Adagio trial results show Teva's AZILECT(TM) 1 mg tablets slow progression of Parkinson's disease



    Results Presented at 12th Congress of European Federation of Neurological
    Societies

    MONTREAL, Sept. 3 /CNW Telbec/ - Teva Neuroscience Canada announces that
results of the phase III ADAGIO trial, presented at the 12th Congress of
European Federation of Neurological Societies (EFNS) held in Madrid, Spain as
part of the August 26 "Late Breaking News" session, showed that Parkinson's
disease (PD) patients who took AZILECT(TM) (rasagiline) 1mg tablets once-daily
upon entry into the trial, demonstrated a significant improvement compared to
those who initiated the drug 9 months later. The 1mg dose met all three
primary end points, as well as the secondary end point, with statistical
significance.
    The primary analysis included three hierarchical endpoints based on
Total-UPDRS (Unified Parkinson's Disease Rating Scale) scores: A) superiority
of slopes in weeks 12-36 (-0.05; p=0.013, 95%CI -0.08,-0.01), B) change from
baseline to week 72 (-1.7 units; p=0.025, 95%CI -3.15,-0.21), and C)
non-inferiority of slopes (0.15 margin) in weeks 48-72 (0.0; 90%CI
-0.04,0.04). The safety profile of AZILECT(TM) seen in the ADAGIO study was
similar to previous experience with AZILECT(TM). Main results were presented
at the congress by Professor Olivier Rascol, M.D., Ph.D., Department of
Clinical Pharmacology, University Hospital, Toulouse, France, one of two
principal investigators of the trial.
    "The rigorous trial design and the fact that all three primary endpoints
were met with statistical significance reinforce the quality of the data,
supporting the potential for AZILECT(TM) to have an effect on disease
progression," said Dr. Michel Panisset, Associate Clinical Professor and
Co-Director André-Barbeau Movement Disorders Clinic, Hôtel-Dieu (CHUM) in
Montreal, and ADAGIO investigator present at the EFNS. "The successful outcome
of the study provides further rationale for the early use of AZILECT(TM) among
Parkinson's disease patients," he added.
    "Delaying disease progression is the most important unmet need in the
management of Parkinson's disease," stated Dr. Mandar Jog, Professor of
Neurology, University of Western Ontario and Director, Movement Disorders
Program at the London Health Science Centre in London, Ontario, and ADAGIO
investigator. "The ADAGIO study, the first of its kind, was prospectively
designed to demonstrate if AZILECT(TM) can slow down the progression of
Parkinson's disease. Results of the study show that early treatment with
once-daily rasagiline 1mg tablets provided significant clinical benefits that
were not obtained by those patients where initiation of AZILECT- therapy was
delayed by nine months."
    The ADAGIO study, one of the largest conducted in PD, included 1,176
patients with very early Parkinson's disease in 14 countries and 129 medical
centers who were randomized to receive rasagiline 1 or 2 mg/day for 72 weeks
(early start) or placebo for 36 weeks followed by rasagiline 1 or 2 mg/day for
36 weeks (delayed start).
    Description of trial results can be found online
(http://www.abstracts2view.com/ana) in the abstract submitted by Prof. Olanow
and Prof. Rascol to the 133rd Annual Meeting of the American Neurological
Association, Salt Lake City, UT, September 21-24, 2008. Prof. Olanow will be
presenting these results during the Works in Progress poster session on
Tuesday, September 23, 2008. The abstract was also chosen to be presented
orally by Prof. Olanow on Tuesday from 11:45 a.m.-Noon.
    Teva Neuroscience Canada intends to submit these results to the Canadian
regulatory authorities and work with them to incorporate the results into the
label for AZILECT(TM).

    For more information on AZILECT(TM), please visit www.azilect.ca.

    About the Study

    ADAGIO is a randomized, multi-center, double-blind, placebo-controlled,
parallel-group study prospectively examining rasagiline's potential
disease-modifying effects in 1,176 patients with early, untreated Parkinson's
disease. Patients from 129 centers in 14 countries were randomized to
early-start treatment (72 weeks rasagiline 1 or 2 mg once daily) or
delayed-start treatment (36 weeks placebo followed by 36 weeks rasagiline 1 or
2 mg once daily (active treatment phase)). The primary analyses of the trial
were based on change in total UPDRS (Unified Parkinson's Disease Rating Scale)
and included slope superiority of rasagiline over placebo in the
placebo-controlled phase, change from baseline to week 72, and non-inferiority
of early-start vs. delayed-start slopes during weeks 48-72 of the active
phase. UPDRS is the most commonly used rating scale to assess disease status.

    About AZILECT (TM)

    AZILECT(TM) 1mg tablets (rasagiline tablets) are indicated for the
treatment of the signs and symptoms of Parkinson's disease both as initial
therapy alone and to be added to levodopa later in the disease. AZILECT(TM)
1 mg tablets are currently available in 30 countries, including Canada, the
U.S., Israel, Mexico, and most of the EU countries.

    About Parkinson's Disease

    Parkinson's disease is an age-related degenerative disorder of the brain.
Symptoms can include: tremor, stiffness, slowness of movement, and impaired
balance. An estimated 100,000 Canadians suffer from the disease, which usually
affects people over the age of 60.

    About Teva

    Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among
the top 20 pharmaceutical companies in the world and is the world's leading
generic pharmaceutical company.  The Company develops, manufactures and
markets generic and innovative human pharmaceuticals and active pharmaceutical
ingredients, as well as animal health pharmaceutical products.  Over 80
percent of Teva's sales are in North America and Europe.


    Safe Harbor Statement under the U. S. Private Securities Litigation
    Reform Act of 1995:

    This release contains forward-looking statements. Such statements are
based on management's current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause Teva's future
results, performance or achievements to differ significantly from the results,
performance or achievements expressed or implied by such forward-looking
statements, including statements relating to the results of the ADAGIO phase
III trial and the potential efficacy or future market or marketability of
AZILECT(TM). Following further analysis, Teva's interpretation of the results
could differ materially depending on a number of factors, and we caution
investors not to place undue reliance on the forward-looking statements
contained in this press release as there can be no guarantee that the results
from the phase III trial discussed in this press release will be confirmed
upon full analysis of the results of the trial and additional information
relating to the safety, efficacy or tolerability of AZILECT(TM) may be
discovered upon further analysis of data from the phase III trial. Even if the
results described in this release are confirmed upon full analysis of the
ADAGIO study, we cannot guarantee that AZILECT(TM) will be approved for
marketing in a timely manner, if at all, by regulatory authorities in the EU
or in the U.S. Additional risks relating to Teva and its business are
discussed in Teva's Annual Report on Form 20-F and its other filings with the
U.S. Securities and Exchange Commission. Forward-looking statements speak only
as of the date on which they are made and the Company undertakes no obligation
to update or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.




For further information:

For further information: Joan Beauchamp, Enigma Communications, (514)
982-0308, ext. 209 or 1 888 787-0308, j.beauchamp@enigma.ca

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