NitroMed Ramps Up For Solo BiDil Launch In July
This article was originally published in The Pink Sheet Daily
Executive Summary
NitroMed’s 190-person sales force has begun detailing the heart failure therapy, according to CEO Loberg. The firm expects to launch BiDil in two to four weeks, without a partner. Labeling provides defense against generic substitution, Loberg says.
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NitroMed began detailing physicians on BiDil (hydralazine/isosorbide dinitrate) June 27 with its 190-rep sales force. The company is pursuing the launch of BiDil without a commercial partner, CEO Michael Loberg said during a same-day presentation outlining NitroMed's launch plan for the heart failure therapy. "Our 190 person sales force concluded their product training [June 24], and are - effective this morning - in the field detailing physicians on BiDil's approved features, benefits and safety information," Loberg said. BiDil is expected to be available to patients within two to four weeks of its June 23 approval by FDA The therapy, which cleared FDA for the treatment of severe heart failure in self-identified black patients, is the first drug approved for a race-based indication (1 (Also see "NitroMed's BiDil Approved For Heart Failure In Self-Identified Black Patients" - Pink Sheet, 23 Jun, 2005.)). "I am pleased to confirm that all launch elements are in place, and we expect that the actual BiDil launch will indeed occur within a very few weeks," Loberg stated. NitroMed will support the introduction with two-week product samples, which will be distributed to physicians through sales reps, he said, noting that "all new patient stocks will be by route of sample." The company also intends to implement a patient assistance program to help patients for whom price is an impediment, the exec said. "We will see that every patient who needs BiDil and cannot afford it actually gets it from us," he said. The company estimated that 85% of patients who use BiDil will have coverage; it expects "at least" a third tier placement on most formularies. NitroMed said it has not yet finalized pricing for the therapy. Loberg indicated that the approved labeling provides defense against generic substitution. The FDA-approved package insert notes a lack of information about treating heart failure with doses of hydralazine and isosorbide dinitrate other than those recommended; it also states that neither component has been studied for heart failure as separate agents and neither drug is approved for heart failure. "In many ways what we've always thought was a strong position that BiDil enjoyed versus the generic has been further strengthened," he suggested. BiDil is approved in 37.5 mg doses of hydralazine and 20 mg doses of isosorbide dinitrate. Both compounds are also available generically, hydralazine in 10, 25, 50 and 100 mg tablets and isosorbide dinitrate in 20 mg tablets. While the individual compounds are unprotected, NitroMed has patent protection for the combination until 2007 - the approval for African-American patients extends the patent life until 2020, the company asserts. Loberg maintained that the company has been "unable to identify a stakeholder that would benefit" from the use of the two generics versus BiDil. He also argued that there is a benefit in the single copay for BiDil. The firm is "actively pursuing" new indications for BiDil. NitroMed is currently analyzing a subgroup of responders in A-HeFT to identify a biomarker, which it believes could expand use to other races. - Jessica Merrill |