NEW YORK, Feb. 18, 2021 /PRNewswire/ -- Seelos
Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage
biopharmaceutical company focused on the development of therapies
for central nervous system disorders and rare diseases, announced
today an amendment of the agreement with Vyera Pharmaceuticals AG
("Vyera") for the development of SLS-002 (intranasal racemic
ketamine) to repurchase in cash a significant portion of the
royalties payable on any future net sales of SLS-002.
On March 6, 2018, Seelos entered
into an asset purchase agreement with Vyera, currently known as
Phoenixus AG, to acquire the assets and liabilities of Vyera's
intranasal racemic ketamine program, which Seelos now calls
SLS-002. As additional consideration to certain upfront cash and
equity payments and success-based milestone payments contemplated
under the prior agreement, Seelos agreed to pay a mid-teens
percentage royalty on any future net sales of SLS-002. Under this
amendment, for additional cash payments, Seelos has agreed to
repurchase 9% of the future royalties and reduce its royalty
obligations to a mid-single digit percentage on any future net
sales of SLS-002.
"We believe this repurchase of a significant portion of
royalties due on SLS-002 has the potential to return meaningful
future value to Seelos stockholders, assuming we are successful in
the clinical development, FDA approval process, and
commercialization of the intranasal ketamine program," said Raj
Mehra Ph.D., Chairman and CEO of Seelos. "The current study of
SLS-002 is dosing patients with major depressive disorder who are
at imminent risk of suicide. We plan to further evaluate ketamine
in front-line major depression and other related indications."
Seelos has begun dosing patients in Part A of its
Proof-of-Concept study, which is a 16-patient, open-label cohort,
using 90mg of SLS-002 in patients who are imminently suicidal. Part
A of the Proof-of-Concept study precedes Part B, which is a
registrational double blind placebo-controlled trial.
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 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 addresses 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 Seelos' ability to repurchase future
royalties under the asset purchase agreement with Vyera, the
ability of the royalty repurchase to return meaningful future value
to Seelos stockholders, Seelos' ability to succeed in the clinical
development, FDA approval process and commercialization of its
intranasal ketamine program (SLS-002), Seelos' plans to evaluate
ketamine in front-line major depression and other related
indications, the design of the Proof of Concept study, the expected
timing for commencing Part B 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 to Seelos' business include, but are
not limited to, 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 Ave., 12th Fl
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
www.seelostherapeutics.com
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
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