LOS ANGELES & TORONTO--(BUSINESS WIRE)--June 7, 2006--Abraxis
BioScience, Inc. (NASDAQ:ABBI):
Newly Released Data From Pivotal Trial Demonstrate ABRAXANE
Significantly Improves Progression-Free Survival and Time to Tumor
Progression and Nearly Doubles the Response Rate Versus Taxol
Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global
biopharmaceutical company, today announced it has received approval
for ABRAXANE(TM) for Injectable Suspension (paclitaxel powder for
injectable suspension) (nanoparticle, albumin-bound (nab) paclitaxel)
from the Therapeutic Products Directorate of Health Canada under a
Notice of Compliance for the treatment of metastatic breast cancer in
Canada. Canada is the first major commercial market to grant an
approval for ABRAXANE that includes first-line treatment of metastatic
breast cancer. The company, through its Canadian affiliate of Abraxis
Oncology, anticipates launching ABRAXANE late in the third
quarter of 2006.
Data from the pivotal head-to-head trial results demonstrated that
ABRAXANE nearly doubled the overall target lesion response rate versus
Taxol(R) and achieved a 37 percent improvement in progression-free
survival when compared to Taxol. In addition, time to tumor
progression versus Taxol was significantly prolonged in patients
receiving ABRAXANE. ABRAXANE is the first and only protein bound
particle chemotherapy, and unlike other taxane-based chemotherapies
such as Taxol, does not used solvents to help deliver the medicine to
tumors.
"I am very pleased that this approval of ABRAXANE includes
first-line treatment for metastatic breast cancer. This approval
allows doctors to offer their patients with metastatic breast cancer
ABRAXANE earlier, providing them a chance to fight tumors more
aggressively," said Patrick Soon-Shiong, M.D., chief executive officer
and chairman of the board of Abraxis BioScience.
"I have seen promising results from my recent experience with
ABRAXANE in clinical trials, and I'm heartened to hear that it has now
been approved for use in Canada. The efficacy of ABRAXANE provides
patients dealing with this life-threatening disease hope for better
outcomes," said Dr. Andre Robidoux, M.D., and Professor of Surgery at
the Hotel-Dieu Hospital in Montreal.
ABRAXANE was approved in the United States 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. ABRAXANE is currently in various stages of development
for the treatment of the following cancers: first-line metastatic
breast and non-small cell lung, adjuvant breast, neo-adjuvant breast,
malignant melanoma, ovarian, prostate, pancreatic, gastric, and head
and neck. Recent data presented at this year's American Society of
Clinical Oncology (ASCO) Annual Meeting demonstrated in a Phase 2
study that ABRAXANE administered weekly achieved a 50 percent response
rate and an 86 percent disease control rate in patients with non-small
cell lung cancer receiving the drug in combination with Carboplatin as
first-line therapy. By comparison, previous clinical trial experience
with solvent-based paclitaxel given weekly and standard carboplatin
demonstrated a 32 percent response rate in a similar patient
population. The grade three and four adverse events observed with
ABRAXANE were neutropenia, thrombocytopenia and anemia.
The nanoparticle albumin-bound (nab) tumor-targeting technology
developed by Abraxis exploits the natural properties of a human
protein, albumin, for drug delivery. By wrapping albumin around active
drug and creating particles of approximately 130 nanometers, Abraxis
has found a way to eliminate the need for solvents and deliver higher
concentrations of chemotherapy without the solvent-related toxicities
compared with solvent-based taxanes.
Clinical Trial Results
This first-line approval for ABRAXANE is based on the results of
data from the pivotal Phase III multicenter, randomized, comparative
study of 460 women with metastatic breast cancer. This randomized
trial was designed to compare ABRAXANE at a dose of 260 mg/m2 given as
a 30-minute infusion without pre-medication versus paclitaxel
injection (Taxol) at 175 mg/m2 given as a 3-hour infusion with
standard steroid and antihistamine pre-medication. Of the patient
population, 41 percent were first-line patients, and 59 percent
received study drug as second or greater than second-line therapy.
Seventy-seven percent of patients had been previously exposed to
anthracyclines. Despite a 50 percent higher dose of chemotherapy
infused over 30 minutes without pre-medication for hypersensitivity,
ABRAXANE was well tolerated in the pivotal Phase III trial.
Patients in the ABRAXANE treatment arm had a superior investigator
overall target lesion response rate of 33.2 percent, compared to 18.7
percent for patients in the paclitaxel injection treatment arm. Time
to Tumor Progression (TTP) was significantly prolonged in the ABRAXANE
group than in the paclitaxel injection group for all patients (23.0
vs. 16.6 weeks (5.3 vs. 3.8 months), (p=0.003)). Median
Progression-Free Survival (PFS) was significantly longer for the
ABRAXANE group than for the paclitaxel injection group for all
patients (22.7 vs. 16.6 weeks (5.2 vs. 3.8 months), (p=0.002)).
Survival for patients treated with ABRAXANE was prolonged by 10 weeks;
median time to death for Abraxane and paclitaxel injection groups for
all patients was 65.0 vs. 55.3 weeks (14.9 vs. 12.7 months)
respectively.
Most patients taking ABRAXANE will experience side effects,
although it is not always possible to tell whether such effects are
caused by ABRAXANE, another medicine they may be taking, or the cancer
itself. Important side effects are described below; however, some
patients may experience other side effects that are less common. In
the randomized metastatic breast cancer study, the most important
adverse events included neutropenia (all cases 80%; severe 9%), anemia
(all 33%; severe 1%), infections (24%), sensory neuropathy (any
symptoms 71%; severe 10%), nausea (any 30%; severe 3%), vomiting (any
18%; severe 4%), diarrhea (any 26%; severe <1%), myalgia/arthralgia
(any 44%; severe 8%), and mucositis (any 7%; severe <1%). Other
adverse reactions included asthenia (any 47%; severe 8%),
ocular/visual disturbances (any 13%; severe 1%), fluid retention (any
10%; severe 0%), alopecia (90%), hepatic dysfunction (elevations in
bilirubin 7%, alkaline phosphatase 36%, AST (SGOT) 39%), and renal
dysfunction (any 11%; severe 1%). Thrombocytopenia (any 2%; severe
<1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular
reactions (severe 3%), and injection site reactions (1%) were
uncommon.
Canadian Market for ABRAXANE(R)
Breast cancer is the most common cancer among Canadian women, and
in 2006, an estimated 22,300 will be diagnosed with breast cancer and
5,300 will die from the disease.
About ABRAXANE(R)
The U.S. Food and Drug Administration approved ABRAXANE(R) 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. ABRAXANE, the first commercially
approved product based on the nab(TM) technology platform, received
approval by the U.S. Food and Drug Administration (FDA) in January
2005 for the treatment of breast cancer. For the full prescribing
information for ABRAXANE(R) please visit www.abraxane.com.
About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical
company dedicated to meeting the needs of critically ill patients. The
company develops, manufactures and markets one of the broadest
portfolios of injectable products and leverages revolutionary
technology such as its nab(TM) platform to discover and deliver
breakthrough therapeutics that transform the treatment of cancer and
other life-threatening diseases. The first FDA approved product to use
this nab platform, ABRAXANE(R), was launched in 2005 for the treatment
of metastatic breast cancer. Abraxis trades on the Nasdaq National
Market under the symbol ABBI. For more information about the company
and its products, please visit www.abraxisbio.com.
Forward-Looking Statement
The statements contained in this press release that are not purely
historical are forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements in this press release include statements
regarding our expected launch of ABRAXANE in Canada. Because these
forward-looking statements involve risks and uncertainties, there are
important factors that could cause actual results to differ materially
from those in the forward- looking statements. These factors include,
without limitation, the market adoption and demand of ABRAXANE in
Canada, the costs associated with the ongoing launch of ABRAXANE, the
impact of competitive products and pricing, the availability and
pricing of ingredients used in the manufacture of pharmaceutical
products, the ability to successfully manufacture products in a
time-sensitive and cost effective manner, the acceptance and demand of
new pharmaceutical products, the impact of patents and other
proprietary rights held by competitors and other third parties.
Additional relevant information concerning risks can be found in
Abraxis BioScience's Form 10-K for the year ended December 31, 2005
and other documents it has filed with the Securities and Exchange
Commission.
Taxol(R) is a registered trademark of Bristol Myers-Squibb
Company.
CONTACT: Abraxis BioScience, Inc.
Investors and Media:
Christine Cassiano, 310-826-5102
or
Canada
Ketchum Public Relations Canada
Diana Arajs, 416-544-4922
SOURCE: Abraxis BioScience, Inc.