FDA grants Abraxis BioScience orphan drug designation for ABRAXANE

Nov 5 2009

Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation to the chemotherapy agent ABRAXANE^® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of pancreatic cancer as well as stage IIB-IV melanoma.

“As we advance our pivotal clinical trials of ABRAXANE in pancreatic cancer and melanoma, we look forward to the potential of bringing a new treatment option to patients with these difficult to treat cancers,” said Lonnie Moulder, President and Chief Executive Officer.

Pancreatic cancer and metastatic melanoma can be particularly hard to treat cancers. This year alone, more than 42,000 people are expected to be diagnosed with pancreatic cancer in the United States. Many patients are diagnosed with pancreatic cancer after their disease has spread and more than 35,000 people annually will die from the disease.Enrollment is ongoing in a Phase III study that will evaluate ABRAXANE plus gemcitabine versus gemcitabine alone as a first line therapy for advanced metastatic pancreatic cancer.

Melanoma is an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year. Melanoma is the leading cause of skin cancer death and the current five-year survival rate for patients with advanced stage melanoma is 25 percent. A phase III registration study comparing ABRAXANE to dacarbazine (or DTIC) in the treatment of stage IV chemotherapy naïve melanoma patients is actively enrolling.

Abraxis continues to study the potential of ABRAXANE in a variety of tumor types.