Wednesday, November 10, 2004

BIDIL IMPROVES SURVIVAL IN BLACK PATIENTS WITH HEART FAILURE, TRIAL DEMONSTRATES

NitroMed Inc.'s pharmaceutical brand, BiDil (isosorbide dinitrate/hydralazine) improved survival, likelihood of hospitalization and quality of life in an 18-month trial of black patients with heart failure, according to data published in The New England Journal of Medicine and presented at the American Heart Association's Scientific Sessions 2004.

The study included 1,050 patients who had New York Heart Association Class III or Class IV heart failure with dilated ventricles and who identified themselves as being black. The subjects were randomly assigned to receive BiDil or placebo in addition to standard heart failure therapy.

In July of this year, the study was terminated ahead of schedule because of a significant survival benefit observed in the BiDil group. Study data show 6.2 percent of BiDil-treated patients died during the study, compared with 10.2 percent of patients in the placebo group, a 43 percent difference.

In addition, BiDil treatment resulted in a 33 percent relative reduction in the risk of a first hospitalization for heart failure (16.4 percent in the BiDil group vs. 22.4 percent in the placebo group) and significantly improved quality-of-life scores.

The researchers noted that symptoms of headache and dizziness were significantly more common in the BiDil group.

NitroMed Chief Executive Officer Michael Loberg said the company expects to complete a filing with the Food and Drug Administration for BiDil by the end of 2004, according to The Wall Street Journal. The agency could reach a decision by mid-year, potentially making BiDil the first treatment specifically approved for black patients who experience a disease that is common in the general population, the Journal said.

The biotechnology firm has endured some criticism for designing a heart failure trial that excluded non-black patients. The combination of isosorbide dinitrate and hydralazine was examined in multiple studies many years ago for the treatment of heart failure and was found inferior to other drugs, such as ACE inhibitors, according to a commentary by Dr. M. Gregg Bloche, which accompanied the study's publication in The New England Journal of Medicine. It was not until 1999 that investigators analyzed the earlier trial data and discovered the drug combination prolonged the lives of black patients in those studies.

"At this point, it might have made clinical and scientific sense to add isosorbide dinitrate and hydralazine to conventional therapy (which by now typically included an ACE inhibitor) and to compare this combination to conventional therapy alone--for all patients with heart failure, regardless of race," Bloche suggested.

NitroMed, however, elected instead to run its trial in black patients, in part because it offered "a faster way through the FDA's regulatory maze" and allowed NitroMed to extend its intellectual property protection from 2007 to 2020, Bloche said.

The study and Bloche's commentary are available on The New England Journal of Medicine's Web site and will be included in the Nov. 11 print edition.

Tuesday, July 20, 2004

SIGNIFICANT PATIENT SURVIVAL BENEFIT PROMPTS NITROMED TO HALT TRIAL OF HEART FAILURE TREATMENT BIDIL

NitroMed Inc. halted a Phase III trial of its heart failure treatment BiDil (isosorbide dinitrate and hydralazine) due to a significant survival benefit noted among patients receiving the drug.

The double-blind, placebo-controlled study, known as the African-American Heart Failure Trial, was designed to evaluate the efficacy of BiDil when taken daily in addition to the best current therapy. More than 1,000 patients were enrolled in the trial.

The trial's data safety and monitoring board and its steering committee both unanimously recommended that the trial be halted in order to offer all patients participating in the trial the opportunity to be treated with BiDil.

"Based on the size and consistency of the survival benefit, the [steering] committee believed it would be unethical for physicians to continue to withhold BiDil from patients taking a placebo in the study," NitroMed said in a press release.

"NitroMed will work closely with the FDA . . . to ensure a complete and prompt filing of the data as an amendment to our previously submitted New Drug Application," said Michael Loberg, NitroMed's president and chief executive officer. "[W]e intend to have the necessary commercial resources in place to support a product launch by early 2005," he added.

NitroMed expects data from the trial will be available in the fourth quarter of this year.

Shares of NitroMed Inc. closed at $10.21, up $4.31, or 73.1 percent, after heavy trading on the Nasdaq.