American Pharmaceutical Partners (APP) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ABI-007 for metastatic breast cancer. Fast Track designation is intended to expedite product development by providing for scheduled meetings to seek FDA input into the development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints. Fast Track designation is intended for a product and a claim that addresses an unmet medical need.

In granting Fast Track designation, the FDA recognized that the current formulation of TAXOL(R) (Bristol-Myers Squibb) and its generic equivalents, which contain cremophor, is responsible for many of the well-known side effects and administration problems which limit the dose of paclitaxel that currently can be delivered. ABI-007, a cremophor-free nanoparticle paclitaxel, received Fast Track product status from FDA on the basis that it has the potential to address an unmet medical need in treating metastatic breast cancer.

"We have been working closely with FDA since 1996 on the development of this important nanoparticle compound and are pleased that with Fast Track designation we may be able to more quickly provide a new therapeutic approach to the treatment of metastatic breast cancer," said Patrick Soon-Shiong, chairman, president and chief executive officer.

In early December 2002, APP announced it had completed patient enrollment in the pivotal Phase III clinical trial evaluating ABI-007 in 460 patients with metastatic breast cancer. The randomized controlled Phase III study, designed in close collaboration with FDA and initiated in the summer of 2001, compared the safety and efficacy of 260 mg/m2 of ABI-007 to 175 mg/m2 of Taxol administered every three weeks. ABI-007 was infused over 30 minutes without steroid pretreatment at a higher dose than Taxol, which requires steroid therapy and infusion over three hours. APP has secured that North American marketing and manufacturing rights for ABI-007 from American Bioscience Inc., which is responsible for conducting the clinical studies of ABI-007.