Novartis Suspends Canadian Marketing and Sales of Zelnorm in Response to Request From Health Canada- Recent retrospective analysis of pooled clinical trial data shows that the incidence of cardiovascular ischemic events in patients taking Zelnorm higher than in those taking placebo
- Novartis believes Zelnorm provides important benefits for appropriate patients.
- Discussions ongoing with Health Canada to evaluate best way to continue to make Zelnorm available to appropriate Canadian patients >>
DORVAL, QC, March 30 /CNW Telbec/ - Novartis is complying with a request from Health Canada to suspend Canadian marketing and sales of Zelnorm(R)(1) (tegaserod maleate) as a treatment for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
This action has been taken following a retrospective analysis of data from more than 18,000 patients in the Zelnorm clinical trial database.
A small (but non statistically significant) imbalance in cases of angina pectoris was recorded and included in the Canadian label when Zelnorm was approved in 2002. However, a recent analysis of the entire Zelnorm clinical database revealed a statistically significant imbalance in the incidence of cardiovascular ischemic events in patients taking Zelnorm compared to those taking placebo. These events included myocardial infarction, stroke, and unstable angina pectoris.
The data, which were reviewed by independent experts, showed that events occurred in 13 out of 11,614 Zelnorm-treated patients (0.11%), compared to one case out of 7,031 placebo-treated patients (0.01%). All patients affected had pre-existing cardiovascular disease and/or CV risk factors.
Results obtained from multiple mechanistic studies do not suggest any arterial vasoconstrictive effects of tegaserod.
"My review of the data suggested that a causal relationship is unlikely between tegaserod and the rare cardiovascular ischemic events observed in clinical trials," said Jeffrey L. Anderson, MD, Professor of Internal Medicine at the University of Utah and Associate Chief, Cardiology Division, LDS Hospital in Salt Lake City and an independent cardiologist who reviewed the data. "Furthermore, the data did not show any consistent pattern of event type, time to event or dose relationship in tegaserod-treated patients."
Nevertheless, Novartis has suspended the marketing and sales of Zelnorm in response to Health Canada's request in order to further evaluate this important safety information.
Novartis and Health Canada will communicate this information to physicians and patients, and will discuss the best way to continue to make Zelnorm available to appropriate patients. Canadian patients taking Zelnorm are being advised to stop taking their medication and consult their physicians regarding alternative treatment options.
Zelnorm received Health Canada approval for the treatment of women with IBS-C in Canada in March 2002. Zelnorm also received Health Canada approval for the treatment of patients less than 65 years of age with chronic idiopathic constipation in Canada in October 2005. Zelnorm/Zelmac is approved for the treatment of IBS with constipation in more than 50 countries including Australia, Switzerland, Canada, the US, Mexico, China and Brazil. Zelnorm is also approved for the treatment of chronic constipation in more than 20 countries including the US, Canada and Mexico. Novartis markets the therapy under the trademark Zelnorm (tegaserod maleate) in the US, Canada, Philippines and South Africa; and as Zelmac (tegaserod) in Switzerland, Latin America and the Asia-Pacific region.
The foregoing release contains certain forward-looking statements that can be identified by terminology such as "will," "outlook," or similar expressions, or by express or implied discussions regarding potential future approvals to return Zelnorm/Zelmac to the market, or potential future sales of Zelnorm/Zelmac, or the potential impact of Zelnorm/Zelmac on the potential future sales or earnings of the Novartis Group or its Pharmaceuticals Division. Such forward-looking statements involve known and unknown risks, uncertainties or other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Zelnorm/Zelmac will be approved by the FDA or other health authorities for return to the market for any indication, or that Zelnorm/Zelmac will achieve any particular level of sales. Nor can there be any guarantees that the Novartis Group, or the Pharmaceuticals Division, will achieve any particular financial results. In particular, management's expectations regarding these matters could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results or results of data analysis, including additional analysis of existing clinical data and other data regarding patients' experience with Zelnorm/Zelmac, or unexpected new clinical or other such data; competition in general; government, industry and general public pricing pressures; the ability to obtain or maintain patent or other proprietary intellectual property protection; as well as factors discussed in the Company's Form 20-F filed with the US Securities and Exchange Commission. 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 Canada
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, diabetes, cancer, organ transplantation, musculoskeletal diseases and ophthalmic diseases. In 2005, the Company invested over $65 million in research and development. Novartis Pharmaceuticals Canada Inc. employs approximately 800 people in Canada and its headquarters are located in Dorval, Quebec. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., (including Novartis Nutrition Corporation and Gerber (Canada) Inc.) Sandoz Canada and CIBA Vision Canada Inc. For further information about Novartis Canada, please visit http://www.novartis.ca">www.novartis.ca.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 101,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com">http://www.novartis.com.
-------------- (1) Also marketed as Zelmac in some countries
/For further information: Jason Jacobs, Communications, Novartis Pharmaceuticals Canada, (514) 633-7872, firstname.lastname@example.org/
Posted: April 2007