The European Commission (EC) has authorized the Trade Mark Implementation (MAA) for CAMCEVI® 42 mg protracted suspended for infusion, for the treatment of oestrogen advanced prostate cancer, as well as high-risk localized prostate and advanced or metastatic hormone-dependent prostate in combination with radiotherapy, according to Foresee Pharmaceuticals (6576.TWO). The clearance applies to all 27 EU member states, as well as Iceland, Norway, and Liechtenstein.
“We are delighted that CAMCEVI 42 mg has indeed been authorized in the European Union. This European Commission clearance is another another exciting step forward in our quest to improve patient care and quality of life “Founder, Chairman, and CEO of Foresee, Dr. Ben Chien. “It also demonstrates Foresee’s groundbreaking Stabilized Injection Formulation (SIF) technology’s success. We sincerely appreciate the team’s persistent efforts, our outstanding licensing partners Accord, and all stakeholders’ long-term support.”
CAMCEVI® is the first prepared sterile leuprolide mesylate for subcutaneously that comes in a pre-filled syringe and requires no mixing. The approval of CAMCEVI® 42 mg comes after a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in March, which was based on information from an effective Phase 3 study in 137 Advanced Bladder Carcinoma patients, in which treatment with CAMCEVI® 42 mg intramuscularly every 6 months was shown to be effective, safe, and well tolerated. In the intent-to-treat (ITT) population, the primary efficacy end objective was the percentage of individuals with serum testosterone suppression (50 ng/dl) by day 28 and from day 28 to day 336.
On day 28, the primary effectiveness endpoint was met in 97 percent of participants, with mean testosterone levels lowered below decapitate levels to 17.6 ng/dL. Hot flush, hypotension, injection site responses, upper respiratory infections, muscle problems, weariness, and pain in extremity were the most prevalent (10%) adverse events.
In May 2021 and November 2021, the US Food and Drug Administration (FDA) and Health Canada, respectively, approved CAMCEVI® 42 mg for the treatment of adults with advanced prostate cancer. In the European Union, Accord Healthcare has exclusive commercialization rights to CAMCEVI® 42 mg injection.
Foresee Pharmaceuticals Co. Ltd. is a pharmaceutical company based in Hong Kong.
Foresee is a biopharmaceutical firm established in Taiwan and the United States that is registered on the Taipei Exchange (6576.TWO). Foresee’s research and development efforts are focused on two key areas: its distinctive relatively stable intravenous clarification (SIF) go down shipping technology with derived drug products aimed at specialty markets, and its transcendent pre – clinical and clinical first-in-class NCE programs aimed at rare and severe disease areas with high unmet needs.
Late-stage and early-stage programs are included in Foresee’s product range. CAMCEVI® 42 mg has been found effective, Canada, and the European Union, and is now available in the United States. Additionally, regulatory filings for CAMCEVI® 21 mg are being prepared in the United States and the European Union. FP-025 is a selective oral MMP-12 antagonist that targets inflammatory and fibrotic illnesses. It is now in a Phase 2 proof-of-concept research in allergic asthmatic patients and a Phase 2/3 research for the therapy of COVID-19 virus-induced ARDS, with Phase 2 results expected in 2H2022. A Phase 1b/2 Fanconi Anemia research is presently underway for FP-045, a selective oral specific molecular dynamic inhibitor of ALDH2, a mitochondrial enzyme.