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December 9, 2003
Annual General & Special Meeting of Shareholders.
Neurochem announces continued positive results for Alzhemed™ in open-label
phase 2 extension study for the treatment of Alzheimer's disease.
- At its annual general and special meeting of shareholders, Neurochem Inc. (NASDAQ: NRMX, TSX: NRM)
announced today additional positive interim results on cognitive function as measured by the
ADAS-cog1 test in mild2-to-moderate3 Alzheimer's Disease (AD) patients
participating in its ongoing open-label Phase II extension study. Neurochem is reporting on patients
who have completed nine and also 12 months of treatment on the highest dose (300 mg daily) of the
investigational product candidate Alzhemed™.
"To date, the majority of our patients treated with Alzhemed™ have stabilized or improved.
Even though the numbers are not statistically significant, the results are impressive and have never
been seen before," stated Dr. Francesco Bellini, Chairman and CEO of Neurochem. "The results
obtained are consistent with all our previously reported data. Neurochem has a strong commitment to
develop much awaited solutions to treat AD. The Alzhemed™ program is one part of our
multi-pronged approach against this disease. Continuing research efforts and discovery are on-going
and include much more potent second and third generation compounds as well as a synthetic vaccine
program to prevent and treat AD," he added.
Most recent results in 23 mild-to-moderate patients using the ADAS-cog test indicate that
patients treated with Alzhemed™ have shown an average score of +2.0 points after nine months, as
opposed to +5.0 points on average in comparable historical controls in a longitudinal study4
with AD patients. Of that group, 14 mild AD patients showed a score after nine months of treatment
of -0.8 points on average as opposed to + 4.3 points on average in comparable historical controls.
In five mild-to-moderate AD patients (mild: n=4) who completed 12 months of treatment, the difference
between the treated and the historical controls broadens with time. After 9 months, the treated group
has an average ADAS-cog of -2.2 as opposed to +5.0 on average in comparable historical controls.
After 12 months, the same treated group scored an average of -1.0 points as compared to an average
of +6.6 points in comparable historical controls. This difference is reflected in their day-to-day
life as an improvement in their cognitive function. For some, the improvement has been clinically
important.
Outlook
Neurochem foresees a period of intense activity in terms of drug development and strategic alliances.
The Company expects to complete the Phase II trial for Cerebril™ in January 2004. In addition, it
will advance the 24-month open-label Phase II extension study for Alzhemed™ and expects to initiate
the Phase III trials for this product candidate in the spring of 2004. At the same time, it will move
forward on the Phase II/III trial for Fibrillex™, as well as its open-label extension study on this
product candidate, with commercialization planned for the end of 2005.
The Company's experienced management, strong pipeline and solid financial basis are all key success
factors which will drive its continued efforts in the coming months to emerge as a leading, profitable
biopharmaceutical company in the field of neurology.
Alzheimer's Disease will become the Company's major disease target, with Alzhemed™ as its first
generation product candidate. Neurochem believes that AD will require a multi-product treatment, just
as in other complex diseases such as AIDS and Cancer.
Regarding strategic alliances for Fibrillex™ in Japan and Alzhemed™ worldwide, Neurochem is
presently negotiating with a number of companies and expects to sign a term sheet when it is confident
that it will maximize the long-term interest of its shareholders.
In terms of infrastructure, Neurochem expects to double its number of employees over the next twelve
months, particularly in the fields of marketing and drug development. The Company is therefore
looking at various sites to regroup its personnel presently working in different locations.
About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics for
neurological disorders. The Company's staged pipeline of proprietary, disease-modifying, oral products
addresses critical unmet medical needs. Fibrillex™, designated an orphan drug, is in a Phase
II/III clinical trial for AA amyloidosis. Alzhemed™ has completed a Phase II clinical trial for
the treatment of Alzheimer's Disease. Cerebril™ is in a Phase II trial for the prevention of
hemorrhagic stroke caused by cerebral amyloid angiopathy. For additional information on Neurochem,
please visit our website at: (www.neurochem.com).
1 - Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog). The ADAS-cog is a 70- point
scale designed to measure, with the use of questionnaires, the progression and the severity of
cognitive decline as seen in AD. The ADAS-cog scale quantifies the number of wrong answers.
Consequently, a high score on the scale indicates a more severe case of cognitive decline. When
analysing results, a negative score indicates the improvement of cognitive function and a positive
score the deterioration of such function. The ADAS-cog has been validated by the regulatory
authorities as the gold standard scale for the monitoring of cognitive function in AD patients. This
scale is a compulsory parameter of efficacy when submitting for market approval of an AD drug to the
authorities such as the Food and Drug Administration.
2 - Mini Mental State Exam (MMSE): 19-25
3 - Mini Mental State Exam (MMSE): 13-18
4 - Stern, R.G., et al. Am.J.Psychiatry 151:3, March 1994.
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 as well as other risks included 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 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.
For further Information, please contact:
Dr. Lise Hébert
Vice President, Corporate Communications
lhebert@neurochem.com
275 Armand-Frappier
Laval (Quebec)
H7V 4A7
Tel: (450) 680-4500
Fax: (450) 680-4501
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