FDA Approves Camcevi (leuprolide mesylate) for the Treatment of Advanced Prostate Cancer

Foresee Pharmaceuticals (6576.TWO), ("Foresee") 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 approval of Camcevi 42 mg is a significant step toward our mission in improving the standard of care and the lives of patients," said Dr. Ben Chien, founder and Chairman of Foresee. "It also demonstrates the success of Foresee's pioneering Stabilized Injectable Formulation (SIF) technology. We want to thank the tireless work from the team and all stakeholders, which has made this approval possible.

The FDA approval was based on a successful Phase 3 study in 137 Advanced Prostate Carcinoma patients, where treatment with Camcevi 42 mg injection every 6 months was demonstrated to be effective, safe and well tolerated (most common adverse events listed below in ISI). The primary efficacy end point was the percentage of subjects with suppression of serum testosterone (≤50 ng/dl) by day 28 and from day 28 to day 336 in the intent-to-treat (ITT) population. The primary efficacy endpoint was successfully achieved in 97% of subjects, with mean testosterone concentration suppressed below castrate levels to 17.6 ng/dL on day 28.

 Camcevi 42 mg injection is exclusively licensed to Accord BioPharma in the U.S. for commercialization. "Camcevi 42mg is an important addition to of the rapidly expanding Accord Biopharma oncology portfolio and provides clinicians an important option for the treatment of advanced prostate cancer," Said Chrys Kokino, U.S. President Accord BioPharma specialty products.

Important Safety Information for the U.S.

Camcevi 42 mg subcutaneous injection is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer. Camcevi is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or the components of Camcevi.

Patients may develop tumor flare during the first few weeks of treatment, which is a transient worsening of bone pain, uretral obstruction, spinal cord compression, or the occurrence of additional signs and symptoms of prostate cancer. Monitor patients closely and manage symptoms.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice.

Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in men receiving GnRH agonists. Patients should be monitored for cardiovascular disease and according to current clinical practice.

Androgen deprivation therapy may prolong the QT interval. Consider periodic monitoring of electrocardiograms and electrolytes.

Convulsions have been reported in patients receiving GnRH agonists, like Camcevi. Patients experiencing convulsions should be managed according to the current clinical practice.

Based on findings in animal studies and mechanism of action, Camcevi may cause fetal harm.

The most common (≥10%) adverse reactions were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.