Taipei, Taiwan, May 31th, 2022 – Foresee Pharmaceuticals (6576.TWO), (“Foresee”) announced today that the European Commission (EC) has approved the Marketing Authorization Application (MAA) for CAMCEVI® 42 mg prolonged-release suspension for injection, for the treatment of hormone-dependent advanced prostate cancer and for the treatment of high-risk localized prostate cancer and locally advanced hormone-dependent prostate cancer in combination with radiotherapy. The approval is applicable to all 27 European Union (EU) Member States, Iceland, Norway and Liechtenstein.
“We are very pleased CAMCEVI 42 mg has been approved in the EU. This European Commission approval represents another exciting step toward our mission in improving the standard of care and the lives of patients,” said Dr. Ben Chien, Founder, Chairman and CEO of Foresee. “It also demonstrates the success of Foresee’s pioneering Stabilized Injectable Formulation (SIF) technology. We truly want to thank the tireless work from the team, our remarkable licensing partner Accord, and the long-term support from all stakeholders as well.”
CAMCEVI® is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. The approval of CAMCEVI® 42 mg follows the positive opinion granted in March by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), based on data from a successful Phase 3 study in 137 Advanced Prostate Carcinoma patients, where treatment with CAMCEVI® 42 mg injection every 6 months was demonstrated to be effective, safe and well tolerated. The primary efficacy end point was the percentage of subjects with suppression of serum testosterone (≤50 ng/dl) by day 28 and from day 28 to day 336 in the intent-to-treat (ITT) population. The primary efficacy endpoint was successfully achieved in 97% of subjects, with mean testosterone concentration suppressed below castrate levels to 17.6 ng/dL on day 28. The most common (≥10%) adverse reactions were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.
CAMCEVI® 42 mg received U.S. Food and Drug Administration (FDA) approval and Health Canada marketing approval, for the treatment of adult patients with advanced prostate cancer in May 2021 and November 2021, respectively. CAMCEVI® 42 mg injection is exclusively licensed to Accord Healthcare in the E.U. for commercialization.
About Foresee Pharmaceuticals Co. Ltd.
Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (6576.TWO). 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, and secondly its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs.
Foresee's product portfolio includes late stage and early stage programs. CAMCEVI® 42 mg is now approved in the U.S., Canada and EU, and launched in the U.S.. Additionally, U.S. and EU regulatory submissions are under preparation for CAMCEVI® 21 mg. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in a Phase 2 proof-of-concept study in allergic asthmatic patients, and a Phase 2/3 study for the treatment of COVID-19 virus-induced acute respiratory distress syndrome (ARDS), for which Phase 2 results are anticipated in 2H2022. FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 Fanconi Anemia study is currently being initiated. www.foreseepharma.com