NitroMed, manufacturer of BiDil, the controversial heart-failure drug approved specifically for African American, suspended the drug's sales and promotional activities, although the treatment will remain available to the people.
Despite the announcement, NitroMed plans to continue the development of a new form of BiDil, a once-a-day formulation rather than the presently three times daily dosage.
Also, the company has implemented a restructuring plan that will eliminate approximately 70 positions over the next month, reducing headcount from approximately 90 to 20.
NitroMed anticipates that headcount may be further reduced over the next several months. The company estimates that it will record restructuring charges in a range of approximately $2.5 million to $3.0 million in the first quarter of 2008.
The company received minutes of its December 10, 2007 meeting with the US Food and Drug Administration during which the development plan of an extended release formulation of BiDil (the fixed-dose combination isosorbide dinitrate/hydralazine hydrochloride), known as BiDil XR, was discussed. The agency agreed that NitroMed's clinical development plan to conduct bioequivalence and pharmacodynamic studies comparing an extended release formulation of BiDil to the current commercial immediate release formulation of BiDil is acceptable. Such a plan could support FDA approval to commercialise BiDil XR, if bioequivalence is demonstrated.
The bioequivalence study design compares the pharmacokinetics of the XR formulation to the pharmacokinetics of the immediate release formulation. The adequacy of the results will ultimately be determined during the regulatory review period. BiDil is an orally-administered medicine approved in the United States for the treatment of heart failure in self-identified black patients, it said.
"We are very pleased with both the FDA's reaction to our proposed program for BiDil XR and with the results we achieved in our pharmacokinetic studies. We believe that our ability to successfully advance the goal of commercialising BiDil XR is now within reach, especially because our successes with formulation prototypes developed to date suggest bioequivalence may be demonstrated," said Kenneth M. Bate, chief executive officer, NitroMed.
Mr. Bate continued, "We find ourselves at an important strategic juncture. We believe that BiDil is promotionally sensitive, and we have seen new prescriptions for BiDil increase by approximately 8-9 per cent from the third quarter to the fourth quarter in 2007 as we heightened our marketing efforts and increased our field force. However, we believe that in order for BiDil to achieve its full potential, a larger marketing and sales effort than we can presently generate is required. In addition, NitroMed also faces a challenging capital market environment."
The new formulation of the drug is expected to 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. In light of the operational considerations it face, with regard to both BiDil and BiDil XR, NitroMed retained Cowen and Company to advise them on exploring strategic options to maximize shareholder value.