Deal combines HemoShear’s REVEAL-Tx™ platform
with Takeda’s drug discovery and development capabilities
Takeda Pharmaceutical Company Limited (TSE: 4502) and HemoShear
Therapeutics, LLC, a privately held biotechnology company, today
announced a partnership to discover and develop novel therapeutics
for liver diseases, including nonalcoholic steatohepatitis
(NASH).
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“The ability to study pathophysiology in a human multi-cell
system is crucial for our understanding of disease and how to
develop best-in-class therapies,” said Gareth Hicks, Ph.D., Head of
the GI Drug Discovery Unit at Takeda. “We see the HemoShear
platform as an integral component in our overall liver disease
strategy that focuses on a ‘human first’ approach to the
identification and validation of novel targets in NASH and other
liver diseases.”
HemoShear’s proprietary disease modeling
platform, REVEAL-Tx™, applies principles of physiological
blood flow to tissue derived from patients. REVEAL-Tx™ allows drug
candidates to be studied at human concentrations and provides
valuable insights into complex pathophysiological pathways by
replicating human disease with great accuracy. REVEAL-Tx™ was
recognized recently at the American Association for the Study of
Liver Disease annual meeting where its NASH model received four
Presidential Awards based on publications demonstrating the
platform’s ability to replicate many clinical observations from
clinical stage drugs.
“We are excited about our collaboration with Takeda,” said Jim
Powers, HemoShear’s CEO. “From the beginning, Takeda has recognized
the value and potential of our platform and its ability to identify
and validate therapeutic targets in liver diseases. Our ability to
replicate NASH and other liver diseases for drug discovery, coupled
with Takeda’s expertise in developing and commercializing
therapeutics, can yield safer and more effective therapies for NASH
and potentially other liver diseases.”
Under the terms of the agreement, HemoShear will receive upfront
payments and R&D funding, and Takeda will receive exclusive
access to HemoShear’s proprietary disease modeling platform to
discover and develop best-in-class therapeutics for specific liver
diseases. HemoShear is also eligible to receive milestone payments
of potentially $470 million and royalties. Further financial terms
were not disclosed. Liver diseases may progress to end-stage
disease requiring liver transplantation and represent a serious
unmet medical need. One of the leading causes of transplantation,
NASH, is a serious, chronic liver disease that is estimated to
impact over 16 million people in the United States alone. NASH is
characterized by inflammation and excessive fat accumulation in the
liver that may progress to fibrosis, cirrhosis, liver cancer and
eventually liver failure. There is currently no FDA approved
therapeutic available for NASH and liver fibrosis.
Cowen acted as financial advisor to HemoShear in this
transaction.
About HemoShear Therapeutics
HemoShear Therapeutics discovers novel biological targets and
advances drug programs to treat metabolic disorders with
significant unmet patient need. HemoShear’s proprietary drug
discovery platform, REVEAL-TX™, enables HemoShear to create
best-in-class, biologically relevant human disease models to
uncover and explain the underlying mechanisms of disease, translate
those discoveries into drug candidates, and predict which drug
candidates will treat patients successfully. HemoShear’s current
drug discovery programs are focused on nonalcoholic steatohepatitis
(NASH) and propionic and methylmalonic acidemias, rare genetic
metabolic disorders. For more information visit
www.HemoShear.com.
About HemoShear’s REVEAL-Tx™ Platform
Existing human experimental disease models do not reliably
represent human biology. HemoShear has developed a
transformational platform, REVEAL-Tx™, which applies principles of
physiological blood flow to tissue from patients to recapitulate
disease. REVEAL-Tx™ provides unprecedented insights into
complex pathophysiological pathways by replicating human disease
with great accuracy. HemoShear’s human disease models, in
combination with its advanced proprietary computational biology
tools, identify novel treatment approaches and reduce risk of
failure by enabling HemoShear’s scientists to deeply interrogate
disease pathways, test hypotheses and select meaningful targets in
physiologically accurate disease conditions.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and
development-driven pharmaceutical company committed to bringing
better health and a brighter future to patients by translating
science into life-changing medicines. Takeda focuses its R&D
efforts on oncology, gastroenterology and central nervous system
therapeutic areas plus vaccines. Takeda conducts R&D both
internally and with partners to stay at the leading edge of
innovation. New innovative products, especially in oncology and
gastroenterology, as well as Takeda’s presence in Emerging Markets,
are currently fueling the growth of Takeda. Takeda’s 30,000
employees are committed to improving quality of life for patients,
working with Takeda’s partners in health care in more than 70
countries. For more information visit www.takeda.com/news.
Takeda’s Commitment to Gastroenterology
More than 70 million people worldwide are impacted by
gastrointestinal (GI) diseases, which can be complex, debilitating
and life-changing. Takeda is driven to improving the lives of
patients with GI diseases through innovative medicines, dedicated
patient disease management support and the evolution of the
healthcare environment. Takeda is leading in gastroenterology
through the delivery of innovative medicines in areas associated
with high unmet needs, such as inflammatory bowel disease, GI
acid-related diseases and GI motility disorders. Our GI research
& development team is also exploring solutions in celiac
disease and liver diseases, as well as scientific advancements
through microbiome therapies. With more than 25 years of experience
in this area, our broad approach to treating many diseases that
impact the GI system and our global network of collaborators,
Takeda aims to advance how patients manage their disease.
Takeda’s Forward-Looking Statements
This press release contains “forward-looking statements.”
Forward-looking statements include all statements other than
statements of historical fact, including plans, strategies and
expectations for the future, statements regarding the expected
timing of filings and approvals relating to the transaction, the
expected timing of the completion of the transaction, the ability
to complete the transaction or to satisfy the various closing
conditions, future revenues and profitability from or growth or any
assumptions underlying any of the foregoing. Statements made in the
future tense, and words such as “anticipate,” “expect,” “project,”
“continue,” “believe,” “plan,” “estimate,” “pro forma,” “intend,”
“potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,”
“assume,” “will,” “may,” “should,” and similar expressions are
intended to qualify as forward-looking statements. Forward-looking
statements are based on estimates and assumptions made by
management that are believed to be reasonable, though they are
inherently uncertain and difficult to predict. Investors and
security holders are cautioned not to place undue reliance on these
forward-looking statements.
Forward-looking statements involve risks and uncertainties that
could cause actual results or experience to differ materially from
that expressed or implied by the forward-looking statements. Some
of these risks and uncertainties include, but are not limited to:
required regulatory approvals for the transaction may not be
obtained in a timely manner, if at all; the conditions to closing
of the transaction may not be satisfied; competitive pressures and
developments; applicable laws and regulations; the success or
failure of product development programs; actions of regulatory
authorities and the timing thereof; changes in exchange rates; and
claims or concerns regarding the safety or efficacy of marketed
products or product candidates in development.
The forward-looking statements contained in this press release
speak only as of the date of this press release, and neither
HemoShear Therapeutics nor Takeda undertake any obligation to
revise or update any forward-looking statements to reflect new
information, future events or circumstances after the date of the
forward-looking statement. If one or more of these statements is
updated or corrected, investors and others should not conclude that
additional updates or corrections will be made.
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For HemoShear TherapeuticsFeinstein Kean HealthcareLynn
Blenkhorn –
USALynn.blenkhorn@fkhealth.com+1-508-851-0930orHemoShear
Therapeutics, LLCJeremy Mauldin –
USAmauldin@hemoshear.com+1-434-872-0196orFor Takeda:Tsuyoshi
Tada – Japantsuyoshi.tada@takeda.com+81-3-3278-2417orKelly Schlemm
– USAkelly.schlemm@takeda.com+1-617-551-8865