Press release from Business Wire
Teva Announces AZILECT® (Rasagiline Tablets) Data to Be Presented at the 2013 International Congress of Parkinson's Disease and Movement Disorders
<p class='bwalignc'> <i>Studies Further Define the Clinical Utility of AZILECT</i><sup><b>®</b></sup><i> in the Treatment of Parkinson's Disease (PD)</i> </p>
Friday, June 14, 2013
Teva Announces AZILECT® (Rasagiline Tablets) Data to Be Presented at the 2013 International Congress of Parkinson's Disease and Movement Disorders08:00 EDT Friday, June 14, 2013
JERUSALEM (Business Wire) -- Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that a number of abstracts will be presented during the 17th Annual International Congress of Parkinson's Disease and Movement Disorders in Sydney, Australia, June 16-20, 2013, also known as the Movement Disorders Society (MDS). These presentations affirm Teva's ongoing commitment to Parkinson's disease (PD) research and underscore the potential of AZILECT® as a treatment modality for PD.
“The AZILECT® abstract topics presented at MDS demonstrate our efforts to further clarify the clinical utility of rasagilineto prescribers and PD patients across various stages of the disease,” said Michael Hayden, MD, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “We are committed to driving advances in research to help address the treatment needs of those impacted by neurological conditions.”
Some of the presentations include:
-  Efficacy and Tolerability of Rasagiline in Daily Clinical Use – A Post Marketing Observational Study in Patients with Parkinson's Disease Focusing on Nonmotor Symptoms and QoL Data (Poster Session Topic: PD: Quality of Life/Caregiver Burden, Monday, June 17, 2013) Heinz Reichmann, Prof, Dr., Rainer Apfel, PhD, Sabrina Schroeder, PhD
-  Efficacy of Rasagiline 1mg/day on Key Motor Symptoms of Early Parkinson Disease: Post-hoc Analysis from the Attenuation of Disease Progression with Azilect ® GIven Once-Daily (ADAGIO) Study (Poster Session Topic: PD: Clinical Trials, Tuesday, June 18, 2013) Eduardo Tolosa, MD, on behalf of the ADAGIO investigators (Selected for a guided poster tour: Thursday, June 20, 2013)
-  A Placebo-Controlled, Randomized, Double-Blind Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add-On to Dopamine Agonist Monotherapy in Early Parkinson's Disease (PD): The ANDANTE Study (Poster Session Topic: PD: Clinical Trials, Tuesday, June 18, 2013) Robert A Hauser, MD, Dee Silver, MD, Azhar Choudhry, MD, Stuart Isaacson, MD (Selected for a guided poster tour: Thursday, June 20, 2013)
-  A Randomized, Double Blind, Placebo-Controlled Study to Assess the Effect of Rasagiline on Mild Cognitive Impairment in Patients with Parkinson's Disease: The MODERATO Study (Poster Session Topic: PD: Clinical Trials, Tuesday, June 18, 2013) D. Weintraub MD, R.A. Hauser MD, MBA, A. Choudhry MD, MBA
ABOUT AZILECT ® (UNITED STATES)
AZILECT® (rasagiline tablets) is indicated for the treatment of the signs and symptoms of Parkinson's disease (PD) both as initial therapy alone and to be added to levodopa later in the disease.
Patients should not take AZILECT® if they are taking meperidine, tramadol, methadone, propoxyphene, dextromethorphan, St. John's Wort, cyclobenzaprine, or other monoamine oxidase inhibitors (MAOIs), as it could result in a serious reaction. Patients should inform their physician if they are taking, or planning to take, any prescription or over-the-counter drugs, especially antidepressants and ciprofloxacin. Patients with moderate to severe liver disease should not take AZILECT®. Patients should not exceed a dose of 1 mg per day of AZILECT® in order to prevent a possibly dangerous increase in blood pressure.
Side effects seen with AZILECT® alone are flu syndrome, joint pain, depression, and indigestion; and when taken with levodopa are uncontrolled movements (dyskinesia), accidental injury, weight loss, low blood pressure when standing, vomiting, anorexia, joint pain, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, and fall.
See additional important information at http://www.azilect.com/Resources/PDFs/PrescribingInformation-pdf.aspx. For hardcopy releases, please see enclosed full prescribing information.
AZILECT® is currently available in more than 40 countries worldwide, including the U.S., Canada, Israel, Mexico, and all EU countries. Teva has a long-term agreement for the joint development and marketing of AZILECT® in Europe and some additional markets with H. Lundbeck A/S. In North America, AZILECT® is marketed by Teva's wholly-owned subsidiary, Teva Neuroscience, Inc. (www.tevaneuro.com).
Teva Pharmaceutical Industries Ltd. (NYSE: 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 leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.
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 develop and commercialize additional pharmaceutical products, competition for our innovative products, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our innovative R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation. our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, any failures to comply with complex Medicare and Medicaid reporting and payment obligations, governmental investigations into sales and marketing practices (particularly for our specialty pharmaceutical products), uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology-based products, adverse effects of political or economical instability, corruption, major hostilities or acts of terrorism on our significant worldwide operations, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, any failure to retain key personnel or to attract additional executive and managerial talent, the impact of continuing consolidation of our distributors and customers, variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities, the termination or expiration of governmental programs or tax benefits, environmental risks and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2012 and in our 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.
Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
Tomer Amitai, 972-3-926-7656
Iris Beck Codner, 972-3-926-7687
Denise Bradley, 215-591-8974