(Pr)Tasigna* receives Canadian approval

A significant improvement over the gold standard in treating a white blood cell cancer

DORVAL, QC, June 27, 2011 /CNW/ - Over a decade ago, Canadian patients diagnosed with chronic myeloid leukemia (CML), celebrated when PrGleevec* (imatinib mesylate) was approved in Canada. Those stricken with the white blood cell cancer finally had an effective treatment option that changed their cancer from a terminal disease to a manageable, chronic illness. Considered groundbreaking in the world of cancer, the new treatment even made major headlines around the world.

Today, a more effective and well tolerated therapeutic option has been added to the treatment arsenal in the war against CML. Tasigna* (nilotinib capsules) 150 mg has been granted a marketing authorization with conditions by Health Canada  for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive CML (Ph+ CML) in the chronic phase (first phase) of the disease.

"We are pleased by Health Canada's approval of Tasigna* for newly diagnosed CML patients," says Dr. Jeffrey Lipton, a medical oncologist with Princess Margaret Hospital in Toronto, Ontario. "This means Canadian physicians now have a more effective option than the current gold standard which has significant benefit for patients. Whereas Gleevec* provided a good response for CML patients, targeting cancer cells, Tasigna* goes even further by putting patients into a faster and deeper remission, rendering the disease almost undetectable. Most importantly, disease progression has been markedly reduced."

What is CML?
CML is one of the four types of leukemia.1 It is caused by an abnormal chromosome, called the Philadelphia (Ph+) chromosome which produces an abnormal cancer protein called Bcr-Abl, which is responsible for blocking the normal signal that tells the body to stop producing white blood cells. As a result, CML patients have a significantly elevated cancerous white blood cell count.

Without treatment, CML typically progresses over three to five years from the initial (chronic) phase through a transition period (accelerated phase) to a rapidly fatal form (blast crisis).2

"While absorbing the news of my CML diagnosis was difficult, I was grateful to learn that excellent targeted therapies existed to help me manage my disease," says Brian Milsom, a retired pilot from Surrey, British Columbia, who was diagnosed with CML over 3 years ago. "I was lucky to gain access to Tasigna* through a clinical trial immediately after being diagnosed. Since beginning treatment my cancer is virtually undetectable and I am able to lead the life I had before my diagnosis."

How it works
Taken twice daily as a 300 mg capsule (2 x 150 mg capsules) at approximately 12 hour intervals, on an empty stomach, Tasigna* works by inhibiting the proliferation of cells containing the Ph+ chromosome. It does this by targeting the production of the Bcr-Abl protein, which is produced only by cells containing the abnormal Ph+ chromosome. This protein is recognized as the key cause and driver of the overproduction of cancer-causing white blood cells in patients with Ph+ CML.

"In the past decade, targeted therapies have helped extend patient lives and improve their quality of life," says Cheryl-Anne Simoneau, President and CEO of the CML Society of Canada.  "However, nearly 40% of our CML patients need access to newer targeted therapies in order to stop disease progression and continue to see an improvement in their quality of life.  While we applaud Health Canada's decision to approve Tasigna, we are asking provincial governments to ensure that their citizens can access this treatment option in a timely manner.  Patients who receive the right drug, at the right time at the right dose have a better chance to win their battle over cancer."

Data demonstrates superior efficacy3
The Health Canada approval was based on the Phase III, randomized, open-label, multicenter ENESTnd trial, also known as (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients), which compared the efficacy and safety of Tasigna* versus Gleevec* in adult patients with newly diagnosed Ph+ CML in chronic phase.

The 12 month study, which included 846 patients from 34 countries, including Canada, demonstrated superiority to the standard of care Gleevec* in achieving both molecular response (a measure of deep reduction in Bcr-Abl, considered to be a critical therapeutic milestone associated with good long-term outcomes for patients)4, 5, 6 and complete cytogenetic response (undetectable Philadelphia chromosome, which is the hallmark of this cancer).

Tasigna* eliminated Bcr-Abl faster and more deeply than Gleevec* and resulted in lower rates of cancer progression after 12 months of therapy.

The ENESTnd trial is the largest global comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients in chronic phase. The most commonly reported adverse drug reactions included rash, pruritus, headache, nausea, fatigue, and myalgia.  Most of these adverse drug reactions were mild to moderate in severity.

About Tasigna*
On July 22, 2010, Health Canada approved Tasigna* (nilotinib capsules) with conditions, for the treatment of chronic phase (CP) Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including Gleevec* (imatinib mesylate).

On September 9, 2008, Health Canada approved Tasigna* (nilotinib capsules) with conditions, for the treatment of accelerated-phase (AP) with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including Gleevec* (imatinib mesylate).

Tasigna* was specifically designed - based on the success of Gleevec* - to preferentially target Bcr-Abl, the key cause and driver of Ph+ CML.

Tasigna* important safety information
Tasigna* prolongs the QT interval.  Sudden cardiac deaths have been reported in patients receiving Tasigna*. Tasigna* should not be used in patients with a known long QT prolongation or with a persistent QTc of >480 msec. Tasigna* should not be used in patients with uncorrectable hypokalemia (low potassium levels), hypomagnesemia (low magnesium levels).  Hepatotoxicity/Hepatic failure, pancreatitis and myelosuppression have been reported. Hypokalemia or hypomagnesemia must be corrected prior to Tasigna* administration and should be periodically monitored. Drugs known to prolong the QTc interval and strong CYP3A4 inhibitors should be avoided. Tasigna* must not be taken with food since its absorption is increased if taken with food.

For additional information, please refer to the product monograph.

Gleevec* important safety information
The majority of patients experienced adverse events at some point in time, however, most events were of mild to moderate grade. In adult clinical trials, drug discontinuation for drug-related adverse events was observed in 2.4% of newly diagnosed patients, in 5% of patients in chronic phase, 8% in accelerated phase and 9% in blast crisis.

Rare/serious adverse reactions include: sepsis, pneumonia, depression, convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis, hepatic failure, exfoliative dermatitis, angioedema, Stevens-Johnson syndrome, renal failure, fluid retention, edema (including brain, eye, pericardium, abdomen and lung), hemorrhage (including brain, eye, kidney and gastrointestinal tract), diverticulitis, gastrointestinal perforation, tumor hemorrhage/ necrosis, hip osteonecrosis/avascular necrosis.

For additional information, please refer to the product monograph.

The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology, such as "to file", "may", "should", "potential", "promise", "plans", "will", or similar expressions, or by express or implied discussions regarding potential new indications or labelling for Tasigna* or regarding potential future revenues from Tasigna* or Gleevec*. 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 Tasigna* or Gleevec* to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Tasigna* will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Tasigna* or Gleevec* will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Tasigna* and Gleevec* could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; 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; 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.

About Novartis Pharmaceuticals Canada Inc.

Novartis Pharmaceuticals Canada Inc. 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 2010, the Company invested close to $100 million in research and development and conducted clinical trials across the country seeking new treatments in Ophthalmology, Respiratory diseases, Neurosciences (including MS), Immunology and Infectious diseases, Cardiovascular, Oncology (including Hematology) and organ transplantation. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., Alcon Canada Inc. and Sandoz Canada Inc. For further information about Novartis Canada, please consult www.novartis.ca.

*Tasigna  and *Gleevec are registered trademarks.




1 CML Society of Canada: Understanding CML - http://www.cmlsociety.org/?q=node/14. Accessed July 15, 2010.

2 Hematologica 2008; 93(s1): 47 Abstract 0118

3 Tasigna* Product Monograph.  Novartis Pharmaceuticals, June 23, 2011.

4 Hochhaus A, O'Brien SG, Guilhot F,et al. IRIS Investigators. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia. Leukemia. 2009 Jun;23(6):1054-61.

5 Müller MC, Hanfstein B, Erben P, et al. Molecular response to first line imatinib therapy is predictive for long term event free survival in patients with chronic phase chronic myelogenous leukemia - an interim analysis of the randomized German CML Study IV. Blood (ASH Annual Meeting Abstracts) 2008, 112: Abstract 333.

6 Baccarani M, Cortes J, Pane F, et al. Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet. J Clin Oncol. 2009 Dec 10;27(35):6041-51.

SOURCE Novartis Pharmaceuticals Canada Inc.

For further information:

For additional information or to arrange an interview with a physician, please contact:

Dita Kuhtey
Cohn & Wolfe
(416) 924-5700, ext. 4032
      Lise Huneault
Novartis Pharmaceuticals Canada Inc.
(514) 631-6775, ext. 1203



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