IACTA Pharmaceuticals Enters Exclusive Licensing Agreement with Zhaoke Ophthalmology to Accelerate Development of IC-265 for Dry Eye Disease and IC-270 for Allergic Conjunctivitis

IRVINE, Calif. and HONG KONG, July 28, 2020 /PRNewswire/ -- IACTA Pharmaceuticals, Inc. (“ IACTA”or“the Company”) with Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, a leading Hong Kong-based pharmaceutical company) today announced that it has entered into a definitive licensing agreement for two of the Company’s products: IC 265 for dry eye disease and IC 270 for allergic conjunctivitis. The exclusive license covers ophthalmic indications in China and other Southeast Asian countries. This agreement will accelerate the development of IC 265 and IC 270 in both China and the United States.

IACTA CEO Damon Burrows stated:“We are pleased to partner with Zhaoke, a subsidiary of Lee’s Pharmaceutical Holdings Limited, to jointly develop and commercialize IC 265 and IC 270. This agreement has the potential to bring next-generation therapies to millions of people in China and other regions. Zhaoke is equippedAdvancedmanufacturing facilities, and has received strong support from leading venture capitalists and investors, making it the ideal partner for this global initiative.”

IC 265 was developed for the treatment of dry eye disease. Driven by various factors, including the lack of approved therapies for this condition, an aging population, and prolonged screen time, dry eye disease has become an increasingly serious public health issue in China. In the United States, it is estimated that 80% of patients with moderate-to-severe dry eye disease are not using prescription medications. Globally, an estimated 345 million people are affected by dry eye disease.

IACTA’s IC 265 is a highly potent and selective Syk kinase inhibitor that exerts broad anti-inflammatory effects. In Phase II clinical trials, IC 265 was more effective than the vehicle control group in reducing inflammation and erythema. IC 265 also demonstrated good tolerability in this study.

IC 270 is a combination formulation developed for allergic conjunctivitis. In the Phase II conjunctival allergen challenge study, IACTA’s IC 265 demonstrated statistically significant reductions in redness and inflammation compared with the vehicle group. By incorporating a leading antihistamine that controls itching,“First-in-Class”Ophthalmic anti-allergy medications not only have the potential to alleviate itching but also to address redness and inflammation associated with allergic conjunctivitis. An estimated 40% of users in the United States are dissatisfied with current therapies. The global market for ocular allergy treatments represents a multi-billion-dollar business opportunity, with strong growth projected in the coming years.

IACTA Chief Operating Officer Steve Johnson stated:“IC 265 and IC 270 Bring Benefits for Dry Eye Disease and Allergic Conjunctivitis, RespectivelyOptimizationTherapeutic Potential. Zhaoke Ophthalmology provides its partners with extensive commercialization and regulatory expertise in Asia. This collaboration combines the global clinical and regulatory strengths of our contract research organization partner, Ora Inc., with IACTA Pharmaceuticals’ drug development expertise to create a highly robust global R&D platform. This platform will not only facilitate the development of IC 265 and IC 270 but can also be applied to the development of other therapies in the future.”

Dr. Orest Olejnik, Chief Technology Officer of IACTA, stated:“We are pleased to have a drug development partner committed to bringing advanced ophthalmic assets to the Asian region.”He added:“We Believe in the World of Zhaoke OphthalmologyLeadingCombined with IACTA’s decades of experience in ophthalmic drug development, the formulation laboratory will establish an ideal partnership in the field of ophthalmology.”

This agreement enables IACTA Pharmaceuticals to engage in an unprecedented drug development collaboration with Zhaoke Ophthalmology Limited, including the sharing of existing and future data and regulatory documents, access to existing or upcoming drug raw materials, and acceleration of activities in, but not limited to, ChinaMainland China, Hong Kong, Macau, Singapore, Thailand, and Vietnam. Through this partnership, IACTA can leverage global data to accelerate its regulatory approvals in the U.S. market, while Zhaoke Ophthalmology can introduce compounds developed by IACTA into China (one of the fastest-growing markets globally) and Southeast Asia.

Under the agreement, the Company will receive an upfront, non-dilutive license fee and certain cost-sharing subsidies for development expenses. Additional payments may be received upon the achievement of specified development milestones, as well as additional milestone payments upon the achievement of specified commercial milestones. The agreement also includes provisions for the payment of potential tiered royalties.

Dr. Gerald DeVries (IACTA consultant and former Vice President of Pharmacology and Project Lead at Allergan, Inc.) stated:“IACTA is dedicated to developing therapies with significant activity in modulating innate and adaptive immune responses. This positions IACTA to deliver important clinical treatments for ocular allergies, dry eye disease, and a broad range of ophthalmic indications.”

Benjamin Li, Chairman of Zhaoke Ophthalmology, stated:“By leveraging IACTA compounds, we are well-positioned to accelerate the development and regulatory approval of IC 265 and IC 270 in China and other Southeast Asian markets. The efficacy of IC 265 and IC 270 is supported by robust clinical data, aligning seamlessly with our strong product development strategy.”

Forward-Looking Statements

Any statements in this press release that are not historical facts are forward-looking statements made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from historical results or from any future results expressed or implied by such forward-looking statements. There can be no assurance that any current or future animal studies or clinical trials sponsored by the Company or its authorized licensees will commence on schedule, be completed within the anticipated timeframe, or result in products with future value or regulatory approval. Likewise, there can be no assurance that the Company or any of its authorized licensees will file for regulatory approval in the United States or abroad in the future, nor can there be any assurance that, if the Company or any of its authorized licensees does apply for regulatory approval, such applications will be accepted by the U.S. Food and Drug Administration (FDA) or any similar regulatory authorities in other countries. Any forward-looking statements in this press release represent the Company’s views only as of the date of this press release and should not be construed as representing its views as of any subsequent date. The Company expressly disclaims any obligation to update these statements due to future events or other reasons, except as required by applicable law.