TARRYTOWN, N.Y., March 11, 2019 /PRNewswire/ --
All sequenced data linked to detailed health-related records,
creating first widely available 'Big Data' resource of its
kind
Represents first tranche to be released; data from all
500,000 UK Biobank participants will ultimately be made available
via larger biopharma consortium effort
Regeneron (NASDAQ: REGN) and UK Biobank announced today
that a vast tranche of new human sequencing data is now available
to health researchers, offering an unprecedented 'Big Data'
resource to enhance understanding of human biology and aid in
therapeutic discovery.
The exome sequence data of 50,000 UK Biobank participants were
generated at the Regeneron Genetics Center (RGC) through a
collaboration between UK Biobank, Regeneron and GlaxoSmithKline
(GSK) and are linked to detailed de-identified health records, imaging and
other health-related data. Regeneron is also leading a consortium
of biopharma companies (including Abbvie, Alnylam, AstraZeneca,
Bristol-Myers Squibb, Biogen, Pfizer and Takeda) to complete exome
sequencing of the remaining 450,000 UK Biobank participants by
2020.
Consistent with the founding principles of UK Biobank, the first
tranche of data has now been incorporated back into the UK Biobank
resource for the global health research community to use. It
follows a brief exclusive research period for Regeneron and GSK.
Additional tranches of data will similarly be released over the
next two years. All sequencing and analyses activities are
undertaken on a de-identified basis, with the utmost consideration
and respect for participant privacy and confidentiality
principles.
This major enhancement to UK Biobank would have been
unimaginable when the study began recruiting participants in 2006
and makes it one of the most important studies of population health
in the world. It represents huge leverage of the public and charity
investment that has supported UK Biobank up to this point; the
costs of such a project would have been prohibitive had UK Biobank
had to raise the funding itself.
"We believe this is the largest open access resource of exome
sequence data linked to robust health records in the world – and
this is just the beginning," said Aris
Baras, MD, Senior Vice President and Head of the RGC. "There
is so much actionable information in this resource that can be
utilized by scientific minds around the globe. We are hard at work
mining the data for novel findings that will accelerate science,
innovative new medicines and improved patient care, and we are excited to have others join us in
this important quest."
"We strongly support the UK's life sciences strategy, and this
is a great example of what can be achieved by all parts of the
sector working together to make sure the UK remains at the
cutting-edge of research," said Tony
Wood, Senior Vice President of Medicinal Science and
Technology at GSK. "Genetics is playing an increasingly important
role in research, and by generating and now integrating these exome
data, UK Biobank has some of the richest health and genetics data
available for use by the broader scientific community to enhance
their understanding and research effort. We expect this will
ultimately lead to more scientific breakthroughs that can improve
health."
The exome makes up the 1-2 percent of a human genome where the
actual protein-coding genes are contained. It is this area that
scientists believe has most relevance for discovering genetic
variants that may inform the discovery and development of new and
improved medicines. The exome sequencing work supports other UK
Biobank genetics analyses under way, including whole genome
sequencing of 50,000 participants funded by UK Research and
Innovation as part of the Industrial Strategy Challenge Fund.
Researchers from Regeneron and GSK also released a preprint of a
manuscript describing their findings from examination of the
first 50,000 exomes. Key findings included novel loss of function
associations with large effects on disease risk, including between
PIEZO1 and varicose veins, MEPE and bone mineral
density and osteoporosis, COL6A1 and ocular traits, and
IQGAP2 and GMPR associated with blood cell traits.
The researchers also explored population-based genetic risk for a
number of important diseases, such as BRCA1- and
BRCA2-associated cancers.
Regeneron and GSK have significant expertise in genomics. The
sequencing was performed by the RGC, one of the world's largest
human genetics sequencing and research programs. The RGC is
currently sequencing at a rate of 500,000 exomes per year, and
Regeneron has advanced multiple new targets and development
programs based on its genetics discoveries. GSK is also
increasingly incorporating the almost daily advances in genetics
and genomics into its drug research programs, forming
collaborations and working closely with other world-leading
organizations.
"UK Biobank was established to do science in new ways, and it is
very pleasing to see industry and academia tackling health research
together," said Professor Fiona
Watt, Executive Chair of the UK Medical Research, which has
funded UK Biobank since its inception and continues to support
enhancement activities. "Industry has led the way on this exome
sequencing project, and the fruits of that work mean UK Biobank can
now deliver important genetic data that would otherwise not be
available to researchers."
"Today's announcement proves the immense value of the UK Biobank
and we look forward to seeing many new collaborations between UK
Biobank, industry and academia on the back of this new data being
released," said Sara Marshall, Head
of Clinical Research & Physiological Sciences at the Wellcome
Trust, which also funds UK Biobank. "The success of UK Biobank is
thanks to the 500,000 people who have generously agreed to have
their lives studied for years."
"We are excited about the possibilities of letting loose the
imaginations of scientists from around the world on these
large-scale genomic data linked to so much detailed information
related to health in the 500,000 UK Biobank participants," said
Professor Sir Rory Collins, UK
Biobank's Principal Investigator, who encouraged approved
researchers to use the data.
UK Biobank has also updated a range of other health information
on its 500,000 participants. This includes updates of hospital,
cancer and death data, infectious disease data (including human
immunodeficiency virus, human papillomavirus and chlamydia) and
blood biomarkers. New disease-related algorithms are provided on
asthma, kidney disease, dementia and Parkinson's disease, and the
stroke and heart attack algorithms have been updated. Researchers
can find more details on how to access the data at
https://bbams.ndph.ox.ac.uk/ams/.
About UK Biobank
UK Biobank is the most comprehensive resource of its kind in
the world. Its 500,000 participants have provided information about
their health, well-being and lifestyle, as well as blood and other
biological samples for long-term storage and analysis. In addition,
they have agreed to have their health followed through medical
records for many years. Scientists from around the world are able
to use anonymized data from the resource for research intended to
improve the prevention and treatment of a wide range of common
disorders.
UK Biobank is funded primarily by the UK Medical
Research Council and the Wellcome Trust. For more
information, visit www.ukbiobank.ac.uk.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, neuromuscular diseases,
infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, including
VelocImmune® which produces optimized fully-human
antibodies, and ambitious initiatives such as the Regeneron
Genetics Center, which is conducting one of the largest genetics
sequencing efforts in the world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Regeneron Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements.
Words such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these
risks and uncertainties include, among others, the nature, timing,
and possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation the use of
human genetics in Regeneron's research programs; the extent to
which the results from Regeneron's research programs or preclinical
testing may lead to advancement of product candidates to clinical
trials or therapeutic applications; unforeseen safety issues
resulting from the administration of products and product
candidates in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates in clinical trials; the likelihood and timing of
possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates and new indications for marketed
products; the likelihood and timing of achieving any of the
anticipated milestones described in this press release; the extent
to which the results from the research and development programs
conducted by Regeneron or its collaborators may be replicated in
other studies and lead to therapeutic applications; ongoing
regulatory obligations and oversight impacting Regeneron's marketed
products, research and clinical programs, and business, including
those relating to patient privacy; determinations by regulatory and
administrative governmental authorities which may delay or restrict
Regeneron's ability to continue to develop or commercialize
Regeneron's products and product candidates; competing drugs and
product candidates that may be superior to Regeneron's products and
product candidates; uncertainty of market acceptance and commercial
success of Regeneron's products and product candidates and the
impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary) on the commercial success of
Regeneron's products and product candidates; the availability and
extent of reimbursement of the Company's products from third-party
payers, including private payer healthcare and insurance programs,
health maintenance organizations, pharmacy benefit management
companies, and government programs such as Medicare and Medicaid;
coverage and reimbursement determinations by such payers and new
policies and procedures adopted by such payers; the ability of
Regeneron to manufacture and manage supply chains for multiple
products and product candidates; the ability of Regeneron's
collaborators, suppliers, or other third parties to perform
filling, finishing, packaging, labeling, distribution, and other
steps related to Regeneron's products and product candidates;
unanticipated expenses; the costs of developing, producing, and
selling products; the ability of Regeneron to meet any of its sales
or other financial projections or guidance and changes to the
assumptions underlying those projections or guidance; risks
associated with intellectual property of other parties and pending
or future litigation relating thereto, including without limitation
the patent litigation proceedings relating to EYLEA® (aflibercept)
Injection, Dupixent® (dupilumab) Injection, and Praluent®
(alirocumab) Injection, the ultimate outcome of any such litigation
proceeding, and the impact any of the foregoing may have on
Regeneron's business, prospects, operating results, and financial
condition; and the potential for any license or collaboration
agreement, including Regeneron's agreements with Sanofi, Bayer, and
Teva Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated without
any further product success. A more complete description of
these and other material risks can be found in Regeneron's filings
with the U.S. Securities and Exchange Commission, including its
Form 10-K for the fiscal year ended December
31, 2018 in the section thereof captioned "Item 1A. Risk
Factors." Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
publicly any forward-looking statement, including without
limitation any financial projection or guidance, whether as a
result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
UK Biobank Media Relations
Andrew Trehearne
Tel: +44 1865 743960
Mobile: +44 7979 940972
Andrew.trehearne@ukbiobank.ac.uk
Regeneron Media Relations
Alex Bowie
Tel: +1 (914)
847-3407
alexandra.bowie@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.