Accord BioPharma, Inc. Recognizes Milestone as More Than 10,000 Patients Gain Access to CAMCEVI® (leuprolide)

Convenience and simplicity of the product appeal to the advanced prostate cancer community and healthcare providers

RALEIGH, N.C., Jan. 16, 2025 /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. For Accord BioPharma, this milestone represents their ongoing commitment to providing affordable, accessible patient therapies to those facing cancer and other life-threatening conditions.

CAMCEVI, which was approved by the FDA in May 2021 and commercially launched in the U.S. in March 2022, has allowed Accord to significantly grow its share of the advanced prostate cancer market. As the first ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection, CAMCEVI comes in a no-mix, prefilled syringe, which simplifies training and preparation for healthcare providers. To learn more about CAMCEVI, please see full indication and Important Safety Information below. 

"At Accord BioPharma, we are deeply dedicated to our mission to increase the number of affordable and accessible therapies that are available to patients," said Chrys Kokino, U.S. president of Accord. "This CAMCEVI milestone illustrates our success in delivering on that promise, while giving providers an effective treatment option that is easy to deliver."

The growth of advanced prostate cancer makes CAMCEVI even more significant in today's market. According to the American Cancer Society, prostate cancer is the most commonly diagnosed cancer among American men after skin cancers. In addition, a study from Keck Medicine of USC shows that rates of advanced prostate cancer are growing, likely due to a decline in prostate cancer screenings and an aging U.S. population. While all men are at risk for developing prostate cancer, Black men in the U.S. and Caribbean have the highest documented prostate cancer incidence rates in the world and are more likely to be diagnosed at an advanced stage compared to non-Hispanic white men.

Peter, a patient with reoccurring advanced prostate cancer, has been taking CAMCEVI for over a year. "I just had my third injection. The every six months dosing is convenient for me," he said. "As far as treatment goes, I would say to a man who's just been diagnosed, 'Why would you not give yourself the best chance possible?'" After his prostate cancer returned aggressively, Peter found strength by reaching out to other men facing the disease. "I started a fitness group for men who have prostate cancer. We meet once a week at a local park, train for an hour, and then stay to talk on our own."

To help reach all men affected by prostate cancer, including underserved populations, Accord BioPharma offers several CAMCEVI resources for patients through AccordCares®, a program that includes a nurse-staffed helpline and copay assistance. To date, this program has supported over 2,300 patients. This high-touch level of support extends to urologists and other healthcare professionals who treat patients with prostate cancer; for example, providers have access to AccordConnects®, a mobile application designed to help manage in-practice inventory of CAMCEVI.

"When I first heard about CAMCEVI, I was interested in trying it right out of the gate," says Sarah Locasto, nurse educator/advanced prostate cancer navigator at Associated Urological Specialists LLC in the southwest Chicago suburbs. "What appealed to me was the simplified preparation, knowing that it already came prefilled and that you don't have to mix it. I typically give about 40 injections in a day, so convenience is very important to me."

While Accord BioPharma recognizes the growing role of CAMCEVI in advanced prostate cancer treatment, the company is dedicated to growing education, empowerment, and support for those facing the disease. Through their PRO•STATE of Mind campaign, Accord BioPharma is encouraging men and their loved ones to learn more about prostate cancer, get screened, and get involved in the cause. Accord BioPharma has also partnered with ZERO Prostate Cancer, the leading national nonprofit working to end prostate cancer and help all who are impacted, to create change at the community level and beyond.

To learn more about CAMCEVI, visit camcevi.com.

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 and 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 be managed according to current clinical practice.

Androgen deprivation therapy may prolong the QT/QTc 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 extremity.

INDICATION
CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.

Click here for full Prescribing Information.

About Accord BioPharma
Accord BioPharma, Inc., 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 patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access and options for patients and deliver savings to the U.S. healthcare system, and is striving to offer one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com. 

References: 
1. CAMCEVI (leuprolide) 42 mg injection emulsion. Prescribing Information. Accord BioPharma; May 2021.
2. Accord BioPharma. Data on file for total CAMCEVI patients treated, April 2022 – October 2024.

CAMCEVI^® is a registered trademark of Foresee Pharmaceuticals, Co LTD. used under a license with Accord BioPharma, Inc. 

Contact:
[email protected]

SOURCE Accord BioPharma