Formosa Pharma Licenses Clobetasol Ophthalmic Suspension to Apotex for Ocular Surgery Recovery

Formosa Pharmaceuticals, a biotech company based in Taiwan, has announced an exclusive licensing agreement with Apotex Inc. for the commercialization rights of clobetasol propionate ophthalmic suspension, 0.05% (APP13007) in Canada. This innovative medication, used for treating inflammation and pain after ocular surgery, was recently approved by the U.S. FDA on March 4, 2024.

The licensing arrangement involves an upfront payment to Formosa Pharmaceuticals, along with additional milestone payments contingent on achieving specific regulatory and sales benchmarks. The active ingredient, clobetasol propionate, is a highly potent corticosteroid formulated using Formosa Pharma's unique APNT® nanoparticle technology. This advanced formulation allows for an easy dosing schedule of twice daily for 14 days, offering rapid and lasting relief from inflammation and pain. Phase 3 clinical trials demonstrated that APP13007 significantly outperformed its placebo counterpart both statistically and clinically (p<0.001).

This product is set to enter the Canadian market for topical ophthalmic steroids and their combinations, valued at approximately C$50 million and expanding at an annual rate of about 5%. This market growth is driven by an estimated 500,000 ocular surgeries performed in Canada each year.

Erick Co, President and CEO of Formosa Pharmaceuticals, expressed enthusiasm about the partnership with Apotex, citing their reputable history and dedication to ophthalmology products. Co believes that Apotex's commitment will ensure the success and wide adoption of APP13007 in Canada. Allan Oberman, President and CEO of Apotex, echoed this sentiment, emphasizing the importance of expanding their portfolio with innovative treatments like APP13007 to better support Canadian patients in their post-operative recovery.

Formosa Pharmaceuticals, Inc. is a clinical-stage biotechnology company that specializes in ophthalmology and oncology. Their proprietary nanoparticle technology, APNT®, enhances the dissolution and bioavailability of active pharmaceutical ingredients (APIs) for various forms of administration, including topical, oral, and inhaler. This technology enables the development of formulations with high uniformity, purity, and stability, making it possible to utilize poorly soluble or highly potent drugs that face significant delivery challenges.

Apotex Inc., a global health company headquartered in Toronto, is dedicated to improving access to affordable and innovative medicines. With a wide-ranging portfolio that includes generic, biosimilar, and branded pharmaceutical products, Apotex operates regional offices in the United States, Mexico, and India. The company is the largest Canadian-based pharmaceutical firm and a preferred health partner for pharmaceutical licensing and product acquisitions across the Americas.

In summary, the exclusive licensing deal between Formosa Pharmaceuticals and Apotex Inc. marks a significant step in bringing APP13007, a potent treatment for post-operative ocular inflammation and pain, to the Canadian market. This collaboration leverages both companies' strengths to provide an innovative solution that is expected to benefit numerous Canadian patients undergoing ocular surgery.