- Measures taken to safeguard workforce and continuity of operations
- Recent FDA update on continued efforts to facilitate development of treatments
LAVAL, QC, and CAMBRIDGE, UK, March 22, 2020 /CNW Telbec/ - Liminal BioSciences Inc. (Nasdaq: LMNL) (TSX: LMNL) ("Liminal BioSciences" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing novel treatments for patients suffering from diseases related to fibrosis, including respiratory, liver and kidney diseases that have high unmet medical need, commented today on the impact of the current COVID-19 pandemic on its operations.
"We have been following the rapidly-changing situation with COVID-19 and following the appropriate advice from government agencies with respect our operations. We have taken active steps to ensure continuity in our operations with many of our employees working remotely. For those employees continuing to operate in our production facilities, laboratories, plasma collection centers and administrative offices, as necessary, we have taken reasonable additional precautions and measures", stated Kenneth Galbraith, Liminal's Chief Executive Officer. "To date, we are thankfully not aware of any employees stricken with COVID-19, and we have not had any material disruptions to our ongoing business activities – although it is possible that we could be subject to disruptions or delays as the situation evolves."
Mr. Galbraith added "The current COVID-19 pandemic and our industry's response is a reminder of the critical importance of innovation in healthcare, and the value of development of new medicines to sustain and improve human health. We at Liminal BioSciences remain committed to advancing our work in discovering, developing and commercializing novel product candidates for patients suffering from diseases related to fibrosis, including respiratory, liver and kidney diseases that have high unmet medical needs."
"Despite not having internal R&D capabilities in virology or vaccines, we are still evaluating specific ways that we could use our expertise and experience to be helpful to our industry and government response to the COVID-19 pandemic."
Liminal's wholly owned subsidiary, Prometic Bioproduction Inc. (PBP) is focused on the development, manufacture and commercialization of Liminal's lead plasma-derived product candidate, Ryplazim® (plasminogen). We expect to resubmit a Biologics License Application (BLA) for Ryplazim® (plasminogen) for the treatment of patients with congenital plasminogen deficiency with the U.S. Food and Drug Administration (FDA) in the first half of 2020. PBP is focused on bioseparation technologies to isolate and purify biopharmaceuticals from human plasma, with production facilities in Laval, Quebec, plasma collection centres in Canada and the United States and R&D operations in Rockville, Maryland.
On March 19, 2020, the FDA announced that it continues to play a role in facilitating medical countermeasures to treat and prevent COVID-19. In that same announcement, the FDA indicated that there is interest in evaluating whether therapies, such as convalescent plasma and hyperimmune globulin, antibody-rich blood products that are taken from blood donated by people who have recovered from the virus, could shorten the length, or lessen the severity, of the illness. The FDA further announced that it is taking the lead on an urgent cross-government approach to facilitate the development of these products.
"We are reviewing our own research conducted on plasminogen and other plasma-derived product candidates to determine if there are any further steps that we could be taking towards evaluating the potential benefit to COVID-19 patients," added Mr. Galbraith. "Given the global healthcare emergency and that these activities are outside our current focus, we expect to coordinate further actions, if any, with other researchers, government departments, regulatory authorities and non-profit agencies, all of whom continue searching in an integrated manner for potentially effective treatments and vaccines."
About Ryplazim® (plasminogen)
Ryplazim® (plasminogen) is an investigational product candidate based on a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is a fundamental component of the fibrinolytic system and is the main enzyme involved in the lysis of blood clots and clearance of extravasated fibrin. Plasminogen is therefore vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.