DENDREON RESPONDS TO THE COVID-19 PANDEMIC


Updated 19 March 2020

Like most organizations around the world, Dendreon has been closely monitoring the COVID-19 pandemic and its impact on our patients, healthcare professionals and community. We continue to monitor and respond to this rapidly changing situation based on updates and recommendations from the CDC and local health officials, so please visit this page for updates.

To reach us directly with any questions, please email Corporate.Communications@Dendreon.com.

Protecting Our Employees and Their Families

One of our chief priorities is to ensure the health and safety of our employees – not just for their own well-being and that of their families, but also to protect our ability to make and supply PROVENGE® (sipuleucel-T) to the patients who need this life-extending treatment.

To reduce the risk of virus transmission, we are taking measures to maximize “social distancing” by asking all Dendreon employees, including field-based associates, to work from home if they are able; minimize non-essential travel; and leverage digital tools and platforms in lieu of face-to-face meetings to ensure access to PROVENGE for patients.

No Impact on PROVENGE Manufacturing

Dendreon manufacturing facilities in Seal Beach, Calif., and Union City, Georgia, remain open and operational. As an added precaution, Dendreon has limited access to our manufacturing facilities to essential personnel only to reduce the risk of transmission. The entire Dendreon team remains fully committed to the delivery of PROVENGE treatments to our patients.

Commercial Airlines Critical to PROVENGE Delivery

The PROVENGE manufacturing process requires logistical precision to ensure patient treatments are received and delivered on time. From beginning to end, we have just three days to collect a patient’s cells, manufacture PROVENGE and infuse the patient.

Dendreon relies on the airline industry to deliver this life-extending treatment. We are closely monitoring the impact of COVID-19 and, in anticipation of any disruption to commercial flights, have put contingency plans in place to protect/maintain the delivery of our patients’ treatments.

Working Closely with Cell Collection Partners

Dendreon works with a large apheresis network to collect the cells needed to manufacture PROVENGE, and they are working diligently to keep the apheresis center as safe as possible for our PROVENGE patients and their employees.

Many of our apheresis partners have taken additional measures to maintain patient safety in response to COVID‐19. These measures include: screening incoming patients regarding recent travel, and pre-screening to assess patients’ health and well-being.

Working Closely with Lawmakers

We continue to engage public officials working to develop policies in response to COVID-19. We are advocating for policies that will protect men’s access to PROVENGE in an environment where travel is uncertain. We are also advocating for policies that support our skilled Dendreon team members to ensure they can care for themselves and loved ones while continuing to manufacture PROVENGE for men with advanced prostate cancer.

important safety information

INDICATION

PROVENGE® (sipuleucel-T) is a prescription medicine that is used to treat certain patients with advanced prostate cancer. PROVENGE is made from your own immune cells.

IMPORTANT SAFETY INFORMATION

  • Before getting PROVENGE, tell your doctor about all your medical problems, including problems with your heart or lungs, or if you have had a stroke
  • Tell your doctor about all the medicines you take, including prescription and nonprescription drugs, vitamins, and dietary supplements
  • PROVENGE is made from your own immune cells, collected approximately 3 days before each scheduled infusion of PROVENGE. The collection is called "leukapheresis" (pronounced loo-kuh-fuh-REE-sis). You will get PROVENGE in 3 intravenous infusions (put into your veins), about 2 weeks apart. Each infusion takes about 60 minutes. You will then be monitored for at least 30 minutes. Your doctor will give you a schedule for your cell collection and infusion appointments. It is very important that you arrive on time for your appointments
  • The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment
  • PROVENGE infusion can cause serious reactions. Tell your doctor right away if you:
    • Have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after getting PROVENGE. Any of these may be signs of heart or lung problems
    • Develop numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking. Any of these may be signs of a stroke
    • Develop symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain that worsens on deep breathing
    • Get a fever over 100?, or redness or pain at the infusion or collections sites. Any of these may be signs of infection
  • Tell your doctor about any side effect that concerns you or does not go away. For more information, talk with your doctor

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information.