On July 27, 2020 Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee"), reported that it has submitted to the U.S. Food and Drug Administration a 505(b)(2) New Drug Application for Camcevi 42mg (FP-001 LMIS 50mg), a ready-to-use 6-month depot formulation of leuprolide mesylate (Press release, Foresee Pharmaceuticals, JUL 27, 2020, View Source [SID1234562417]). The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer.

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This NDA submission is supported by a previously communicated successful Phase 3 study in 137 Advanced Prostate Carcinoma patients, where treatment with LMIS 50 mg injection every 6 months was demonstrated to be effective, safe and well tolerated.

"In the NDA submission in 2019, FDA suggested that additional device design verification data on the combination product be provided. Since then, with tireless efforts and commitment from the Foresee team and collaborators, as well as continued support of our investors, we have undertaken diligent preparation for the requested information," said Dr. Ben Chien, Founder and Chairman of Foresee. "We are confident in the resubmission of the NDA."

"Next step for the FP-001 franchise will be to establish a strong commercial partnership in the US and to prepare for the NDA submission of the 3-month depot of Camcevi. We look forward to the successful launch of the FP-001 franchise, providing patients with its differentiated ready-to-use profile." said Dr. Ben Chien.