Formosa Pharmaceuticals has announced another milestone in its international collaboration efforts. On the 5th, the company revealed that it has granted Apotex, a Canadian company, the exclusive commercial rights for the Canadian market for its patented new drug APP13007 (Clobetasol Propionate Ophthalmic Suspension 0.05%), which is used to treat inflammation and pain following ocular surgery.
The licensing agreement includes an upfront signing fee, development milestone payments, royalties, and sales milestone payments, among other compensations during the contract period.
APP13007, which contains the ultra-potent steroid Clobetasol Propionate, was approved by the U.S. FDA for market release on March 4th of this year. It utilizes Formosa Pharmaceuticals' proprietary APNT nanoparticle formulation platform to create a novel drug form. This innovative formulation provides rapid and sustained relief from inflammation and pain with a simple and convenient dosing regimen (twice daily for 14 days). In Phase III clinical trials, APP13007 demonstrated statistically significant superiority over placebo (p<0.001).
According to Apotex's market analysis, there are approximately 500,000 ophthalmic surgeries in Canada each year. The market for single and combination steroid eye drops is valued at around $36 million USD and is growing at a rate of 5% annually.
Dr. Erick Co, General Manager and CEO of Formosa Pharmaceuticals, stated: "We are honored to partner with the long-established and reputable Apotex. Their initiative to introduce a series of new ophthalmic drugs into the Canadian market gives us great confidence in the future success of APP13007 in Canada. We look forward to working with the Apotex team to provide this differentiated new treatment to Canadian physicians and patients."
Allan Oberman, President and CEO of Apotex, commented: "We are delighted to offer Canadian patients APP13007 as a new option for treating post-operative ocular inflammation and pain. Including this ophthalmic product, we continue to expand our portfolio of new drugs, leveraging our commercialization capabilities to support more patients on their path to health."
Resource (mandarin): 台新藥眼部術後新藥APP13007加拿大市場授權Apotex公司
