Pride-HD Study Enrolling Patients Globally to Further Evaluate Pridopidine for the Symptomatic Treatment of Huntington’s Disease
– Study initiation represents significant milestone for patients with a disease with limited effective treatment options –
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today enrollment of the first patient in The Pride-HD study, a phase II, randomized, double-blind, placebo-controlled global study designed to evaluate the impact of pridopidine, an investigational medication, on motor impairment in patients with Huntington’s disease (HD).
“Huntington’s disease represents a significant unmet medical need as there are currently no treatments that improve the motor movements that are crucial for gait, balance and coordination –things that greatly impact a patient,” said Professor G. Bernhard Landwehrmeyer, M.D., Ph.D, FRCP, lead study investigator and professor of neurology, Ulm University Hospital, Germany. “Based on previous observations using the compound, we believe pridopidine holds promise for symptomatic relief with an acceptable safety profile.”
“Existing treatments aren’t appropriate for some patients due to side effects and the predominant effect on involuntary movements,” said Karl Kieburtz, M.D., study investigator and director of the Clinical & Translational Science Institute, University of Rochester Medical Center. “Based on the preliminary clinical evidence to date, we believe pridopidine has the potential to make a real difference in the lives of HD patients and families.”
The start of patient enrollment in The Pride-HD Study represents the latest milestone in Teva’s commitment to developing medicines to improve the quality of life for patients suffering from devastating CNS diseases, such as Huntington’s disease.
“People with HD are in urgent need of new treatments and we are committed to investigating the potential benefit of pridopidine as quickly as possible," said Michael Hayden, M.D., a leading expert in the study of Huntington’s disease and President of Global R&D and Chief Scientific Officer at Teva.
“Pridopidine has shown promising results in previous advanced-stage clinical trials and merits additional study, as it has the potential to have a significant effect on Total Motor Score (TMS) – the endpoint most commonly used in the assessment of treatment efficacy in HD,” said Dr. Ralf Reilmann, study investigator and founding director and C.E.O., George-Huntington-Institute, Münster, Germany.
ABOUT THE PRIDE-HD STUDY
The Pride-HD Study, a phase II, dose-finding, randomized, parallel-group, double-blind, placebo-controlled study, that aims to enroll approximately 400 patients at 30 sites across the globe and evaluate the safety and efficacy of pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg twice daily (bid) versus placebo for symptomatic treatment in patients with HD.
The primary objective will be to assess the efficacy of pridopidine on motor impairment after 26 weeks of treatment using the Unified Huntington’s Disease Rating Scale (UHDRS) Total Motor Score (TMS). The study will also examine the effect of treatment with pridopidine on the Physical Performance Test (PPT), as well as the safety and tolerability across the range of pridopidine doses in patients with HD during the 26 weeks of treatment.
Qualifying patients for The Pride-HD study must be 21 years of age or older, with an onset of HD after age 18 and must have a diagnosis of HD based on clinical features and the presence of ≥36 cytosine-adenosine-guanine (CAG) repeats in the HTT gene. More information about the study can be found at http://clinicaltrials.gov/ct2/show/NCT02006472 or by calling 1-800-896-5855.
Pridopidine is an investigational, oral, small molecule being developed for the symptomatic treatment of Huntington’s disease (HD). Teva intends to design and complete new clinical studies of pridopidine to assess its potential for symptomatic relief of HD. Earlier clinical studies of pridopidine conducted in the U.S., EU and Canada in patients with HD indicate a significant treatment effect on an important secondary endpoint, Total Motor Score (TMS).
In previous studies, where doses up to 45 mg bid were tested, pridopidine was well tolerated with an adverse event profile similar to placebo, and treatment with pridopidine was not associated with worsening of disease signs and symptoms.
ABOUT HUNTINGTON’S DISEASE
Huntington’s disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. The classic onset of HD symptoms typically occurs in middle age, but the disease also manifests in children and the elderly. HD is the most common genetic cause of abnormal involuntary writhing movements called chorea. Disease progression is characterized by a gradual decline in motor control, cognition and mental stability and generally results in death within 15‐25 years of clinical diagnosis.
HD is a genetic disease, passed from parent to child through a gene mutation. Each child of an HD parent has a 50-50 chance of inheriting the HD gene. If a child does not inherit the HD gene, he or she will not develop the disease and cannot pass it to subsequent generations. A person who inherits the HD gene will sooner or later develop the disease. According to the World Health Organization, Huntington’s disease affects about five to seven people per 100,000 in Western countries.
Teva Pharmaceutical Industries Ltd. 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 approximately 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 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which 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 orally-administered alternatives, as well as from potential purported generic equivalents); the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; our potential exposure to product liability claims that are not covered by insurance; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; uncertainties related to our recent management changes; the effects of increased leverage and our resulting reliance on access to the capital markets; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; the impact of continuing consolidation of our distributors and customers; significant impairment charges relating to intangible assets and goodwill; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2013 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 we assume no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Kevin C. Mannix, United States, 215-591-8912
Ran Meir, United States, 215-591-3033
Tomer Amitai, Israel, (972 (3) 926-7656
Iris Beck Codner, Israel, 972 (3) 926-7687
Denise Bradley, United States, 215-591-8974
Nancy Leone, United States, 215-284-0213