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UPDATE 2-Novartis stops Tasigna trial in patients with GIST
April 11, 2011 / 6:44 AM / in 7 years

UPDATE 2-Novartis stops Tasigna trial in patients with GIST

* Independent data monitoring c‘ttee recommended trial end

* Interims showed Tasigna unlikely to show superiority

* Glivec is current standard of care in this setting

* Gets positive data for MS drug Gilenya

(Adds details, background)

By Katie Reid

ZURICH, April 11 (Reuters) - Novartis AG NOVN.VX has stopped a late-stage trial for Tasigna in intestinal tumors after a committee said the cancer drug was unlikely to show it was more effective than Glivec, the current standard of care.

An independent data monitoring recommended stopping the trial, known as ENESTg1, for Tasigna in newly diagnosed patients with unresectable and/or metastatic GIST that has spread to other parts of the body as interim efficacy results showed Tasigna was unlikely to show superiority to Novartis’s older drug.

Novartis said it remained committed to advancing treatment options for patients with GIST, or gastrointestinal stromal tumours. Symptoms of this disease vary but include bleeding, dyspepsia and obstruction, according to the Merck Manual.

The Swiss drugmaker is hoping Tasigna will ultimately replace Glivec, which raked in sales of more than $4 billion last year for Novartis. Tasigna has already received European backing to treat patients with a type of blood cancer.

But this setback deals Novartis’s oncology pipeline a blow at a time when the group is increasingly focusing on drugs prescribed by specialists for diseases such as cancer to protect profitability when top-selling drugs, including blood pressure drug Diovan, start to face generic competition.

Separately on Monday, Novartis said its multiple sclerosis medicine Gilenya delayed the progression of disability both for patients who had already been treated for MS and for those who had not received prior treatment.

At 0907 GMT, Novartis shares were trading 0.6 percent lower, underperforming a slightly weaker European healthcare index .SXDP.

“Gilenya good news, Tasigna diappointing news. The effects of today’s news should neutralise each other. We will be increasing Gilenya estimates by $500 million and reducing Tasigna by the same amount,” Vontobel analyst Andrew Weiss said in a note. (Editing by Jon Loades-Carter and Louise Heavens)

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