Newsroom 2006
Attention Business/Financial Editors:
Neurochem receives approvable letter for eprodisate (Kiacta(TM)) for treatment of AA amyloidosis - Neurochem will host a conference call on August 14, 2006, at 8:30 A.M. ET
LAVAL, QC, Aug. 11 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX, TSX: NRM)
announces that it has received an approvable letter from the U.S. Food and
Drug Administration (FDA) for eprodisate (Kiacta(TM) - formerly Fibrillex(TM))
for the treatment of Amyloid A (AA) amyloidosis.
In its action letter, the FDA requested additional efficacy information,
as well as a safety update. The FDA stated that this efficacy information
would probably need to be addressed by one or more additional clinical trials.
As an alternative, the FDA also stated that significant findings obtained from
a complete follow-up of patients in the existing study could be persuasive.
The FDA asked for further manufacturing and pharmacokinetic information, and
acknowledged that a QT clinical study should be submitted as part of a Phase 4
(post approval) commitment.
"We are pleased with the FDA's response and the constructive relationship
we have with them," said Dr. Francesco Bellini, Chairman, President and CEO of
Neurochem. "We are working closely with the agency to secure as soon as
possible the final approval without conducting a new efficacy clinical trial.
We are already starting to collect additional information as suggested by the
FDA," he concluded.
A progressive and fatal condition, AA amyloidosis occurs in a proportion
of patients with chronic inflammatory disorders, chronic infections and
inherited diseases such as Familial Mediterranean Fever. The kidney is the
organ most frequently affected and progression to dialysis and end stage renal
disease is the most common cause of death in this disease. Currently, there is
no FDA-approved therapy to treat AA amyloidosis and half of all patients
diagnosed with the disease die within five years of diagnosis.
About Kiacta(TM)
Kiacta(TM) underwent a landmark international, randomized, double-blind,
placebo-controlled, and parallel-designed clinical trial in which 183 patients
were enrolled in 27 sites around the world.
In April 2006, the FDA granted Priority Review to Kiacta(TM), a
classification reserved for product candidates that would offer a significant
improvement in the treatment, diagnosis or prevention of a disease or that
address an unmet medical need. Over the course of its development, Kiacta(TM)
received Orphan Drug Designation and Fast Track status by the FDA and was
accepted by the Agency for the Continuous Marketing Application (CMA) Pilot 1
and 2 programs.
Conference Call
Neurochem will host a conference call at 08H30 Eastern Time, Monday,
August 14, 2006.
To participate in the conference call, please dial the following numbers
approximately 10 minutes prior to the start of the call: 416-644-3430 or
1-800-814-4861. A replay of the conference call will be available for one week
(until August 21, 2006), commencing one hour after the end of the call. The
instant replay numbers are 416-640-1917 or 1-877-289-8525. The access code for
the replay is 21200044. Please mention that you are calling for the Neurochem
conference replay.
About Neurochem
Neurochem is focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(Kiacta(TM)) is currently being developed for the treatment of AA amyloidosis
and has received in August 2006 from the FDA an approvable letter.
Tramiprosate (Alzhemed(TM)), for the treatment of Alzheimer's disease, is
currently in Phase III clinical trials in both North America and Europe and
tramiprosate (Cerebril(TM)), for the prevention of Hemorrhagic Stroke caused
by Cerebral Amyloid Angiopathy, has completed a Phase IIa clinical trial.
To Contact Neurochem
For additional information on Neurochem and its drug development
programs, please call the North American toll-free number 1-877-680-4500 or
visit our Web Site at www.neurochem.com.
This news release contains forward-looking statements regarding
Kiacta(TM), as well as regarding continuing and further development efforts.
These statements are based on the current analysis and expectations of
management. Drug development necessarily involves numerous risks and
uncertainties, which could cause actual results to differ materially from this
current analysis and these expectations. Analysis regarding the results of
clinical trials may not provide definitive results regarding safety,
tolerability or therapeutic benefits. Even if all the endpoints sought in the
clinical trials were met (which is not certain), there is no certainty that
regulators would ultimately approve Kiacta(TM) for sale to the public. Risks
and uncertainties may include: failure to demonstrate the safety, tolerability
and efficacy of our product, the expense and uncertainty of obtaining
regulatory approval, including from the FDA, and the possibility of having to
conduct additional clinical trials. Further, even if regulatory approval is
obtained, therapeutic products are generally subject to: stringent on-going
governmental regulation, challenges in gaining market acceptance, and
competition. Neurochem does not undertake any obligation to publicly update
its forward-looking statements, whether as a result of new information, future
events, or otherwise. Please see the Annual Information Form for further risk
factors that might affect the Company and its business.
For further information: Lise Hébert, PhD, Vice President, Corporate
Communications, (450) 680-4570, lhebert@neurochem.com
