On the 18th, Foresee Pharmaceuticals announced the shipment of its first batch of CAMCEVI, a new formulation drug for prostate cancer. The CAMCEVI 42 mg six-month depot injection was produced by the French contract manufacturer Fareva Pau and has been transported to the designated storage facility of its partner, Accord Healthcare, in Germany. This marks the initial launch of CAMCEVI in the German market and Foresee's official entry into the EU pharmaceutical market.
In 2019, Foresee licensed the global rights (excluding China, the United States, Japan, and Taiwan) of CAMCEVI for prostate cancer to Accord Healthcare, with a focus on the European market.
CAMCEVI 42 mg received marketing authorization from the European Medicines Agency (EMA) in May 2022 for the treatment of hormone-dependent advanced prostate cancer, as well as for use in combination with radiation therapy to treat high-risk localized and locally advanced hormone-dependent prostate cancer. This authorization applies to all 27 EU member states, as well as Iceland, Norway, and Liechtenstein. Marketing authorization in the United Kingdom was granted in November 2024.
Accord Healthcare is responsible for planning and managing the sales and distribution of CAMCEVI in the EU and UK. Under the licensing agreement, Foresee will recognize revenues from milestone payments, supply income, royalties, and other related earnings. The drug is protected by patents until 2039.
Foresee Pharmaceuticals is seeing its operations enter a harvest phase, reporting NT$403 million in revenue for the first 11 months of this year, a 143% year-over-year increase. However, due to ongoing clinical development of new drugs, the company reported a net loss of NT$4.35 per share for the first three quarters.
In addition to the six-month formulation of CAMCEVI, Foresee has submitted a New Drug Application (NDA) to the U.S. FDA for a three-month sustained-release version, with approval expected next year and sales anticipated to begin in 2026.
Furthermore, Foresee's Chinese licensing partner, Changchun GeneScience Pharmaceutical, plans to submit a drug registration application for CAMCEVI 42 mg to China’s National Medical Products Administration (NMPA) by the end of this year or early next year. Additionally, Phase III clinical trials for CAMCEVI's applications in treating central precocious puberty in children and premenopausal breast cancer are ongoing.
Resource: 前進歐盟 逸達前列腺癌新劑型新藥CAMCEVI出貨
