aaiPharma receives FDA approval and shared market exclusivity for Calcitriol Injection
aaiPharma Inc announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Calcitriol Injection, a liquid, injectable vitamin D product, and the first line extension to its family of critical care nutrition products. With this approval, the FDA has also granted shared market exclusivity to aaiPharma, and the Company expects to launch its Calcitriol Injection vial within the next 45 days.
"This approval is another prime example of aaiPharma delivering on its strategy to acquire, improve and market well-known medicines," said Dr. Philip Tabbiner, President and Chief Executive Officer of aaiPharma. "The convenience of a vial is an important innovation in vitamin D injectable nutrition, and we expect that this unique attribute will be a benefit for health care professionals administering Calcitriol therapy."
This Calcitriol product will join M.V.I.-12(R), M.V.I.-Pediatric, Aquasol A, Aquasol E, Brethine and Azasan as the newest product in the Company's critical care product line. The product is used primarily to treat chronic kidney dialysis patients with abnormally low levels of calcium in the circulating blood. According to 2002 IMS data, annual sales for similar injectable vitamin D nutritional products are in excess of $300 million. Unlike other Calcitriol products, which are packaged as ampoules, aaiPharma's product is the only Calcitriol product with final approval for marketing in vial form, which may lead to greater ease of use in the hospital setting.
aaiPharma is increasing its full-year 2003 revenue guidance, to between $280 million and $290 million from between $275 million and $280 million. Also, the Company is raising its full-year 2003 earnings per diluted share guidance to between $1.66 and $1.75 from between $1.58 and $1.65. Following the previously announced three for two stock split, the estimated full-year 2003 earnings per diluted share are expected to be between $1.11 and $1.17. The record date for the split was February 19, 2003, with a distribution date of March 10, 2003.