Neurochem will host a live web conference today November 8, 2007, at
8:30 AM ET
LAVAL, QC, Nov. 8 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX, TSX: NRM)
announces today important initiatives including the expansion of its product
candidate portfolio, the refocusing of its proprietary R&D assets and the
expected reduction of its burn rate compared to fiscal 2007. As part of these
initiatives, Neurochem is:
- Moving its next generation lead candidate NRM-8499 into preclinical
development for the treatment of Alzheimer's disease (AD) and is also
announcing the early termination of its European Phase III clinical
trial for tramiprosate (ALZHEMED(TM)).
- Taking steps, in light of promising results from preliminary post-hoc
analysis of the data from the North American Phase III trial for
tramiprosate, to commercialize this product as a branded nutraceutical,
starting as early as 2008.
- Continuing to advance its programs for Amyloid A (AA) amyloidosis as
well as for Diabetes Type II/features of metabolic syndrome.
"Our goal is to provide innovative health solutions to patients suffering
from serious diseases as soon as possible," said Dr. Francesco Bellini,
Chairman, President and CEO of Neurochem. "With the strategy unveiled today,
the Company plans to make tramiprosate available to consumers. As well,
Neurochem is confirming its commitment to developing new drugs for AD by
advancing into preclinical development a prodrug which improves tramiprosate
concentration in the brain several fold, thus leveraging the wealth of
knowledge the Company has gained from the work accomplished to date in this
field. Neurochem will be dedicating its resources to building a strong and
diversified pipeline of product candidates, which could potentially provide
cash flow in the near term. As a result, our business model is expanding
beyond the traditional biopharmaceutical strategy to one that embraces shorter
term projects. These projects should fund research and development activities,
while complementing our longer term prescription drug programs geared at
sustaining the Company's future growth," he concluded.
Seeking Medical and Health Benefits in Significant Therapeutic Areas
Alzheimer's disease - Next Generation - Tramiprosate (ALZHEMED(TM))
As part of the initiatives announced today, Neurochem will leverage the
numerous years of accumulated knowledge and the experience it has gained in
developing tramiprosate (ALZHEMED(TM)) for AD, and will prioritize and
accelerate the development of its next generation lead compound NRM-8499, a
new chemical entity (NCE) and a prodrug(1) of tramiprosate for the treatment
of AD. Pharmacokinetic studies performed in mice with NRM-8499 have already
demonstrated greater than five-fold increases in brain concentration as
compared to the original tramiprosate molecule.
As announced previously, descriptive data from the North American Phase
III clinical trial shows numerical differences in favor of tramiprosate on the
primary clinical endpoints. The descriptive data also shows by magnetic
resonance imaging differences between groups on the primary disease
modification endpoint of change in the volume of the hippocampus, a structure
of the brain that is considered to be important in memory function.
Additional findings obtained from a preliminary post-hoc analysis
performed by the Company's external team of statisticians that allowed
adjustment for potential confounding factors showed a dose-dependent reduction
in hippocampal atrophy in patients treated with tramiprosate. When compared to
placebo, patients treated with 200 mg of tramiprosate per day experienced
significantly less atrophy (relative difference of 65%; P = 0.036) and
patients treated with tramiprosate with 300 mg of tramiprosate per day
presented no atrophy (P = 0.003).
The Company is committed to analyzing and understanding the wealth of data
generated by the Phase III clinical trials. It is pursuing several post-hoc
analyses which are revealing promising preliminary results. Neurochem is
currently working to submit results for publication in a peer-reviewed
In view of these results, coupled to the large number of physicians and
families requesting access to the compound, and given that tramiprosate occurs
naturally in certain foods, Neurochem is planning to provide commercial access
to tramiprosate as a branded nutraceutical product, potentially as early as
2008, via the creation of a new self-sustaining company. This decision was
taken in view of the fact that AD is a devastating disease and remains an
unmet medical need.
Early discontinuation of Phase III Tramiprosate Clinical Trial in Europe
In light of the information gathered to date, Neurochem was faced with the
decision of completing the European Phase III clinical trial and/or initiating
another Phase III study to support the approval of tramiprosate by regulatory
agencies and/or investing in the development of a next generation compound
related to the original product candidate. Considering the current scientific
and medical knowledge about AD, and the changing environment with widespread
use of currently available medications, Management strongly believes that the
expected lengthy and costly clinical and regulatory paths for tramiprosate
prohibit its further development as a pharmaceutical entity.
The Special Advisory Board highlighted the inherent challenges associated
with advancing Phase III clinical trials for AD with large cohorts of patients
over very long periods of time. The challenges include enrolling the patients
that have the right disease profile while dealing with a high degree of
In summary, Neurochem strongly believes that the best course of action is
to terminate early the drug development activities surrounding the European
Phase III clinical trial for the study of tramiprosate, but to complete the
ongoing North American Phase III open-label extension study. The Company will
redirect its in-house AD efforts to the development of NRM-8499 and plans to
make tramiprosate available as a branded nutraceutical as soon as possible.
Following a second approvable letter received by the Company in July 2007,
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. Neurochem filed a response to the approvable
letter in September 2007.
In September 2006, the European Medicines Agency (EMEA) confirmed that it
had commenced a regulatory review of eprodisate (KIACTA(TM)). The Marketing
Authorization Application is being 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. An oral
hearing is scheduled with the EMEA later this month to discuss outstanding
issues raised with respect to the eprodisate (KIACTA(TM)) application and a
decision from the EMEA is expected by year-end, or shortly thereafter.
The Company also filed for marketing approval for eprodisate (KIACTA(TM))
for the treatment of AA amyloidosis in Switzerland. A decision is expected in
DiabetesType II/Features of Metabolic Syndrome
As announced in May 2007, eprodisate has shown beneficial effects in
preclinical in vivo models of Diabetes Type II/features of metabolic syndrome.
Preliminary results have shown that eprodisate protects the kidney function 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
an increase in insulin plasma levels.
The Company is on track to initiate a Phase II clinical trial in diabetic
patients in Canada in early 2008.
Live Web Conference
Neurochem will host a teleconference and web cast at 8:30 A.M., E.T.,
today, November 8, 2007. The live web cast (audio and visual) will be
available on the Company's web site at www.neurochem.com. The telephone
numbers to access the audio portion of the presentation only are (514)
868-1042 or 1 (866) 862-3907.
Three hours following the teleconference and the web cast, a replay of the
presentation will be available until November 15, 2007. The telephone numbers
to access the audio replay are (514) 861-2272 or 1 (800) 408-3053, passcode
3241051#. The replay of the web cast (audio and visual) will be available on
the Company's web site.
The dial-in number will allow participants to listen and ask questions,
while the web cast will host a visual presentation. Please dial-in or access
Neurochem's web site approximately 15 minutes before the teleconference is
scheduled to begin.
Neurochem Inc. is a global health company focused in research, development
and commercialization of products to provide innovative health solutions to
patients suffering from serious diseases.
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.
(1) A prodrug is a pharmaceutical substance which is administered in an
inactive form and once absorbed is metabolized in vivo into its
active form (namely tramiprosate).
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 and/or
nutraceutical 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:
For further information: Lise Hébert, PhD, Vice President, Corporate
Communications, (450) 680-4572, firstname.lastname@example.org