Foresee Announces Successful Completion of Scientific Advice Discussions with German Federal Institute for Drugs and Medical Devices (BfArM) for FP-001 LMIS 50 mg
TAIPEI, Taiwan, Feb. 6, 2017 /PRNewswire/ -- Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee") today announced that it has successfully concluded its scientific advice discussions with German BfArM on key regulatory and development issues relating to a Marketing Authorization Application (MAA) submission of FP-001, Leuprolide Mesylate Injectable Suspension (LMIS) 50 mg, a 6-month depot of leuprolide mesylate for subcutaneous injection. Foresee has very recently completed a global registration study with FP-001 LMIS 50 mg and plans to seek regulatory approvals in the US and several major EU countries.
Foresee reached general agreement with the BfArM on all of the key development and regulatory issues relating to data requirements including clinical, preclinical and CMC for a MAA submission in Germany and other major EU markets. Foresee plans to register LMIS 50 mg through the decentralized procedure in Europe.
"We are very pleased with the positive outcome of our discussions with the BfArM on the regulatory and development strategy for FP-001, LMIS 50 mg," commented Ben Chien, Ph.D., Chairman and CEO of Foresee. "With the general agreement we reached with BfArM, we are confident about our plan to file MAA in 2018."
Following the positive outcome of its discussions with German BfArM, Foresee has now successfully achieved an important milestone towards its ultimate goal of bringing FP-001 to patients in key global markets.
About Foresee Pharmaceuticals
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 platform and derived drug products targeting large specialty markets, and its transformative early stage preclinical and clinical NCE programs targeting inflammatory & fibrotic diseases and other disease areas with high unmet needs. Foresee has a balanced clinical development-stage product portfolio including late stage and early stage programs such as FP-001 which has recently successfully completed a global Phase III Registration Study and FP-025 a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases and is currently completing a Phase 1 study.
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SOURCE Foresee Pharmaceuticals Co., Ltd.