By Debbie Strickland
A company founded in the early days of biotech — back in 1981, in fact — has submitted its first new drug application (NDA) to the FDA.
Scios Inc. is seeking the agency's marketing nod for Natrecor (nesiritide), a hormone-based therapy for acute congestive heart failure (CHF) that, if approved, would be the first new drug for the condition in more than a decade.
"Considering it's taken us this long and we're still here to file this application, it shows we have good science and good management," said Mary Ann Allencourt, spokeswoman for the Mountain View, Calif., company. If all goes well, the drug could be launched in mid-1999, she said.
Analyst David Stone projects sales of $21 million in 1999, with possible growth to the $50 million to $100 million range over three years. Stone is a managing director for Cowen & Co., in Boston.
"We have relatively modest sales expectations at the moment," he said. Additional clinical tests pitting Natrecor against established CHF therapies will "determine its role in the marketplace," Stone added.
The American Heart Association estimates CHF-related costs at $20 billion annually, with more than half of that incurred for hospitalizations related to acute episodes.
First cloned by Scios researchers in 1989, Natrecor's active ingredient, human b-type natriuretic peptide (BNP), is a naturally occurring hormone produced predominantly in the ventricles of the heart. The body secretes BNP — which boosts both sodium and fluid excretion while dilating blood vessels — to combat fluid-overload states such as CHF.
According to the company, BNP seems to lower secretion of neurohormones that lead to vessel constriction, fluid retention and elevated blood pressure.
"This is a new class of therapy based on the body's natural response," Allencourt said. "The body knows what to do with this."
Natrecor passed a Phase III efficacy trial last year, with a low dose producing a 20 percent reduction in pulmonary capillary wedge pressure compared with placebo. A higher dose generated a 30 percent difference. The drug also significantly improved symptom score and cardiac index versus placebo.
The drug is unpartnered, though a deal is likely to come soon, Allencourt said. "We're in late-stage negotiations with a potential worldwide partner," she said. "We hope to have an agreement by the end of [the second quarter], or sooner, if possible."
Applications for marketing approval outside the U.S. will come after the signing of a marketing agreement.
For Scios, the good news comes just over a year after its former lead product, Auriculin, failed in a Phase III trial. Intended to treat oliguric acute renal failure, Auriculin was based on atrial natriuretic peptide. It failed to achieve the primary endpoint of dialysis-free survival.
In addition to its research and development activities, Scios markets psychiatric drugs for other companies, including SmithKline Beecham plc, of London. Scios' first-quarter commercial revenues totaled $9.7 million. The company ended the quarter March 31 with $74.5 million in cash and marketable securities.
Scios' shares (NASDAQ:SCIO) closed Monday at $11.438, down $0.844. *