-- EMPOWER trial fails to demonstrate efficacy in primary and key
secondary endpoints --
WESTON, Mass.--(BUSINESS WIRE)--Jan. 3, 2013--
Today Biogen Idec (NASDAQ: BIIB) reported top-line results of EMPOWER, a
Phase 3 trial investigating dexpramipexole in people with amyotrophic
lateral sclerosis (ALS). The trial did not meet its primary endpoint, a
joint rank analysis of function and survival, and no efficacy was seen
in the individual components of function or survival. The trial also
failed to show efficacy in its key secondary endpoints. Additional
analyses of multiple subpopulations failed to demonstrate any efficacy
among these groups. Based on these results, Biogen Idec will discontinue
development of dexpramipexole in ALS.
"We share the disappointment of members of the ALS community, who had
hoped that dexpramipexole would offer a meaningful new treatment
option,” said Douglas E. Williams, Ph.D., Executive Vice President of
Research and Development at Biogen Idec. “Nevertheless, the EMPOWER
trial represents a significant contribution to ALS research, and Biogen
Idec is committed to advancing ALS science. We continue to work with
researchers around the world to understand the causes of ALS and find
potential treatments for people with ALS.”
The company intends to present detailed results at a future medical
conference.
EMPOWER Trial
EMPOWER was a randomized, double-blind, placebo-controlled Phase 3 trial
which enrolled 943 people with ALS at 81 sites in 11 countries. Patients
were randomized on a one-to-one basis to receive either dexpramipexole
or placebo. The primary endpoint was a joint rank analysis of function
and survival, known as the Combined Assessment of Function and Survival
(CAFS). In addition to CAFS, the trial individually evaluated functional
decline, survival and respiratory decline, among other measures.
“As a physician who has treated people with ALS, I hoped with all my
heart for a different outcome,” said Douglas Kerr, M.D., Ph.D., Director
of Neurodegeneration Clinical Research at Biogen Idec. “While these
results were not what we expected, we hope these data will provide a
foundation for future ALS research.”
Biogen Idec’s Commitment to ALS Research
Biogen Idec has several programs underway in ALS. The company recently
entered into a research collaboration with Duke University and
HudsonAlpha Institute to sequence the genomes of up to 1,000 people with
ALS over the next five years in an effort to gain a deeper understanding
about the fundamental genetic causes of the disease. Duke and
HudsonAlpha will work with several world-class researchers who have deep
expertise and experience with ALS and the genes associated with the
disease.
Biogen Idec recently created a research consortium in collaboration with
several leading academic research centers to identify new approaches to
treating ALS. Each of the centers involved in this consortium brings
different scientific and technical expertise and a shared goal of
improving the understanding of ALS from a basic science perspective.
In addition, Biogen Idec has committed significant funds to the
University of Massachusetts Medical School ALS Champion Fund. The
funding will drive awareness of ALS and support basic and clinical
science research into potential treatments for ALS and other
neurodegenerative diseases.
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers,
develops and delivers to patients worldwide innovative therapies for the
treatment of neurodegenerative diseases, hemophilia and autoimmune
disorders. Founded in 1978, Biogen Idec is the world’s oldest
independent biotechnology company. Patients worldwide benefit from its
leading multiple sclerosis therapies and the company generates more than
$5 billion in annual revenues. For product labeling, press releases and
additional information about the company, please visit www.biogenidec.com.
Safe Harbor
This press release contains forward-looking statements, including
statements about potential treatments for ALS. These statements may be
identified by words such as "believe," "expect," "may," "plan,"
"potential," "will" and similar expressions, and are based on the
company’s current beliefs and expectations. Drug development involves a
high degree of risk, and only a small number of research and development
programs results in the commercialization of a product. Success in
preclinical work or early stage clinical trials does not ensure that
later stage or larger scale clinical trials will be successful. In
addition, clinical trials may indicate that product candidates have
harmful side effects or raise other safety concerns that may
significantly reduce the likelihood of regulatory approval. For more
detailed information on the risks and uncertainties associated with
Biogen Idec's drug development activities, please review the Risk
Factors section of Biogen Idec's most recent annual or quarterly report
filed with the Securities and Exchange Commission. Any forward-looking
statements speak only as of the date of this press release and the
company assumes no obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise.
Source: Biogen Idec
Biogen Idec Media Contact:
Ligia Del Bianco, +1-781-464-3260
Manager,
Public Affairs
or
Biogen Idec Investor Contact:
Kia
Khaleghpour, +1-781-464-2442
Director, Investor Relations
