NitroMed Looks To 2010 NDA For BiDil XR
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm decides to slash jobs, quit promotion of immediate-release BiDil to fund development and commercialization of extended-release version.
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A once-daily extended-release formulation of the anti-anginal isosorbe BiDil is the foundation on which NitroMed is balancing its entire future. The Lexington, Mass., firm said Jan. 16 that FDA has agreed on a clinical path forward for BiDil XR , a once-daily version of the severe heart failure treatment. At the same time, NitroMed said it will cut its workforce drastically, halt sales and promotion of its immediate-release BiDil and retain an investment bank to advise the firm on strategic alternatives. "We anticipate that a formulation could be finalized in 2008, with a goal of initiating pivotal bioequivalence trials in 2009, and a planned filing of the New Drug Application in 2010," NitroMed CEO Kenneth M. Bate said. Approved in June 2005 to treat severe heart failure in African-American patients, BiDil (a combination of generic isosorbide dinitrate and hydralazine hydrochloride) was the first FDA-approved treatment for a race-based indication. It is dosed orally three times a day (1 (Also see "NitroMed's BiDil Approved For Heart Failure In Self-Identified Black Patients" - Pink Sheet, 23 Jun, 2005.)). NitroMed's restructuring calls for a personnel cut from 90 jobs to 20, a headcount that could be reduced even further over the next several months. Although marketing of BiDil immediate release will cease, the company will keep the drug on the market and available for patients. NitroMed doubled its specialist sales force from 30 reps to 60 in the second half of 2007. New prescriptions for BiDil increased by between 8 percent and 9 percent from the third quarter to the fourth quarter, a reflection of "lack of acceptance of BiDil in the market," Friedman, Billings, Ramsey & Co. analyst Robert Uhl said in a Jan. 16 research note. The firm noted that it faces a "challenging capital market environment." To reach its potential, BiDil needs "a larger marketing and sales effort than we can presently generate," Bate added. NitroMed will record restructuring charges of between $2.5 million and $3 million this quarter. The firm is retaining Cowen and Company to advise it on possible future directions, "which we believe could lead to sale of the company," Uhl noted. NitroMed officials met with FDA in December to map out clinical testing parameters to determine if BiDil XR will be therapeutically equivalent to the current formulation. "We believe that our ability to successfully advance the goal of commercializing BiDil XR is now within reach," Bate said, "especially because our successes with formulation prototypes developed to date suggest bioequivalence may be demonstrated." The extended-release formulation relies on oral controlled-release delivery technology NitroMed inlicensed from Elan last February. Under the worldwide licensing agreement, NitroMed will pay Elan royalties based on net sales of BiDil XR, as well as specified milestone payments (2 (Also see "NitroMed’s BiDil XR Will Use Elan Delivery Technology Under Recent Deal" - Pink Sheet, 12 Feb, 2007.)). NitroMed posted third quarter sales of $3.8 million for BiDil, up 10 percent from a year earlier, and $11 million in sales for the first nine months of 2007. BiDil accounted for all of the firm's revenues. -Joseph Haas ([email protected]) |