Formosa, fresh from Eyenovia deal, sells Brazilian rights to near-approval eye drug

Formosa, fresh from Eyenovia deal, sells Brazilian rights to near-approval eye drug

Formosa Pharmaceuticals has handed over another set of regional rights to its near-approval eye drug candidate APP13007, striking a deal that positions Cristália Produtos Químicos Farmacêuticos to bring the product to market in Brazil.

APP13007 is a nanosuspension of clobetasol propionate, a steroid that is already used to treat swelling and itching in patients with skin conditions such as eczema. Used on the eye, the molecule could counter the inflammation and pain that patients can experience after cataract surgery. Formosa used its APNT nanoparticle platform to get the molecule into a form that is suitable for administration to the eye.

Having generated phase 3 data on the candidate, and filed for approval in the U.S., Taiwan’s Formosa has sold the exclusive rights to commercialize the product in Brazil to Cristália, a local company that already has a portfolio of around 350 drugs.

“If approved, APP13007 will be an attractive new treatment option to ophthalmic surgeons and their patients in Latin America with a convenient posology. Once [it is] approved, Cristália will go full steam ahead with commercialization,” Ricardo Pacheco, chairman of Cristália, said in a statement.

The deal includes an upfront fee, development milestones and sales royalties but Formosa’s statement about the transaction lacks figures. Eyenovia’s deal for the U.S. market offers some clues to the possible value of the Brazilian rights. Five months ago, Eyenovia paid $2 million, split evenly between cash and stock, and agreed to up to $4 million in development milestones and $80 million in sales milestones.

Eyenovia is potentially weeks away from getting the green light to start trying to generate a return on its investment, with the FDA set to make a decision on the application for approval of APP13007 by March 4. The filing is built on data showing APP13007 reduced pain in the two weeks after cataract surgery.

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