ECUBLENS, Switzerland, Dec. 14 /PRNewswire-FirstCall/ - 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 2008.
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: http://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.
Lise Hebert, PhD
Vice President, Corporate Communications
|SOURCE NEUROCHEM INC.|
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