Our response to COVID-19
As we all continue to take steps to address the impact of COVID-19, we would like to provide an update on our response strategy at Akcea.
We are well positioned to address challenges related to COVID-19 and to continue to advance both our clinical programs and our commercial strategies. Thus far, our outstanding team has rapidly adapted to working remotely and we are monitoring daily to ensure we have all necessary plans in place for mitigating any potential disruptions in our daily operations, including clinical programs and ongoing drug supply and nursing support for the patients and physicians trusting us to do so.
Our COVID-19 Task Force is proactively assessing, monitoring and responding to international developments related to the pandemic, and is implementing risk-mitigation plans on an ongoing basis to minimize impact on our clinical trials, supply chain, and business operations. In addition, we are monitoring conditions on the ground to protect the health and welfare of our employees, while serving customers and patients who rely on us.
At the recommendation of our team of international functional leaders and medical staff, we made an early decision to limit access to and then close our offices. We are fully functional from our remote locations and were well structured and equipped for this unfortunate circumstance.
- monitor conditions on the ground for our patients and staff daily, in particular through our global Akcea Connect program, which is setting the standard for patient care in Rare Diseases;
- monitor our supply chain daily;
- continue to actively support our partnerships;
- are in a strong financial position and are working to maximize opportunities related to our commercially available products.
Our mission to advance research to develop new treatments for rare diseases, combined with our strong business operations, reinforce our continuing commitment to the patient populations we serve, including the hereditary transthyretin (hATTR) amyloidosis and familial chylomicronemia syndrome (FCS) communities. We are fortunate to meet regularly with many patients and caregivers, and know firsthand the challenges they face – made even more difficult by the COVID-19 outbreak. Our commitment to patients, caregivers and clinicians on the front lines in managing these diseases is unwavering and our goal is to keep existing patients on therapy safely and to support the initiation of new patients onto therapy.
Our marketed products are both medicines that are administered through self-injection in the comfort and safety of a patient’s home, and they do not require a patient go to an infusion center or hospital for treatment.
As we continue to plan for the future, our patients, clinicians and employees remain our primary considerations. We will continue to evaluate any issues that may affect patients and clinicians who use our products and who participate in our clinical research programs.
Thank you for your continuing interest in our work at Akcea. We continue to globally monitor the situation and take guidance from the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), and will provide updates on our strategies related to COVID-19 in the weeks ahead.
Frequently asked questions (FAQs)
Q: What are the drug supply chain risks regarding COVID-19?
A: Our supply chains remain robust and intact. We have a COVID-19 Task Force in place to monitor and respond to developments related to the pandemic, and they are establishing mitigation plans on an ongoing basis to minimize any impact on trials or business operations.
Q: Are clinical trials and drug launches being affected? And how is this affecting the sales reps?
A: Thus far, our outstanding team has rapidly adapted to working remotely and there have been no major disruptions to our operations including progress in our clinical programs and efforts to supply our products to patients who need them.
Q: What does COVID-19 mean for Akcea’s financials?
A: We are fortunate to be in the position to have a large reserve of $464 million in cash and short-term investments, as of the end of December 2019, and we are working to maximize opportunities related to our two commercially available products.
Q: How has this affected Akcea Connect and their supportive services (i.e. labs and phlebotomy)?
A: Akcea Connect is committed to making sure that patients are supported and we are following all of the same guidelines for conducting patient interactions, albeit now virtually. We understand that limiting patients’ needs to leave their homes and visit clinics is a top priority.
For patients with hereditary ATTR amyloidosis, subcutaneous injections allow patients to receive treatment while in the comfort of their own homes. Our REMS program and associated monitoring program does not alter this fact, and our lab partner Quest and the mobile phlebotomy team are fully operational during this time.
Q: What is Akcea’s plan for patients if there is a nationwide quarantine (or curfew)?
A: To date, our existing patients have remained on therapy and have complied with the monitoring program. Our two commercial products are both medicines that are administered through self-injection in the comfort and safety of a patient’s home, and they do not require a patient to go to an infusion center or hospital for treatment.