JERUSALEM--(BUSINESS WIRE)--Nov. 19, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and University
College London (UCL) announced today the start of a unique study,
combining state-of-the-art brain imaging with key biomarkers, aimed at
building a better understanding of the role of inflammation in
neurodegenerative disease and potentially a new approach in its early
diagnosis and treatment.
The Pilot Longitudinal Study in Alzheimer’s Disease of Central Markers
of Microglial Activation (PADMMA) study is a two-year study in 20
patients that will assess, using PET imaging, the prevalence and pattern
of activation of a specific type of cell, called microglia, in the
central nervous system (CNS) in people with certain symptoms of
neurodegenerative disease. It is key demonstration of Teva's commitment
towards dementia research made following the UK Government’s Dementia
Summit, spearheaded by UK Prime Minister David Cameron.
The role of inflammation is key in the field of neurodegeneration. It is
implicated in the neuronal dysfunction that is the result of some of the
most devastating neurodegenerative diseases. Microglia play a central
role in neuro-inflammation, and defining reliable biomarkers of
microglial activation, and their changes over time, will provide us with
crucial information for developing treatment trials with
neuro-inflammation as a novel therapeutic target.
“This is a very exciting new direction. The insights into the role of
microglial activation provided by the study will facilitate the
development of reliable central and peripheral clinical markers of
inflammation early on in Alzheimer's disease, potentially providing
tools to assess the impact of drugs on a new therapeutic target”, said
Dr Cath Mummery, Consultant Neurologist and Clinical Lead at the DRC's
Cognitive Disorders Clinic.
“The focus on microglial activation heralds a new therapeutic area of
interest for most neurodegenerative diseases, potentially with very high
impact on disease modification therapies”, said Doctor Michael Hayden,
Teva’s President of R&D and Chief Scientific Officer. The PADMMA study
has clear translational value. A greater understanding of the role of
brain inflammation in early disease may lead to development of better
biomarkers that could better inform therapeutic studies and potentially
open the door to new therapeutic options.”
The study will be performed at the University College London (UCL)
Dementia Research Centre (DRC) for which Dr Mummery is Clinical Trials
lead, and the Leonard Wolfson Experimental Neurology Centre (LWENC)
Clinical Research Facility (CRF), headed by Dr Vincenzo Libri, who is
also Co-Investigator of the PADMMA study. Imaging will be undertaken by
Imanova, at the Centre for Imaging Sciences, Imperial College London.
This unique study is the result of an extensive collaborative effort
supported by the UK
Israel Tech Hub at the British Embassy in Israel - helping Teva, UCL
and Imanova, come together in an effort to change the paradigm in
neurodegenerative disease.
David Quarrey, UK Ambassador to Israel, said: "We welcome this project,
part of Teva's multi-million commitment to deepen its research in the
UK. Over the years, Teva has proved a great partner to the UK's
world-class medical research institutions. The UK Israel Tech Hub
remains committed to creating more bilateral collaborations in
innovation, for the benefit of patients in both countries and around the
world".
About the PADMMA Study
The Pilot Longitudinal Study in Alzheimer’s Disease of Central Markers
of Microglial Activation (PADMMA) study is a two-year study in 20
patients that will assess the prevalence and pattern of CNS microglial
activation in individuals with prodromal AD with Mild Cognitive
Impairment (MCI) or mild AD through the use of PET imaging and
comparison with CSF and peripheral markers of inflammation..
The total study duration will be 2 years, with 1 year for the
recruitment period. The study duration for each participant is 12
months. It will be run between the DRC and the LWENC CRF at the UCL
Institute of Neurology (IoN) and the UCLH National Hospital for
Neurology and Neurosurgery (NHNN). Dr Cath Mummery is Consultant
Neurologist and Clinical Lead at the DRC's Cognitive
Disorders Clinic University College London Hospital (UCLH), and is
supported by the NIHR Queen Square Biomedical Research Unit (BRU) and
NIHR UCLH BRC (Biomedical Research Centre). Dr Vincenzo Libri is
Consultant Clinical Pharmacologist and Head of the LWENC.
Participants will only be recruited at a single site - University
College London Hospital (UCLH) and will come from the Dementia Research
Centre cognitive disorder clinics, from the National Institute of Health
Research (NIHR) clinical research network (CRN) and from the UK Dementia
Registry, and JDR (Join Dementia Research).
About the UCL site
The Dementia Research Centre (DRC), based at the National Hospital for
Neurology and Neurosurgery (NHNN) is one of the UK's leading centres for
clinical research into dementia. The DRC is part of the Department of
Neurodegenerative Disease at the UCL Institute of Neurology and has
close links with the NIHR QS Dementia Biomedical Research Unit (BRU-D)
based at the NHNN/UCL. The BRU focuses on young onset and familial
dementias, and aims to develop new diagnostics and novel therapies. The
UCLH BRC focuses on experimental medicine, with the neuroscience
programme seeking to utilise deep phenotyping and genotypic data to
understand disease mechanisms, and develop therapies. The LWENC-CRF is
the clinical hub of translational research at the UCL Institute of
Neurology, bringing together the expertise of leading clinicians and
scientists across a broad range of neurological and neurodegenerative
diseases. It acts as a crucial bridge between laboratory-based research
and clinical expertise and is a major asset in fostering high quality
clinical research studies at UCL.
Further information:
Cognitive Disorders Clinic http://www.uclh.nhs.uk/ourservices/servicea-z/neuro/cdc
Dr Mummery: https://www.uclh.nhs.uk/OurServices/Consultants/Pages/DrCatherineMummery
Dementia Research Centre: www.ucl.ac.uk/drc
Leonard Wolfson Experimental Neurology Centre: www.ucl.ac.uk/LWENC
Dr Libri: https://iris.ucl.ac.uk/iris/browse/profile?upi=VLIBR29
Brain Research Unit www.ucl.ac.uk/bru
Imanova: www.imanova.co.uk/
UK Israel Tech Hub: www.ukisraelhub.com/
About Neurodegenerative Disease
Neurodegenerative diseases (such as Alzheimer’s disease, Huntington
disease and Parkinson’s disease), are devastating conditions. They
progressively destroy people’s lives, and the lives of their families.
The term neurodegenerative disease covers a range of conditions which
primarily affect the neurons in the brain. Neurons are the building
blocks of the nervous system which includes the brain and spinal cord.
Neurons normally don’t reproduce or replace themselves, so when they
become damaged or die the loss is permanent. Loss of neurons results in
progressive degeneration and / or death of nerve cells, causing problems
with movement (called movement disorders), or mental functioning (called
dementias).
Prevalence of neurodegenerative disease is growing (people are living
longer and older populations represent a growing proportion of overall
population). It is one of society’s biggest challenges. The global cost
of managing dementia is significant, and rising. According to the
Alzheimer’s Society, in the US there are currently 5.3 million people
with diagnosed Alzheimer’s disease, costing the US economy more than
$220 billion annually (http://www.alz.org/facts/).
Moreover, according to the World Health Organization (WHO), the number
of people living with dementia worldwide is set to treble to 115 million
in less than 40 years. The economic burden in the US of Parkinson’s
disease was $14.4 billion in 2010. It is estimate that approximately 1
million people in the US (5 million people worldwide) have PD, and its
prevalence is expected to double by 2030*. The number of cases of HD
worldwide is also expected to rise by 5% by 2019**.
There is a wide range of diseases that can be classified as
neurodegenerative. Some are very rare - but all have a significant
impact. Therefore, an important focus of ongoing work in this field is
centered on the identification of convergent pathogenic pathways in
neurodegenerative diseases - which might provide potential for shared
targets for drug development.
* Dorsey, E. R., Constantinescu, R., Thompson, J. P., Biglan, K. M.,
Holloway, R. G., Kieburtz, K., Marshall, F. J., Ravina, B. M.,
Schifitto, G., Siderowf, A. and Tanner, C. M. (2007). Projected number
of people with Parkinson disease in the most populous nations, 2005
through 2030. Neurology 68(5): 384-386
** Decision Resources Report: Huntington’s Disease (updated June 21,
2013)
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 molecules to
produce a wide range of generic products in nearly every therapeutic
area. In specialty medicines, Teva has a world-leading position in
innovative treatments for disorders of the central nervous system,
including pain, as well as a strong portfolio of respiratory products.
Teva integrates its generics and specialty capabilities in its global
research and development division to create new ways of addressing unmet
patient needs by combining drug development capabilities with devices,
services and technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
Teva's 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 specialty products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from generic equivalents such as the recently launched Sandoz product)
and our ability to continue to migrate users to our 40 mg/mL version and
maintain patients on that version; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities (such as our pending acquisitions of Allergan’s generic
business and Rimsa), or to consummate and integrate acquisitions; 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;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
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; adverse effects of political or economic 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; the impact of continuing
consolidation of our distributors and customers; 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; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; 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, 2014 and in our other filings with the U.S. Securities and Exchange
Commission.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
Nancy Leone, 215-284-0213