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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

Tuesday, January 29, 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.

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