NDA Pipeline

Abraxis Research has developed an extensive pipeline which includes further investigation with ABRAXANE® as well as several other promising drug candidates. Key focus areas include an extensive array of oncology drug candidates and a developing cardiovascular portfolio. The following candidates are part of Abraxis’ accelerating pipeline.

Oncology
One of Abraxis’ core focus areas is leveraging and exploiting tumor biology using Abraxis nab™ technology. Several products are under investigation for solid tumors. Key investigational areas include:

• ABRAXANE® is a microtubule stabilizer and is currently being tested in a variety of solid tumors.
• ABI-008 is a microtubule stabilizer and is in the early stages of clinical development.
• ABI-009 is an mTOR inhibitor currently being tested in nonclinical trials.
• ABI-010 is a Hsp90 (heat shock protein 90) inhibitor. Current research is at the nonclinical study stage of development.

Cardiovascular
Angioplasty, or the removal of plaque in arteries, is a short-term solution for a chronic problem in patients with cardiovascular disease. Following the procedure, a bare metal stent (metal tube) is placed to physically keep the vessel from narrowing. Recently, new drug-eluting stents containing either paclitaxel or rapamycin have been approved for treatment of restenosis in the coronary arteries. The drug helps to prevent hardening of the artery in conjunction with the placement of the bare metal stent. COROXANE™, a microtubule stabilizer, is being developed by Abraxis to be used in conjunction with stents to prevent various forms of arterial restenosis. Abraxis’ current research on COROXANE™ is focused on coronary and peripheral artery restenosis and improving hemodialysis.

Coronary Artery Restenosis
Approximately 800,000 procedures of coronary artery stenting are performed in the United States alone every year. Although the results of drug-eluting stents are encouraging, there may be complications after surgery, such as weakening of the artery wall, blood clot formation, and an increased risk of myocardial infarction when the vessel doesn’t heal completely. COROXANE™ is currently in phase 2 trials for coronary artery restenosis.

Peripheral Artery Disease
Peripheral artery disease of the lower extremities is common in older adults with significant morbidity. Similar to coronary artery disease, this disorder is typically caused by thickening of the blood vessel wall that limits blood flow to the legs, particularly due to narrowing or closure of the superficial femoral artery. Currently the standard treatment is angioplasty alone. Surgical placement of bare metal stents or tubes within the blood vessel has had limited success, most often due to the tube breaking. Phase 2 studies are focusing on the use of COROXANE™ along with angioplasty of the affected blood vessel.

Hemodialysis
Patients undergoing hemodialysis often experience abnormal overgrowth of the vessel wall where a graft is implanted in the vessel. Many patients receive the arteriovenous polytetrafluoroethylene graft in the United States. Unfortunately, the rate for graft success is only 50% at one year and 35% at two years due to abnormal overgrowth and stenosis, similar to coronary or peripheral artery restenosis. Currently the only effective procedure is balloon angioplasty of the closed shunt at the site of overgrowth. COROXANE™ is being investigated for treatment of vascular shunt stenosis in patients who require hemodialysis in conjunction with angioplasty of the obstructed vessel.