ECUBLENS, Switzerland, Dec. 14 /CNW Telbec/ - Neurochem (International)
Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ:
NRMX; TSX: NRM), announces that the Committee for Medicinal Products for Human
Use (CHMP), the scientific committee of the European Medicines Agency (EMEA),
has issued a negative opinion recommending refusal of the marketing
authorization application (MAA) for eprodisate (KIACTA(TM)) for the treatment
of Amyloid A (AA) amyloidosis and concluding that another study would be
needed to demonstrate eprodisate's (KIACTA(TM)) effectiveness. The Company is
currently reviewing all of its options in view of this opinion, including the
option of requesting a re-examination of the opinion by CHMP. As provided by
the European regulations, the Company may request that the CHMP consult a
Scientific Advisory Group (SAG) in connection with the re-examination. The
deadline for filing any such request is within fifteen days of receipt of
notification of the opinion.
"We are naturally disappointed with this opinion for KIACTA(TM) as we are
acutely aware of the needs of AA amyloidosis patients who have no specific
therapy presently available," said Dr. Francesco Bellini, Neurochem Inc.'s
Chairman, President and CEO. "In view of the clinical benefit KIACTA(TM) has
shown on the kidney function of patients, we are considering making a request
for re-examination of the opinion which could lead to a decision as early as
the second quarter of 2008. We look forward to further productive interactions
with the EMEA," he concluded.
U.S. New Drug Application (NDA)
In the U.S., Neurochem Inc. received an acknowledgement from the Food and
Drug Administration (FDA) that the Company's response to the second approvable
letter of July 2007 for the NDA for eprodisate (KIACTA(TM)) for the treatment
of AA amyloidosis is a complete, Class 2 response. The PDUFA (Prescription
Drug User Fee Act) goal date by which the FDA is expected to render a decision
is April 2, 2008.
About eprodisate (KIACTA(TM))
Eprodisate (KIACTA(TM)) was investigated in an international, randomized,
double-blind, placebo-controlled, and parallel-designed Phase II/III clinical
trial in which 183 AA amyloidosis patients were enrolled at 27 international
sites (Eprodisate for AA Amyloidosis Trial, EFAAT). Patients who completed the
clinical trial were eligible for enrollment in an ongoing open-label extension
study, some of whom have now been receiving eprodisate (KIACTA(TM)) for more
than six years. Eprodisate (KIACTA(TM)) has received orphan drug status in the
United States, the European Union and in Switzerland.
The Company also filed for marketing approval for eprodisate (KIACTA(TM))
for the treatment of AA amyloidosis in Switzerland. A decision is expected in
Neurochem Inc. sponsored the EFAAT study.
About Amyloid A (AA) Amyloidosis
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/end-stage renal
disease is the most common clinical manifestation in this disease. Currently,
there is no approved therapy to treat AA amyloidosis and about half of all
patients diagnosed with the disease die within five years of diagnosis.
About Neurochem Inc.
Neurochem Inc. is a global health company focused on the research,
development and commercialization of products to provide innovative health
solutions to patients suffering from serious diseases.
To Contact Neurochem Inc
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.
Certain statements contained in this news release, other than statements
of fact that are independently verifiable at the date hereof, may constitute
forward-looking statements. Such statements, based as they are on the current
expectations of management, inherently involve numerous risks and
uncertainties, known and unknown, many of which are beyond Neurochem Inc.'s
control. Such risks include but are not limited to: the impact of general
economic conditions, general conditions in the pharmaceutical and/or
nutraceutical industry, changes in the regulatory environment in the
jurisdictions in which the Neurochem group does business, stock market
volatility, fluctuations in costs, and changes to the competitive environment
due to consolidation, that actual results may vary once the final and
quality-controlled verification of data and analyses has been completed, as
well as other risks disclosed in public filings of Neurochem Inc.
Consequently, actual future results may differ materially from the anticipated
results expressed in the forward-looking statements. The reader should not
place undue reliance, if any, on any forward-looking statements included in
this news release. These statements speak only as of the date made and
Neurochem Inc. is under no obligation and disavows any intention to update or
revise such statements as a result of any event, circumstances or otherwise.
Please see the Annual Information Form of Neurochem Inc. for further risk
factors that might affect the Neurochem group and its business.
For further information:
For further information: Lise Hébert, PhD, Vice President, Corporate
Communications, (450) 680-4572, firstname.lastname@example.org