Formosa Pharmaceuticals announced on the 28th that it has signed an exclusive licensing agreement with Adalvo Limited, granting the latter exclusive commercialization rights in the European and Brazilian markets for its novel post-operative ophthalmic anti-inflammatory and analgesic drug, APP13007 (0.05% clobetasol propionate ophthalmic nanosuspension).
Formosa Pharmaceuticals stated that Adalvo is a global B2B pharmaceutical company and ranks among the top three in Europe. Founded in 2018, Adalvo specializes in market development through agile and innovative commercial strategies. Since its inception, Adalvo has facilitated the launch of nearly 1,100 pharmaceutical products and collaborated with over 170 commercial partners, thereby offering treatments across more than 130 countries, covering a wide range of indications and technologies. The licensing agreement includes an upfront payment, sales-based milestone payments, and a profit-sharing structure, along with other commercial terms throughout the agreement period.
The active ingredient in APP13007 is clobetasol propionate, a superpotent corticosteroid formulated using Formosa’s proprietary APNT nanoparticle delivery platform. This innovative formulation was approved by the U.S. FDA in 2024 and is administered twice daily for 14 consecutive days. The convenient dosing regimen enables rapid and sustained relief of inflammation and pain.
A survey conducted among 100 U.S. ophthalmologists found that by the fourth day post-surgery, approximately 80% of patients experienced pain relief, and the adverse event rate was below 2%. These findings are seen as key factors driving physician adoption of APP13007.
According to Adalvo’s analysis, the European ophthalmic surgery market is projected to reach USD 16 billion in 2024, with Germany and the UK being the largest markets. It is expected to grow to USD 38 billion by 2032. Cataract surgery is one of the most commonly performed procedures in EU hospitals, fueling demand for post-operative ophthalmic treatments.
In the Brazilian market, Formosa previously partnered with Cristalia. However, due to major management changes at Cristalia last year that led to a reorganization of its R&D and regulatory activities, Formosa and Cristalia mutually agreed to terminate the licensing agreement in May of this year. Going forward, Adalvo, which also has a strong presence in Brazil, will handle the regulatory filing and commercialization of APP13007 in that market.
Erick Co, CEO of Formosa Pharmaceuticals, stated, “We are pleased to establish this partnership with Adalvo and complete our licensing strategy for the European market. Adalvo’s strong influence and reputation in Europe are highly recognized, and we are grateful for their confidence in APP13007, which will be a valuable addition to their innovative and impactful product portfolio.”
Anil Okay, CEO of Adalvo, said, “This partnership highlights Adalvo’s continued commitment to expanding access to novel and differentiated treatment options in key therapeutic areas. We are excited to work with Formosa Pharmaceuticals to bring this important ophthalmic product to new markets.”
Resource: 台新藥與Adalvo Limited簽署歐洲、及巴西市場授權協議
