By Kim Coghill
Analysts said Thursday they expect FDA¿s Cardiovascular and Renal Drugs Advisory Committee to recommend approval of Natrecor, a potential $300 million acute heart failure drug made by Scios Inc.
Natrecor, an intravenous therapy used in hospitals, would be the first new treatment for acute congestive heart failure (CHF) in 12 years.
The committee meets today in Bethesda, Md., to review amendments to the new drug application submitted in 1998 and recommended for approval by the committee a year later in a 5-to-3 vote. FDA rejected the drug in January 1999 based on concerns surrounding dosing and hypotension. (See BioWorld Today, Feb. 1, 1999, and April 29, 1999.)
But this time around, the FDA is expected to approve Natrecor (nesiritide) in July and the company likely will launch it in the third quarter, Mark Monane, an analyst with Needham & Co. in New York, said in research notes.
Monane estimates Natrecor will generate sales of $11 million its first year and by 2005, he said the drug should bring in between $200 million and $300 million.
John Sonnier, an analyst with Prudential Securities, released research notes saying Natrecor is expected to sell $12 million, $40 million and $89 million in 2001-2003, respectively. He said the projected market for Natrecor will be between $300 million and $400 million.
Scios¿ stock (NASDAQ:SCIO) closed Thursday at $24.56, down $1.30, or 5 percent.
Wendy Carhart, Scios¿ associate director of investor and corporate communications, said the company believes the amendments submitted in January will satisfy FDA questions that prevented Natrecor from being approved two years ago.
¿There were few FDA concerns, but the most important were on the safety side,¿ Carhart said. ¿There really was no question as to the efficacy of the drug; it was apparent that the drug worked in acute heart failure.¿
In previous studies, Carhart said Scios had used two doses of Natrecor, yet asked FDA to approve use of only one dose. ¿The FDA was a little confused by all of our various dosing schemes. The other issue was low blood pressure (with the lower dose) in 8 percent of the people, and in 14 percent of the people at the higher dose.¿
The primary side effects are headache and possible dizziness. The new recommended dose is an infusion rate about 30 percent lower than previously used.
Scios, of Sunnyvale, Calif., will present data from two trials: the Vasodilation in the Management of Acute Congestive (VMAC) heart failure study and the Prospective Randomized Evaluation of Cardiac Ectopy with Dobutamine or Nesiritide Therapy (PRECEDENT). The Journal of Cardiac Failure in March published a review of the studies and concluded that Natrecor could become a valuable addition to the treatment of acute congestive heart failure, according to a statement released by Scios.
Natrecor, which was first cloned by Scios in 1989, is a genetically engineered version of human b-type natriuretic peptide (BNP) ¿ a 32-amino-acid, naturally occurring peptide 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.
Natrecor is considered a balanced vasodilator, meaning it reduces blood pressure in both the veins leading to the heart (cardiac preload) and in arteries leading away from the heart (cardiac afterload). In addition, the drug doesn¿t raise the heart rate. CHF, a potentially life-threatening disorder with no cure, is a chronic pathophysiological condition that results from an inefficiently pumping heart.
The 498-patient VMAC trial proved that Natrecor, added to standard care, had a statistically significant effect on the primary endpoint of reducing pulmonary capillary wedge pressure, a measure of the pulmonary congestion resulting from acute CHF, in as few as 15 minutes, Scios said. The effect was sustained for at least 48 hours. At three hours, Natrecor plus standard care significantly improved PCWP, compared to either the placebo plus standard care or intravenous nitroglycerin plus standard care regimens tested, and significantly improved patient breathing compared to the placebo plus standard care regimen.
In the PRECEDENT trial, Natrecor produced fewer arrhythmias (irregular heartbeats) and improved overall mortality rates compared to dobutamine, a commonly administered inotropic agent.