- Alar's Lead Asset ALA-1000 Potentially is the First
Three-Month LAI Treatment for OUD -
RICHMOND, Va.,
Oct. 11,
2023 /PRNewswire/ -- Indivior PLC (LSE/Nasdaq: INDV),
a leading addiction treatment company, today announced that it has
gained exclusive global rights to develop, manufacture, and
commercialize Alar Pharmaceuticals Inc.'s ("Alar") portfolio of
long-acting injectable formulations that release a
prodrug1 of buprenorphine at varying durations,
including its lead long-acting injectable ("LAI") candidate,
ALA-1000.
ALA-1000 is a sustained-release LAI prodrug of
buprenorphine. With dosage intervals of potentially up to four
times per year, ALA-1000 could address unmet opioid use disorder
("OUD") patient needs with a longer duration of treatment, which
could provide an option for patients seeking a less frequent
maintenance therapy regimen, for patients living in remote areas
without easy access to care, and for high-risk patients, such as
those transitioning from the Justice system.
Under the agreement with Alar, Indivior will pay
$10 million to secure exclusive
global rights (except in China,
Hong Kong, Taiwan and Macau) to develop, manufacture and
commercialize ALA-1000 and Alar's future buprenorphine-based LAI
product candidates. The $10 million
payment is in addition to an initial $5
million option payment made by Indivior to Alar in Q1. Alar
is entitled to potential milestone payments if various
developmental, regulatory, and commercial goals are achieved.
"Alar provides Indivior with a unique opportunity to further
address unmet patient needs in the treatment of OUD with
potentially the first three-month buprenorphine LAI," said
Christian Heidbreder, Chief
Scientific Officer. "By providing a therapeutic option for patients
who might benefit from less frequent dosing, ALA-1000 has the
potential to broaden the spectrum of care for OUD treatment as well
as enhance the addressable patient population."
ALA-1000 is an investigational drug and is positioned to be the
first three-month buprenorphine administered subcutaneously
entering the clinical stage. Results from a single-ascending dose
("SAD") study, announced by Alar in January
2022, demonstrated the safety, tolerability and sustained
release profile of ALA-1000 over 12 weeks in patients with
OUD2. Alar has been granted composition of matter and
formulation patents for ALA-1000 covering sustained-release
buprenorphine formulations with expiry in 2037 and 2039.
Based in Taichung, Taiwan,
Alar is a drug development company which focuses on developing
long-acting drug products for central nervous system ("CNS")
disorders and chronic diseases, utilizing its proprietary depot
technology. Compared with other long-acting subcutaneous injection
technologies, its proprietary platform has been associated with
distinctive characteristics such as low viscosity solution, small
injection volume and sustained drug release profile.
The transaction is not expected to have a material impact on the
Group's FY 2023 adjusted results.
About Indivior
Indivior is a global
pharmaceutical company working to help change patients' lives by
developing medicines to treat addiction and serious mental
illnesses. Our vision is that all patients around the world will
have access to evidence-based treatment for the chronic conditions
and co-occurring disorders of substance use disorder (SUD).
Indivior is dedicated to transforming SUD from a global human
crisis to a recognized and treated chronic disease. Building on its
global portfolio of OUD treatments, Indivior has a pipeline of
product candidates designed to both expand on its heritage in this
category and potentially address other chronic conditions and
co-occurring disorders of SUD, including alcohol use disorder and
cannabis use disorder. Headquartered in the United
States in Richmond, VA, Indivior employs more than 1,000
individuals globally and its portfolio of products is available in
39 countries worldwide. Visit www.indivior.com to learn more.
Connect with Indivior on LinkedIn by
visiting www.linkedin.com/company/indivior.
Important Cautionary Note Regarding Forward-Looking
Statements
This news release contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, implied statements regarding the safety and efficacy of
ALA-1000, including its ability to potentially have a three month
duration, statements regarding future clinical trials of
ALA-1000 and their timing, the potential clinical benefits of
ALA-1000, and other statements containing the words "believe",
"anticipate", "plan", "expect", "intend", "estimate", "forecast,"
"strategy," "target," "guidance," "outlook," "potential",
"project", "priority," "may", "will", "should", "would", "could",
"can", "outlook," "guidance", the negatives thereof, and variations
thereon and similar expressions. By their nature, forward-looking
statements involve risks and uncertainties as they relate to events
or circumstances that may or may not occur in the future.
Actual results may differ materially from those expressed or
implied in such statements because they relate to future events.
Various factors may cause differences between Indivior's
expectations and actual results, including, among others, the
material risks described in the most recent Indivior PLC Annual
Report and in subsequent releases; the substantial litigation and
ongoing investigations to which we are or may become a party; our
reliance on third parties to manufacture commercial supplies of
most of our products, conduct our clinical trials and at times to
collaborate on products in our pipeline; our ability to comply with
legal and regulatory settlements, healthcare laws and regulations,
requirements imposed by regulatory agencies and payment and
reporting obligations under government pricing programs; risks
related to the manufacture and distribution of our products, some
of which are controlled substances; market acceptance of our
products as well as our ability to commercialize our products and
compete with other market participants; the uncertainties related
to the development of new products, including through acquisitions,
and the related regulatory approval process; our dependence on a
small number of significant customers; our ability to retain key
personnel or attract new personnel; our dependence on third-party
payors for the reimbursement of our products and the increasing
focus on pricing and competition in our industry; unintended side
effects caused by the clinical study or commercial use of our
products; our use of hazardous materials in our manufacturing
facilities; our import, manufacturing and distribution of
controlled substances; our ability to successfully execute
acquisitions, partnerships, joint ventures, dispositions or other
strategic acquisitions; our ability to protect our intellectual
property rights and the substantial cost of litigation or other
proceedings related to intellectual property rights; the risks
related to product liability claims or product recalls; the
significant amount of laws and regulations that we are subject to,
including due to the international nature of our business;
macroeconomic trends and other global developments such as the
COVID-19 pandemic; the terms of our debt instruments, changes in
our credit ratings and our ability to service our indebtedness and
other obligations as they come due; changes in applicable tax rate
or tax rules, regulations or interpretations; and our ability to
realize our deferred tax assets.
Forward-looking statements speak only as of the date that they
are made and should be regarded solely as our current plans,
estimates and beliefs. Except as required by law, we do not
undertake and specifically decline any obligation to update,
republish or revise forward-looking statements to reflect future
events or circumstances or to reflect the occurrences of
unanticipated events.
1) A prodrug is a pharmacologically
inactive medication or compound that, after intake, is metabolized
into a pharmacologically active drug.
2) 2022/01/13 Alar Announces Significant
Progress on Developing Long-acting Buprenorphine Injectable
ALA-1000 – 昱展新藥生技股份有限公司 (alarpharm.com)
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SOURCE Indivior PLC