West Coast Editor
With an extended-release version of its heart drug for black patients in the works, NitroMed Inc. is cutting about 30 positions in research and development and stepping up efforts to out-license or partner its preclinical nitric-oxide enhancing program.
"We will be delineating some numbers in May," said Jane Kramer, vice president of corporate communications for the Lexington, Mass.-based company, and charges related to the restructuring will be disclosed as part of the first-quarter earnings report.
NitroMed's stock (NASDAQ:NTMD) closed Friday at $8.40, up 34 cents.
NitroMed is designing a once-daily or twice-daily version of BiDil, the U.S.-approved oral drug for heart failure in black patients. BiDil consists of a combination of two generic drugs, isosorbide dinitrate and hydralazine hydrochloride, taken three times per day.
"These patients are on multiple drug therapies, so the ability to cut it down would help," Kramer said, noting that "very often our patients are also diabetic" and may have complications that include renal disease.
BiDil, the first race-specific compound given marketing clearance, was approved by the FDA in summer 2005, specifically as an adjunct to current standard therapies such as ACE inhibitors and/or beta-blockers. Late the previous year, then-chief financial officer Lawrence Bloch predicted the compound could face "challenges." (See BioWorld Today, Nov. 9, 2004, and June 27, 2005.)
He was right. Bloch and CEO Michael Loberg parted ways with NitroMed a few weeks ago, and investors are watching the firm's next moves closely.
NitroMed has method-of-use patent protection that expires in 2020, covering BiDil as used for heart failure in African-Americans. Another patent covers the drug duo when used to reduce mortality associated with chronic congestive heart failure, and expires in 2007. But the drug has not been selling as well as expected.
"The issue that we're addressing is reimbursement - better access," Kramer told BioWorld Today. "We're working with major plans and payers, Medicaid and Medicare, as well as the private plans. We're not seeing tremendous uptake, all of a sudden, in generic prescriptions. Dosages are not equivalent, and the patients need to take the two drugs at exactly the same time."
She said the firm is "making very good progress," and in the second quarter, NitroMed is hiring its own BiDil sales force of 145 staffers originally contracted from Publicis Selling Solutions, of Lawrenceville, N.J.
Partners are being sought for the nitric-oxide program, including NMI-3377, a late-stage preclinical cardio-renal compound. NitroMed plans to focus on out-licensing its portfolio and exploring more cardio-renal targets.
Meanwhile, Wall Street continues to buzz about the possibility of a NitroMed takeover.
"I don't comment on rumors," Kramer said.
Liana Moussatos, analyst with Pacific Growth Equities in San Francisco, said NitroMed has "some attractive assets" that might add up to beauty in the right beholder's eyes, including the sales force and nitric-oxide program.
One potential buyer could be former NitroMed partner Merck & Co. Inc., of Whitehouse Station, N.J., which already has a deal with French nitric-oxide specialist NicOx SA, of Sophia Antipolis. Started in August 2003 as a research collaboration, the arrangement was expanded recently to give Merck exclusive worldwide development and marketing rights to nitric oxide-donating drugs for hypertension - a deal worth up to about $351.4 million for NicOx. (See BioWorld Today, March 22, 2006.)
Nitric oxide is used as coatings on medical devices, Moussatos noted, and Merck's new CEO Richard Clark has said devices represent "an area they might go into. It's not out of the question."
Merck ended a deal with NitroMed for new generations of COX-2 drugs for arthritis in 2004, the same year the pharma firm pulled its COX-2 inhibitor, Vioxx (rofecoxib), off the market because of cardiovascular concerns. (See BioWorld Today, Nov. 9, 2004.)
Another company that might take a look at NitroMed is Forest Laboratories Inc., of New York, which made headlines at the start of the year with a deal worth $75 million up front plus milestones to commercialize and distribute the beta-blocker nebivolol for hypertension from Canonsburg, Pa.-based Mylan Laboratories Inc.
"Maybe Forest would be interested [in NitroMed], at least sales-force wise," Moussatos said.