Global Navigation

Sub Men

Not currently logged in

Novartis' IBS treatment taken off US market

Novartis has suspended sales of irritable bowel treatment, Zelnorm/ Zelmac (tegaserod) in the US, after a review of data revealed a statistically significant increase in cardiovascular ischaemic events

Swiss pharmaceutical company, Novartis, has suspended sales of its constipation-predominant irritable bowel treatment, Zelnorm/ Zelmac (tegaserod) in the US, after a review of data revealed a statistically significant increase in cardiovascular ischaemic events.

The events included myocardial infarction, stroke, and unstable angina pectoris. The FDA has concluded, based on these data that for most patients the benefits of this drug no longer outweigh the risks.

The analysis of more than 11,600 patients treated with Zelnorm and over 7,000 patients treated with placebo showed that the risk of serious cardiovascular adverse events (angina, heart attacks, and strokes) associated with use of Zelnorm was higher than with the placebo.

FDA said in a statement: "Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke."

The FDA added that it would work with Novartis to allow access to Zelnorm as an investigational drug (IND) for "patients with no other treatment options where the benefits may outweigh the risks"

The FDA has also indicated to Novartis the possibility of considering limited re-introduction of Zelnorm at a later date, if a population of patients can be identified in which the benefits of the drug outweigh the risks. Any such proposal would be the subject of a public advisory committee meeting before an FDA decision.

Zelnorm received FDA approval for the short-term treatment of women with IBS in the US in July 2002. The drug also received FDA approval for the treatment of men and women less than 65 years of age with chronic idiopathic constipation in the US in August 2004.

Zelnorm/Zelmac is approved for the treatment of constipation-predominant IBS in 50 countries including Australia, Switzerland, Canada, the US, Mexico, China and Brazil. Zelnorm/Zelmac is also approved for the treatment of chronic constipation in more than 20 countries including the US, Canada and Mexico.

Novartis markets tegaserod under the trademark Zelnorm in the US, Canada, Philippines and South Africa; and as Zelmac in Switzerland, Latin America and the Asia-Pacific region. Novartis is in discussion with health authorities in other countries where Zelnorm/Zelmac is available to determine next steps.

Dr Jeffrey L Anderson, 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, said, however: "My review of the data suggested that a causal relationship is unlikely between tegaserod and the rare cardiovascular ischemic events observed in clinical trials. Furthermore, the data did not show any consistent pattern of event type, time to event or dose relationship in tegaserod-treated patients."

Dr James Shannon, Global Head of Development at Novartis Pharma, added: "Zelnorm/Zelmac provides unique benefits to patients by treating the multiple symptoms of abdominal pain, bloating and constipation that are associated with IBS with constipation. Although we have complied with the FDA's request and are collaborating with the agency, we continue to believe that Zelnorm/Zelmac provides important benefits for appropriate patients."

Financial impact
For its 2007 financial guidance, Novartis has revised its outlook for net sales growth to above five per cent, while for the pharmaceuticals division it has forecast a low- to mid-single-digit rate, both in local currencies. Novartis is still evaluating the impact on the full-year 2007 operating and net income results from continuing operations, excluding the announced divestiture of Medical Nutrition expected to be completed in 2007.

Dresdner Kleinwort analysts have said the Zelnorm suspension would have an impact on Novartis, noting that the drug would have brought the company more than USD 1bn in sales for 2012. The long-term outlook of the company was positive, however, and it should recover after taking a hit in the short term.

Prudential analysts had anticipated Zelnorm sales of USD 660m in global sales in FY07, so the withdrawal could reduce the company's earnings per share by about two per cent. They added that liability lawsuits could soon emerge, but were unlikely to have much financial impact on the company.

Novartis' shares fell four per cent (USD 2.26) to rest at USD 54.63 on 31 March 2007.

4th April 2007