Newsroom 2007
Attention Business/Financial Editors:
At Annual General Meeting of Shareholders (AGM) - Neurochem provides update on core product candidates and recent financing of us$80 million
The Neurochem AGM will be web cast live
LAVAL, QC, May 8 /CNW Telbec/ - 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(TM)) for the treatment of Alzheimer's disease (AD) and
eprodisate (KIACTA(TM)) 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(TM)). "Regarding KIACTA(TM), 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.
(Tramiprosate) ALZHEMED(TM)
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(TM)). 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(TM)) 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(TM)).
Eprodisate (KIACTA(TM)) 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(TM)) 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(TM)). 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(TM)) 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(TM))
Two of the world's leading scientific, peer-reviewed journals,
Neurobiology of Aging, and Neurology, have published articles on tramiprosate
(ALZHEMED(TM)). The article in Neurobiology of Aging covered the preclinical
development of tramiprosate (ALZHEMED(TM)) 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(TM)).
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(TM)), and tramiprosate
(ALZHEMED(TM)), and for the expansion of its pipeline.
AGM Live Webcast
Neurochem's Annual General Meeting of Shareholders will be web cast this
year in real time. The meeting begins at 10:00 A.M. E.T., Tuesday, May 8,
2007. The live web cast and accompanying slide presentation will be available
on the Company's web site at www.neurochem.com. The web cast will be archived
for seven days. The telephone numbers to access the audio portion of the
presentation are (514) 868-1042 or 1 (866) 862-3907. A replay of the
presentation will be available until May 15, 2007. The telephone numbers to
access the replay are (514) 861-2272 or 1 (800) 408-3053, passcode 3222450#.
About Neurochem
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 Amyloid A (AA)
amyloidosis, and is under regulatory review for marketing approval by the
United States Food and Drug Administration and European Medicines Agency.
Tramiprosate (ALZHEMED(TM)), for the treatment of Alzheimer's disease, has
completed a Phase III clinical trial in North America and is currently in a
Phase III clinical trial in Europe, while 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.
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's
control. Such risks include but are not limited to: the impact of general
economic conditions, general conditions in the pharmaceutical industry,
changes in the regulatory environment in the jurisdictions in which Neurochem
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. 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 the forward-looking statements
included in this news release. These statements speak only as of the date made
and Neurochem 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 for further risk factors that might
affect the Company and its business.
For further information: Lise Hébert, PhD, Vice President, Corporate
Communications, (450) 680-4572, lhebert@neurochem.com
