Formosa Pharmaceuticals Partners with Cipla to Launch APP13007 in 11 Countries
In a move set to bolster global ophthalmic care, Formosa Pharmaceuticals has entered into a licensing agreement with Cipla Limited, providing the latter exclusive rights to commercialize APP13007 in 11 countries, including India, South Africa, and Colombia. APP13007 is a clobetasol propionate ophthalmic suspension (0.05%) designed to treat post-operative inflammation and pain.
Approved by the U.S. Food and Drug Administration (FDA) in March 2024, APP13007 offers a patient-friendly, twice-daily dosing regimen for 14 days without the need for tapering. Its rapid onset and sustained efficacy make it a valuable option for managing ocular inflammation following surgery.
Key Markets and Regional Expansion
Under the terms of the agreement, Cipla gains exclusive commercialization rights in the following regions:
• South Asia: India, Nepal, Sri Lanka, Bangladesh
• Southeast Asia: Malaysia, Myanmar
• Africa: Kenya, Nigeria, South Africa
• Latin America: Argentina, Colombia
This marks Cipla's first multi-regional licensing deal in ophthalmology and enhances its presence in specialized therapeutic areas.
Ongoing Global Licensing for APP13007
Formosa has adopted a region-specific licensing strategy for APP13007:
• United States: Rights acquired by Eyenovia in August 2023
• Brazil: Cristália Produtos Químicos Farmacêuticos LTDA secured rights in January 2024
• Canada: Apotex Inc. acquired exclusive commercialization rights in August 2024
These partnerships reflect a broader strategy to expand the availability of APP13007 worldwide through regional market leaders.
Leadership Commentary on the Agreement
Erick Co, President and CEO of Formosa Pharmaceuticals, emphasized the significance of the partnership:
“Formosa Pharma welcomes this partnership with Cipla, a well-renowned and respected global pharmaceutical brand. We appreciate their recognition and desire to add APP13007 to their rich portfolio of innovative medicines and look forward to working together to provide our novel therapy to ocular surgery patients to their audience.”
Achin Gupta, Cipla’s Global Chief Operating Officer, highlighted the agreement’s strategic impact:
“The partnership with Formosa Pharmaceuticals marks a significant milestone for Cipla, as it is our first multi-regional licensing agreement in ophthalmology. It reinforces our commitment to bringing cutting-edge treatments to patients worldwide.”
Deal Structure and Forward Outlook
The agreement includes upfront payments, milestone-based royalties, and other value-based components. It underscores the growing trend of regional collaborations in ophthalmology aimed at delivering advanced therapies to broader populations.
