By Kim Coghill
Richard Brewer, CEO of Scios Inc., said the company will immediately begin shipping Natrecor (nesiritide), its acute congestive heart failure drug, approved Monday by the FDA.
The first new treatment for acute congestive heart failure developed and approved in 12 years, Natrecor was given the agency¿s nod for intravenous treatment of patients with acutely decompensated congestive heart failure (ADCHF) who have shortness of breath (dyspnea) at rest or with minimal activity.
¿With Natrecor¿s approval and imminent launch, Scios is one of very few biotechnology companies that has brought a product from discovery, to research, all the way across the finish line and into the marketplace,¿ Brewer said Monday in a conference call with investors and the media.
Scios¿ stock (NASDAQ:SCIO) closed Monday at $20.12, down 23 cents.
Natrecor is the first in a class of new drugs called human B-type natriuretic peptides (hBNP) to be made available as a therapeutic for human disease. The drug is a recombinant form of hBNP, a natural protein found in the body.
Natrecor will be priced at $380 a vial, and typically a patient will need only one vial per hospital visit. The average wholesale cost to the hospital will be about $456 per bottle.
¿We decided on this price based on numerous factors,¿ Brewer said. ¿[With] our clinical data, the label and a comprehensive pricing analysis, both quantitative and qualitative, we believe the $380 represents the ideal price and will result in the greatest penetration with the least resistance from prescribers and pharmacists.¿
Furthermore, Brewer stated that he believes Natrecor will meets its revenue forecast of $10 million to $12 million in the remainder of fiscal 2001. At its peak, analysts have predicted Natrecor will generate between $200 million and $300 million per year.
Natrecor will be sold by 165 new sales people, most of whom have previous success in selling cardiovascular products in the hospital setting. The team will be directed by 20 sales managers.
The FDA¿s Cardiovascular and Renal Drugs Advisory Committee gave Scios a nod of approval in May when the 10-member committee voted unanimously to recommend approval. (See BioWorld Today, May 29, 2001.)
The decision was based on Scios¿ success in two trials including a 489-patient study in which participants with exacerbations of CHF and dyspnea were randomized to placebo (142), nitroglycerin (143) or nesiritide (204) during a nine-month period. The primary endpoints (change in pulmonary capillary wedge pressure and patient self-evaluation of dyspnea) compared Natrecor to placebo at three hours.
In the other study, known as the Prospective Randomized Evaluation of Cardiac Ectopy with Dobutamine or Nesiritide Therapy (or PRECEDENT), Natrecor produced fewer incidents of arrhythmia and improved overall mortality rates compared to Dobutamine, a commonly administered inotropic agent.
But life hasn¿t always been so good for Scios. In 1999, after an advisory committee voted 5 to 3 recommending approval of Natrecor, the FDA refused to give its final approval due to concerns surrounding safety and dosing. (See BioWorld Today, Feb. 1, 1999, and April 29, 1999.)
This latest ruling was based on amendments to the original NDA. The trials conducted after the 1999 failure were designed to satisfy the FDA¿s questions concerning hypotension as an adverse event. Other side effects associated Natrecor are dizziness or headaches.
Scios has a commercialization deal with Quintiles Transnational Corp., of Research Triangle Park, N.C., whereby Quintiles has agreed to fund the $35 million commercialization costs through its corporate group, PharmaBio Development. (See BioWorld Today, Jan. 12, 2001.)