Press Releases

HSG Press Release: September 2012

2CARE (Coenzyme Q10 in Huntington’s Disease) Study Update

September, 2012

Enrollment for the 2CARE study was closed on 25 July 2012, at which time the 609th participant joined the study. The study team has met the challenge of completing enrollment for the largest and longest clinical trial in Huntington disease (HD) to date. Forty-eight sites in North America and Australia contributed to the enrollment of these participants. The study will continue until the last participant completes the study, projected in mid-2017.

The 2CARE study involves collaboration of individuals with HD, caregivers or ‘study buddies’, along with the investigators, coordinators and research staff at the participating sites.

We have come a long way since the first enrollment in April of 2008, and none of our success would have been possible without the commitment and participation of those enrolled in 2CARE. We realize that not everyone can find time to be involved in clinical trials, but thanks to the willingness of those who can, we will be able to learn whether a high dosage of coenzyme Q10 (CoQ) is effective in treating HD.

A very important requirement of being able to learn whether CoQ is effective in slowing the progression of functional decline is that we have enough people remaining in the study through the entire five years. We encourage all enrolled participants to stay committed to the study as much as possible. Remember, HD is a slowly progressive disease, so it will take time to know if there are effects of the study drug.

Beginning in the spring of 2013, we will begin to see some of the earlier enrolled participants complete their five years of participation. We deeply thank all the patients and families who are part of the study, as well as those who have made it possible in so many ways– the National Institute of Neurological Disorders and Stroke, patient advocacy organizations, site investigators, coordinators, and members of the project team.

2CARE Principal Investigators and Study Team of the Huntington Study Group

HSG Press Release: May 14, 2009

FOR IMMEDIATE RELEASE

Huntington Study Group to Conduct Therapeutic Research Study in Pre-manifest Huntington’s Disease

May 14, 2009 – Physicians at 10 clinical sites are taking part in a nationwide study investigating coenzyme Q10 in gene positive, premanifest Huntington’s disease. This study is known as PREQUEL (Study in PRE-manifest Huntington’s disease of coenzyme Q10 (UbiquinonE) Leading to preventive trials).

Coenzyme Q10 is a nutritional supplement. The objective of the PREQUEL study is to evaluate the safety and tolerability of coenzyme Q10. A secondary objective is to assess the change from baseline to 20 weeks on biomarkers and DNA repair mechanisms in pre-manifest participants treated with coenzyme Q10.

Research participants who are 18 years of age and older and meet all eligibility criteria will be randomly assigned (like the flip of a coin) to receive 600, 1200 or 2400 mg/day of coenzyme Q10 capsules in a blinded fashion. Participants will be seen over 20 weeks. All participants will initiate treatment at 600 mg/day of coenzyme Q10 and then titrate to their assigned dosage over 4 weeks. Following the 4 week titration all participants will be maintained on their assigned study dosage for an additional 16 weeks of follow-up. Researchers at 10 clinical sites in the United States will enroll a total of 90 research participants who have tested positive for the Huntington’s disease (HD) gene expansion and not have features on a physical exam that would suggest a diagnosis of Huntington’s disease (pre-manifest). Each center will enroll approximately 9 participants.

Huntington’s disease (HD) is an inherited disease of the brain that usually begins between the ages of 30 to 50, and includes motor, cognitive and behavioral signs and symptoms. While there are medications to help relieve some of the disease symptoms, there is no known treatment to slow the progression of HD, which affects about 30,000 people in North America.

The HSG is a worldwide, not-for-profit group of physicians and other clinical researchers who are experienced in the care of Huntington’s disease patients and are dedicated to clinical research of Huntington’s disease. The study is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) and will be conducted under the direction of Principal Investigator Christopher Ross, MD PhD (Johns Hopkins University) and Co-Principal Investigator Kevin Biglan, MD MPH (University of Rochester) and Michael McDermott, PhD (University of Rochester).

Drs. Christopher Ross and Kevin Biglan state, “This will be the first therapeutic research study in pre-manifest HD and will hopefully lead to larger trials designed to delay the onset of HD.”

There is no cost to participate in the study. Participants will be followed for 20 weeks with participation being evaluated monthly. Persons who have tested positive for Huntington’s disease who are interested in participating in this study should visit the Huntington Study Group website at: www.HuntingtonStudyGroup.org.

press release final version 2.25.2009

HSG Press Release: December 2, 2008

FOR IMMEDIATE RELEASE

HSG Begins Phase IIb Study in Huntington Disease (HD)

December 2, 2008 – The Huntington Study Group (HSG) is conducting a clinical trial in HD, “A multi-center, North American, randomized, double-blind, parallel group study comparing three doses of ACR16 versus placebo for the symptomatic treatment of Huntington disease” (HART) with the research medication ACR16. The HSG is a not-for-profit group of physicians and other clinical researchers who are experienced in the care of Huntington disease patients and dedicated to clinical research of Huntington disease. This study is sponsored by NeuroSearch (NEUR), www.neurosearch.com.

Huntington disease (HD) is an inherited neurodegenerative disease characterized by brain cell death that usually begins between the ages of 30 to 50, and includes motor, cognitive and behavioral signs and symptoms. While there are medications to help relieve some of the disease symptoms, there is no known treatment to slow the progression of HD, which affects about 30,000 people in both North America and Europe.

ACR16 belongs to a novel class of agents called dopaminergic stabilizers, which have the ability to either enhance or inhibit dopamine controlled functions depending on the initial level of dopaminergic activity. ACR16 was previously evaluated in four clinical Phase I/II studies for patients with Huntington disease, Parkinson disease and psychosis, and demonstrated a good safety and tolerability profile. In a Phase II study with ACR16 in Huntington disease, the results showed that 28 days of treatment with ACR16 led to an improvement in the patients’ voluntary movements, including parkinsonism and gait function.

In the current study participants will receive two daily doses of either 10mg, 22.5mg, or 45mg of ACR16 or matching placebo, to evaluate the efficacy and safety of ACR16 over a treatment period of three months. The primary measure of the study will be the effect of ACR16 on Huntington disease patients’ voluntary motor function measured by the modified Motor Score (mMS), a subscale of the Unified Huntington’s Disease Rating Scale (UHDRS). Secondary endpoints include the overall clinical impression of the subjects, cognitive function, and psychiatric symptoms such as depression and anxiety. NeuroSearch is a biopharmaceutical company with locations in Ballerup, Denmark and Gothenburg, Sweden seeking to develop new drugs for the treatment of disorders that affect the Central Nervous System and primarily through the modulation of ion channels and monoamine transporters. NeuroSearch has recently been listed as a ‘Top 10’ European biotech company with many candidate drugs moving into the late development phases.

For more information regarding this study please visit http://clinicaltrials.gov

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HUNTINGTON STUDY GROUP

For more information, contact:

Drea Clark

585-273-4244

andrea.clark@ctcc.rochester.edu

HSG Press Release: October, 2014

Announcement of CREST-E Early Study Closure

October 2014

The National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health (NIH), has discontinued its study of creatine for treating the progressive functional decline that occurs in Huntington’s Disease (HD). The study, known as the Creatine Safety, Tolerability and Efficacy study (CREST-E), was being conducted by the Huntington Study Group (HSG) under the leadership of Dr. Steven Hersch of Massachusetts General Hospital and Dr. Giovanni Schifitto of the University of Rochester School of Medicine.. The CREST-E Data and Safety Monitoring Board (DSMB) recently reviewed the existing study data from a planned interim analysis. The DSMB reported that there were no safety concerns. However the analysis also showed with high confidence that it was unlikely that the study would be able to show that creatine was effective in slowing loss of function in early symptomatic Huntington’s Disease.  Site investigators and coordinators have informed participants of the study closure and have encouraged each participant to schedule a final visit to their research center.

The CREST-E study enrolled 551 research participants with early Huntington’s Disease from 46 sites throughout the United States, Canada, Australia, and New Zealand. Participants were randomized to receive up to 40 grams per day of active creatine or matching placebo for a treatment period up to four years in duration. The Principal Investigators and the Huntington Study Group are committed to conducting a detailed analysis of the complete data set from the CREST-E study and to disseminating the results through the scientific review process. Even though creatine was not found to slow the progression of HD, the study amassed a large amount of invaluable longitudinal clinical and biological data, which will provide considerable information to facilitate future clinical studies.  It has also produced a unique safety database for creatine and has demonstrated the feasibility of conducting such a large controlled clinical trial in Huntington’s Disease. The research team is indebted to the participants for their time and dedication to this study.

Any questions or comments may be directed to the Huntington Study Group – 800-487-7671 (Toll Free – North America).

HSG Press Release: August 8, 2014

Announcement of 2CARE Early Study Closure

August 2014

 The National Institute of Neurological Disorders and Stroke (NINDS) stopped its study of coenzyme Q10 for the treatment of Huntington’s disease (HD) on July 14, 2014. The study (2CARE), conducted by the Huntington Study Group (HSG), was stopped for futility. The NINDS and the HSG acted on the recommendation of the study’s independent Data and Safety Monitoring Board (DSMB). Following the most recent DSMB review of the study data, an interim analysis was conducted that showed that, given the current data, it would be very unlikely (less than a 5 in 100 chance) to see a statistically significant benefit of active treatment (coenzyme Q10, 2400 mg/day) over placebo at the scheduled end of the trial. The DSMB also noted a higher number of deaths in the coenzyme Q10 group (7%) in comparison to the placebo group (4%); most of these deaths appeared to be related to HD, which is a severe, progressive neurological disorder. Although this number may have been due to chance, and was not statistically significant, the DSMB noted it in their decision. Site investigators and coordinators have informed participants of the study closure and have encouraged each participant to schedule a final visit to the clinic.

The 2CARE study enrolled 609 research participants with early Huntington’s disease from 48 sites throughout North America and Australia. Participants were randomized to receive either 2400 mg per day of active coenzyme Q10 or matching placebo. The Principal Investigators and the Huntington Study Group are committed to conducting a detailed analysis of the complete data set from the 2CARE study and to disseminating the results through the scientific review process. Even though coenzyme Q10 was not found to be helpful, the study amassed a large amount of longitudinal clinical data which will provide useful information on HD for clinical studies. The study also demonstrated the feasibility of conducting such a large controlled clinical trial in Huntington’s disease. The research team is indebted to the participants for their time and dedication to this study.

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Teva Press Release: April 24, 2014

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 –

JERUSALEM–(BUSINESS WIRE)–Apr. 24, 2014– 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 athttp://clinicaltrials.gov/ct2/show/NCT02006472 or by calling 1-800-896-5855.

ABOUT PRIDOPIDINE

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.

ABOUT TEVA

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.

Source: Teva Pharmaceutical Industries Ltd.

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This article originally appeared on tevapharm.com, April 24, 2014: http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle_Print&ID=1921917
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