Mediwound Provides Corporate Update Related To Covid-19 Pandemic
The following excerpt is from the company's SEC filing.
YAVNE, Israel, March 30, 2020
-- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today provided an update on certain impacts of the COVID-19 pandemic on its business operations and clinical programs.
In response to the evolving situation related to the spread of COVID-19, MediWound’s priority continues to be protecting the health of its employees and the communities in which they live and work. At the same time, the Company is working to ensure that he althcare providers and patients have uninterrupted access to our commercial and products under development. With this in mind, MediWound has adopted a series of precautionary measures to mitigate the potential spread of COVID-19, while also permitting the continuation of critical business functions. The Company has instituted a global remote work policy and is now leveraging virtual tools and digital communication technologies to continue important interactions with its employees, healthcare professionals, patients and other stakeholders.
In light of the COVID-19 substantial impact on the global healthcare delivery system, and taking into account regulatory, institutional, and government guidance and policies, the Company has decided to temporarily suspend the initiation of additional clinical sites and new patient enrollment in our U.S. EscharEx phase 2 study for the treatment of venous leg ulcers (“VLUs”). Existing EscharEx clinical sites are continuing to manage randomized patients currently on treatment, including with the adoption of enhanced safety measures, such as the implementation of remote site monitoring, virtual tools and digital communication. Importantly, the Company is prepared and committed to resume site expansion, patient screening and randomization once the situation permits.
The NexoBrid expanded access (“NEXT”) program continues to enroll patients, thus enabling U.S. burn centers to treat burn patients with NexoBrid. In addition, patient follow-up in the pivotal U.S. Phase 3 clinical study (“DETECT”) of NexoBrid remains ongoing and the preparation of the Biologics License Application for NexoBrid continues as planned.
Currently, the Company’s manufacturing facility is operational, and there is sufficient inventory of NexoBrid on hand to meet expected demand over the next several quarters. However, the Company continues to assess the potential impact of COVID-19 on its manufacturing operations and global supply chain, including potential adjustments to the U.S. Biomedical Advanced Research and Development Authority’s (“BARDA”) delivery plan of NexoBrid emergency stock. At this time, the Company does not anticipate a change to its 2020 cash use guidance as a result of COVID-19.
“As a result of the COVID-19 pandemic and subsequent shelter-in-place orders that are occurring globally, we have made the decision to temporarily suspend patient enrollment in our EscharEx phase 2 study, said Sharon Malka, CEO of MediWound. “Our priorities now are the safety of the patients and healthcare providers who are participating in our clinical trials, the health and safety of our employees and external partners conducting our trials, as well as reducing stress on the healthcare system.”
“In view of the challenges of the healthcare system, national burn care associations, including the Italian Society of Burn Surgery, have stressed the need to shift more burn patients toward non-surgical care in order to alleviate the burden on acute care staff and inpatient operating rooms. This is consistent with clinical guidelines issued by national healthcare systems, such as the United Kingdom’s National Health Service, for the management of acute burns during the COVID-19 pandemic, underscoring the role of enzymatic debridement for burn care in emergencies.”
Mr. Malka concluded, “Given the dynamic nature of the COVID-19 pandemic, we will continue to monitor its operations and will assess the need for further actions as appropriate. Supported by our strong balance sheet, I firmly believe we can weather this storm. Our thoughts and prayers are with patients and families globally as we all face this pandemic together.”
