Updated: May 4, 2020
As the COVID-19 situation continues to evolve, we would like to provide you with important updates. Our top priority is the health and safety of our community including patients, caregivers, healthcare providers, partners, and employees. For patients specifically, this means that we are committed to our goal of continuing to deliver an uninterrupted supply of our medicines to the patients who rely on them.
Ensuring Access and Supply of our Medicines
We currently continue to provide an uninterrupted supply of our medicines to patients around the world as our manufacturing and distribution sources continue to function normally. Even if supply chains are interrupted, we do not anticipate a shortage of any of our medicines in the near term due to ample inventory levels.
Patients who have questions or concerns about their treatment should consult with their doctor, and can also contact UltraCare at 1-888-756-8657, Monday through Friday 8AM - 8PM EST or by email at Ultracare@ultragenyx.com.
Continuing our Clinical Studies
For patients in our clinical trials receiving investigational treatment, we do not see an issue with continued supply at this time. We continue to monitor the evolving situation and support clinical trial sites, which in turn includes supporting those patients participating in the studies.
Ongoing Discussions with Regulators
We are continuing interactions with our regulatory authorities and will continue to monitor this situation. We currently have two investigational therapies that are being reviewed by the U.S. Food and Drug Administration (FDA). At this time, we do not anticipate delays in these reviews.
- Crysvita for the treatment of tumor-induced osteomalacia (TIO) has a Prescription Drug User Fee Act (PDUFA) target date of June 18, 2020. The FDA has not indicated, up to this time, that any inspections will be required for completion of their review.
- UX007 for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD) has a PDUFA date of July 31, 2020. A number of anticipated clinical and manufacturing inspections for UX007 have been successfully completed and the FDA has not indicated, up to this time, that any additional inspections will be required for completion of their review.
Supporting our Workforce and our Community
We have put measures in place to prepare for and protect against the transmission of COVID-19 in our offices and our community, while ensuring the critical work required to bring our medicines to patients continues.
- All employees who are able to work from home to do so until further notice. This includes employees at all of our offices throughout the world.
- We have enhanced cleaning procedures at all office locations to help protect those who continue to work onsite.
- Ultragenyx has suspended in-person attendance at conferences and other large events until further notice.
- Ultragenyx has suspended international and domestic business travel.
Overall Business Outlook
We have activated our business continuity plans to avoid or minimize business disruption and ensure the well-being of our staff. Given the fluidity of the current environment, we cannot rule out future impact to our business as a result of the ongoing COVID-19 pandemic. We will continue to monitor the situation closely.
This business update includes forward-looking statements based on our current expectations and beliefs that are subject to risks and uncertainties. Our actual results may differ materially. Please consult the risk factors section of our SEC filings.
UltraCare is here to assist you in getting access to your treatment 1-888-756-8657 Monday - Friday 8AM EST to 8PM EST
FOR MEDICAL PROFESSIONALS
Ultragenyx Medical Information Support
1-888-756-8657, select option #2
FOR INVESTORS OR MEDIA