CAMBRIDGE, MASS., August 14 /CNW/ - Biogen Idec (NASDAQ: BIIB) has
announced that positive results of a Phase II study of oral ADENTRI(R), an A1
adenosine receptor antagonist, in stable heart failure patients have been
published in today's issue of the Journal of the American College of
Cardiology. Results showed that administration of oral ADENTRI for 10 days, in
addition to standard heart failure therapy, was well tolerated and resulted in
clinically significant increases in sodium excretion while preserving renal
"We are excited to have these data published showing the potential of
ADENTRI in patients with heart failure. Worsening kidney function occurs
commonly in these patients and it is typically associated with adverse
outcomes," said Barry H. Greenberg, MD, Professor of Medicine and Director of
the Advanced Heart Failure Program at University of California, San Diego
Medical Center. "Our results demonstrate significant increases in salt
excretion without significant adverse events on renal function, suggesting
that ADENTRI may have the potential to improve the standard of treatment that
is currently offered."
According to the American Heart Association (AHA), there are currently
five million people that suffer from heart failure in the United States. In
this patient population studies have demonstrated that renal function is one
of the most important independent determinants of survival. Heart failure
patients with renal insufficiency are also considered to be among the most
challenging to treat. It is believed that worsened renal function is caused by
a combination of pre-existing medical conditions and the chronic use of
"Biogen Idec is committed to developing novel compounds for patients with
cardiopulmonary diseases with high unmet need," said Barry Ticho, M.D., Ph.D,
Senior Director of Medical Research at Biogen Idec. "We are moving forward
with oral and intravenous formulations of ADENTRI for acute and chronic heart
failure, as well as two additional compounds; LIXIVAPTAN for the treatment of
hyponatremia in congestive heart failure and AVIPTADIL for the treatment of
pulmonary arterial hypertension."
The trial was a randomized, double blind, placebo-controlled study that
sought to assess the pharmacokinetics and pharmacologic effects of ADENTRI in
heart failure patients.
Fifty patients were maintained on their usual medications, including ACE
inhibitors and diuretics, and were dosed with placebo or one of four doses of
ADENTRI, administered once daily for 10 days.
The study showed increases in sodium excretion above baseline and placebo
beginning on Day 1, continuing over the 10-day dosing period. Notably, these
effects were not accompanied by reductions in renal function nor substantial
increases in potassium excretion. Trends toward beneficial effects in clinical
measures of heart failure, including body weight, edema, and physician global
assessment, were also observed. The safety evaluation did not reveal any
significant concerns during dosing nor during 30 days of additional follow-up.
The incidence of adverse events was similar to placebo, and higher doses of
ADENTRI were not associated with an increase in adverse events. The
pharmacokinetic profile was consistent with once daily dosing.
Preliminary results of this study were presented in 2003 at the annual
meeting of the American Heart Association.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high
unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the
discovery, development, manufacturing, and commercialization of innovative
therapies. Patients in more than 90 countries benefit from Biogen Idec's
significant products that address diseases such as lymphoma, multiple
sclerosis, and rheumatoid arthritis. For product labeling, press releases and
additional information about the company, please visit www.biogenidec.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding
ADENTRI(R). These statements are based on Biogen Idec's current beliefs and
expectations. The commercial potential of ADENTRI is subject to a number of
risks and uncertainties, including the risk of unexpected delays or hurdles
and the uncertainty of obtaining regulatory approval. Drug development and
commercialization involves a high degree of risk.
For more detailed information on the risks and uncertainties associated
with Biogen Idec's drug development and other activities, see Item 1A "Risk
Factors" in Biogen Idec's most recent Form 10-Q filing with the Securities and
Exchange Commission. These forward looking statements speak only as of the
date of this press release, and we assume no obligation to update any
forward-looking statements, whether as a result of new information, future
events or otherwise.
For further information:
For further information: MEDIA CONTACT Biogen Idec Shannon Altimari,
617-914-6524 or INVESTOR CONTACT Biogen Idec Eric Hoffman, 617-679-2812