The U.S. Food and Drug Administration (FDA) has approved the aaiPharma's abbreviated new drug application (ANDA) for Azasan (azathioprine) 75 mg and 100 mg tablets. Previously unavailable, these new 75 mg and 100 mg Azasan tablet strengths will provide physicians with more flexible dosage options and contribute to enhanced patient compliance. With this approval and the Company's currently marketed 50 mg dosage form, aaiPharma now offers the most comprehensive line of azathioprine dosage forms on the market today, the company announced.
“Azathioprine is a proven and useful immunosuppressant, but until now physicians and patients have had to manage the inconvenience of a single oral dosage form,” said Frank A. Snyder, MD, of Wilmington Internal Medicine, Adjunct Professor of the Vascular Biology Working Group, and Associate Professor at University of North Carolina at Chapel Hill. “By providing more dosing options, Azasan should offer physicians greater accuracy and flexibility when prescribing higher doses of azathioprine, and will make it easier for patients to take the medication as prescribed.”
Azasan is indicated as an adjunct for the prevention of rejection in renal (kidney) homotransplantations. It is also indicated for the management of severe, active rheumatoid arthritis unresponsive to rest, aspirin, or other non-steroidal anti-inflammatory drugs, or to agents in the class of which gold is an example.
According to IMS market data, the 2002 azathioprine market totaled nearly $55 million and continues to grow. A recent survey by IMS in November 2002 indicated that 66 per cent of all uses of azathioprine are at 100 mg or more per day. The new Azasan dosage forms may reduce the number of tablets patients would need to take to achieve an effective dose, a convenience that may translate into better therapeutic compliance. aaiPharma plans to launch the new products on March 1, 2003.
In addition, the Company is increasing its full-year 2003 revenue estimates, which originally included some revenue from Azasan, to between $275 million to $280 million from between $270 million to $275 million. Also, the Company is raising its full-year 2003 earnings per diluted share estimates to between $1.58 and $1.65 from between $1.53 and $1.58.
The Company also announced that it has declared a three for two stock dividends. The record date for the dividend is February 19, 2003, and the distribution date for the dividend is approximately March 10, 2003. Following the stock split, the estimated first quarter and full-year 2003 earnings per diluted share are expected to be between $0.23 and $0.25, and $1.05 and $1.10 respectively.
“The newly approved Azasan 75 mg and 100 mg products complement our currently available 50 mg tablet, giving aaiPharma the most comprehensive azathioprine product offering on the market today,” stated Dr. Philip S. Tabbiner, President and CEO of aaiPharma. “The Azasan product line is the first proprietary brand to be developed, manufactured, and commercially launched exclusively by aaiPharma, and further demonstrates our ability to execute on our strategy to enhance well-known medicines through research and bring these new, branded products to market.”
According to the Arthritis Foundation, rheumatoid arthritis (RA) is one of the most disabling forms of arthritis. RA affects more than two million Americans, with women outnumbering men nearly three to one. RA is characterized by chronic inflammation that affects the lining of joints, causing pain, stiffness, redness and swelling. Without proper treatment there is a high risk of permanent joint damage. In addition, RA can also cause inflammation in the blood vessels and the linings of the heart and lungs.
Chronic immunosuppression with this purine antimetabolite increases risk of neoplasia in humans. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. The most commonly reported side effects are leukopenia and/or thrombocytopenia, secondary infections, neoplasia, nausea, vomiting, diarrhea, fever, myalgias, skin rashes, and hepatotoxicity. Azasan therapy should be given cautiously when used concomitantly with allopurinol, ACE inhibitors, and other agents affecting myelopoiesis. Azasan is contraindicated in pregnant and lactating women and patients who have shown hypersensitivity to this product.