IACTA Pharmaceuticals and Zhaoke Ophthalmology Pharmaceutical (ZKO), a Hong Kong-based pharmaceutical company, announced 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.
Financial terms of the deal were not disclosed.
“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,” Damon Burrows, CEO of IACTA, said in a company news release.
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 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 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.