Biogen Idec (Nasdaq: BIIB) and Cardiokine, Inc. today announced
the initiation of a Phase III multi-center, randomized, placebo
controlled, double-blind study of lixivaptan for congestive heart
failure patients who suffer from hyponatremia, which is an electrolyte
disturbance marked by low sodium levels in the blood. The trial will
compare treatment with lixivaptan to placebo in approximately 650
patients in the U.S. and Europe.
Lixivaptan is an oral vasopressin V2 receptor antagonist that
works by causing a decrease in renal water reabsorption (an increase
in urine volume) and a decrease in urine osmolality. In prior clinical
studies, lixivaptan-treated patients showed improvement in serum
sodium concentrations, decreases in body weight, and increases in
urine volume. The safety profile supports continued development.
THE BALANCE (Treatment of HyponatrEmia BAsed on LixivAptan in NYHA
Class III/IV Cardiac Patient Evaluation) study is a multi-center,
randomized, placebo controlled, double-blind study of lixivaptan, a
selective V2 vasopressin receptor antagonist. Hyponatremia is common
in patients who have been hospitalized with worsening heart failure.
The primary endpoint of the study is to evaluate the safety and
effectiveness of lixivaptan, when compared to placebo, in increasing
serum sodium from baseline in heart failure patients with
hyponatremia.
"The effect of hyponatremia on congestive heart failure patients
is substantial and there are limited treatment options available to
these patients," said lead investigator William Abraham, M.D.,
Professor of Internal Medicine and Director of the Division of
Cardiovascular Medicine, Ohio State University Medical Center.
"Lixivaptan shows the potential to correct serum sodium levels in
these patients."
Hyponatremia is a condition that can occur in isolation, but is
most often a complication of another disease including heart failure.
At least a quarter of patients with heart failure have hyponatremia
and recent studies have demonstrated that low sodium levels are an
independent predictor of worsening outcomes in heart failure patients.
Hyponatremia can also occur in patients with cirrhosis or syndrome of
inappropriate anti-diuretic hormone secretion (SIADH).
"We are excited to see lixivaptan enter into Phase III studies as
it is Biogen Idec´s lead cardiology program," said Barry Ticho, M.D.,
Ph.D, Vice President, Cardiology, Biogen Idec. "Lixivaptan has the
potential to address significant unmet needs for heart failure
patients as well as other clinical conditions associated with
hyponatremia."
"This multi-national study utilizes a novel design and addresses
the needs of an important subset of the heart failure population,"
said Cesare Orlandi, M.D. Senior Chief Medical Officer at Cardiokine,
which is responsible for running the trial. "THE BALANCE study is the
first of several planned trials for lixivaptan. We anticipate
initiating pivotal studies in SIADH later this year."
Under the terms of the collaboration, Biogen Idec and Cardiokine
expect to jointly develop lixivaptan. Biogen Idec will be responsible
for its global commercialization and Cardiokine will have an option
for co-promotion in the US.
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.
About Cardiokine
Headquartered in Philadelphia, Cardiokine, Inc. is a specialty
pharmaceutical company focused on the development of pharmaceuticals
for the treatment and prevention of heart failure and related
cardiovascular indications. Additional information about Cardiokine is
available at www.cardiokine.com.
Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding
lixivaptan. These statements are based on Biogen Idec´s current
beliefs and expectations. The commercial potential of lixivaptan is
subject to a number of risks and uncertainties, including the risk of
meeting the end points in clinical trials, other 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.
