(Pr)Tasigna* receives Canadian approval

New hope for patients with chronic myeloid leukemia

DORVAL, QC, Aug. 20 /CNW/ - Lisa Machado, who was diagnosed with chronic myeloid leukemia (CML) two years ago, a life-threatening form of leukemia, is grateful that another option is available to keep her cancer in check.

Tasigna* (nilotinib) capsules have been approved with conditions in Canada as a new therapy for patients with CML, in the chronic phase (first phase) of the disease. Patients must be resistant to or intolerant of at least one prior therapy, including (Pr)Gleevec* (imatinib mesylate), an established standard of care.

Before Gleevec*, patients' options were limited. However, in a landmark clinical trial, 86.4 per cent of newly diagnosed chronic-phase Philadelphia chromosome-positive (Ph+) CML adult patients, treated with Gleevec*, were alive after 7 years(1). Despite this success, about 20 per cent of those diagnosed with CML will be resistant or intolerant to Gleevec*, driving the need for new treatment options like Tasigna*(2).

"Thankfully, I have had an excellent response to Gleevec," says Machado. "Knowing that there are alternatives like Tasigna should Gleevec stop working for me, gives me and thousands of other Canadians with CML the ability to look to the future with a little more certainty."

What is CML?

CML is one of the four types of leukemia(3). 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)(4).

"Targeted therapy offers hope to those living with CML and will make a huge difference for many of them and their families," says Cheryl-Anne Simoneau, president and CEO of The CML Society of Canada. "While we applaud Health Canada's approval of Tasigna*, we urge provincial governments to act quickly and provide reimbursement to patients who need access to this important treatment option. Available options can mean the difference between success with achieving treatment goals or having the disease become critical and or fatal for some patients."

How it works

Taken twice daily 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.

The Health Canada conditional approval was based on the interim analysis of an ongoing Phase II open label, multicenter clinical trial of 280 patients, which evaluated the drug's safety and rates of major cytogenetic response (MCyR) (where a significant reduction or no CML cells containing the Ph chromosome can be seen in a sample of bone marrow) and rates of complete hematologic response (CHR) (normalization of white blood cell counts) in Gleevec* resistant or intolerant patients with Ph+ CML in chronic phase(5). Tasigna* reduced or eliminated cells carrying the abnormal Ph chromosome in 52 per cent of patients in the chronic phase of the disease after a median treatment duration of 261 days(5).

"Although Gleevec remains a wonderful drug for the majority of patients who are taking it and doing well, for those patients whose disease did not respond or no longer responds, Tasigna represents an important advance," says Dr. Jeffrey Lipton, a medical oncologist with Princess Margaret Hospital in Toronto, Ontario. "Treatment options are important for cancer patients, since not all therapies work or are tolerated by every patient. This approval means Canadian physicians have another option or choice to treat their CML patients. However, a treatment is only effective when it can be accessed, so public funding is critical to allow these patients to effectively manage their cancer."

Access to treatment is paramount

It was a strange bruise on her forearm that prompted Lisa Machado, a mother of two young children, to seek medical attention. "When I found out I had CML, all I could think about was whether or not I would see my babies grow up," says Machado. "Gleevec has given me hope. It has meant that I can still be an active and involved mom even though I have cancer. The fact that there are other medications, like Tasigna, is a gift. But accessibility is key - nobody with a life-threatening disease wants to be told they can't get the medication that could save their life."

"Novartis is pleased to bring another targeted therapy to market that will benefit CML patients in Canada. We will work with governments and payers to ensure that patients have access to this innovative treatment," says Tom Rossi, president of Novartis Pharmaceuticals Canada Inc.

About Tasigna

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 QT of (greater than)480 msec. Tasigna* should not be used in patients with uncorrectable hypokalemia (low potassium levels), hypomagnesemia (low magnesium levels). Hepatotoxicity/Hepatic failure, and pancreatitis have been reported. Hypokalemia or hypomagnesemia must be corrected prior to Tasigna* administration and should be periodically monitored. Drugs known to prolong the QT 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 treated with Gleevec* in clinical trials experienced adverse events at some time. Most events were of mild to moderate grade and treatment discontinuation was not necessary in the majority of cases.

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., 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 hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, oncology, diabetes, cancer, ophthalmology and organ transplantation. In 2009, the Company invested close to $110 million in research and development. Novartis Pharmaceuticals Canada Inc. employs more than 750 people in Canada and its headquarters are located in Dorval, Québec. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc. and Sandoz Canada Inc. For further information about Novartis Canada, please consult www.novartis.ca.

*Gleevec is a registered trademark.

*Tasigna is a registered trademark.

    (1) Gleevec* Product Monograph. Novartis Pharmaceuticals, July 17,
    (2) Deininger M, et al. Blood. 2009;114(22):462
    (3) CML Society of Canada: Understanding CML -
        http://www.cmlsociety.org/?q=node/14. Accessed July 15,
    (4) Hematologica 2008; 93(s1): 47 Abstract 0118
    (5) Tasigna* Product Monograph. Novartis Pharmaceuticals, July 20,


For further information: For further information: or to arrange an interview with a physician, please contact: Dita Kuhtey, Cohn & Wolfe, (416) 924-5700, ext. 4032, dita.kuhtey@cohnwolfe.ca; Lise Huneault, Novartis Pharmaceuticals Canada Inc., (514) 631-6775, ext. 1203, lise.huneault@novartis.com

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