LOS ANGELES--(Business Wire)--
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.iii
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. iii 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.
About ABRAXANE
ABRAXANE® is a solvent-free chemotherapy treatment option for metastatic breast
cancer which was developed using Abraxis BioScience's proprietary nab®
technology platform. This protein-bound chemotherapy agent combines paclitaxel
with albumin, a naturally-occurring human protein. By wrapping the albumin
around the active drug, ABRAXANE can be administered to patients at higher
doses, delivering higher concentrations of paclitaxel to the tumor site than
solvent-based paclitaxel. ABRAXANE is currently in various stages of
investigation for the treatment of the following cancers: expanded applications
for metastatic breast, non-small cell lung, malignant melanoma and pancreatic.
The U.S. Food and Drug Administration approved ABRAXANE for Injectable
Suspension (paclitaxel protein-bound particles for injectable suspension)
(albumin-bound) in January 2005 for the treatment of breast cancer after failure
of combination chemotherapy for metastatic disease or relapse within six months
of adjuvant chemotherapy. Prior therapy should have included an anthracycline
unless clinically contraindicated. The U.S. Food and Drug Administration granted
orphan-drug designation for ABRAXANE for the treatment of pancreatic cancer in
September 2009 and stage IIb to IV melanoma in October 2009. For the full
prescribing information for ABRAXANE please visit www.abraxane.com.
About Abraxis BioScience, Inc.
Abraxis BioScience is a fully integrated global biotechnology company dedicated
to the discovery, development and delivery of next-generation therapeutics and
core technologies that offer patients safer and more effective treatments for
cancer and other critical illnesses. The company's portfolio includes the
world's first and only protein-bound nanoparticle chemotherapeutic compound
(ABRAXANE(R)), which is based on the company's proprietary tumor targeting
technology known as the nab(R) platform. The first FDA approved product to use
this nab platform, ABRAXANE, was launched in 2005 for the treatment of
metastatic breast cancer and is now approved in 38 countries. The company
continues to expand the nab platform through a robust clinical program and deep
product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol
ABII. For more information about the company and its products, please visit
www.abraxisbio.com.
i Korn, EL et al. Meta-Analysis of Phase II Cooperative Group Trials in
Metastatic Stage IV Melanoma to Determine Progression-Free and Overall Survival
Benchmarks for Future Phase II Trials. J Clin Oncol. 26:527-534 (2008).
ii American Cancer Society. Cancer Facts & Figures 2009. Atlanta: American
Cancer Society; 2009. Available at http://www.cancer.org/docroot/STT/STT_0.asp.
iii American Cancer Society. Cancer Facts & Figures 2009. Atlanta: American
Cancer Society; 2009. Available at http://www.cancer.org/docroot/STT/STT_0.asp.
Abraxis BioScience, Inc.
Investors and Media Inquiries
Maili Bergman, 310-883-1300
investorrelations@abraxisbio.com
or
Media Inquiries
Victoria Fort, 202-361-0445
Victoria.Fort@zenogroup.com
Copyright Business Wire 2009
