NEW YORK, April 6, 2021 /PRNewswire/ -- Seelos
Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage
biopharmaceutical company focused on the development of therapies
for central nervous system (CNS) disorders and rare diseases,
announced today the signing of an agreement between Seelos and
AptarGroup, Inc. (NYSE: ATR) for the co-exclusive use and supply of
Aptar Pharma's Bidose (BDS) Liquid System device for Seelos'
intranasal ketamine product candidate, SLS-002, in the
investigational development programs for the treatment of
suicidality, depression, and Post-Traumatic Stress Disorder (PTSD).
Under the terms of the agreement, Seelos has certain rights to add
other undisclosed indications to the Strategic Device
Partnership.
Aptar's patented BDS Liquid System has been approved by the
United States Food and Drug Administration (FDA) and European
Medicines Agency (EMA) for the delivery of other therapeutics and,
to date, millions of the Bidose and Unidose (UDS) Systems have been
sold and are used daily by thousands of patients worldwide. Aptar's
BDS Liquid System is ideal for intranasal therapies, like SLS-002,
where a precise delivery of active CNS drug formulations is
required. The BDS Liquid System is ready-to-use, requiring no
priming or shaking, making the device ideal for use in a crisis
situation.
"Aptar is a world-class organization and has been an integral
partner for our intranasal ketamine program since our inception,"
said Raj Mehra Ph.D., Chairman and CEO of Seelos. "This partnership
strengthens the collaboration between Seelos and Aptar, and further
protects the SLS-002 franchise."
The Strategic Device Partnership covers Seelos' use of Aptar's
BDS Liquid System with its SLS-002 program, which is currently in
development for the treatment of Acute Suicidal Ideation and
Behavior (ASIB) in patients with Major Depressive Disorder
(MDD).
Seelos has completed Part 1, the 16-patient, open-label cohort,
of its Proof-of-Concept study, which uses the Aptar BDS Liquid
System to deliver 90mg of SLS-002 to patients who are imminently
suicidal. Part 1 of the Proof-of-Concept study precedes Part 2,
which is a registrational double blind placebo-controlled
trial.
Seelos expects to release key open-label data in the second
quarter of 2021, after analyzing the data received from Part 1 of
the study. The last patient completed Part 1 of the study
on March 30, 2021.
If you or a loved one are having thoughts of suicide, please
seek immediate medical help, go to your nearest emergency room, or
call the National Suicide Prevention Lifeline at
1-800-273-8255.
About Aptar
Aptar is a global leader in the design and manufacturing of a
broad range of drug delivery, consumer product dispensing and
active material solutions. Aptar's innovative solutions and
services serve a variety of end markets including pharmaceutical,
beauty, personal care, home, food and beverage. Using insights,
design, engineering and science to create dosing, dispensing and
protective packaging technologies for the world's leading brands,
Aptar in turn making a meaningful difference in the lives, looks,
health and homes of millions of patients and consumers around the
world. The company is headquartered in Crystal Lake, Illinois and has 13,000
dedicated employees in 20 countries. For more information,
visit www.aptar.com.
About SLS-002
SLS-002 is intranasal racemic ketamine with two investigational new
drug applications for the treatment of Acute Suicidal Ideation and
Behavior in Major Depressive Disorder or Post-Traumatic Stress
Disorder. SLS-002 was originally derived from a Javelin
Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical
studies involving approximately 500 subjects. SLS-002 is being
developed to address an unmet need for a therapy to treat
suicidality in the U.S. Traditionally, anti-depressants have been
used in this setting but many of the existing treatments are known
to contribute to an increased risk of suicidal thoughts in some
circumstances, and if they are effective, it often takes weeks for
the full therapeutic effect to be manifested. The clinical
development program for SLS-002 included two parallel healthy
volunteer studies (Phase I), and is being followed by pivotal
registration studies after meeting with the FDA. Based on
information gathered from the databases of the Agency for
Healthcare Research and Quality, there were more than 1,000,000
visits to emergency rooms for suicide attempts in 2019 in the U.S.
alone. Experimental studies suggest ketamine has the potential to
be a rapid, effective treatment for depression and suicidality.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on the development and advancement of novel
therapeutics to address unmet medical needs for the benefit of
patients with central nervous system (CNS) disorders and other rare
diseases. The Company's robust portfolio includes several
late-stage clinical assets targeting indications including Acute
Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder
(MDD) or Post-Traumatic Stress Disorder (PTSD), amyotrophic
lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson's Disease,
other psychiatric and movement disorders plus orphan diseases.
For more information, please visit our
website: http://seelostherapeutics.com, the content of which
is not incorporated herein by reference.
Forward Looking Statements
Statements made in this press release, which are not
historical in nature, constitute forward-looking statements for
purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. These statements include, among
others, those regarding the Strategic Device Partnership
between Seelos and Aptar, the benefits of Aptar's BDS Liquid
System, Seelos' expectation that Aptar's BDS Liquid System is ideal
for delivery of SLS-002 in crisis situations, the ability of the
collaboration between Seelos and Aptar to protect the SLS-002
franchise, commencement of Part 2 of the Proof-of-Concept study,
Seelos' expected timing for key open-label data from Part 1 of the
Proof-of-Concept study and for the last patient's completion of
Part 1 of the Proof-of-Concept study, and the potential for
ketamine to be a rapid, effective treatment for refractory
depression and suicidality. These statements are based on Seelos'
current expectations and beliefs and are subject to a number of
factors and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
Risks associated with Seelos' business include, but are not limited
to, the risk that Seelos' agreement with Aptar does not produce the
benefits expected, the risk of not successfully executing its
preclinical and clinical studies, including the Proof-of-Concept
study of SLS-002, and not gaining marketing approvals for its
product candidates, the risk that prior test results may not be
replicated in future studies and trials, the risks that clinical
study results may not meet any or all endpoints of a clinical study
and that any data generated from such studies may not support a
regulatory submission or approval, the risks associated with the
implementation of a new business strategy, the risks related to
raising capital to fund its development plans and ongoing
operations, risks related to Seelos' current stock price, risks
related to the global impact of COVID-19, as well as other factors
expressed in Seelos' periodic filings with the U.S. Securities and
Exchange Commission, including its Annual Report on Form 10-K and
Quarterly Reports on Form 10-Q. Although we believe that the
expectations reflected in our forward-looking statements are
reasonable, we do not know whether our expectations will prove
correct. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
even if subsequently made available by us on our website or
otherwise. We do not undertake any obligation to update, amend or
clarify these forward-looking statements, whether as a result of
new information, future events or otherwise, except as may be
required under applicable securities laws.
Contact Information:
Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
http://seelostherapeutics.com
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
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SOURCE Seelos Therapeutics, Inc.