Newsroom 2006
Attention Business/Financial Editors:
At Annual General Meeting of Shareholders Neurochem highlights important developments for key product candidates - The Company Announces New Appointments
LAVAL, Quebec, May 9 /CNW Telbec/ - At its annual general meeting of
shareholders, Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) highlighted important
developments for its advanced investigational product candidates, eprodisate
(Fibrillex(TM)) for the treatment of Amyloid A (AA) amyloidosis and
tramiprosate (Alzhemed(TM)) for the treatment of Alzheimer's disease (AD).
Neurochem emphasizes its commitment to remain focused on the development and
commercialization of new therapies for patients facing serious, life
threatening diseases.
"We have achieved major milestones for Fibrillex(TM) and Alzhemed(TM) in
the past year and fiscal 2006 promises to be as exciting," said
Dr. Francesco Bellini, Neurochem's Chairman, President and CEO. "We continue
to strengthen our Company by reaching important stages in the development of
our key product candidates. The filing by the FDA of the NDA for
Fibrillex(TM), along with the priority review designation that we have
recently announced is a major accomplishment for our Company. With the
completion of the North American Phase III clinical trials for Alzhemed(TM)
scheduled for January 2007, we are taking important strides towards the
possibility of introducing our innovative product candidates to patients
around the world, pending approval by the regulatory agencies."
Eprodisate (Fibrillex(TM))
NDA Filed by the FDA and Granted Priority Review
The new drug application (NDA) for eprodisate (Fibrillex(TM)) for the
treatment of AA amyloidosis has been filed and granted priority review by the
US Food and Drug Administration (FDA). Priority review status of the
application normally reduces the standard review time for an application to
six months and the FDA's target for a response will be around August 13, 2006,
on eprodisate's (Fibrillex(TM)) NDA.
"There is currently no approved therapy for AA amyloidosis, and we look
forward to continuing to work closely with the FDA in the coming months as we
seek regulatory approval for this potential new treatment for this serious
disease," stated Denis Garceau, Ph.D., Neurochem's Senior Vice President, Drug
Development. "Fast track and priority review designations are used to expedite
the drug development and review process of products addressing diseases with
significant unmet medical needs. The priority review designation is an
acknowledgement that the FDA intends to direct attention and resources to
review the eprosidate (Fibrillex(TM)) application."
While eprosidate (Fibrillex(TM)) did not achieve the study's pre-
specified p-value of 0.01 on the composite primary endpoint, the 12-month
analysis of the open-label extension combined with the randomized Phase II/III
clinical trial showed that, in patients continuously treated with eprodisate
(Fibrillex(TM)) for three years, there was a reduction in the risk of renal
decline or all-cause mortality to 41% (p=0.011) relative to
patients who received placebo for two years and then switched to eprodisate
(Fibrillex(TM)) for one year. The data also show that by impacting on the
kidney function, as measured by the rate of creatine clearance, continuous
treatment with eprodisate (Fibrillex(TM)) could delay dialysis by many years.
Furthermore, eprodisate (Fibrillex(TM)) has a safety profile that is
comparable to placebo.
In December 2004, Neurochem signed a definitive collaboration and
distribution agreement, granting Centocor, Inc. exclusive distribution rights
for eprodisate (Fibrillex(TM)) worldwide, with the exception of Canada,
Switzerland, Japan, China, South Korea and Taiwan.
Tramiprosate (Alzhemed(TM))
Two Phase III Clinical Trials on Track
In April 2006, data from the open-label extension study of the Phase II
clinical trial for tramiprosate (Alzhemed(TM)), involving mild-to-moderate AD
patients, continued to show clinically important benefits on cognitive and
global performance measures, consistent with the stabilization of the disease
in a proportion of mild patients (four out of nine) after three years on study
medication. The data were presented by Paul S. Aisen, M.D., Professor of
Neurology and Medicine at Georgetown University Medical Center, and principal
investigator in the United States of the ongoing Phase III clinical trial for
tramiprosate (Alzhemed(TM)). The presentation was given at the 9th
International Geneva/Springfield Symposium on Advances in Alzheimer Therapy
(Geneva, Switzerland).
Additional efficacy results on tramiprosate (Alzhemed(TM)) were also
presented. Further to the capability of tramiprosate (Alzhemed(TM)) to bind to
soluble amyloid (beta) (A(beta)) peptide and interfere with the amyloid
cascade, data from in vitro studies have shown that tramiprosate
(Alzhemed(TM)) has an effect on neuronal cells, protecting against A(beta)
peptide-induced toxicity and cell death. Tramiprosate (Alzhemed(TM)) decreases
A(beta)42-induced cell death in primary rat neuronal cell cultures by 38% (p-
value(less than)0.01).
Tramiprosate (Alzhemed(TM)) is currently in a multicenter, randomized,
double-blind, placebo-controlled, three-armed, parallel-designed Phase III
clinical trial in North America. A total of 1,052 patients in close to
70 clinical sites across the United States and Canada have been randomized to
receive study medication over a period of 18 months. The clinical trial is
scheduled to be completed in January 2007. To date, 108 patients completed the
trial and 573 patients have already completed 12 months. All patients who
complete the North American Phase III clinical trial will be offered the
opportunity to receive tramiprosate (Alzhemed(TM)) in an open-label extension
study.
The safety profile of tramiprosate's (Alzhemed(TM)) is well
characterized. During 2005 and subsequent to year end, Neurochem received four
consecutive recommendations from its Independent Safety Review Board for
tramiprosate (Alzhemed(TM)) to continue the Company's North American Phase III
clinical trial for the treatment of AD. The Company also launched its Phase
III clinical trial in Europe in September 2005. This international,
multicenter, randomized, double-blind, placebo-controlled, three-armed,
parallel-designed Phase III clinical trial is progressing on schedule. Just as
for the North American trial, the European study will investigate the safety,
efficacy and the potential to arrest or slow the progression of AD with
tramiprosate (Alzhemed(TM)) in some 930 mild-to-moderate AD patients.
Enrolment is on schedule with more than 290 patients randomized in the
clinical trial; enrolment is expected to be completed in the fall of 2006.
Appointments
The Company announced the appointment of Mr. Barry D. Greenberg, Ph.D. as
Senior Director, Pharmacology, and the promotion of Mr. David Skinner to the
position of Vice President, General Counsel and Corporate Secretary.
Dr. Greenberg's responsibilities will include strategic planning for
biological and pharmacological development including in vitro and in vivo
pharmacology and toxicology studies. With almost 25 years experience in
pharmaceutical and biotech R&D, Dr. Greenberg comes to Neurochem from
AstraZeneca Pharmaceuticals where, over the past eight years, he held a series
of discovery and strategic positions in the United States and in Sweden. He
also served as Director, Alzheimer amyloid research program at Cephalon, Inc.
from 1993-1997. Dr. Greenberg has a Ph.D degree from the University of North
Carolina and postdoctoral training at Stanford University. He also holds
Masters and Bachelor degrees from Northwestern University in Evanston
(Illinois).
Mr. Skinner, a lawyer, joined Neurochem as General Counsel and Corporate
Secretary in April 2003. He has more than thirteen years experience, mostly
international, including complex cross-border mergers and acquisitions and
private equity transactions. Among his previous positions, Mr. Skinner served
in the corporate commercial departments of two leading international law
firms. He holds a Bachelors degree in Geology from Williams College in
Massachusetts, as well as a Bachelor of Common Law and a Bachelor of Civil Law
from McGill University. He is a member of the Quebec, the New York and the
Massachusetts bars.
Financial Position
Neurochem strengthened its financial position early in 2005, by raising
additional capital through a public offering of 4 million common shares,
resulting in total gross proceeds of approximately US$61.2 million. In
July 2005, and in February 2006, Picchio Pharma exercised warrants previously
issued generating proceeds of approximately C$18.1 million to Neurochem. In
November 2005, Neurochem concluded a sale and leaseback of its campus located
in Laval, Quebec, generating gross proceeds of C$32 million for the Company.
As of December 31, 2005, pro-forma the warrant exercised by Picchio Pharma in
February 2006, Neurochem reported cash, cash equivalents and marketable
securities of approximately $US69 million.
Future Outlook
Fiscal 2006 and 2007 will feature major milestones for Neurochem's
development into an international biopharmaceutical company. In August 2006,
the Company expects a decision from the FDA on eprodisate (Fibrillex(TM)).
This will be followed in the fall of 2006 by the expected completion of
patient recruitment for the European Phase III clinical trial for tramiprosate
(Alzhemed(TM)) and by a planned submission of a Marketing Authorization
Application for eprodisate (Fibrillex(TM)) to European regulatory authorities.
In January 2007, Neurochem expects to complete the North American Phase III
clinical trial for tramisprosate (Alzhemed(TM)) for an expected release of the
results from this trial in the spring of 2007.
About Neurochem
Neurochem is focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(Fibrillex(TM)) is designated as an orphan drug, is a Fast Track product
candidate and is also part of the US Food and Drug Administration's (FDA)
Continuous Marketing Application Pilot 1 and Pilot 2 programs. In April 2006,
the FDA filed and granted the eprodisate (Fibrillex(TM)) new drug application
for priority review. Tramiprosate (Alzhemed(TM)), for the treatment of
Alzheimer's disease, is currently in Phase III clinical trials in both North
America and Europe and 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, 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) 680-4570, lhebert@neurochem.com
