Amicus COVID-19 Statement to Pompe Community Partners

March 19, 2020

To: All Pompe Patient Advocacy Organizations
Re: COVID-19

To Our Pompe Community Partners,

First and foremost, your safety and welfare and that of your families always has been and continues to be our number one priority. This is especially true in view of the global COVID-19 outbreak.
We are committed to complete openness and frequent communications to address any questions in this community. We are in this fight together.

Importantly, given current information, we have a high degree of confidence that patients enrolled in all clinical studies for AT-GAA for Pompe disease, including our PROPEL pivotal study, will continue to receive study drug and that this study will be completed on schedule.

And in line with our Amicus access policy, all Pompe patients in all clinical studies for AT-GAA will be offered the ability to continue receiving AT-GAA through extension studies where the patients and their physician agree.  These will also continue uninterrupted. We want you to know that:

• Amicus Clinical Operations is in constant almost daily contact with all of our Pompe study sites around the world to manage any challenges caused by the COVID-19 outbreak.
• Each individual patient’s situation is being addressed to best accommodate his/her needs or concerns.  Our teams are developing customized solutions for each study participant.  We will do whatever it takes, in accordance with local conditions.
• Contingency plans, proactively developed weeks ago, are discussed regularly with study site staff and implemented as needed.
• Importantly, plans are updated to help ensure uninterrupted access to study treatments.  We have great confidence that we can continue to provide study participants with access to study drug and that we will successfully complete the important Phase 3 PROPEL study.
• Contingency plans for individual patients may include:
• Special travel assistance to/from study sites for infusions and/or evaluations
• Alternative infusion sites, perhaps closer to a participant’s home
• Home infusions, where permitted
• Other changes as identified
• Amicus is working with the study sites and our supply chain to ensure uninterrupted supply of the investigational medicine.  We have already manufactured all of the drugs necessary for the completion of all studies, for instance.  And these supplies are held at multiple distribution sites around the world.

These plans are based on the most current information available. We will continue to monitor and will provide updates of any changes.

Amicus Patient & Professional Advocacy (P&PA) and the entire Team Amicus recognizes and appreciates all that our community partners do to support clinical research and the drug development process as we collectively seek to improve outcomes for people living with Pompe disease. Call ANYTIME. P&PA always is available as a resource during this or any time. We can be reached at patientadvocacy@amicusrx.com, toll-free in the US and Canada at 1(866) 9-AMICUS (926-4287) and Internationally at patientadvocacyintl@amicusrx.com.

With best wishes for your good health and safety,

Jayne C Gershkowitz
Chief Patient Advocate