PRESS RELEASE: Data Show Rasagiline, Added to Levodopa, Reduced Freezing of Gait in Patients With Parkinson's Disease
Thursday April 29, 8:07 am ET
SAN FRANCISCO, April 29 /PRNewswire-FirstCall/ --Rasagiline 1 mg once daily, added to levodopa, significantly reduced
freezing of gait (FoG), the sudden but temporary inability to move the legs and feet when walking -- the feeling of
feet being glued to the floor -- experienced by Parkinson's disease (PD) patients, according to new data presented at
the 56th annual meeting of the American Academy of Neurology (AAN) in San Francisco.
Parkinson's disease is a degenerative disorder of the central nervous system. Symptoms can include tremors, stiffness,
slowness of movement and impaired balance. An estimated one million North Americans have the disease, which usually
affects people over the age of 50. FoG is more common in patients in advanced stages of PD and is often poorly
responsive to current PD therapies.
"These new data are consistent with other rasagiline findings that show improvement in motor function in patients with
more advanced PD symptoms," said Nir Giladi, M.D., Tel-Aviv Sourasky Medical Center, Sackler School of Medicine, Tel-
Aviv University. "Freezing of gait is a common and very disabling symptom in advanced stages of PD, with unpredictable
response to dopaminergic therapy. It is one of the most difficult motor disturbances of advanced PD, on which
rasagiline demonstrated significant improvement based on reductions in FoG-Q scores in this study." The FoG-Q is a
validated 24-point scale that measures the severity of freezing of gait, with scores greater than 15 representing
severe freezing of gait.
The data on FoG-Q were obtained from a pre-specified ancillary study to the 18-week LARGO trial conducted in Europe,
Israel and Argentina. The ancillary study included 454 patients and compared the effects of once-daily rasagiline (1
mg) or entacapone (ComtanŽ 200 mg) three to eight times daily or placebo added to individualized levodopa therapy in PD
patients experiencing motor fluctuations.
FoG ratings were measured at baseline and again 10 weeks into the trial. A statistically significant reduction in
average FoG-Q scores of 1.2 was seen with rasagiline when added to levodopa compared to a reduction of 0.5 with placebo
added to levodopa (p=0.045). Reductions in FoG-Q scores in patients taking entacapone plus levodopa did not reach
statistical significance (1.1 points decrease from baseline) compared to placebo (p=0.066). The full LARGO study
results also were presented in a platform session at the AAN annual meeting.
"We continue to be excited about the potential for rasagiline to help people living with Parkinson's disease," said
Rivka Riven Kreitman, Ph.D., vice president of Innovative R&D with Teva Neuroscience. "These results showed rasagiline
significantly improved one of the most troublesome and limiting symptoms in advanced PD."
In the larger LARGO trial, rasagiline added to levodopa therapy reduced the total time when Parkinson's symptoms are
not adequately controlled ("off" time) by 1.2 hours daily or 21 percent. Additionally, rasagiline significantly
improved motor function and activities of daily living based on the Unified Parkinson's Disease Rating Scale (UPDRS) in
both the "on" (time when medication effectively manages symptoms of PD) and "off" states. The UPDRS includes measures
such as a patient's ability to perform simple motor tasks and activities of daily living. ComtanŽ taken with each dose
of levodopa, improved the UPDRS scores similarly to rasagiline in the "on" state, but did not significantly affect the
UPDRS scores in the "off" state.
Patients who used rasagiline and those taking entacapone also experienced significant reductions in levodopa dose, even
though the protocol restricted dosing adjustments to the first six weeks only. Patients who used rasagiline experienced
side effects similar to those of patients using placebo. The only adverse event more common with rasagiline than with
placebo (at least 2% difference) was postural hypotension (dizziness upon standing).
Rasagiline is a novel, potent, second-generation, selective, irreversible monoamine oxidase type-B (MAO-B) inhibitor
that blocks the breakdown of dopamine, a substance in the brain needed to facilitate movement. A new drug application
for rasagiline for the treatment of Parkinson's disease was submitted to the U.S. Food and Drug Administration (FDA)
Sept. 5, 2003. Indications are being sought for once-daily rasagiline as a monotherapy in early Parkinson's disease and
as an adjunct to levodopa in moderate to advanced disease.
The development of rasagiline is part of a long-term alliance for co-development in Parkinson's disease and European
marketing between Teva and H. Lundbeck A/S. Rasagiline was developed cooperatively by Teva and the Technion - Israel
Institute of Technology.
Teva submitted an application to market rasagiline as a treatment for PD with the European Agency for Evaluation of
Medicinal Products (EMEA) Oct. 10, 2003. Rasagiline also was submitted for review in Canada Sept. 24, 2003, where, upon
approval, it will be marketed by Teva Neuroscience, Inc.
Teva Neuroscience, Inc. and Eisai Inc. will co-promote rasagiline in the United States, once approved by the FDA, as
part of a long-term strategic alliance between Teva Pharmaceutical Industries Ltd. and Eisai Co., Ltd.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News), headquartered in Israel, is among the top 30 pharmaceutical
companies in the world. The company develops, manufactures and markets generic and branded human pharmaceuticals and
active pharmaceutical ingredients. Close to 90 percent of Teva's sales are in North America and Europe. Teva's
innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company
that discovers, develops and markets products in more than 30 countries. Established in 1995, Eisai Inc. began
marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical
business with sales of nearly $1.5 billion in fiscal year 2002 (year ending March 31, 2003). Eisai focuses its efforts
in four therapeutic areas: neurology, gastrointestinal disorders, oncology and acute care.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-
looking statements, which express the current beliefs and expectations of management. Such statements are based on
current expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's and
Eisai's future results, performance or achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute
to such differences include Teva's and Eisai's ability to successfully develop and commercialize additional
pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name
companies that sell their own generic products or successfully extend the exclusivity period of their branded products,
Teva's or Eisai's ability to rapidly integrate the operations of acquired businesses, including Teva's recent
acquisition of Sicor Inc., the availability of product liability coverage in the current insurance market, the impact
of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the
difficulty of predicting U.S. Food and Drug Administration and other regulatory authority approvals, the regulatory
environment and changes in the health policies and structure of various countries, acceptance and demand for new
pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly
launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic
alliances, exposure to product liability claims, dependence on patent and other protections for innovative products,
fluctuations in currency, exchange and interest rates, operating results and other factors that 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 publicly
or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Source: Teva Pharmaceutical Industries Ltd.
SOURCE: Yahoo News (press release)
http://biz.yahoo.com/prnews/040429/lnth001_1.html
* * *
----------------------------------------------------------------------
To sign-off Parkinsn send a message to: mailto:[log in to unmask]
In the body of the message put: signoff parkinsn
