July 28, 2020
IRVINE, Calif. and HONG KONG -- IACTA Pharmaceuticals, Inc. ("IACTA" or the "Company") and Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited ("ZKO"), a leading Hong Kong-based pharmaceutical company, today announces they have entered into a definitive license agreement on the licensing of two of the Company's products, IC 265 for dry eye and IC 270 for allergic conjunctivitis. The exclusive license is for ophthalmic indications in China and other countries of Southeast Asia. The agreement will accelerate the development of IC 265 and IC 270 in both China and the U.S.
"We are excited to partner with the subsidiary of Lee's Pharmaceutical Holdings Limited, ZKO, to develop and commercialize IC 265 and IC 270. This agreement creates the potential to bring next-generation therapeutics to millions of people in China and beyond. With a state-of-the-art manufacturing facility and backing from major, well-known VCs and investors, ZKO is the perfect partner for this global initiative," said Damon Burrows, CEO of IACTA.
IC 265 is being developed for dry eye. Dry eye is a large and growing problem in China due to several factors including a lack of approved drugs for the condition, an aging population, and prolonged screen viewing. In the United States, an estimated 80% of patients with moderate to severe dry eye are not on a prescription medication. It is estimated 345 million people suffer from dry eye globally.
IACTA's IC 265 is a very potent and selective Syk tyrosine kinase inhibitor with the potential to act as a broad-spectrum anti-inflammatory agent. In a Phase 2 trial, IC 265 was more efficacious in reducing inflammation and redness than vehicle. IC 265 was also very well tolerated in the study.
IC 270 is a combination product being developed for allergic conjunctivitis. In a phase 2 study conducted by Ora, Inc., which utilized the Ora-CAC® Conjunctival Allergen Challenge Model, IACTA's IC 265 demonstrated a statistically significant reduction in redness and inflammation versus vehicle. By adding a leading antihistamine that can control itching, there is the potential for a 'first-in-class' ophthalmic allergic medicine to address not only itching but also redness and inflammation associated with allergic conjunctivitis. It is estimated that 40% of U.S. users are unsatisfied with current therapies. The global eye allergy treatment market is a multi-billion-dollar opportunity expected to have strong growth over the next several years.
"IC 265 and IC 270 offer the potential for unique and improved therapies for dry eye and allergic conjunctivitis, respectively. ZKO brings strong Asian commercialization and regulatory experience to the partnership. This partnership combined with the global clinical and regulatory strength of our CRO partner, Ora Inc., and IACTA's drug development expertise creates an extremely strong global R&D platform for developing not only IC 265 and IC 270 but also additional therapies in the future," said Steve Johnson, COO of IACTA.
"We are excited to have a drug development partner committed to bringing cutting edge ophthalmology assets to the Asian region," said Orest Olejnik PhD, CSO of IACTA, who also added, "We believe the combination of ZKO's world-class formulation laboratories and IACTA's decade's long ocular drug development experience will result in an ideal partnership for the field of ophthalmology."
The agreement enables unprecedented drug development cooperation between IACTA and ZKO, including the sharing of existing and future data and regulatory documents, access to existing or soon-to-be-produced drug materials, and expedited regulatory and development plans in territories including but not limited to China, Hong Kong, Macau, Singapore, Thailand, and Vietnam. This partnership will allow IACTA to draw upon a global data set to accelerate its regulatory approvals in the U.S. market while ZKO brings IACTA-developed compounds to one of the world's fastest-growing markets in China and Southeast Asia.
Under the agreement, the Company shall receive non-dilutive, upfront license fees, and reimbursement for certain development costs. There is potential for additional payments upon achievement of certain development milestones as well as additional milestone payments for achievement of certain commercial milestones. The agreement also includes the payment of potential tiered royalties.
"IACTA is focused on developing therapeutics with significant activity regulating both innate and adaptive immune responses. This uniquely positions IACTA to offer clinically important treatments for ocular allergy, dry eye disease, and a broad range of ophthalmic indications," said Gerald DeVries PhD, consultant to IACTA and former Vice President of Pharmacology and Program Team Leader for Allergan, Inc.
"With access to the IACTA compounds, we are now well-positioned to accelerate the development of IC 265 and IC 270 for approval in China and other markets in Southeast Asia. The efficacy of IC 265 and IC 270 is supported by significant clinical data and it is a natural fit for our robust product development strategy," said Dr. Benjamin Li, Chairman of ZKO.
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 mid-2021. For more information on IACTA Pharmaceuticals, Inc., visit www.iactapharma.com.
About Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited
ZKO is a wholly owned subsidiary of China Ophthalmology Focus Limited, which is an indirect non-wholly owned subsidiary of Lee's Pharmaceutical Holdings Limited. In addition to its in house R&D projects, ZKO also focuses on licensing potential ophthalmology products from the rest of the world and introduce them as accessible and affordable therapies to patients suffering from ophthalmic diseases in China. It has built up a state-of-the-art development and production facility to support the development and future commercialization of its over 23 proprietary products and difficult to manufacture generics.
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or 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 licensees, will start on time, be completed within a projection timeframe, or result in future value or approved products. There can also be no assurance that the Company or any of its licensees will apply for regulatory approvals in the U.S. or abroad in the future or that if the Company or any of its licensee applies for regulatory approval, that it will be accepted by the FDA or any similar regulatory agency in another country. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information as a result of future events or otherwise, except as required by applicable law.