Liminal BioSciences Receives FDA Approval for its US-based Plasma Collection Center
Liminal BioSciences Inc. (Nasdaq: LMNL) announced FDA approval for its plasma collection center in Amherst, NY, marking a significant milestone as it expands operations in the U.S. This center, operational since early 2020, is now licensed to trade human source plasma, enhancing Liminal's ability to supply raw materials for its biopharmaceutical products. The FDA inspection that preceded this approval was conducted in September 2020. This strategic move allows Liminal to meet growing demand and support its clinical programs, which include treatments for diseases related to fibrosis and congenital plasminogen deficiency.
- FDA approval granted for plasma collection center in Amherst, NY.
- Enhances ability to supply raw materials internally or sell to customers.
- Strategic expansion into the U.S. market is ahead of schedule.
- No significant negative aspects reported.
LAVAL, QC and CAMBRIDGE, England, Jan. 11, 2021 /PRNewswire/ - 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 Alström 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.
Forward Looking Statement
This press release contains forward-looking statements about Liminal BioSciences' objectives, strategies and businesses that involve risks and uncertainties. Forward–looking information includes statements concerning, among other things, statements with respect to the timing for FDA review of the BLA for Ryplazim®, the ability or projections regarding the use or sale of source plasma, the potential of our product candidates and development of R&D programs and the timing of initiation of clinical trials.
These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Among the factors that could cause actual results to differ materially from those described or projected herein include, but are not limited to, risks associated with FDA review, our ability to effectively establish a commercial organization, Liminal BioSciences' ability to develop, manufacture, and successfully commercialize product candidates, if ever, the impact of the COVID-19 pandemic on its business operations, plasma collection, clinical development, regulatory activities and financial and other corporate impacts, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical trials, the ability of Liminal BioSciences to take advantage of business opportunities in the pharmaceutical industry, uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals and general changes in economic conditions. You will find a more detailed assessment of these risks, uncertainties and other risks that could cause actual events or results to materially differ from our current expectations in the filings the Company makes with the U.S. Securities and Exchange Commission and Canadian Securities Commissions filings and reports filings and reports, including in the Annual Report on Form 20-F, as amended, for the year ended December 31, 2019 and future filings and reports by the Company, from time to time. Such risks may be amplified by the COVID-19 pandemic and its potential impact on Liminal BioSciences' business and the global economy. As a result, we cannot guarantee that any forward-looking statement will materialize. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. We assume no obligation to update any forward-looking statement contained in this Press Release even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations.
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SOURCE Liminal BioSciences Inc.
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