Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI for the Treatment of Advanced Prostate Cancer; Accord BioPharma to Head the U.S. Commercialization - Seite 2

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.

Please see the full prescribing information for CAMCEVI 42 mg for more information.

About Foresee Pharmaceuticals Co. Ltd.

Foresee is a Taiwan and U.S.-based biopharmaceutical company listed on the Taipei Exchange. Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, and secondly its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high unmet needs.

Foresee's product portfolio includes late stage and early stage programs. CAMCEVI 42 mg is now approved in the U.S. and under regulatory review in the EU. Additionally, U.S. and EU regulatory submissions are in preparation for CAMCEVI 21 mg. Foresee is in clinical stage development of FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. FP-025 is currently in Phase 2/3 studies, including a Phase 2/3 study for COVID-19 virus-induced acute respiratory distress syndrome (ARDS). Foresee is also developing FP-045, a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia, and FP-004, a novel, subcutaneously injectable product in development for the treatment of opioid use disorder and pain.

www.foreseepharma.com

About Accord BioPharma

Accord BioPharma is the U.S. specialty division of India-based Intas Pharmaceuticals, Ltd., one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. The Company is known for its range of products in three important therapeutic areas, oncology, immunology and critical care. Accord BioPharma is developing an exciting portfolio of specialty, complex molecules and biosimilar products. It is committed to improving patient access as well as providing affordable treatment options.

For more information, visit https://www.accordhealthcare.us/accord-biopharma