Novartis ends Tekturna trial on safety concerns

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Bad news for Novartis' ($NVS) blood pressure med Tekturna (aka Rasilez). The drug company has decided to end a trial evaluating the med in Type 2 diabetes patients with renal impairment who are also at high risk of cardiovascular and renal events after researchers saw an increased number of adverse events--including nonfatal stroke, renal complications, hyperkalemia and hypotension--in the Tekturna plus standard of care arm.

There are many treatments for high blood pressure, but Tekturna works differently versus other meds. The company was trying to establish with this and other studies whether Tekturna, if taken over a longer period of time could protect key organs, such as kidneys and the heart, Dow Jones notes.

The company says it is in ongoing talks with health authorities worldwide about the implications of the trial's findings. As a precautionary measure, Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE inhibitor or angiotensin receptor blocker.

Kepler's Martin Voegtli notes that the higher number of adverse events with the Novartis drug was a "major setback" and could lead to the drug being pulled from the market, according to a Bloomberg report. And it also could serve as bad news to members of Novartis' sales force. Some analysts are speculating that Novartis will now accelerate plans to reduce its sales force in the U.S. to cut costs. In fact, Deutsche Bank estimates that the Swiss drugmaker may reduce as many as 1,000 sales jobs as a direct result of the study results, according to Dow Jones. The drugmaker hasn't commented on this prediction.

"The finding comes very unexpected," says Vontobel's Andrew Weiss, who once saw Tekturna as generating peak sales of about $2.9 billion if it could be shown that the drug had additional benefits for key organs if taken over a long period of time. Now, however, he will reduce his sales estimates.

Still, the company has a number of successful meds in its portfolio, including Gilenya for multiple sclerosis, so Novartis does have some backup. Total sales of Rasilez/Tekturna-based products for the first 9 months of this year were $449 million, or 1% of Novartis' sales, and product profitability in 2011 was negative. Novartis predicts in its statement that Tekturna sales "are likely to be negatively impacted by the study results going forward."

- check out the Novartis release
- see Dow Jones' take
- get more from Bloomberg

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