Formosa Pharmaceuticals enters into licensing agreement with Cipla for commercialization of APP13007 across 11 countries

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Formosa Pharmaceuticals and Cipla Limited have entered into an exclusive licensing agreement for the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007) for post-operative inflammation and pain following ocular surgery.

Under the terms of the agreement, Cipla has exclusive rights to market APP13007 across 11 countries: India, Nepal, Sri Lanka, Bangladesh, Malaysia, Myanmar, Kenya, Nigeria, South Africa, Argentina, and Colombia.¹

APP13007 was approved by the US Food and Drug Administration (FDA) in March 2024. It offers a twice-daily dosing regimen for 14 days without tapering, providing rapid and sustained relief from inflammation and pain.¹ The rights to APP13007 have been split depending on the country, with numerous deals being made, and the deal with Cipla adds to the list.

Eyenovia acquired US commercial rights to the drug in August 2023 from Formosa. Cristália Products Químicos Farmacêuticos LTDA acquired exclusive Brazilian rights from Formosa in January 2024. In Canada, Apotex Inc. acquired exclusive rights in August 2024.

Erick Co, president and CEO of Formosa Pharmaceuticals, and Achin Gupta, global chief operating officer of Cipla, both commented on the recent partnership in a press release.

"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," said Co.

"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. With exclusive rights to market APP13007 across 11 countries, we are excited to expand access to this innovative therapy and strengthen our ophthalmology portfolio,” said Gupta.

The strategic licensing agreement between Cipla and Formosa Pharmaceuticals includes upfront payments, royalty milestones, and additional value-driven considerations throughout its term.

References:

1. Cipla and Formosa sign multi-regional licensing deal for Clobetasol Suspension. PRnewswire. Published March 18, 2025. Accessed March 20, 2025. https://www.prnewswire.com/news-releases/cipla-and-formosa-sign-multi-regional-licensing-deal-for-clobetasol-suspension-302403405.html