Camcevi 42 mg (leuprolide 6-month depot) / Foresee Pharma, Intas, GeneScience - LARVOL DELTA

Foresee Pharmaceuticals Receives the Third Positive Recommendation from the DSMB to Continue the Casppian Study (PRNewswire) - "There has been no safety concern with the use of leuprolide (FP-001) injectable Emulsion in pediatric CPP patients....The DSMB recommended that Foresee Pharmaceuticals continue the trial as planned without any modification...The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial to evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg- controlled release in patients with central (Gonadotropin-Dependent) precocious puberty...'anticipated top-line results from this trial, expected in 2025.'"

DSMB • P3 data: top line • Rare Diseases

Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects with Central Precocious Puberty (clinicaltrials.gov) - P3 | N=93 | Recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Trial completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Endocrine Disorders

Accord BioPharma, Inc. Recognizes Milestone as More Than 10,000 Patients Gain Access to CAMCEVI (leuprolide) (PRNewswire) - "Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, is recognizing a critical milestone: As of fall 2024, more than 10,000 patients have received access to CAMCEVI (leuprolide) 42 mg injectable emulsion, underscoring the value of the treatment to the advanced prostate care community and healthcare providers....The growth of advanced prostate cancer makes CAMCEVI even more significant in today's market."

Commercial • Prostate Cancer

Biomedical stocks: Yida’s new drug for prostate cancer, CAMCEVI 42 mg, has been approved for marketing in Israel [Google translation] (China Times) - "Ita pointed out that the company's authorized partner Megapharm submitted an application for marketing authorization for the new dosage form of prostate cancer drug CAMCEVI 42 mg six-month sustained-release injection to the Israeli Ministry of Health (MOH) on April 4, 2012. The company received a notice from the authorized partner today that the Israeli Ministry of Health has completed the review of CAMCEVI 42 mg injection and granted marketing authorization. Subsequently, the company's partner Megapharm will be responsible for the sales of CAMCEVI in Israel."

Approval • Prostate Cancer

McKesson Introduces FDA-Approved Prostate Cancer Drug (Business Insider) - "McKesson Corporation's (NYSE:MCK) Biologics by McKesson...has been selected by Accord BioPharma, Inc. as an exclusive specialty pharmacy provider for CAMCEVI (leuprolide) 42mg injection emulsion for subcutaneous use."

Commercial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Foresee Pharmaceuticals Announces FDA Orange Book Listing of New U.S. Patent for CAMCEVI, Extending Patent Protection to 2039 (PRNewswire) - "Foresee Pharmaceuticals...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."

Patent • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

"Biomedical Stocks" Yida's improved new drug for breast cancer received clinical trial application in China [Google translation] (stock.yahoo) - "The latest announcement from Yida (6576) is that the application for a phase III clinical trial of the improved new drug FP-001 42 mg for the treatment of premenopausal breast cancer has been approved by the China National Medical Products Administration and is expected to be launched in 2026 After completing clinical trials, if the product is successfully commercialized in the Chinese market in the future, sales mileage fees and sales profit sharing will be collected, which is expected to inject momentum into operations....Yida expects to complete clinical trials in 2026, and the actual execution time will depend on the status of the case acceptance."

New P3 trial • Breast Cancer • Oncology • Solid Tumor

[Announcement] The Phase III clinical trial application of Yida’s improved new drug FP-001 42 mg for the treatment of premenopausal breast cancer has received an acceptance notice from the National Medical Products Administration (NMPA) of China and entered the substantive review stage [Google translation] (stock.yahoo) - "The Phase III clinical trial application of Yida’s improved new drug FP-001 42 mg for the treatment of premenopausal breast cancer received an acceptance notice from the National Medical Products Administration (NMPA) of China and entered the substantive review stage....Authority (NMPA) proposes modified new drug FP-001 42 mg to treat premenopausal breast cancer (premenopausal breast cancer) for the treatment of HR+ (ER+ and/or PR+)/HER2-patients with mild to moderate lymph node involvement and receive standard care with tamoxifen....The acceptance notice from the Administration indicates that the Phase III clinical trial application has entered the substantive review stage; from the date of acceptance."

New P3 trial • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

[Announcement] Changchun Jinsai Pharmaceutical, an authorized partner of Yida, submitted a Phase III clinical trial application for FP-001 42 mg (i.e. CAMCEVI 42 mg) to the China National Medical Products Administration (NMPA) for the treatment of premenopausal breast cancer. [Google translation] (stock.yahoo) - "The company’s authorized partner Changchun Jinsai Pharmaceutical has completed the submission to the China National Medical Products Administration (NMPA)...Improved new drug FP-001 42 mg to treat premenopausal breast cancer...For the treatment of HR+ (ER+ and/or PR+)/HER2- type patients with mild to moderate lymph node invasion...Patients, combined with standard care Tamoxifen (Tamoxifen) Phase 3 clinical trial application...This Phase III clinical trial is an open-label, randomized, parallel-controlled multi-center clinical trial in China; subject to....The trial group is patients aged 18-59 years old with premenopausal breast cancer. It is expected to recruit approximately 220 patients in China."

New P3 trial • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty (clinicaltrials.gov) - P3 | N=93 | Recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2022 ➔ Jun 2023

Enrollment open • Trial initiation date • Endocrine Disorders

Suspension culture of human induced pluripotent stem cell-derived intestinal organoids using natural polysaccharides. (PubMed, Biomaterials) - "The observed activities of the drug metabolizing enzymes and drug transporters in the generated HIOs suggested that they have pharmacokinetic functions. We believe that suspension culture of HIOs using FP001 or FP003 can be widely applied to not only drug discovery research but also disease research and regenerative medicine."

Journal

Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty (clinicaltrials.gov) - P3 | N=93 | Not yet recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd.

New P3 trial • Endocrine Disorders

Accord BioPharma and EVERSANA Announce Partnership to Support the Launch of CAMCEVI for the Treatment of Advanced Prostate Cancer in Adults in the U.S. (Canada Newswire) - "EVERSANA...and Accord BioPharma...announced a partnership to support the recent launch of CAMCEVI® (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults....Leveraging the power of the company's integrated solutions, EVERSANA will provide multiple services to Accord BioPharma for CAMCEVI, including field deployment solutions, training, and the company's comprehensive data and analytics platform. Together, EVERSANA and Accord BioPharma will empower specialized pharmaceutical sales teams with the resources they need to connect with clinicians across the country to drive adoption of this therapy."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Urothelial Cancer

Accord BioPharma Announces U.S. Launch for CAMCEVI (Leuprolide) Injection Emulsion for the Treatment of Advanced Prostate Cancer in Adults (PRNewswire) - "Accord BioPharma...announced today the U.S. launch of CAMCEVI™ (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. Accord BioPharma is heading distribution in the U.S."

Launch US • Genito-urinary Cancer • Oncology • Prostate Cancer

New medicines recommended for approval by EMA’s CHMP in March (The Pharma Letter) - "Two medicines, both from Accord Healthcare, were submitted in hybrid applications, which means they relied in part on the results of pre-clinical tests and clinical trials of an already authorized reference product, and in part on new data: Camcevi (leuprorelin) for the treatment of hormone-dependent prostate cancer...."

European regulatory • Genito-urinary Cancer • Oncology • Prostate Cancer

Microbial α-L-Rhamnosidases of Glycosyl Hydrolase Families GH78 and GH106 Have Broad Substrate Specificities toward α-L-Rhamnosyl- and α-L-Mannosyl-Linkages. (PubMed, J Appl Glycosci (1999)) - "SpRhaM, a GH106 family α-L-Rha-ase from Sphingomonas paucimobilis FP2001, was found to have relatively higher α-L-mannosidase activity as compared with three GH78 α-L-Rha-ases...In summary, we have shown that α-L-Rha-ases also have α-L-mannosidase activity. Our findings will be useful in the identification and structural determination of α-L-mannose-containing polysaccharides from natural sources for use in the pharmaceutical and food industries."

Journal

Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI for the Treatment of Advanced Prostate Cancer; Accord BioPharma to Head the U.S. Commercialization (PRNewswire) - “Foresee Pharmaceuticals…announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI® 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, as a treatment of advanced prostate cancer…The FDA approval was based on a successful Phase 3 study in 137 Advanced Prostate Carcinoma patients…”

NDA • Genito-urinary Cancer • Oncology • Prostate Cancer • Urothelial Cancer

Foresee Pharmaceuticals Enters Exclusive License Agreement with GenSci for the Commercialization of Camcevi(TM) in China (PRNewswire) - “Foresee Pharmaceuticals…announced today that it has entered into an exclusive license agreement with GenScience Pharmaceuticals…for the commercialization of Foresee's novel FP-001 program, Leuprolide Mesylate Injectable Suspension (LMIS) ready-to-use subcutaneous 6-month and 3-month depot formulations (‘Camcevi™’). The license agreement will cover the China market. Under the terms of this partnership, Foresee, a Taiwan and US-based biopharmaceutical company, will receive 8 million US dollars upfront, and a combination of regulatory milestones, technology transfer milestones, and commercialization milestones payments totalling up to 123.85 million US dollars in addition to a share of the product revenue in the territory. GenSci will cover all costs of development, registration, and commercialisation in the territory.”

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer

Foresee Pharmaceuticals Announces Submission of NDA for FDA Approval of LMIS 50 mg (Foresee Pharmaceuticals Press Release) - "Foresee Pharmaceuticals...announced today that it has submitted to the U.S. Food and Drug Administration a 505(b)(2) New Drug Application for Camcevi® 42mg (FP-001 LMIS 50mg), a ready-to-use 6-month depot formulation of leuprolide mesylate...for the palliative treatment of advanced prostate cancer....This NDA submission is supported by a previously communicated successful Phase 3 study in 137 Advanced Prostate Carcinoma patients..."

NDA • Genito-urinary Cancer • Oncology • Prostate Cancer

Maturational Characterization of Mouse Cortical Neurons Three-Dimensionally Cultured in Functional Polymer FP001-Containing Medium. (PubMed, Biol Pharm Bull) - "These results suggested that glutamatergic neurotransmission in neurons three-dimensionally cultured in the FP001-containing medium may be upregulated compared to neurons two-dimensionally cultured in the FP001-free medium. Thus, neurons with the properties close to those in the embryonic brain could be obtained by three-dimensionally culturing neurons using FP001, compared to two-dimensional culture with a conventional adhesion method."

Journal • Preclinical

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer (clinicaltrials.gov) - P3; N=144; Completed; Sponsor: Foresee Pharmaceuticals Co., Ltd.; Active, not recruiting ➔ Completed; Trial completion date: Nov 2018 ➔ Feb 2019

Clinical • Trial completion • Trial completion date

Foresee Pharmaceuticals announces successful topline results from phase 3 registration study of LMIS 25 mg in prostate cancer (PRNewswire) - P3, N=144; NCT03261999; Sponsor: Foresee Pharmaceuticals; “Foresee Pharmaceuticals…announced today the topline results of FP-001 LMIS (Leuprolide Mesylate Injectable Suspension) 25 mg phase 3 clinical trial, an open-label, single-arm study in subjects with Prostate Carcinoma. LMIS 25 mg is a 3-month depot injection. The primary efficacy end point was achieved in 97.9% of subjects….By day 28, mean testosterone concentration was suppressed below castrate levels to 17.8 ng/dL, the suppression rate was 98.6% (141 out of 143 subjects achieved medical castration).”

P3 data: top line