Foresee Pharmaceuticals Announces Submission of NDA for FDA Approval of LMIS 50mg
TAIPEI, Taiwan, July 27, 2020 /PRNewswire/ -- Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee"), announced today 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. The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer.
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.
About Foresee Pharmaceuticals Co., Ltd.
Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange. Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, secondly its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high unmet needs.
Foresee's product portfolio includes late stage and early stage programs such as FP-001, 6-month and 3-month, stable, ready-to-use versions of leuprolide mesylate for injection, for which regulatory submissions are planned since 2020; FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in a Phase 2 proof-of-concept study, and target to initiate Phase 2 study for COVID-19 virus induced acute respiratory distress syndrome (ARDS); FP-045, a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia, a mitochondrial-mediated disease; and FP-004, a novel, subcutaneously injectable product in development for the treatment of opioid use disorder and pain.
SOURCE Foresee Pharmaceuticals Co., Ltd.
Company Codes: Gretai:6576