Foresee Pharmaceuticals (TPEx: 6576), (“Foresee”) today announces that a new U.S. patent which covers CAMCEVI® (leuprolide mesylate) and its labeled indication is now listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as “the Orange Book”.
| TAIPEI, Aug. 29, 2023 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), (“Foresee”) today announces that a new U.S. patent which covers CAMCEVI® (leuprolide mesylate) and its labeled indication is now listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as “the Orange Book”. On August 8, 2023, the United States Patent and Trademark Office (USPTO) issued U.S. patent No. 11,717,555 B2, under the title “Pharmaceutical Compositions Having a Selected Release Duration”, which has extended the patent protection on CAMCEVI® to January 1, 2039. The formulation patent covers not only CAMCEVI® but also Foresee’s other LHRH products in development. The listing of the patent brings the total number of Orange Book-listed patents from three to four. “We are excited to further strengthen our intellectual property protection for CAMCEVI® and other developing LHRH products with the newly granted patent,” said Dr. Ben Chien, Foresee’s Chairman and CEO. “Additionally, this serves as another milestone to validate our SIF technologies and to potentially bring in more commercial value through the extended patent life and royalty terms.” About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee’s R&D efforts are focused in two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable 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 and early-stage programs. CAMCEVI® 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, and EU and launched in the U.S. in April 2022. Additionally, U.S. and EU regulatory submissions are under preparation for CAMCEVI® 21 mg. The U.S. regulatory submission is anticipated in 2024. The second indication of CAMCEVI® 42 mg – central precocious puberty (CPP), the Phase 3 clinical study, has been initiated. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, a Phase 2 proof-of-concept study in allergic asthmatic patients has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. 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, and a Phase 2 study in pulmonary hypertension-ILD patients is in planning. www.foreseepharma.com
SOURCE Foresee Pharmaceuticals Co., Ltd. | ||
Company Codes: Gretai:6576 |
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