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NitroMed says BiDil XR will be tested in pilot study this year
By Jennifer Lanning Drey
Eugene, Ore., Sept. 8 - NitroMed, Inc. said BiDil XR, the pulse-dosed version of its currently commercialized drug BiDil (isosorbide dinitrate/hydralazine hydrochloride) will be studied in a pilot test in humans later this year.
BiDil was approved in an immediate-release form for treatment of heart failure in black patients in 2005. The drug is indicated to improve survival, prolong time to hospitalization and improve patient-reported functional status.
NitroMed will announce additional details on the timing of a possible filing with the Food and Drug Administration for BiDil XR after data from the pilot test are available, said Jerry Karabelas, chief executive officer of NitroMed, at the Thomas Weisel health care conference Friday.
In addition, Karabelas said NitroMed plans to announce new clinical data on BiDil in five presentations at the Heart Failure Society's annual meeting, which will be held Sept. 10 through Sept. 13.
The new data demonstrate that BiDil provides longer-term outcomes, survival benefits in post-menopausal women and decreased cardiac mortality, Karabelas said.
The company also plans to announce a new genotype that predicts benefit with BiDil, he said.
"The commercial opportunities continue to be very large and exciting," Karabelas said.
NitroMed estimates that the current market for BiDil is more than $1 billion, and the drug has no direct competitors, he said
"At the end of the day, there's nobody counter-detailing it, and that's a benefit," Karabelas said.
The company has launched a consumer campaign for BiDil and recently received 18-month dating for the drug, he said.
NitroMed, based in Lexington, Mass., is a research-based emerging pharmaceutical company.
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