ECUBLENS, Switzerland, Sept. 28 /PRNewswire-FirstCall/ - Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. , announces today that its Marketing Authorization Application (MAA) for eprodisate (Kiacta(TM); formerly Fibrillex(TM)) has been validated by the European Medicines Agency (EMEA), which confirms that the regulatory review has started. The Company is seeking marketing approval of its investigational product candidate, Kiacta(TM), for the treatment of Amyloid A (AA) amyloidosis in the European Union (EU).
The MAA for Kiacta(TM) will be reviewed under the Centralized Procedure, where marketing authorization is applied for all EU Member States (numbering 25 countries today), plus Norway and Iceland. Kiacta(TM) has been designated as an Orphan Medicinal Product in Europe, which normally provides ten years of market exclusivity upon regulatory approval.
"Neurochem looks forward to working with the European Authorities as they begin the review process for Kiacta(TM) as a potential and specific treatment for AA amyloidosis," said Dr. Francesco Bellini, Chairman, President and Chief Executive Officer of Neurochem Inc. "We remain committed to the advancement of this product candidate with the hope of making it available as soon as possible to the doctors and the patients who could benefit from Kiacta(TM)."
In August 2006, Neurochem Inc. received an approvable letter from the U.S. Food and Drug Administration (FDA) for Kiacta(TM) for the treatment of AA amyloidosis. Neurochem Inc. plans to respond to the FDA and submit an amendment to the New Drug Application shortly.
Neurochem has an exclusive collaboration and distribution agreement for Kiacta(TM) with Centocor, Inc.
About Kiacta(TM)
Kiacta(TM) was investigated in a landmark international, randomized, double-blind, placebo-controlled, and parallel-designed clinical trial in which 183 patients were enrolled at 27 sites around the world. Patients who completed the clinical trial were eligible for enrollment in an ongoing open-label extension 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 and end stage renal disease is the most common cause of death 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 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 is under regulatory review for marketing approval by the U.S. Food and Drug Administration and European Medicines Agency. 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 eprodisate (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 eprodisate (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. Neither Neurochem Inc., nor Neurochem (International) Limited undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise. Please see Neurochem Inc.'s Annual Information Form for further risk factors that might affect Neurochem Inc., Neurochem (International) Limited and their respective businesses.
NEUROCHEM INC.CONTACT: Lise Hebert, Ph.D., Vice President, Corporate Communications,(450) 680-4570, lhebert@neurochem.com
