The Burrill Report

A prospective, randomized 7,000-patient study found Scios/Johnson & Johnson’s intravenous heart failure drug Natrecor (nesiritide) was ineffective for trial patients and linked to potentially dangerous increased rates of low blood pressure. Results of the study were published in the July 7 issue of the New England Journal of Medicine. Natrecor, a recombinant B-type natriuretic peptide, was approved in 2001 for use in patients with acute heart failure, based on several small studies. Later meta-analyses of those studies and other small trials, however, indicated that the drug worsened renal function and nearly doubled early mortality. The larger ASCEND-HF study was initiated by Johnson & Johnson to assess whether the drug affected mortality or renal function. It found that use of Natrecor in patients with acute decompensated heart failure did not decrease the incidence mortality, nor did it impair renal function. However, the drug also failed to improve self-reported shortness of breath at 6 hours or 24 hours and it almost doubled the rates of both symptomatic and asymptomatic hypotension. The ASCEND-HF results were presented at the annual scientific sessions of the American Heart Association in November 2010. “It has taken a full decade to learn the truth about nesiritide’s lack of efficacy in acute heart failure,” said Eric Topol, director of the Scripps Translational Science Institute, La Jolla, California, in an editorial accompanying the study. “Along the way, well more than $1 billion was wasted on purchasing the drug.”

Sanofi is halting a clinical trial aimed at getting another indication approved for its key heart drug Multaq after it saw increased cardiovascular problems among patients taking the drug, Reuters reported. The drug was approved for marketing in Europe in July 2009 and in early 2010 in the United States. Sanofi was conducting the trial to determine whether Multaq was effective in treating irregular heartbeats in people with a permanent version of the condition. The company said it had decided to stop the Phase 3b trial after an independent safety monitor saw a “significant increase in cardiovascular events” in the group of patients taking Multaq. Sanofi says it is “committed to Multaq as an essential treatment option for non-permanent atrial fibrillation patients.” The company has high hopes for Multaq as it seeks to replace revenue lost to competition from generics. Analysts expect sales of Multaq to reach $1.35 billion by 2014, according to consensus forecasts from Thomson Reuters Pharma. The drug had sales of $246 million in 2010.

Addex Pharmaceuticals is slashing its staff by 25 percent as it restructures to focus on its core programs in the field of allosteric modulation-based drug discovery and development. “Our objective is to realize annual savings of approximately $9.45 million, through improved operational effectiveness, extending the cash reach of the company through the end of 2013 and providing a stronger financial base for future success,” says Tim Dyer, the company’s CFO. Addex plans to pursue new strategic partnerships with industry leaders it says. Its three existing drug discovery and development partnerships remain fully funded by Ortho-McNeil-Janssen Pharmaceuticals and Merck, which have assumed full responsibility for further development following successful discovery collaborations.

Merck is planning to close the former Inspire Pharmaceutical headquarters in Raleigh, North Carolina, and lay of 51 employees, reports the Triangle Business Journal. Merck announced it would buy Inspire in May for $430 million, at which point Inspire had 175 employees. At the time of the acquisition, Merck said many of Inspire’s employees would be moved into open positions within Merck. The terminations will become effective August 31 with the completion of the sale of Inspire. Inspire President and CEO Adrian Adams is also leaving the company.

Fate Therapeutics has trimmed staff and is focusing on biotech drugs, says its executive chairman, John Mendlein. The San Diego-based stem cell firm has reduced its staff to about 25 people as it eliminated jobs of a “handful” of small molecule chemists, reports Xconomy. Fate has shelved two small molecule drug development programs that focused on altering the hedgehog pathway. The strategic changes followed CEO Paul Grayson’s exit from the company.


July 08, 2011
http://www.burrillreport.com/article-heart_failure_drug_natrecor_found_to_be_ineffective.html