Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global
biopharmaceutical company, today presented data in an oral
presentation at the 29th Annual San Antonio Breast Cancer Symposium
(SABCS) from an interim analysis of a randomized, head-to-head Phase
II trial of ABRAXANE(R) for Injectable Suspension (paclitaxel
protein-bound particles for injectable suspension) (albumin bound)
versus Taxotere(R) (docetaxel) Injection Concentrate, in the
first-line treatment of metastatic breast cancer. The interim analysis
showed that first-line treatment with weekly ABRAXANE (100 and 150
mg/m(2)) increased tumor response rate by greater than 60 percent with
less toxicity versus Taxotere (100 mg/m(2)) given every three weeks in
patients with metastatic breast cancer. The interim analysis also
showed that weekly ABRAXANE nearly doubled the response rate with less
toxicity compared to ABRAXANE (300 mg/m(2)) dosed every three weeks.
Although the data are not fully mature, the interim analysis showed
that all three ABRAXANE regimens currently have longer
progression-free survivals than Taxotere dosed every three weeks. A
blinded, independent radiological review of the response data is in
process and the company intends to submit the final analysis of the
data to the American Society of Clinical Oncology (ASCO) in 2007.
Based on these encouraging data, Abraxis plans to initiate a
worldwide head-to-head Phase III registration trial comparing weekly
ABRAXANE to every three week Taxotere for the treatment of first-line
metastatic breast cancer. The Phase III registration trial is expected
to begin in the first half of 2007 in multiple sites throughout North
America, Eastern and Western Europe, and Asia-Pacific.
"These interim data show that weekly ABRAXANE, when used in the
first-line treatment of patients with metastatic breast cancer,
increased the response rate by over 60 percent with less toxicity than
the FDA-approved dose of Taxotere given every three weeks," said
William Gradishar, M.D., F.A.C.P, Director, Breast Medical Oncology at
Robert H. Lurie Comprehensive Cancer Center Northwestern University, a
lead investigator in the study. "These data are consistent with
previous study results of both ABRAXANE and Taxotere, and are very
encouraging for both physicians and patients."
"The high response rate to weekly ABRAXANE observed in this study
is consistent with other data presented at this symposium by the NSABP
Foundation Research Group and the International Oncology Network, and
provides new insight into the clinical development of ABRAXANE," said
Michael Hawkins, M.D., chief medical officer of Abraxis BioScience.
"The Phase II results provide the direction needed to initiate a Phase
III trial examining weekly ABRAXANE versus Taxotere in first-line
treatment of metastatic breast cancer. We look forward to presenting
the final analysis of this Phase II study next year."
About the Study
In the randomized Phase II study more than 300 patients with stage
4 metastatic breast cancer and no prior chemotherapy treatments
received one of four treatment regimens: ABRAXANE 300 mg/m(2) (n= 76)
dosed every three weeks, ABRAXANE 100 mg/m(2) (n= 76) or 150 mg/m(2)
(n= 74) dosed weekly for three weeks out of four, and Taxotere 100
mg/m(2) (n= 76) dosed every three weeks. The purpose of the study was
to obtain comparative toxicity and preliminary anti-tumor response
data addressing three issues:
-- ABRAXANE versus Taxotere;
-- Weekly versus every three week dosing of ABRAXANE; and
-- A high and low dose of ABRAXANE.
The secondary endpoint of the study was progression-free survival.
Data from this trial were intended to provide direction for the design
of future trials with ABRAXANE.
The prospectively planned interim analysis demonstrated that
first-line treatment with ABRAXANE 100 or 150 mg/m(2) weekly compared
to Taxotere resulted in a statistically significant increase in
response rates of 61 percent (58% vs. 36%, p=.004) and 72 percent (62%
vs. 36%, p=.0016), respectively. Both weekly dose regimens of ABRAXANE
also increased the response rate compared to every three week ABRAXANE
(58% and 62% vs. 33%; p less than 0.001). Although these data are not
mature with only 33 percent of potential events having occurred, in
the current analysis, all three ABRAXANE treatment arms have longer
progression-free survivals compared to Taxotere (by log rank).
Compared to Taxotere, all three ABRAXANE treatment arms (300
mg/m(2) q3w, 100 mg/m(2) wkly, 150 mg/m(2) wkly) demonstrated less
frequent adverse events with regard to:
-- Grade 4 Neutropenia (74% Taxotere vs. 4%, 3%, 7% ABRAXANE,
respectively);
-- Febrile neutropenia (7% Taxotere vs. 1%, 1%, 1% ABRAXANE,
respectively); and
-- Grade 1/2 Mucositis/stomatitis (20% Taxotere vs. 3%, 1%, 0%
ABRAXANE, respectively).
There was no grade 4 peripheral neuropathy reported in any of the
treatment arms. There were no statistical differences in peripheral
neuropathy between the ABRAXANE regimens compared to Taxotere.
In this study, ABRAXANE (100 mg/m2 wkly) demonstrated a better
therapeutic index as compared to the other two regimens of ABRAXANE
and Taxotere, demonstrating a response rate of 58 percent versus 36
percent for Taxotere with improvement in the adverse event profile.
There was no statistical difference in arthralgias between ABRAXANE
100 mg/m2 compared to Taxotere. Fatigue was significantly lower in
ABRAXANE 100 mg/m2 compared to Taxotere (21% vs. 46%, p < 0.001).
ABRAXANE 100 mg/m2 weekly compared to the other two ABRAXANE treatment
arms (300 mg/ m2 q3w, 150 mg/m2 wkly) resulted in less peripheral
neuropathy (37% vs. 51% and 47%, respectively), arthralgias (16% vs.
33% and 35%, respectively), and fatigue (21% vs. 33% and 39%,
respectively). The only adverse event occurring at a greater frequency
with ABRAXANE (300 mg/m2 q3w and 150 mg/m2 wkly) compared to Taxotere
was arthralgia (33% and 35% vs. 16%, respectively, p <= 0.03).
Other Data Presented on ABRAXANE
Neoadjuvant chemotherapy with sequential weekly nanoparticle
albumin-bound paclitaxel (ABI-007, ABRAXANE) followed by
5-fluorouracil, epirubicin and cyclophosphamide (FEC) in locally
advanced breast cancer (LABC): a phase II trial of the NSABP
Foundation Research Group (Poster Number: 3068)
Single agent ABRAXANE given weekly (3/4) as first-line therapy for
metastatic breast cancer (an International Oncology Network Study,
#I-04-012) (Poster Number: 6073)
Conference Call Information
On Monday, December 18, 2006, the company will host a conference
call with interested parties beginning at 11:00 a.m. ET/8:00 a.m. PT
to discuss the data presented at the San Antonio Breast Cancer
Symposium. The conference call may be heard through a live audio
Internet broadcast at www.abraxisbio.com and www.earnings.com. For
those unable to listen to the live broadcast, a playback of the
webcast will be available at both websites for approximately six
months beginning shortly after the conclusion of the call. In
addition, the slides presented at the San Antonio Breast Cancer
Symposium will be available at www.sabcs.org.
About Breast Cancer
According to the American Cancer Society, breast cancer is the
most common cancer among women, other than skin cancer, and is the
second leading cause of cancer death in women in the United States.
The risk of having breast cancer for a woman sometime during her life
is about one in eight. In 2006 alone, an estimated 213,000 new cases
of breast cancer are expected to occur in women, and an estimated
41,000 women are expected to 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. The most serious adverse events
associated with ABRAXANE in the randomized metastatic breast cancer
study for which FDA approval was based included neutropenia, anemia,
infections, sensory neuropathy, nausea, vomiting, and
myalgia/arthralgia. Other common adverse reactions included anemia,
asthenia, diarrhea, ocular/visual disturbances, fluid retention,
alopecia, hepatic dysfunction, mucositis, and renal dysfunction. For
the full prescribing information for ABRAXANE(R), please visit
www.abraxane.com.
ABRAXANE was developed by Abraxis BioScience, Inc. ABRAXANE is
marketed in the United States under a co-promotion agreement between
Abraxis and AstraZeneca Pharmaceuticals LP.
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 Stock 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 expectations, beliefs, hopes, goals, intentions,
initiatives or strategies, including statements regarding future
clinical trials for ABRAXANE. 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 continued market adoption and demand of ABRAXANE in
North America and its potential market penetration outside of the
U.S., the costs associated with the ongoing launch of ABRAXANE, the
success of our co-promotion agreement with AstraZeneca, the impact of
pharmaceutical industry regulation, 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.
The information contained in this press release is as of the date
of this release. Abraxis assumes no obligations to update any
forward-looking statements contained in this press release as the
result of new information or future events or developments.
Taxotere(R) is a registered trademark of Sanofi Aventis.
