TIDMPRTC
PureTech Health PLC
28 January 2019
28 January 2019
PureTech Health plc
PureTech's Alivio Therapeutics Enters into Partnership with
Purdue Pharma LP to Advance ALV-107, A Non-Opioid Product Candidate
for Interstitial Cystitis/Bladder Pain Syndrome
Alivio to receive up to $14.75 million in upfront and near-term
license exercise payments and is eligible to receive royalties on
product sales and over $260 million in research and development
milestones
PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) Axis, is pleased to note
that Purdue Pharma LP ("Purdue") and Alivio Therapeutics, Inc., an
affiliate of PureTech Health, today announced that they have
entered into a partnership to advance Alivio's product candidate
ALV-107, a non-opioid treatment being developed for interstitial
cystitis/bladder pain syndrome (IC/BPS), through clinical
development. Under the terms of the agreement, Alivio will receive
up to $14.75 million in upfront and near-term license exercise
payments and is eligible to receive royalties on product sales and
over $260 million in research and development milestones. Purdue
also has an option to collaborate on a limited number of additional
compounds utilising Alivio's inflammation-targeting technology, as
well as an option to invest in Alivio's next equity financing.
Bharatt Chowrira, JD, PhD, President and Chief of Business and
Strategy at PureTech Health, said: "We are pleased to advance
ALV-107 as a potential non-opioid treatment option for interstitial
cystitis/bladder pain syndrome (IC/BPS). This programme reflects
PureTech's ongoing commitment to addressing pain through novel,
non-opioid approaches. Our other efforts include the first-in-class
oral small molecule programme KarXT, being advanced by our
affiliate Karuna Pharmaceuticals for a range of pain indications,
in addition to treating psychosis and cognition. The Alivio
platform technology also has broad potential to address a range of
inflammatory conditions beyond pain, which Alivio will continue to
evaluate as part of Alivio's internal R&D efforts."
The full text announcement from Alivio and Purdue Pharma LP is
as follows:
Purdue Pharma L.P. and Alivio Therapeutics Enter into
Partnership to Advance ALV-107, a Non-Opioid Interstitial
Cystitis/Bladder Pain Syndrome Treatment
Alivio to receive up to $14.75 million in upfront and near-term
license exercise payments and is eligible to receive royalties on
product sales and over $260 million in research and development
milestones
STAMFORD, Conn. and BOSTON, Mass Jan 28, 2019 - Purdue Pharma
L.P. ("Purdue") and Alivio Therapeutics today announced that they
have entered into a partnership to advance one of Alivio's product
candidates through clinical development with an option exercisable
by Purdue to collaborate on a limited number of additional
compounds utilising Alivio's inflammation-targeting technology.
ALV-107 is a non-opioid treatment being developed for interstitial
cystitis/bladder pain syndrome (IC/BPS).
Alivio will receive up to $14.75 million in upfront and
near-term license exercise payments and is eligible to receive
royalties on product sales and over $260 million in research and
development milestones. Purdue also has an option to invest in
Alivio's next equity financing.
"This collaboration with Alivio is an important milestone in our
continued pursuit of non-opioid treatments for pain and represents
yet another step to further diversify our portfolio," said Craig
Landau M.D., President and CEO of Purdue Pharma LP. "We are
impressed with Alivio's innovative platform technology as we focus
on addressing patient needs - especially in areas where there are
few efficacious treatment options."
Alivio's inflammation-targeting technology is designed to enable
therapeutics such as small molecules, biologics and nucleic acids
to act exclusively at sites of inflammation based on the degree of
inflammation in the tissue, while sparing healthy tissue. This
approach is being evaluated by Alivio internally across a variety
of inflammatory diseases, including IC/BPS, pouchitis, and
inflammatory bowel disease (IBD).
"We are delighted to enter into this partnership to advance
ALV-107 for the potential treatment of interstitial
cystitis/bladder pain syndrome. Alivio's non-opioid approach could
provide a novel treatment option for a disease where there is a
tremendous unmet need," said Eric Elenko, PhD, PureTech's Chief
Innovation Officer and a Co-founder of Alivio Therapeutics. "The
Alivio platform technology is designed to address a range of
inflammatory conditions, and we are rapidly progressing its
potential application across pouchitis and inflammatory bowel
disease as part of our internal R&D."
The ALV-107 programme recently received a $3.3 million U.S.
Department of Defense (DoD) Technology/Therapeutic Development
Award. The funds are directed to support Alivio's preclinical
research and development activities, including GMP manufacturing,
to enable the filing of an investigational new drug (IND)
application.
Alivio's platform technology has demonstrated proof-of-concept
in ten different preclinical models of inflammation including a
validated preclinical model for the treatment of IC/BPS.
ALV-107relieved pain at all study time points post therapy (vs.
vehicle-only control: at 2 hr, p=0.002; 4 hr, p=0.002; 24 hr,
p=0.0003). In contrast, the conventional lidocaine-treated group
showed statistically significant pain relief only 2 hours
post-treatment (p=0.03). Safety and efficacy of ALV-107 will be
evaluated during a clinical development programme. There is no
guarantee that this investigational agent will successfully
complete clinical development or gain health authority
approval.
About Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Interstitial Cystitis or Bladder Pain Syndrome (IC/BPS) is a
chronic bladder condition that consists of discomfort or pain in
the bladder or surrounding pelvic region and is often associated
with frequent urination. It is estimated to affect up to 12 million
people in the U.S. and is more common in women than men. Current
treatments fail to control pain in many patients.
About Purdue Pharma
Purdue Pharma L.P. develops and provides prescription medicines
that meet the evolving needs of healthcare professionals, patients,
and caregivers. We were founded by physicians and we are currently
led by a physician. Beyond our efforts to provide quality
medications, Purdue is committed to supporting national, regional
and local collaborations to drive innovations in patient care.
Privately held, Purdue is pursuing a pipeline of new medications
and technologies through internal research & development and
strategic industry partnerships. For more information, please visit
www.purduepharma.com.
About Alivio Therapeutics
Alivio Therapeutics, an affiliate of PureTech Health (PRTC.L),
is pioneering targeted disease immunomodulation to treat a range of
chronic and acute inflammatory disorders. Targeted disease
immunomodulation involves acting exclusively at the site of
inflammation rather than systemically, to minimize impacts on the
wider immune system and healthy tissue. To achieve this, Alivio's
technology is engineered to bind selectively to inflamed tissue and
dynamically release incorporated therapeutics based on the degree
of inflammation. The therapeutics could potentially include a range
of drug classes including small molecules, biologics, and nucleic
acids. Alivio's pipeline includes candidates for interstitial
cystitis/bladder pain syndrome (IC/BPS), pouchitis, and
inflammatory bowel disease (IBD), and the platform technology has
been validated in multiple pre-clinical models, including models of
osteoarthritis.
The technology platform has been validated in ten different
preclinical models of inflammation at multiple labs and published
in peer-reviewed journals, including in Science Translational
Medicine and Nature Communications. The technology is the first of
its kind to demonstrate reproducible targeting of immunomodulatory
compounds to inflamed tissue. Alivio was cofounded by PureTech
Health, Jeffrey Karp, Ph.D., Professor of Medicine at Brigham and
Women's Hospital, and Robert Langer, Sc.D., Non-Executive Director
at PureTech Health and David H. Koch Institute Professor at
MIT.
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced biopharmaceutical
company developing novel medicines for dysfunctions of the
Brain-Immune-Gut (BIG) Axis. The Company has developed deep
insights into the connection between these systems and the
resulting role in diseases that have proven resistant to
established therapeutic approaches. By harnessing this emerging
field of human biology, PureTech Health is developing new
categories of medicines with the potential to have great impact on
people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies across two divisions: its Affiliates and its Internal
labs. PureTech's Affiliates include seven clinical-stage platforms
with two product candidates that have been filed with the US Food
and Drug Administration (FDA) for review and other novel
pre-clinical programmes. These Affiliates are developing
ground-breaking platforms and therapeutic candidates in
collaboration with some of the world's leading experts.
PureTech's Internal research and development is centred on
tissue-selective immunomodulation for the treatment of oncology,
autoimmune, and CNS-related disorders, with a near-term focus on
targeting newly-discovered, foundational immunosuppressive
mechanisms in oncology and novel approaches that harness the
lymphatic infrastructure.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
PureTech Health owns approximately 82.8% of Alivio on a diluted
basis(1) and approximately 80.0% on a fully-diluted basis.(2)
(1) This calculation of PureTech's holding includes issued and
outstanding shares as well as options and warrants to purchase
shares, but excludes unallocated shares authorised to be issued
pursuant to equity incentive plans.
(2) This calculation includes issued and outstanding shares,
outstanding options and warrants to purchase shares, and
unallocated shares authorised to be issued pursuant to equity
incentive plans.
PureTech Health:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
Purdue:
Robert Josephson
1-203-588-7114
Robert.josephson@pharma.com
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END
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