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Liminal BioSciences Receives FDA Approval for its US-based Plasma Collection Center
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LAVAL, QC and CAMBRIDGE, England , Jan. 11, 2021 /CNW/ - Liminal BioSciences Inc. (Nasdaq: LMNL) ("Liminal BioSciences" or the "Company"), a clinical-stage biopharmaceutical company, announced that the Company's wholly-owned subsidiary, Prometic Plasma Resources ( USA ) Inc., has received U.S. Food and Drug Administration ("FDA") approval for its plasma collection center located in Amherst, NY .
The center commenced operations and initiated source plasma collection in early 2020, and is now FDA licensed to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S. The approval follows the FDA's pre-licensure inspection in September 2020 .
"FDA approval of our second plasma collection facility, and first outside of Canada , is an important milestone that enables us to continue to internally supply a portion of our raw material, or sell to other customers," stated Bruce Pritchard , Chief Executive Officer of Liminal BioSciences. "I am pleased that we obtained approval of this center well ahead of our expected timelines and we are grateful to our dedicated staff for helping achieve this important milestone."
For individuals interested in donating plasma or for more information, please visit us at plasma.prometic.com.
About Liminal BioSciences Inc.
Liminal BioSciences is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing novel treatments for patients suffering from diseases of high unmet medical need, primarily related to fibrosis, including respiratory, liver and kidney diseases. Liminal BioSciences has a deep understanding of certain biological targets and pathways that have been implicated in the fibrotic process, including fatty acid receptors such as FFAR1, G-protein-coupled receptor 84 (GPR84), and peroxisome proliferator-activated receptors (PPARs). Our lead small molecule product candidate, fezagepras (PBI-4050), has entered a Phase 1 clinical trial in Q4-2020 in the UK to evaluate multiple ascending doses in normal healthy volunteers, at daily dose exposures higher than those evaluated in our previously completed Phase 2 clinical trials. Fezagepras is expected to be further evaluated in a global Phase 2b clinical trial in patients with idiopathic pulmonary fibrosis (IPF) anticipated to be initiated in H2-2021. In addition, we expect to initiate a Phase 1b /2a clinical trial of fezagepras, for patients with high triglyceride levels (hypertriglyceridemia) in H2-2021.
Fezagepras has previously been granted Orphan Drug Designation by the FDA and the European Medical Agency (EMA) for the treatment of IPF. The treatment has also received a Promising Innovative Medicines (PIM) designation by the Medicines and Healthcare products Regulatory Agency (MHRA) for IPF and Alstrm syndrome.
Liminal BioSciences has also leveraged its experience in bioseparation technologies through its subsidiary Prometic Bioproduction Inc. to isolate and purify biopharmaceuticals from human plasma. Liminal BioSciences' lead plasma-derived product candidate is Ryplazim ® (plasminogen) ("Ryplazim ® "), for which the Company, through its US subsidiary, Prometic Biotherapeutics Inc., resubmitted a BLA in September 2020 with the FDA seeking approval to treat patients with congenital plasminogen deficiency. The PDUFA target action date for this BLA filing is June 5, 2021 . Ryplazim ® has previously been granted Orphan Drug and Rare Pediatric Disease Designations by the FDA for the treatment of congenital plasminogen deficiency.
Prometic Plasma Resources, a subsidiary of Liminal BioSciences, has joined the CoVIg-19 Plasma Alliance to contribute to the acceleration of the development of a potential new therapy for COVID-19. Liminal BioSciences' Canadian plasma collection center located in Winnipeg, Manitoba is licensed by the FDA and Health Canada, and is certified by the European Union and the Plasma Protein Therapeutics Association. Liminal BioSciences' American plasma collection center located in Amherst, New York has been granted a Clinical Laboratory Permit by the State of New York and is licensed by the FDA.
Liminal BioSciences has active business operations in Canada , the United Kingdom and the United States .