lucentis have been shown to reverse the scarring and to stop the growth of these abnormal blood vessels. While not a cure for macular degeneration, these treatments have shown considerable promise to not only halt the progression of the disease, but in some cases, reverse the damage.

It must be noted, these are not cures for macular degeneration, but merely treatments for the disease. Wet Macular Degeneration can reoccur and require an additional treatment of these types of drugs.

Thus, the answer to the question “Is there a Macular Degeneration Cure?”, is NO, there is no cure for macular degeneration.