Foresee Pharmaceuticals and Accord Healthcare Announce MAA Submission for Camcevi(R) 42mg
Pubblicato il: 27/03/2020 12:54
TAIPEI, March 27, 2020 /PRNewswire/ -- Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee") and Accord Healthcare announced today that a Marketing Authorization Application (MAA) for Camcevi® 42mg (FP-001 LMIS 50mg), a ready-to-use 6-month depot formulation of leuprolide mesylate, has been submitted to the European Medicines Agencies (EMA). The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer.
This MAA 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.
"The submission of this MAA represents another exciting milestone towards Foresee's goal to generate revenue, create sustainable growth, and continue to reinvest smartly into our R&D pipeline," said Dr. Ben Chien, Founder and Chairman of Foresee. "With the commitment and tireless work from our team and close collaborators, we are extremely proud to achieve this step towards bringing Camcevi® 42mg to the patients with its differentiated ready-to-use profile."
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 and derived drug products targeting specialty markets, and 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 depot for injection, for which regulatory submissions are planned in 2020; FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in a Phase 2 proof-of-concept study; FP-045, a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently in planning (Fanconi Anemia; mitochondrial-mediated diseases); and FP-004, a novel, subcutaneously injectable depot product in development for the treatment of opioid use disorder and pain.