IACTA Pharmaceuticals and Pharmaleads to Develop the World's First Epithelial Protective Drug Harnessing Endogenous Analgesia for the Topical Treatment of Acute and Chronic Ocular Pain

IACTA Pharmaceuticals, Inc. and Pharmaleads, with Pharmaleads Greater China, today announced they have entered into licensing agreements, with IACTA acquiring global rights to Pharmaleads' Dual Enkephalinase Inhibitors (DENKI®), a novel class of non-opioid compounds for the treatment of acute and chronic ocular pain.

"With this agreement, IACTA and Pharmaleads will collaborate to develop next-generation pain treatments to help the millions of people across the globe living with the debilitating effects of ocular pain," said Damon Burrows, CEO of IACTA. "We believe that the epithelial protective properties of DENKI observed in preclinical studies, combined with its pain-relieving properties will revolutionize eye care."

"Today's announcement further exemplifies IACTA's business momentum, as we continue to foster research and development initiatives to address unmet medical needs in the global eye care market," continued Damon Burrows.

Under the terms of these agreements, Pharmaleads and Pharmaleads Greater China have granted IACTA an exclusive, worldwide, royalty-bearing license to lead the clinical and commercial development of IC800 (acute) and IC805 (chronic) and other DENKI drugs from Pharmaleads' portfolio. Pharmaleads and Pharmaleads Greater China will together be eligible to receive up to $100M in total deal value including upfront, development, regulatory, and commercial milestone payments. Based on the ocular preclinical package already available and human systemic safety data, IACTA expects to start human proof of concept trials in ocular pain in 2021. IACTA's ophthalmic drug development expertise combined with Pharmaleads breakthrough discoveries will work to bring to market the world's first non-opioid, epithelial protective drug harnessing endogenous analgesia for the treatment of chronic (i.e., neuropathic pain and dry eye) and acute (e.g., post-surgical) ocular pain, which is estimated to affect more than 175 million people globally.

"We are thrilled to be partnering with IACTA, as we remain focused on advancing our pipeline of candidates targeting pain management, including a program for acute migraine headache. This partnership will give us the opportunity to accelerate the development of our drugs and to bring alternative non-addictive pain treatments to address the opiate crisis," said Tanja Ouimet, PhD, COO of Pharmaleads. "IACTA's expertise in the development of ocular drugs will reveal the full potential of DENKI-based treatments to protect and extend the life of enkephalins expressed locally on the eye surface and work to bring the first dedicated ocular pain treatments to the market and to many suffering patients who currently have no treatment for their pain besides NSAIDs or opiates."

"This partnership stands for a pivotal move towards our organization's overall strategic direction to foster opportunities for delivering transformative treatments which at the same time puts the human aspect of medicine in focus," said Tian Ye, CEO of Pharmaleads Greater China. "We believe that as a first-of-its-kind treatment in non-addictive pain management, this breakthrough alternative has unprecedented potential in addressing unmet medical needs in eye care."

"DENKI has the potential to transform the treatment of ocular pain, advance patient care, and become one of the most significant scientific innovations for the eye care industry." said Taryn Conway, former Associate Vice President of Marketing, for Allergan, Inc., and Strategic Advisor to IACTA Pharmaceuticals.

"Ocular pain management, whether as a disease or a symptom, has been hampered by the lack of local, non-epithelial-toxic analgesics," said Dr. Marjan Farid Director of the Cornea, Cataract, and Refractive Surgery and Vice Chair of Ophthalmic Faculty at the Gavin Herbert Eye Institute. "DENKIs could provide the first chronic pain management option for the millions of patients suffering from ocular pain and be a true game-changer in the field of ophthalmic therapeutics."

About DENKIs

DENKIs (Dual ENKephalinase inhibitors) aim to protect enkephalins from degradation, hence increasing their local concentrations and thereby inducing a physiological analgesia, which improves pain management.

About IACTA Pharmaceuticals, Inc.

IACTA is an ophthalmic focused pharmaceutical company led by former top executives from one of the leading eye care companies in the world, Allergan. The company currently has six products in development for major market opportunities. The Company's lead product, IC 265, is ready to enter a Phase 2 clinical study with data outcomes expected in 2022. For more information on IACTA Pharmaceuticals, Inc., visit www.iactapharma.com

In addition, this announcement comes on the heels of the recent agreement between IACTA Pharmaceuticals, Inc. and Zhaoke (Hong Kong, S.A.R., China) Ophthalmology Pharmaceutical Limited ("ZKO"), on the licensing of two of the Company's products, IC 265 for dry eye and IC 270 for allergic conjunctivitis.

About Pharmaleads

Headquartered in Paris, Pharmaleads, with its sister company Pharmaleads Greater China, is a clinical stage private biotech company creating and developing innovative non-opiate, non-addictive products for the management of acute and chronic moderate to severe pain, a growing market with significant unmet medical need. Pharmaleads' drugs are based on its deep knowledge and understanding of the metabolism of enkephalins, a key element of the body's natural pain management system. 

Pharmaleads has two products in clinical development, targeting multi-billion-dollar markets: chronic neuropathic pain (oral), post-surgical/breakthrough cancer pain as a substitute for injectable opiates (intravenous.), and acute migraine headache (oral). Pharmaleads is also collaborating with academic partners to explore the potential therapeutic actions of IC800 in opiate use and withdrawal disorders.