Results from the ADAGIO trial, published online today in The New
England Journal of Medicine, demonstrated that Parkinson’s disease
patients receiving AZILECT® (rasagiline) 1mg/day at the start
of the study (early-start group) experienced superior benefit over 18
months compared with those who started the exact same treatment nine
months later (delayed-start group).1 This finding is
consistent with a possible disease-modifying effect for AZILECT®
(rasagiline) 1mg/day.
Professor C. Warren Olanow, MD, Department of Neurology, Mount Sinai
School of Medicine, New York and co-principal investigator of the ADAGIO
study, commented, "A therapy that slows or stops disease progression is
the greatest unmet need in the treatment of patients with Parkinson’s
disease. Current therapies do not prevent the development of disability
in such patients. The results of the ADAGIO study provide support for
the possibility that early treatment with AZILECT®
(rasagiline) 1mg/day may slow the development of disability.”
AZILECT® is the first Parkinson’s disease treatment to
succeed in a prospective delayed-start study, a trial design
specifically developed to test for the possibility of a
disease-modifying effect.
Professor Olivier Rascol, Department of Clinical Pharmacology,
University Hospital, Toulouse, France and ADAGIO co-principal
investigator, stated, "The results of the ADAGIO study provide novel
data to support the use of AZILECT® 1mg daily as initial
treatment of patients with Parkinson's disease. The ADAGIO study, which
utilized a novel trial design with three primary endpoints, suggests
that the drug has a positive impact on slowing the progression of
patients' disability, beyond its already known symptomatic benefit.”
In the study, rasagiline 2mg/day, which is not a marketed dose for
AZILECT®, did not meet the second primary endpoint. As
discussed in The
New England Journal of Medicine article,
it is possible that a greater symptomatic effect of the 2mg/day dose may
have masked a benefit associated with early-start treatment in the
population of patients with very mild disease included in the ADAGIO
study. A post-hoc analysis conducted on a sub-group of patients with
highest baseline UPDRS (the upper quartile) showed positive results with
the 2mg/day dose, supporting this hypothesis.
"Patients with Parkinson’s disease are in need of treatments that can
slow or even halt the progression of their disease. After years of
clinical experience and innovative scientific study with AZILECT®,
we are proud to have contributed to the expanding body of knowledge in
Parkinson’s disease,” said William S. Marth, President and Chief
Executive Officer of Teva North America. "Teva has been working to
respond to questions raised by the FDA regarding ADAGIO and anticipates
further discussions with the FDA to review and interpret the findings
from this landmark study. Following those discussions, we expect to file
a supplemental NDA in 2010, with the scope of any modification to the
AZILECT® 1mg/day label remaining subject to the conclusion of
those discussions.”
Teva to Host Conference Call with Professor C. Warren Olanow, MD
Teva will host a conference call with Professor C. Warren Olanow, MD,
co-principal investigator of the ADAGIO trial and William Marth,
President and Chief Executive Officer, Teva North America to discuss the
ADAGIO study results on Thursday, September 24, 2009, from 8:30 a.m. –
9:30 a.m. ET. The number to call from within the United States is (866)
700-7101 or (617) 213-8837 internationally and using the participant
code 30733492. The call will also be webcast and may be accessed through
the Company's website at www.tevapharm.com.
Following the conclusion of the call, a replay of the webcast will be
available within 24 hours at the Company's Web site. To access the
replay, go to Investor Relations and click on Conference Calls.
About ADAGIO
ADAGIO (Attenuation of Disease
progression with AZILECT®
GIven Once-daily)
was 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
participated and were randomized to initiate treatment for 72 weeks with
rasagiline 1mg/day or 2mg/day, or to initiate treatment for 36 weeks
with a placebo followed by 36 weeks with rasagiline 1mg/day or 2mg/day.
The primary analysis included three hierarchical endpoints based on
total scores in the Unified Parkinson’s Disease Rating Scale (UPDRS).
AZILECT® 1 mg/day early-start met all endpoints of the
primary analysis: less deterioration in UPDRS score than placebo between
weeks 12 and 36; less worsening than delayed-start in UPDRS score in
comparing change between baseline and week 72 despite being on the same
medication for the last 9 months; and non-inferiority to delayed-start
in rate of deterioration between weeks 48 and 72. The ADAGIO study also
confirmed the positive symptomatic effect and safety profile of AZILECT®,
in line with prior studies.2
About AZILECT®
AZILECT® (rasagiline) 1mg 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® 1mg tablets are now available in 38 countries,
including the U.S., Canada, Israel, Mexico and all of the European Union
countries, where it is marketed by Teva in collaboration with Lundbeck
A/S as part of a long-term strategic alliance.
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 four million people worldwide suffer from
the disease, which usually affects people over the age of 60.
About Teva
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in
Israel, is among the top 20 pharmaceutical companies in the world and is
the leading generic pharmaceutical company. The company develops,
manufactures and markets generic and innovative pharmaceuticals and
active pharmaceutical ingredients. Over 80 percent of Teva's sales are
in North America and Western Europe.
Teva's 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, the timing of a submission to the FDA, if any, the
possibility of any modification to the AZILECT®
label and the scope of any such modification, and the potential efficacy
or future market or marketability of AZILECT®.
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®
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 any
submission related to AZILECT® will be approved
in a timely manner, if at all, by regulatory authorities in the European
Union 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.