Company focused on continued advancement of its small
molecule therapeutics platform including development of fezagepras
and evaluating strategic alternatives for its plasma-derived
therapeutics business and other non-core assets.
LAVAL, Canada and CAMBRIDGE, England, Jan. 27, 2021 /PRNewswire/ - Liminal BioSciences
Inc. (Nasdaq: LMNL) ("Liminal BioSciences" or the "Company"), a
clinical-stage biopharmaceutical company, provided an update today
regarding the Company's corporate strategy for its small molecule
therapeutics and plasma-derived based therapeutics
platforms.
Following a review of its corporate business strategy, aimed at
maximizing the use of capital resources, the Company has decided to
re-focus its resources on its small molecule therapeutics business.
It has therefore determined that its plasma-derived therapeutics
business is no longer aligned with this new corporate business
strategy.
As previously disclosed, the Company has been engaged in a
process to find a commercialization partner for Ryplazim®
(plasminogen) ("Ryplazim"), which has to date not resulted in an
executable transaction. As a consequence, and considering the
ongoing cash burn associated with the plasma-derived therapeutics
business, the Company announced that it has commenced a process to
evaluate potential strategic alternatives for that portion of its
business aimed at minimizing cash burn. These alternatives may
result in a divestment, in whole or in part, of the plasma-derived
therapeutics business and/or other non-core assets, or in other
courses of action including but not limited to other strategic
transactions or the closure of its Ryplazim related operations.
The Company believes that such change in its business strategy
will allow it to become more streamlined and with a singular focus
on its core research capabilities and emerging pipeline.
"We believe that this change in our business strategy will
allow us to focus our resources on the development of our
lead product candidate fezagepras and our small molecule
therapeutics drug discovery program and to become a more capital
efficient organization", stated Mr. Bruce
Pritchard, Chief Executive Officer of Liminal BioSciences.
However, as of the date hereof, the Company has not made any
decisions related to any specific strategic alternatives for its
plasma-derived therapeutics business and there can be no assurance
of a successful outcome from these efforts, or of the form or
timing of any outcome. The Company will update the market on this
process when it determines that further disclosure is appropriate
or necessary, including impacts on its financial results.
About Ryplazim® (plasminogen)
Ryplazim® (Plasminogen) is an investigational drug 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.
Through its US subsidiary, Prometic Biotherapeutics Inc.,
Liminal BioSciences resubmitted a Biologic License Application
("BLA") in September 2020 with the
U.S. Food and Drug Administration (FDA) seeking approval of
Ryplazim for the treatment of clinical signs and symptoms
associated with congenital plasminogen deficiency ("C-PLDG"). The
FDA has provided a Prescription Drug User Fee Act ("PDUFA") target
action date of June 5, 2021.
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 of fezagepras 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.
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 clinical signs and symptoms
associated with congenital plasminogen deficiency. The PDUFA target
action date for Ryplazim® 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.
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
target PDUFA action date, the ability or projections regarding the
use or sale of source plasma, the form, timing, ability to
consummate or successful outcome of any strategic transactions
pertaining to the Company's non-core assets, including a potential
divestment or the Company's Ryplazim related business or assets,
the Company's ability to reduce its cash burn, the potential of our
product candidates and development of R&D programs and the
timing of initiation or nature 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 consummate any
strategic transaction relating to our plasma-derived therapeutics
business and/or non-core assets, 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,
manufacturing operations or commercialization activities, 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.