– U.S. Launch Supported by Accord BioPharma's parent company, Intas Pharmaceuticals –
DURHAM, N.C., April 4, 2022 /PRNewswire/ — Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd. focused on development of oncology, immunology, and critical care therapies, announced today, in partnership with Foresee Pharmaceuticals Co., Ltd., the U.S. launch of CAMCEVI™ (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. The U.S. Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021. CAMCEVI™ 42 mg injection is exclusively licensed to Accord BioPharma in the U.S. for commercialization.
"The U.S. launch of CAMCEVI validates the importance of Foresee's pioneering Stabilized Injectable Formulation (SIF) technology and is a monumental step toward fulfilling our mission of improving on a standard of care," said Dr. Ben Chien, founder and Chairman of Foresee. "We know that Accord BioPharma shares in that important goal."
CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, CAMCEVI offered consistent testosterone suppression to castrate levels after the initial injection, from Week 4 to Week 48.1 CAMCEVI should not be used in patients with hypersensitivity to GnRH or GnRH analogs due to possible anaphylactic reactions.1 The most common adverse reactions (≥10%) occurring during a median follow-up duration of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.1
"Accord Healthcare has been providing quality pharmaceutical products in the U.S. since the early 2000s. Through this partnership with Foresee on the launch of CAMCEVI, we are excited to formally launch Accord BioPharma with razor sharp focus on specialty pharmaceuticals, which will go beyond biology to bring more access to high-quality medicines to patients across the U.S.," said Binish Chudgar, Chairman, Accord Healthcare and Accord BioPharma.
"Foresee's technology allows us to offer a therapy for advanced prostate cancer that is both effective and convenient for practitioners, with the pre-filled syringe providing simplified preparation that leads to an improved treatment experience for healthcare professionals," said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. "CAMCEVI marks an important example of our philosophy – going beyond biology – in action."
Important Safety Information: CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment which can cause transient worsening of symptoms. Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy. 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 association with the use of GnRH agonists. Patients should be monitored for cardiovascular disease and according to current clinical practice. Androgen deprivation therapy may prolong the QT interval. Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Monitor serum levels of testosterone following injection of CAMCEVI. Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm when administered to pregnant women. The most common (≥10%) adverse reactions during a median follow-up of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremities.
About Foresee Pharmaceuticals Co., Ltd.
Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (6576.TWO). 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 rare and severe 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. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in Phase 2/3 studies, including a Phase 2/3 study for COVID-19 virus-induced acute respiratory distress syndrome (ARDS). 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. www.foreseepharma.com
About Accord BioPharma
Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patient's perspective and develop high-quality therapies that impact patient's lives. The founders of Accord BioPharma have dedicated their time, passion, and resources to focusing on specialty care and treatments, proactively developing better ways of working, and delivering enhanced therapies. For more information, Visit AccordBioPharma.com.
References:
1. CAMCEVI. Prescribing Information. Accord BioPharma; May 2021.
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