Abraxis Bioscience Launches ABRAXANE® in China for Women with Metastatic Breast Cancer

Business Wire, June 12, 2009

First approved solvent-free taxane chemotherapy to demonstrate nearly double response rate compared to solvent-based paclitaxel

LOS ANGELES & BEIJING -- Abraxis Bioscience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, has now made ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) (nab-paclitaxel) available in China for the treatment of patients with metastatic breast cancer. In a global Phase III clinical trial, and in a Phase II clinical trial in China, the tumor response rate for patients who received ABRAXANE for the treatment of metastatic breast cancer was nearly double the response rate compared to patients who received solvent-based paclitaxel.i

In China, women with breast cancer are often diagnosed in advanced stages of the disease.ii Breast cancer is the leading cause of death among patients with malignant tumors in China. iii According to the Beijing Municipal Health Bureau, which compared data from 1998, the occurrence rate of breast cancer among Beijing's women residents has increased approximately 110 percent in the past decade.iv

“We are seeing a significant rise in the incidence of breast cancer in China due to the aging population and the environmental factors,” said Prof. Zefei JIANG, Director of Breast Cancer Dept., Beijing No. 307 Hospital. “The availability of new therapies, like ABRAXANE, is important to meeting the unmet needs of women fighting breast cancer in China.”

ABRAXANE is approved by the State Food and Drug Administration for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. The recommended regimen is 260 mg/m2 administered intravenously over 30 minutes every three weeks. ABRAXANE uses a novel technology called nab®-Technology to deliver the drug paclitaxel to the tumor site. The formulation combines paclitaxel with albumin, a naturally occurring protein, which eliminates the need for solvents in the standard delivery of chemotherapy.

“ABRAXANE is a novel chemotherapy. The unique characteristics of the nab-technology platform enable more drug to be delivered directly to tumors by leveraging cancer biology. ABRAXANE is an effective and convenient treatment option for Chinese patients with metastatic breast cancer,” said Prof. Binghe XU, Deputy Director of Medical Oncology Dept., Cancer Hospital and Institute, Chinese Academy of Medical Sciences.

In the randomized study comparing nab-paclitaxel with solvent-based paclitaxel in Chinese patients with metastatic breast cancer, ABRAXANE demonstrated a significantly higher overall response rate than solvent-based paclitaxel, consistent with the results seen in the global Phase III study in Caucasian patients. The primary endpoint was investigator assessed overall response rate and assessment of safety and tolerability. Secondary endpoints included time to tumor progression (TTP), survival and pharmacokinetics. ABRAXANE significantly improved the investigator assessed overall response rate versus solvent-based paclitaxel (54% vs. 29%; P =0.001). In an unplanned analysis, the response rate was greater in the nab-paclitaxel treatment arm for first-line therapy when patients had no prior anthracycline-containing therapy (61% v.21 %, p=0.001).The median time to progression was longer for ABRAXANE than for solvent-based paclitaxel, but the difference was not significant (7.6 months vs.6.2 months p=0.078) . ABRAXANE also achieved a 26 percent improvement in progression free survival when compared to solvent-based paclitaxel (7.6 months vs. 6.2 months; P = 0.118).

Both therapies had acceptable toxicity profiles with the most common toxicities similar between treatment arms. A total of 212 patients were randomized from 29 June 2005 through 1 August 2006. 85 patients (40%) had received prior chemotherapy for metastatic disease. The median age was 50 years, 94 percent of participants were less than 65 years old and 70 percent of participants were postmenopausal.v

The incidences of most adverse events in both treatment arms were generally similar in Chinese patients. Both treatment arms were well tolerated. The incidence of laboratory assessed neutropenia was higher in patients receiving ABRAXANE (92% vs. 77%, p<0.001), although the incidence of grade 3 or 4 neutropenia was not significantly higher (44% vs. 35%, p=0.258). Alopecia was the most common adverse event for ABRAXANE and solvent-based paclitaxel, and was not different between treatment groups (76% vs 81%, p=0.403). No significant difference was seen between the groups in sensory neuropathy (Abraxane 76% vs. solvent-based paclitaxel 74%, P = 0.752).