TAIPEI, Nov. 28, 2024 /PRNewswire/ — Taiwan-based Formosa Pharmaceuticals (“Formosa”, 6838.TW) announced that the company has entered into an exclusive licensing agreement with Medvisis Switzerland AG (“Medvisis”) in Switzerland and Liechtenstein, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative treatment of post-operative inflammation and pain following ocular surgery. Medvisis, led by industry veterans with experience in multi-national pharma such as Novartis and GSK, holds close ties with Swissmedic, Switzerland’s independent registration authority. Clobetasol propionate ophthalmic suspension, 0.05% (APP13007), approved by the U.S. Food and Drug Administration (FDA) in March, 2024, was recently launched in the United States in September, 2024. The licensing agreement includes upfront payment and sales milestones, with additional considerations throughout the term of the agreement.
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. In a recent US survey of 100 ophthalmic surgeons, rapid resolution of pain (~80% pain-free four days post-surgery) and low incidence of adverse events (<2%) were highlighted as key drivers to prescribing APP13007. In a Medvisis-led KOL survey, ophthalmologists collectively appreciated APP13007’s convenient posology and remarkable safety profile. APP13007 anticipates having significant potential in Switzerland, which reports greater than 100,000 cataract surgeries, annually. These surgical rates have driven a single-agent corticosteroid market of greater than USD $2.1 million, utilizing treatments with a less convenient dosing regimen (4 to 6 times daily).
“We are pleased to partner with Medvisis, marking our second foothold in Europe. Medvisis’ strong connections with their national regulatory agency and rich KOL network give us great confidence that the Swiss public will benefit from this novel and effective treatment for ocular surgery recovery.” said Erick Co, President and CEO of Formosa Pharmaceuticals.
Manuel Ackermann, CEO of Medvisis Switzerland, stated, ” We are pleased to provide patients with post-operative inflammation and pain following ocular surgery a new, best-in-class treatment option that leads to faster symptom relief. APP13007 is of great value to Swiss patients while it sets the foundation for Medvisis to build a strong portfolio of innovative ophthalmology solutions.”
About Formosa Pharmaceuticals, Inc.
Formosa Pharmaceuticals, Inc. (6838.TW) 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 safety, delivery, and penetration to target tissues. For more details about Formosa Pharma and APNT®, visit www.formosapharma.com.
About Medvisis Switzerland AG
Medvisis Switzerland AG is the partner of choice for innovative specialty, rare disease, and hospital products in Switzerland with expertise in product registration, reimbursement and market access, and rapid commercialization uptake. The company targets the in-licensing of pharmaceutical products for which there is high medical need along with strong endorsement from key opinion leaders. To know more about Medvisis, visit www.medvisis.com.
SOURCE Formosa Pharmaceuticals Inc.,
