-----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, D9AN2z3khKbOn4L6nKj6fsYj3qKxFBNlITI7EYJlPImJtK3FdtWxbj5d/0Bm8Yxm ZSY2aPbEh6ORKqD16Ajb8w== 0001206212-05-000105.txt : 20050420 0001206212-05-000105.hdr.sgml : 20050420 20050420173102 ACCESSION NUMBER: 0001206212-05-000105 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20050420 FILED AS OF DATE: 20050420 DATE AS OF CHANGE: 20050420 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: 05762764 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 m16450orform6vk.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: April 2005 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. April 20, 2005 By: /s/ David Skinner --------------------------------------- David Skinner General Counsel and Corporate Secretary FORM 51-102F3 MATERIAL CHANGE REPORT ITEM 1 NAME AND ADDRESS OF COMPANY Neurochem Inc. ("Neurochem") 275 Armand-Frappier Blvd. Laval, Quebec H7V 4A7 ITEM 2 DATE OF MATERIAL CHANGE April 18, 2005 ITEM 3 NEWS RELEASE A press release was disseminated by Canada Newswire on April 18, 2005 from Montreal, Quebec. ITEM 4 SUMMARY OF MATERIAL CHANGE Neurochem (International) Limited, a wholly-owned subsidiary of Neurochem, announced preliminary results from the Phase II/III clinical study for its investigational product candidate Fibrillex(TM) for the treatment of Amyloid A (AA) Amyloidosis. ITEM 5 FULL DESCRIPTION OF MATERIAL CHANGE Phase II/III was the largest placebo-controlled study ever done in this patient population. There were 183 patients enrolled in the Phase II/III clinical trial: 89 on Fibrillex(TM) and 94 on placebo. Patients were treated for 24 months. The objective of the study was to determine the ability of Fibrillex(TM) to treat AA Amyloidosis and to assess safety compared with placebo in the patient population with impaired renal function at baseline. The composite primary endpoint of the study included kidney function measurements and death and called for a 20 percent absolute difference in the number of patients stabilized/improved between the Fibrillex(TM) and placebo groups. An assessment of the preliminary data on the composite primary endpoint indicates that there were 13.4 percent more patients whose condition remained stable or improved on Fibrillex(TM) compared to placebo (p-value of 0.06). However, Fibrillex(TM) did not achieve the study's pre-specified p-value of 0.01 on the primary endpoint. Preliminary analysis of all parameters of the secondary efficacy endpoints measuring the decline in renal function, including progression to end-stage renal failure/dialysis and slope of decline of creatinine clearance, suggests that Fibrillex has a clinical effect on the course of AA Amyloidosis. The preliminary data also suggest Fibrillex(TM) is well tolerated and the overall incidence of adverse events, including serious adverse events, is not significantly different between Fibrillex(TM)-treated and placebo-treated patients. Neurochem intends to continue with plans to seek regulatory approval of Fibrillex(TM). As part of this process, Neurochem will pursue discussions about its data with the U.S. Food and Drug Administration (FDA) in line with established procedures for its on-going Pilot 2 Program. Neurochem plans to complete its analysis of the Phase II/III data and present it to the FDA as soon as possible. It also plans to present data at international medical conferences in the first half of 2005. Neurochem intends to honor its commitment to continue to supply Fibrillex(TM) to any patient receiving the drug through the 24-month on-going open-label extension study. ITEM 6 RELIANCE ON SUBSECTION 7.1(2) OR (3) OF NATIONAL INSTRUMENT 51-102 This report is not being filed on a confidential basis. ITEM 7 OMITTED INFORMATION N/A ITEM 8 EXECUTIVE OFFICER For further information, please contact Lise Hebert, Vice-President, Corporate Communications, at 450.680.4572. ITEM 9 DATE OF REPORT April 20, 2005 (signed) David Skinner -------------------------------------------- David Skinner General Counsel and Corporate Secretary -----END PRIVACY-ENHANCED MESSAGE-----