CUTTER's PROLASTIN ALPHA-1 ANTITRYPSIN WILL BE AVAILABLE

CUTTER's PROLASTIN ALPHA-1 ANTITRYPSIN WILL BE AVAILABLE by mid-January following approval of a product license application (PLA) by FDA on Dec. 7. Derived from human plasma, Prolastin is administered weekly by injection in patients deficient of the natural protein alpha-1 antitrypsin with early signs of lung disease. Deficiency of alpha-1 antitrypsin can lead to emphysema. Prolastin received an "orphan" drug designation from FDA in 1984. Prolastin is Miles' first orphan product. Cutter began study of the biological product in 1981. A Product License Application for Prolastin was submitted to FDA in May 1986 based on clinical studies involving about fifty patients. Prolasatin will be marketed to both hospital and office-based pulmonary specialists. According to the FDA approved labeling, Prolastin is indicated for "chronic replacement therapy of individuals having congenital deficiency of alpha-1 proteinase inhibitor [alpha-1 antitrypsin] with clinically demonstrable panaciner emphysema." The labeling adds that clinical data "are not available as to the long term effects derived from chronic replacement therapy" with the plasma-derived protein. In addition, the labeling notes that the treatment has only been studied in adults. The target population, according to press materials from Cutter's parent company Miles, is adults aged 30 to 40 years with alpha-1 antitrypsin deficiency and early signs of emphysema. The U.S. patient population is estimated by Miles at 20,000 to 40,000. Clinical studies of the plasma-derived protein were conducted by the National Heart, Lung and Blood Institute, the University of California - San Diego, and at several medical centers in West Germany. The labeling points out that no long term studies have been done. Cooper Labs is curretly working on a recombinant form of alpha-1 antitrypsin. The Cooper product is reportedly in early clinical study. Prolastin is Miles' second approval in the past two months. In late October, the quinolone anti-infective Cipro (ciprofloxacin) received FDA marketing clearance. Miles has at least three other NDAs nearing approval at the agency including the calcium channel blockers Baypress (nitrendipine) and Nimotop (nimodipine), and the antifungal Mycospor (bifonazole).