Andrx Corporation announced that it has expanded its brand product portfolio by entering into a supply and distribution agreement with Pfizer Inc regarding Pfizer's New Drug Application (NDA) for Cardura XL, a sustained-release formulation of doxazosin mesylate, used to treat benign prostatic hyperplasia (BPH).
Filed in April 2001, the company anticipates FDA approval of Cardura XL in mid-2004. Under terms of the agreement, Andrx will pay a total of $35 million upon execution of the exclusive distribution agreement in the United States and upon FDA approval of the NDA with certain minimum claims. Andrx will market Cardura XL and purchase certain minimum quantities of Cardura XL from Pfizer for three years.
Richard J Lane, Andrx's CEO, said, "Cardura XL represents a significant opportunity, both for Andrx and for people who suffer from the affects of BPH. We are eager to begin marketing the benefits of Cardura XL to both general practitioners and urologists, who can then make this important medicine available to their patients."
BPH is the most common benign neoplasm (non-cancerous enlargement of the prostate gland) in men and its prevalence increases with age. According to empirical data, BPH is estimated to occur in 25 per cent-50 per cent of men in their 50s to early 60s, and in as many as 80 per cent of men in their 70s and 80s. Bothersome and restrictive symptoms place a significant burden on the daily lives of men with BPH, and complications of severe BPH can be dangerous. Annual growth of the BPH market is estimated to be between 7 per cent and 30 per cent, but many patients are not treated. Aging but active baby-boomers are expected to increase the level of treatment, as they are likely to be less tolerant of the impact of BPH on the quality of their lives.
In connection with the addition of Cardura XL, Andrx is in the process of determining how to adjust the utilization and size of its brand sales force to more appropriately handle the brand products it intends to promote in 2004. Andrx's brand product portfolio currently includes Altocor (extended release lovastatin) for hyperlipidemia and, in 2004, is expected to include Fortamet (extended release metformin HCL) for type-2 diabetes (for which an FDA approvable letter has been received), both of which were developed by Andrx.