On June 29, 2022 EVERSANA, the pioneer of next-generation commercial services to the global life sciences industry, and Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., reported a partnership to support the recent launch of CAMCEVI (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults (Press release, EVERSANA, JUN 29, 2022, View Source [SID1234616365]). Accord BioPharma is heading distribution in the United States. The U.S. Food and Drug Administration approved the New Drug Application (NDA) for CAMCEVI from Foresee Pharmaceuticals on May 25, 2021.
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CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide 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 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. As with other GnRH agonists, cases of ureteral obstruction, spinal cord compression, have been observed, which may contribute to paralysis with or without fatal complications. 1 Click here for full Prescribing Information.
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.
"Accord Healthcare has been offering quality pharmaceutical products in the U.S. and globally since the early 2000s. Through this strategic partnership with EVERSANA for the launch of CAMCEVI, we are excited to sharpen Accord BioPharma’s focus on specialty pharmaceuticals. This will help us enable better access to therapy for advanced prostate cancer patients across the U.S.," said Binish Chudgar, Managing Director – Accord Healthcare and Accord BioPharma.
"The commercialization of therapies, especially in oncology, requires deep knowledge of the industry and rich data on point-of-care options to help the treatment get to those patients in need," said Jim Lang, CEO, EVERSANA. "It’s why we built EVERSANA, to support the needs of clients like Accord BioPharma and help bring innovative drugs like CAMCEVI to market."
EVERSANA will also provide additional services to Accord BioPharma as part of the commercialization agreement. EVERSANA brings extensive experience in the oncology sector, including patient services, channel management, medical information, pharmacovigilance and more.
"Accord BioPharma is committed to going beyond biology when it comes to drug development. Creating therapies that people will use is not just about following the science, but about pursuing innovative thinking in healthcare," said Chrys Kokino, U.S. president of Accord BioPharma. "EVERSANA’s services, experience, and depth of commercial solutions make them the ideal partner for us in pursuing that commitment."
IMPORTANT SAFETY INFORMATION
Do not use CAMCEVI in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI as anaphylactic reactions to these drugs have been reported in the medical literature. 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. As with other GnRH agonists, cases of ureteral obstruction, spinal cord compression, have been observed, which may contribute to paralysis with or without fatal complications. 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. The risk appears low based on the reported odds ratios and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. 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. 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.