UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT
TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of: July, 2004
Commission File Number: 000-50393
NEUROCHEM INC.
275 Armand-Frappier Boulevard
Laval, Quebec
H7V 4A7
Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40 F. Form 20-F [ ] Form 40-F [X]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
Yes [ ] No [X]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7):
Yes [ ] No [X]
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g-3 under the Securities Exchange Act of 1934.
Yes [ ] No [X]
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
SIGNATURES:
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
NEUROCHEM INC.
July 7, 2004
By: /s/ David Skinner
---------------------------------------
David Skinner
Director, Legal Affairs,
General Counsel and Corporate Secretary
NEUROCHEM INC.
275 Armand-Frappier Blvd.
[NEUROCHEM - (LOGO)] Laval, Quebec, Canada H7V 4A7
________________________________________________________________________________
NEUROCHEM'S FIBRILLEX(TM) SELECTED FOR NEW FDA PILOT 2 PROGRAM
FIBRILLEX(TM) ALREADY GRANTED FAST-TRACK PRODUCT DESIGNATION
MONTREAL, JULY 7, 2004 - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) announced today
that Fibrillex(TM), the Company's investigational product candidate for the
treatment of Amyloid A (AA) Amyloidosis, has been selected by the Cardio-Renal
Drug Product Division of the US Food and Drug Administration (FDA) to be part of
the Continuous Marketing Applications Pilot 2 program aimed at further
accelerating the development and eventual marketing of this product candidate.
Under this Pilot 2 program, each FDA division is permitted to select only one
product candidate.
The selection of Fibrillex(TM) by the FDA is based in part on the fact that it
has been designated as a Fast Track Product due to the life-threatening nature
of AA Amyloidosis, an unmet medical need which often results in end-stage renal
disease. The decision is based on other criteria as well. For example, the FDA
looked at the potential value of enhanced interaction with Neurochem and
emphasized the potential public health benefit from the development of the
product and the likelihood that concentrated scientific dialogue could
facilitate the availability of Fibrillex(TM) as a promising novel therapy.
Fibrillex(TM) is presently in an on-going Phase II/III clinical trial which
Neurochem expects to complete by January 2005.
"We are very pleased that the FDA's Cardio-Renal Division has accepted
Fibrillex(TM) to be part of this new pilot project under which Neurochem and the
FDA will engage in frequent scientific feedback and interaction during the
development of this product candidate," said Francesco Bellini, Ph. D., Chairman
and CEO of Neurochem. "This frequent communication based on a prospectively
defined agreement between the FDA and Neurochem should allow us to agree on
information to be presented in our NDA submission. These on-going interactions
could further expedite the FDA's review of Fibrillex(TM)."
Fibrillex(TM) has already received orphan drug status designation in the United
States and Orphan Medicinal Product designation in Europe, which normally
provide a drug seven and ten years of market exclusivity, respectively, upon
market entry.
ABOUT FIBRILLEX
The Phase II/III clinical trial for Fibrillex(TM) is a two-year, international,
multi-center, randomized, double-blind, placebo-controlled, and
parallel-designed trial to evaluate the safety and efficacy of Fibrillex(TM) in
patients suffering from AA Amyloidosis. Neurochem has successfully completed the
enrollment of 183 patients for the Phase II/III trial, which is being conducted
at 27 sites located across North America, Europe and Israel. Neurochem
anticipates completing the trial by January 2005. To date, approximately 42
patients have
completed the two-year Phase II/III trial for Fibrillex(TM). A two-year
open-label extension study for the product candidate is on-going.
Fibrillex(TM) is an oral product candidate for the treatment of AA Amyloidosis
through the prevention of amyloid fibril formation. Fibrillex(TM) belongs to the
class of glycosaminoglycan (GAG) mimetics, better known as disease-modifiers. By
mimicking GAGs, Fibrillex(TM) competitively binds to the AA protein, preventing
natural GAGs from binding to the same AA protein. Fibrillex(TM) is expected to
prevent AA fibril formation and the deposition of AA fibrils in organs.
ABOUT AA AMYLOIDOSIS
AA Amyloidosis is a progressive and fatal condition that occurs in a proportion
of patients with chronic inflammatory diseases, including rheumatoid arthritis,
ankylosing spondylitis, juvenile rheumatoid arthritis, and Crohn's disease. The
disease also occurs in patients suffering from many other conditions ranging
from chronic infections to inherited inflammatory diseases such as Familial
Mediterranean Fever. The most common clinical presentation of AA Amyloidosis is
kidney malfunction. Involvement of the gastrointestinal system is also frequent
and is usually manifested as chronic diarrhea, gastrointestinal bleeding,
abdominal pain and malabsorption. Enlargement of the liver and the spleen may
also occur in some patients.
This disease has a poor prognosis, with a five-year survival rate of
approximately 50%.1 Left untreated, patients gradually progress to end-stage
renal failure, which is the cause of death in at least 35% of the cases.(2),(3)
ABOUT NEUROCHEM
Neurochem is focused on the development and commercialization of innovative
therapeutics for neurological disorders. The Company's pipeline of proprietary,
disease-modifying, oral products addresses critical, unmet medical needs.
Fibrillex(TM), designated as an orphan drug and a Fast Track Product candidate,
is also part of a Continuous Marketing Applications Pilot 2 program and is
currently in a Phase II/III clinical trial for the treatment of AA Amyloidosis.
Alzhemed(TM), for the treatment of Alzheimer's Disease, is in a Phase III
clinical trial and Cerebril(TM), for the prevention of Hemorrhagic Stroke caused
by Cerebral Amyloid Angiopathy, has completed a Phase II 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
website at: www.neurochem.com.
1 Pepys, M., et al. Amyloidosis. Oxford Textbook of Medicine (4th ed.) Oxford:
Oxford University Press 2003; 162-73.
2 Gertz, M.A., et al. Medicine (Baltimore) 1991 Jul: 70(4); 246-56.
3 Joss, N., et al. QJMed. 2000: 93; 535-42.
This news release contains forward-looking statements regarding the potential
for Fibrillex(TM) and further development efforts. These statements are based
on the current expectations of management. Drug development
involves numerous risks and uncertainties, which could cause actual results to
differ materially from expectations. Promising results and successes in early
stage clinical trials do not ensure that later stage or larger scale clinical
trials will be successful.. Additional risks and uncertainties include: 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 or otherwise.
Neurochem does not undertake any obligation to publicly update its
forward-looking statements, whether as a result of new information, future
events, or otherwise.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Lise Hebert, Ph.D.
Vice President, Corporate Communications
lhebert@neurochem.com
Tel: (450) 680-4500
Fax: (450) 680-4501