TEMPO Extension Study Further Demonstrates the Benefits of Azilect in Early Parkinson's Disease Patients
-- Newly Published Data Confirms Long Term Efficacy, Safety and Tolerability in Treating Early Parkinson's Disease --
JERUSALEM & VALBY, Denmark--(BUSINESS WIRE)--Aug 5, 2010 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and H. Lundbeck A/S (Lundbeck) today announced newly published long-term data on Azilect® (rasagiline tablets) from the TEMPO study and its open-label extension. The findings confirm the long-term efficacy, safety and tolerability of Azilect® in patients with Parkinson's disease (PD) and further demonstrate the benefits obtained with early treatment initiation. The data was published in the June 2010 issue of the International Journal of Neuroscience.
“The high proportion of patients (46%) remaining on Azilect® monotherapy after two years in the trial suggests that starting Azilect® earlier in the treatment paradigm offers us an effective and safe alternative to using dopamine agonists for an extended period of time,” said Mark Lew, M.D., lead investigator and vice chair of the Department of Neurology and Director of the Division of Movement Disorders, Keck School of Medicine of the University of Southern California. “These results provide added support for a growing approach to treating patients with PD earlier in the course of their disease as was also shown in the ADAGIO study.”
Two common PD assessment tools were used to analyze the TEMPO trial and its long-term extension - the Unified Parkinson's Disease Rating Scale (UPDRS), and the Hoehn & Yahr (H&Y) scale, both of which assess the severity of symptoms of PD and describe how they progress. Overall, the average annual increase in UPDRS score for all patients taking Azilect® (monotherapy or in combination with -additional dopaminergic therapies) was less than two UPDRS units a year (compared to an increase of 8-12 UPDRS scores per year, typically seen in untreated PD patients). At two years, 46% of patients remaining in trial were maintained on Azilect monotherapy. Additionally, only 25 percent of patients progressed to H&Y stage III by 5.4 years, thus demonstrating initial treatment with Azilect® is a viable and effective treatment option for early PD patients that is sustained in the long-term.
About the TEMPO Trial and Extension
The TEMPO [(TVP-1012) in Early Monotherapy for Parkinson's Disease Outpatients] trial and extension was a multicenter, double-blind, randomized, placebo-controlled, parallel group, delayed-start investigation of once-daily rasagiline in early Parkinson's disease. From the original cohort of 398 patients, 360 patients completed the double-blind phase of TEMPO, and 306 (85 percent) participated in the open-label extension. Patients were followed for up to 6.5 years with a mean of 3.5 ± 2.1 years. After 12 months, additional PD medications were added as required.
During the first 12 months of the study, participants received either rasagiline 1mg per day or rasagiline 2mg/day. During the extension phase, all subjects initially received rasagiline 2mg once daily. The dosing was changed to 1mg/day for all participants after six-month efficacy data showed no difference between the two doses.
Patients were examined approximately every three months during the extension phase. At each visit, the investigator recorded spontaneously reported adverse events (AEs) and assessed need for additional PD therapy. Azilect® was well-tolerated with 11.3 percent of patients (45/398) withdrawing because of an adverse event. The most common adverse events seen in this trial were infection, headache, nausea, dizziness, accidental injury and joint pain. Patients who withdrew because of an adverse event were as likely to be on Azilect® monotherapy (51 percent) as Azilect® combination therapy (49 percent).
Azilect® tablets (rasagiline tablets) are indicated for the treatment of the signs and symptoms of Parkinson's disease both as initial monotherapy and as adjunct to levodopa later in the disease. Azilect® is currently available in 39 countries, including the US, Canada, Israel, Mexico, and all 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 five million people worldwide suffer from the disease, with an average age of onset of about 60 years.
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,250 molecules and a direct presence in approximately 60 countries. Teva's branded businesses focus on neurological, respiratory and women's health therapeutic areas as well as biologics. Teva's leading innovative product, Copaxone®, is the number one prescribed treatment for multiple sclerosis. Teva employs more than 35,000 people around the world and reached $13.9 billion in net sales in 2009.
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improve the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose Lundbeck is engaged in the research and development, production, marketing and sale of pharmaceuticals across the world, targeted at disorders like depression and anxiety, schizophrenia, insomnia, Huntington's, epilepsies, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and employs today approximately 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2009, the company's revenue was DKK 13.7 billion (approximately EUR 1.8 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com.
Lundbeck financial guidance
The content of this release will have no influence on the Lundbeck Group's financial guidance for 2010, which was provided on 4 March 2010 in connection with the release of the financial results for 2009.
Teva's 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 management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our 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 risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin®, Lotrel®, Protonix®, and Yaz® the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone® (including potential generic and oral competition for Copaxone®), the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of our patents and other protections for innovative products, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered by insurance, the termination or expiration of governmental programs or tax benefits, current economic conditions, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").
Teva Pharmaceutical Industries Ltd.
Elana Holzman, 972 (3) 926-7554
Teva North America
Kevin Mannix, 215-591-8912
Teva Pharmaceutical Industries Ltd.
Yossi Koren, 972 (3) 926-7590
Teva North America
Denise Bradley, 215-591-8974
Jacob Tolstrup, +45 36 43 30 79
Palle Holm Olesen, 45 36 43 24 26
Magnus Thorstholm Jensen, +45 36 43 38 16
Mads Kronborg, +45 36 43 28 51
Stine Hove Marsling, +45 36 43 28 33
Posted: August 2010