NitroMed Reports on BiDil XR Progress Following FDA Meeting, Announces Restructuring and Suspension of BiDil(R) Sales Force, and Retains Investment Bank to Advise on Strategic Options
LEXINGTON, Mass. -- Jan. 15, 2008--NitroMed said today that the Company received minutes of its December 10, 2007 meeting with the U.S. Food and Drug Administration during which the development plan of an extended release formulation of BiDil(R) (the fixed-dose combination isosorbide dinitrate/hydralazine hydrochloride), known as BiDil XR(TM), 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 commercialize 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. BiDil is presently dosed three times daily and the Company is seeking to develop a once-a-day formulation.
NitroMed also announced today that it has implemented a restructuring plan that will eliminate approximately 70 positions over the next month, reducing headcount from approximately 90 to 20. The Company anticipates that headcount may be further reduced over the next several months. The Company is discontinuing its sales and promotional activities for BiDil, although the Company intends to keep BiDil available and on the market for patients. 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 has engaged an investment banking firm, Cowen and Company, to advise on strategic alternatives for the Company.
NitroMed's Chief Executive Officer Kenneth M. Bate 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 commercializing BiDil XR is now within reach, especially because our successes with formulation prototypes developed to date suggest bioequivalence may be demonstrated.
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% 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.
"Discussions with the FDA were productive and we remain optimistic about our ability to continue on schedule with our clinical work on BiDil XR," said Mr. Bate. "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. In light of the operational considerations we currently face with regard to both BiDil and BiDil XR, we retained Cowen and Company to advise us on exploring strategic options to maximize shareholder value. Furthermore, in order to conserve cash, NitroMed is today suspending sales and marketing activities for BiDil and is implementing a plan to significantly reduce headcount over the next several months. NitroMed intends to continue to sell BiDil, but we are maintaining only essential functions. As part of our ongoing commitment to patients currently taking BiDil, NitroMed will be working with distributors and health care providers to ensure the availability of BiDil."