Cristália Produtos Químicos Farmacêuticos Ltda.

APP13007 is intended to treat inflammation and pain following ocular surgery. Credit: elenavolf / Shutterstock.com. Cristália Produtos Químicos Farmacéuticos has signed an agreement to license exclusive rights to market Taiwanese company Formosa Pharmaceuticals’ APP13007  (clobetasol propionate ophthalmic nanosuspension, 0.05%) in Brazil. APP13007 is intended to treat inflammation and pain following ocular surgery. The agreement covers the Brazilian market and includes upfront development milestones and sales-based royalty payments other than further deal-associated payments. APP13007 is under review by the US Food and Drug Administration with a decision on the approach under the Prescription Drug User Fee Act expected on 4 March 2024. The active ingredient in the drug is a superpotent corticosteroid known as clobetasol propionate. It is based on Formosa Pharma’s APNT nanoparticle formulation platform. The new formulation of APP13007 allows for a suitable dosing regimen of twice daily for 14 days. It has demonstrated quick and lasting inflammation and pain relief in Phase III clinical trials, showing statistical and clinical superiority versus placebo. APP13007 will enter the Brazilian market for topical ophthalmic steroids. Cristália chairman Ricardo Pacheco stated: “We are pleased to have entered into this agreement with our development partner, Formosa Pharmaceuticals. “If approved, APP13007 will be an attractive new treatment option to ophthalmic surgeons and their patients in Latin America with a convenient posology [determination of appropriate dosage]. Once it is approved, Cristália will go full steam ahead with commercialisation.” Formosa’s APNT technology enhances the dissolution and bioavailability of active pharmaceutical ingredients across a range of administration methods including topical, oral and inhalation. The platform ensures increased uniformity, purity and stability in formulations, enabling the use of poorly soluble or highly potent drug agents that may otherwise encounter significant challenges in delivery and penetration to target tissues. Formosa Pharmaceuticals president and CEO Erick Co stated: “We are honoured to establish this partnership with Cristália, with its storied history in Brazilian pharmaceuticals and expertise in eye health. “Given their dedication to bringing innovation to the market, we are confident APP13007 will reach its potential in providing ophthalmologists and patients a powerful option in recovering from ocular surgery.”

The deal includes an upfront fee, development milestones and sales royalties. 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.

TAIPEI, Jan. 26, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TWO) announced today that the company has entered into a licensing agreement with CRISTÁLIA PRODUTOS QUÍMICOS FARMACÊUTICOS LTDA ("Cristália"), for exclusive Brazilian rights to the commercialization of APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) for the treatment of inflammation and pain following ocular surgery. APP13007 is currently under review by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) date of March 4, 2024. The licensing deal includes upfront, development milestones, and sales royalties, 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, which in Phase 3 trials proved statistically and clinically superior to its matching placebo (p<0.001). If approved, APP13007 will join in a potential and growing market in Brazil for topical ophthalmic steroids. "We are honored to establish this partnership with Cristália, with its storied history in Brazilian pharmaceuticals and expertise in eye health. Given their dedication to bringing innovation to the market, we are confident APP13007 will reach its potential in providing ophthalmologists and patients a powerful option in recovering from ocular surgery," said Erick Co, President and CEO of Formosa Pharmaceuticals. Ricardo S. Pacheco, Chairman of Cristália stated: "We are pleased to have entered into this agreement with our development partner, Formosa Pharmaceuticals. If approved, APP13007 will be an attractive new treatment option to ophthalmic surgeons and their patients in Latin America with a convenient posology. Once is approved, Cristália will go full steam ahead with commercialization." About Formosa Pharmaceuticals, Inc. Formosa Pharmaceuticals, Inc. (6838.TWO) 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 delivery and penetration to target tissues. For more details about Formosa Pharma and APNT™, visit . About Cristália Established 51 years ago, Cristália Laboratory is a 100% Brazilian Pharmaceutical, Pharmochemical, Biotechnological, Research/Development/Innovation-based Industrial Complex. It is a pioneer in thoroughly executing a drug production chain, from its molecule design to the finished product. The company holds 127 patents – a national record – and is a market leader in anesthesia in Latin America. Occupying a forefront position when it comes to innovation, Cristália produces 53% of the raw materials of its drugs at its Pharmacochemical plant. The company is present in over 95% of Brazilian hospitals, being an international reference in active substances and finished products exportation to over 30 countries. For the last 20 years, the company has been investing in biotechnology, owning some of Brazil's first private Biotech plants. Cristália Group has about 5,000 colleagues. | . SOURCE Formosa Pharmaceuticals Inc.