When Pfizer's Cardura XL
was not approved [by the year-end date], we exercised our right to terminate the Pfizer contract.
The launch of Cardura XL is dependent upon FDA approval in 2004 of the product with certain minimum labeling requirements at which time Andrx will pay an additional $25 million to Pfizer and Andrx will be committed to purchase certain annual minimum quantities of this product from Pfizer for a three-year period.
Major factors affecting the Company's operating results include net revenues of its bioequivalent versions of Cardizem CD, and, to a lesser extent, its line of OTC Claritin products, Glucophage, Glucotrol XL, Tiazac, net sales of its Altocor brand product, the launches of Fortamet and Cardura XL and KUDCo licensing revenue.
Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to, the Company's dependence on a relatively small number of products, licensing revenues, the timing and commercial success of Altocor(R) and its future brand product launches, including Cardura XL
, Fortamet(TM) and its Valproate product, government regulation, competition, and manufacturing results.
Filed in April 2001, the Company anticipates FDA approval of Cardura XL