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- Strategic Device Partnership Allows Seelos to Use Aptar Pharma's Bidose (BDS) Liquid System Device with the SLS-002 Program (Intranasal Racemic Ketamine)
- Strategic Device Partnership Covers the Use of the BDS Liquid System for Intranasal Delivery of SLS-002 for the Treatment of Suicidality, Major Depressive Disorder and PTSD, and Agreement Provides Other Rights to Include Additional Undisclosed Indications
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.
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.
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.
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
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