Formosa Pharmaceuticals Announces Licensing Agreement with Apotex Inc., for Commercialization of Clobetasol Propionate Ophthalmic Suspension for Ocular Surgery Relief and Recovery | The Manila Times

TAIPEI, Aug. 5, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TWO) announced today that the company has entered into an exclusive licensing agreement with Apotex Inc. ("Apotex"), for exclusive rights in Canada to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and pain following ocular surgery. Clobetasol propionate ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration (FDA) on March 4, 2024. The licensing deal will include certain payments, including an upfront payment and milestone payments upon achievement of certain regulatory and sales milestones. APP13007's active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT^® nanoparticle formulation platform. The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain, which in Phase 3 trials proved statistically and clinically superior to its matching placebo (p<0.001). APP13007 will enter a ~$C50M market for topical ophthalmic steroids and steroid combinations, growing at around 5% annually, driven by an estimated ~500,000 ocular surgeries annually in Canada.

"Formosa Pharma is honored to partner with Apotex, with its storied history and reputation for success," said Erick Co, President and CEO of Formosa Pharmaceuticals. "Their commitment to branded ophthalmology products gives us full confidence that APP13007 will flourish in the Canadian market. We look forward to working with the Apotex team in providing this differentiated therapy to Canadian physicians and patients."

"We are pleased to provide Canadian patients with APP13007, a new treatment option for post-operative inflammation and pain following ocular surgery," said Allan Oberman, President & CEO, Apotex. "Expanding our portfolio of innovative medicines, including our ophthalmic portfolio, along with our commercial infrastructure, enables us to support more patients along their journey to health."

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TWO) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company's proprietary nanoparticle formulation technology (APNT^®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in delivery and penetration to target tissues. For more details about Formosa Pharma and APNT^®, visit www.formosapharma.com.

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for consumers worldwide, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceutical products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at www.apotex.com.