Neurochem provides update on core product candidates and recent financing of US$ 80 million
At its annual general meeting of shareholders, Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) will highlight fast approaching milestones for its advanced investigational product candidates, tramiprosate (ALZHEMED™) for the treatment of Alzheimer’s disease (AD) and eprodisate (KIACTA™) for the treatment of Amyloid A (AA) amyloidosis. Neurochem will also present for the first time the potential new diabetes and metabolic syndrome indications for eprodisate and express satisfaction at achieving its recently announced financing of US$80 million.
“We expect to release top-line results from the largest and longest clinical trial to date with an anti-amyloid product candidate tested in Alzheimer’s disease patients soon. As we are breaking new ground, we are excited but realistic, about the upcoming developments” said Dr. Francesco Bellini, Neurochem’s Chairman, President and CEO, referring to tramiprosate (ALZHEMED™). “Regarding KIACTA™, we are encouraged by the FDA’s extension of the decision date to July 16 as it provides the Agency with the time necessary to review the information we filed. Now that these clinical programs are very advanced, we want to introduce our shareholders to one more product candidate in our pipeline on which we will be reporting regularly in the future. I am talking about eprodisate for diabetes and metabolic syndrome. Our analysis of this product candidate for these indications is still very early but it is promising,” Dr. Bellini added.
Phase III Clinical Trial Completed in North America Ongoing in Europe
During 2006, Neurochem advanced two large-scale, Phase III clinical trials for tramiprosate (ALZHEMED™). They were multicentered, randomized, double-blind and placebo-controlled. Together, these trials involve more than 2,000 mild-to-moderate AD patients at approximately 140 sites in North America and in Europe. These trials are designed to evaluate the product candidate’s safety, efficacy and disease-modifying potential in stopping or slowing the progression of AD.
The North American Phase III study was completed on schedule in early 2007. Approximately 90% of the patients who went through the entire randomized Phase III trial chose to continue into the open-label extension study. Given the high costs of running this open-label extension study, the Company has decided to limit the duration of this extension to 12 months rather than 18, as initially planned.
The database for the North American Phase III clinical trial for tramiprosate (ALZHEMED™) has been locked and the analysis is ongoing, as previously announced. The top-line results are expected to be released in the second quarter of 2007. More detailed analyses will be released at upcoming medical conferences.
Neurochem will also inform its shareholders today that it has more than 930 patients enrolled in its European clinical trial and is planning to continue recruiting for this study until after the top-line results of the North American clinical trial are known.
To date, Neurochem has received five recommendations from the North American Data Safety Monitoring Board (DSMB) and two from the European DSMB to continue the Phase III clinical trials for tramiprosate (ALZHEMED™).
Eprodisate (KIACTA™) Under Regulatory Review on Two Continents
Following an approvable letter received by the Company in August 2006, the United States Food and Drug Administration (FDA) is completing its review of Neurochem’s New Drug Application for eprodisate (KIACTA™) for the treatment of AA amyloidosis. A decision is now expected in July of this year. The FDA extended the review date by three months from April 16 following the submission by Neurochem of an amendment in February 2007.
The data that emerged from the Phase II/III clinical trial is indicative of the product candidate’s consistent benefit on slowing the decline in kidney function associated with AA amyloidosis.
In September 2006, the European Medicines Agency (EMEA) confirmed that it also had commenced a regulatory review of eprodisate (KIACTA™). The Marketing Authorization Application will be reviewed under the Agency’s centralized procedure. This means that an authorization from this Agency would apply to all 27 European Union member states, as well as Norway and Iceland.
A decision from the EMEA could come by the end of this year.
During the year, the Company also filed for marketing approval for eprodisate (KIACTA™) for the treatment of AA amyloidosis in Switzerland.
Eprodisate in Treatment of Diabetes and Metabolic Syndrome Expanding the Pipeline
Neurochem shareholders will also learn for the first time that eprodisate has shown beneficial effects against diabetes and metabolic syndrome in a rat model. The preliminary results have shown that eprodisate protects the kidney in obese diabetic rats. As well, eprodisate has shown an impact on metabolic changes associated with diabetes and obesity, including a significant decrease of triglyceride levels and cholesterol, a significant decrease of glycemia and increase in insulin secretion and/or sensitivity.
As years of safety information on eprodisate in humans from the AA amyloidosis program have already been collected, the Company plans to initiate a Phase IIa clinical trial in diabetic patients later in 2007.
Leading Medical Journals Publish Findings on Tramiprosate (ALZHEMED™)
Two of the world’s leading scientific, peer-reviewed journals, Neurobiology of Aging, and Neurology, have published articles on tramiprosate (ALZHEMED™). The article in Neurobiology of Aging covered the preclinical development of tramiprosate (ALZHEMED™) and first appeared in an on-line version in May 2006. It was recently published in print in the April 4, 2007, issue, volume 28. The article appearing in Neurology was published in the November 28, 2006, issue and dealt with the Phase II clinical trial of tramiprosate (ALZHEMED™).
US$80 Million in Financing Provides Solid Financial Base
As announced on May 2, the US$80 million in financing consisted of an aggregate principal amount of 6% senior and 5% senior subordinated convertible notes and warrants to purchase common shares.
With the recent financing of US$80 million, the Company has cash on hand of approximately CA$110 million for the continued development of its core investigational product candidates, eprodisate (KIACTA™), and tramiprosate (ALZHEMED™), and for the expansion of its pipeline.
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