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Purdue Pharma L.P. and Alivio Therapeutics Enter into Partnership to Advance ALV-107, a Non-Opioid Interstitial Cystitis/Bladder Pain Syndrome Treatment

January 28, 2019

STAMFORD, Conn. & BOSTON--(BUSINESS WIRE)--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 utilizing 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 program 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=0.030. Safety and efficacy of ALV-107 will be evaluated during a clinical development program. 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 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 and . 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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190127005040/en/

CONTACT: Alivio

Investors

Allison Mead Talbot

+1 617 651 3156

amt@puretechhealth.com

U.S. media

Tom Donovan

+1 857 559 3397

tom@tenbridgecommunications.com

Purdue:

Robert Josephson

1-203-588-7114

Robert.josephson@pharma.com

KEYWORD: UNITED STATES NORTH AMERICA CONNECTICUT MASSACHUSETTS

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY PHARMACEUTICAL

SOURCE: Alivio Therapeutics

Copyright Business Wire 2019.

PUB: 01/28/2019 02:00 AM/DISC: 01/28/2019 02:01 AM

http://www.businesswire.com/news/home/20190127005040/en

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