Foresee Pharmaceuticals is ramping up its new drug development efforts. Following the full-scale launch of the CAMCEVI six-month formulation for treating advanced prostate cancer in the U.S. market, the company plans to apply for U.S. drug approval for the three-month formulation in the fourth quarter of this year, aiming for approval by 2025. After obtaining a CMS-issued J-code, the product is expected to be officially launched in the first half of 2026.
In addition, its European licensing partner Accord Healthcare plans to launch the CAMCEVI six-month formulation in Europe by the end of this year, while its Chinese partner Changchun Jinsai Pharmaceutical is expected to submit a drug approval application for the six-month formulation to China’s NMPA around the end of this year.
Clinical trials for CAMCEVI in treating central precocious puberty in children and pre-menopausal breast cancer are also actively ongoing.
Foresee’s highly selective MMP-12 inhibitor (matrix metalloproteinase-12), the new drug FP-025, has completed its Phase II proof-of-concept trial for allergic asthma in the Netherlands, with positive results. The company plans to further develop this drug for rare immune-related fibrotic diseases.
Another MMP-12 inhibitor, FP-020, is currently in Phase I clinical trials and is expected to target severe asthma, chronic obstructive pulmonary disease (COPD), and inflammatory bowel disease (IBD). Additionally, FP-045, an ALDH2 (aldehyde dehydrogenase) activator, is in Phase II clinical trials for treating Fanconi anemia, a rare disease. A second indication, pulmonary hypertension due to interstitial lung disease (PH-ILD), is set to begin Phase II clinical trials in Q4 of 2024.
Boosted by sales revenue and service income from the CAMCEVI six-month formulation for advanced prostate cancer, Foresee’s revenue in August reached NT$19.14 million, with cumulative revenue for the first eight months totaling NT$253 million, representing a significant year-on-year growth of 284%.
Foresee Pharmaceuticals reported that August’s consolidated revenue was mainly driven by profit-sharing from CAMCEVI sales in the U.S. terminal market, amounting to NT$10.19 million. The company noted that it ships products on an irregular basis per instructions from its U.S. distributor, so there were no commercial supply sales recorded in August.
Additionally, the company recognized NT$5.53 million in service income related to the progress of CAMCEVI’s three-month formulation drug application in the U.S. and NT$3.42 million in sales of sample products for technology transfer to its Chinese partner for the six-month formulation. These were classified as non-recurring income.
In August, the U.S. market saw terminal sales of 1,970 units of the CAMCEVI six-month formulation, a 13% decrease compared to the 2,255 units sold in July due to shifts in the customer mix. However, this still represents a 35% increase compared to the same period last year.
Looking ahead, with the ongoing development of CAMCEVI in new formulations, markets, and indications, Foresee Pharmaceuticals is optimistic that its mid- to long-term revenue will continue to grow significantly.
Resource (mandarin): 逸達新藥火力全開 CAMCEVI 三個月劑型拚第四季申請美國藥證
