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May 9, 2006
At Annual General Meeting of Shareholders
Neurochem highlights important developments for key
product candidates
The Company Announces New Appointments
Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) - At its annual general meeting of shareholders, Neurochem Inc.
(NASDAQ: NRMX; TSX: NRM) highlighted important developments for its advanced investigational product candidates, eprodisate
(Fibrillex™) for the treatment of Amyloid A (AA) amyloidosis and tramiprosate (Alzhemed™) 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™ and Alzhemed™ 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™, 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™
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™)
NDA Filed by the FDA and Granted Priority Review
The new drug application (NDA) for eprodisate (Fibrillex™) 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™) 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™) application."
While eprosidate (Fibrillex™) 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™) 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™) 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™)
could delay dialysis by many years. Furthermore, eprodisate (Fibrillex™) 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™) worldwide, with the exception of Canada, Switzerland,
Japan, China, South Korea and Taiwan.
Tramiprosate (Alzhemed™)
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™),
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™). The presentation was given at the 9th International
Geneva/Springfield Symposium on Advances in Alzheimer Therapy (Geneva, Switzerland).
Additional efficacy results on tramiprosate (Alzhemed™) were also presented. Further to the capability of
tramiprosate (Alzhemed™) to bind to soluble amyloid ß (Aß) peptide and interfere with the amyloid
cascade, data from in vitro studies have shown that tramiprosate (Alzhemed™) has an effect on neuronal cells,
protecting against Aß peptide-induced toxicity and cell death. Tramiprosate (Alzhemed™) decreases
Aß42-induced cell death in primary rat neuronal cell cultures by 38% (p-value < 0.01).
Tramiprosate (Alzhemed™) 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™) in an open-label extension study.
The safety profile of tramiprosate's (Alzhemed™) is well characterized. During 2005 and subsequent to year end,
Neurochem received four consecutive recommendations from its Independent Safety Review Board for tramiprosate
(Alzhemed™) 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™) 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™). 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™) and by a planned submission of a Marketing Authorization Application for eprodisate
(Fibrillex™) to European regulatory authorities. In January 2007, Neurochem expects to complete the North
American Phase III clinical trial for tramisprosate (Alzhemed™) 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™) 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™) new drug application for priority
review. Tramiprosate (Alzhemed™), for the treatment of Alzheimer's disease, is currently in Phase III clinical trials
in both North America and Europe and tramiprosate (Cerebril™), 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, 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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