-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, GBYxyr1OXHXo+EGRPg/XhnE6P3uA1Y67TmmyjydwLuM1zlfCw0NamgV7JFiuAuyv 7sP+hWpvM5NfEiYLhc9pCA== 0001206212-06-000260.txt : 20061106 0001206212-06-000260.hdr.sgml : 20061106 20061106164459 ACCESSION NUMBER: 0001206212-06-000260 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20061106 FILED AS OF DATE: 20061106 DATE AS OF CHANGE: 20061106 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEUROCHEM INC CENTRAL INDEX KEY: 0001259942 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50393 FILM NUMBER: 061190862 BUSINESS ADDRESS: STREET 1: 275 ARMAND-FRAPPIER BLVD. CITY: LAVAL STATE: A8 ZIP: H7V 4A7 BUSINESS PHONE: 450-680-4500 MAIL ADDRESS: STREET 1: 275 ARMAND-FRAPPIER BLVD. CITY: LAVAL STATE: A8 ZIP: H7V 4A7 6-K 1 m33646ore6vk.txt FORM 6-K ================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of: November, 2006 Commission File Number: 000-50393 NEUROCHEM INC. 275 Armand-Frappier Boulevard Laval, Quebec H7V 4A7 Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40 F. Form 20-F [ ] Form 40-F [X] Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): Yes [ ] No [X] Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): Yes [ ] No [X] Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g-3 under the Securities Exchange Act of 1934. Yes [ ] No [X] If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): ================================================================================ SIGNATURES: Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. NEUROCHEM INC. November 6, 2006 By: /s/ David Skinner --------------------------------------- David Skinner, Vice President, General Counsel and Corporate Secretary NEUROCHEM INC. 275 Armand-Frappier Blvd. [NEUROCHEM LOGO] Laval, Quebec, Canada H7V 4A7 - -------------------------------------------------------------------------------- FOR FURTHER INFORMATION, PLEASE CONTACT: Lise Hebert, Ph.D. Tel: (450) 680-4572 Vice President, Corporate Communications lhebert@neurochem.com NEUROCHEM RECEIVES RECOMMENDATIONs FROM DATA SAFETY MONITORING BOARDS TO CONTINUE PHASE III CLINICAL TRIALS FOR TRAMIPROSATE (ALZHEMED(TM)) LAVAL, QUEBEC, NOVEMBER 6, 2006 -- Neurochem Inc. (NASDAQ: NRMX; TSX: NRM), announces that it has received recommendations from both the North American and European Data Safety Monitoring Boards (DSMB) to continue its two Phase III clinical trials currently ongoing for tramiprosate (ALZHEMED(TM)), Neurochem's investigational product candidate for the treatment of Alzheimer's disease (AD). The two DSMBs are made up of independent clinical experts who monitor and evaluate the safety of patients taking part in the tramiprosate (ALZHEMED(TM)) Phase III clinical trials. In North America, this fifth recommendation by the DSMB was based on the recent review of the available safety data from 1,052 patients who have been on study medication for an average of 12.9 months. The Company announced previous recommendations by the North American DSMB in February 2006, and April, June and October 2005. In Europe, this first recommendation by the DSMB members was based on their recent review of the available safety data from 333 patients who have been on study medication for an average of 1.8 months. Tramiprosate (ALZHEMED(TM)) is a small, orally-administered molecule known as an amyloid (BETA) antagonist, which crosses the blood-brain-barrier, binds to soluble A(beta) peptide and interferes with the amyloid cascade that is associated with amyloid deposition and the toxic effects of A(BETA) peptide in the brain. ABOUT THE PHASE III CLINICAL TRIALS FOR TRAMIPROSATE (ALZHEMED(TM)) Neurochem is currently conducting a multi-center, randomized, double-blind, placebo-controlled and parallel-designed, 18-month Phase III clinical trial in 1,052 mild-to-moderate AD patients, which is being carried out at close to 70 clinical sites across the United States and Canada. The trial is scheduled to be completed in January 2007. To date, 542 patients have completed 18 months on study medication. All patients who complete the North American Phase III clinical trial are eligible to receive tramiprosate (ALZHEMED(TM)) in an open-label extension study. -2- Neurochem is also actively advancing an 18-month Phase III clinical trial for tramiprosate (ALZHEMED(TM)) in placeEurope, which was initiated in September 2005. The ongoing European Phase III clinical trial, an international, multi-center, randomized, double-blind, placebo-controlled and parallel-designed study, is progressing on schedule and is designed to investigate the safety, efficacy and disease-modifying potential of tramiprosate (ALZHEMED(TM)). Some 930 mild-to-moderate AD patients are expected to take part and enrollment is expected to be completed in fall 2006. ABOUT ALZHEIMER'S DISEASE Alzheimer's disease (AD), associated with specific brain pathologies, is a progressive form, and the most common cause, of dementia. It impairs a person's cognitive and motor functions, affects their ability to undertake basic daily activities, alters their behavior and gradually destroys their brain. Current treatments for AD provide benefit to patients through the alleviation of symptoms; however, the underlying disease is not directly affected. Research is now capitalizing on advanced knowledge about the biochemistry of A(BETA) and the pathway by which it is produced. The goal is the development of disease-modifying therapies with the capacity to slow or arrest the progression of AD. Almost five million individuals in the United States alone currently suffer from the condition. The U.S. Alzheimer's Association estimates that by the year 2025, over 22 million people worldwide will be afflicted. 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 tramiprosate (ALZHEMED(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 tramiprosate (ALZHEMED(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. -----END PRIVACY-ENHANCED MESSAGE-----