Biotech Values

[DewDiligence]

Tekturna Fails to Show Benefit in ‘Heart-Shaping’ Study

[Tekturna, the much ballyhooed hypertension drug NVS acquired from Speedel, has been a commercial disappointment (in 4Q09 it sold at an annualized rate of $350M) and this study obviously won’t help. Adding Tekturna to SoC not only failed to show efficacy, but also caused more SAE’s. NVS’ own PR is at http://www.novartis.com/newsroom/media-releases/en/2010/1394184.shtml .]

http://www.reuters.com/article/idCNN1625841020100316

›Tue Mar 16, 2010 12:29pm EDT
By Bill Berkrot and Debra Sherman

ATLANTA, March 16 (Reuters) - The addition of the Novartis <NOVN.VX> blood pressure medicine Tekturna to current standard drugs used to treat patients who had a heart attack failed to help prevent changes in the heart's size and worsening of its blood-pumping ability, according to data from a study.

In addition, patients who got Tekturna on top of current therapy, which includes other types of blood pressure drugs, were more likely to have potentially dangerous levels of potassium in the blood, more kidney dysfunction, and hypotension, or blood pressure that is too low.

Tekturna is from a new class of drugs that works by directly blocking the hormone renin. Other hypertension drugs [i.e. the ACE and ARB classes] also work on the renin-angiotensin system, which regulates blood pressure.

"Our results ... showed no benefit and potentially greater risk of adverse events when combining two inhibitors of the renin-angiotensin system," said Dr Scott Solomon of Brigham and Women's Hospital in Boston, who presented the data at the American College of Cardiology scientific meeting in Atlanta.

The primary goal of the study was to measure changes in heart size between those who got the Novartis drug on top of their other medications and those who received their normal therapy plus a placebo.

"We saw no difference," Solomon said.

Researchers had believed that adding Tekturna to current therapy could help slow the enlarging of the heart and the worsening of its pumping ability after a heart attack -- a condition that affects 25 percent to 40 percent of patients who survive a heart attack.

Instead, the study was the latest presented at the ACC meeting to find that more intensive therapy, or adding additional drugs to current standard treatments, failed to improve patient outcomes and possibly led to potentially hazardous side effects.

Solomon said the study was undertaken to provide information that researchers hoped would help them plan a much larger trial to assess if the addition of Tekturna could cut the risk of death and heart failure in patients who survive a heart attack. Given the results of this study, he said, the plan for a so-called outcomes trial will be shelved.

Tekturna, known chemically as aliskiren and sold outside the United States as Rasilez, had global sales of $290 million in 2009 for Novartis. It was launched in 2007 after lowering blood pressure better in clinical trials than an ACE inhibitor, one of the types of drugs currently given to heart attack patients.

The new Tekturna data involved 672 patients who began the study two to six weeks after suffering a heart attack. All had evidence of impaired left ventricle function, with at least 20 percent of the heart unable to contract due to scarring. The patients also had a below-normal ejection fraction -- a measure of the proportion of blood in the left ventricle that is pumped into circulation with each heart beat. Normal ejection fraction is at least 50 percent. Patients in the trial had an average ejection fraction of 38 percent.

In addition to no significant difference in heart size between the Tekturna and placebo groups, the rates of heart-related death, hospitalization for heart failure, another heart attack or stroke were similar in the two groups, researchers said.

Despite the disappointing results, Solomon said the addition of Tekturna to standard therapy was worth studying in other patient populations.‹