iX Biopharma Signs Exclusive License Agreement For Wafermine And Other Sublingual Ketamine Wafer Products

 
 
  •   iX Biopharma will receive an initial US$9 million upfront payment  
  •  
  •   Eligible for up to US$239 million in development and sales milestone payments  
  •  
  •   Double digit royalties on future product sales of any licensed product  
  •  

IX Biopharma Ltd (SGX:42C), a specialty pharmaceutical company that develops innovative therapies using its proprietary sublingual drug delivery technology, WaferiX, announced today that it has, through its subsidiary, entered into an exclusive license agreement with Seelos Therapeutics, Inc ("Seelos") (Nasdaq: SEEL), a company focused on developing novel therapeutics for central nervous systems disorders. Under the agreement, iX Biopharma will license to Seelos its lead drug under development, Wafermine, a sublingual racemic ketamine wafer, and other products incorporating R- and S- enantiomers of ketamine utilising the WaferiX technology (the "Licensed Products").

 
 

  

 

 
 

iX Biopharma will receive a US$9 million upfront payment to be satisfied in cash and shares. iX Biopharma is also eligible for up to US$239 million in milestone payments upon achievement by Seelos of certain development milestones and product sales thresholds. iX Biopharma will also receive double digit royalties on future net sales of any Licensed Product. Seelos will fund all future development, manufacturing and commercialisation of the Licensed Products.

 

  Eddy Lee , Chairman and CEO of iX Biopharma, said: "We are delighted to collaborate with Seelos Therapeutics, whose deep insights in ketamine drug development make them an ideal partner to further the development of Wafermine and the other sublingual ketamine products. Licensing our WaferiX-based pharmaceutical drugs to suitable third parties for development and commercialisation is a core strategy to unlock the value of our assets. We are therefore excited that this commercially significant agreement with Seelos is a validation of our ability to deliver on this strategy."

 

"The licensing of the WaferiX drug delivery platform for sublingual ketamine broadens Seelos' ketamine franchise with formulations that we believe will be suitable for both acute and chronic dosing. This should enable us to study additional indications beyond our current focus," said Raj Mehra, Ph.D., Chairman and CEO of Seelos. "The pharmacokinetics, pharmacodynamics and safety profile that has been demonstrated to date suggests a formulation that has the potential of being prescribed with less restrictions than current formulations. Our team is excited to be able to study additional indications with this very innovative technology."

 

Ketamine, a NMDA receptor antagonist, works through novel mechanisms of action compared to most currently approved therapies and has the potential to treat various conditions with significant unmet medical need, including pain and depression.

 

Prior to the agreement, iX Biopharma had completed Phase 2 clinical studies on Wafermine in the United States (US) which demonstrated strong analgesic efficacy, safety and tolerability in participants experiencing moderate to severe acute pain. Following that, it concluded the End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) and obtained positive Scientific Advice from the European Medicines Agency (EMA) on the Wafermine programme. The FDA has also granted iX Biopharma an orphan drug designation for ketamine for the treatment of Complex Regional Pain Syndrome (CRPS) which is a rare disorder characterised by excess and prolonged pain and inflammation usually affecting limbs, for which there is no approved drug treatment.

 

Under the terms of the agreement, Seelos will have exclusive worldwide rights for Wafermine except China (including Hong Kong , Macau and Taiwan ), and worldwide rights to products incorporating R- and S- enantiomers of ketamine being developed using iX Biopharma's WaferiX technology. iX Biopharma will retain exclusive rights to Wafermine in China (including Hong Kong , Macau and Taiwan ).

 

  About the Licensed Products and WaferiX  

 

The Licensed Products utilise iX Biopharma's patented sublingual wafer technology, known as WaferiX, to disintegrate under the tongue rapidly for faster therapeutic action and predictable dosing. In pharmacokinetic studies, sublingual delivery using WaferiX increased bioavailability of active compounds when compared to oral administration, while avoiding excessively high peak plasma concentrations typical of IV bolus dosing.

 

The Licensed Products will contain ketamine, which provides a non-opioid approach for the treatment of pain by targeting the NMDA receptor. Ketamine has tremendous prospects given its ability to address various forms of pain with significant unmet medical need. Additionally, clinical studies suggest that ketamine has the potential to be a rapid, effective treatment for depression. Current anti-depressants traditionally used in this setting are hindered by slow onset of action, often taking weeks for full therapeutic effect, adverse events and limited efficacy, where up to one in three patients are refractory to therapy. The global pain market is estimated to be valued at   US$74 billion   [1] and the global depression market is estimated to be valued at US$12.7 billion [2] in 2020.  
 

 

  About Seelos Therapeutics, Inc  

 

Seelos Therapeutics, Inc. (Nasdaq: SEEL) 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 disorders. The Company's robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York .

 

For more information, please visit: www.seelostherapeutics.com .

 

  About iX Biopharma Ltd  

 

iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in Australia . The Group is focused on the development and commercialisation of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.

 

iX Biopharma has developed a patented drug delivery platform technology, WaferiX. WaferiX delivers drug sublingually via the mucosa for better absorption, faster onset of action and predictable effect. The WaferiX delivery platform is particularly useful for drug repurposing which is a growing trend with a global market worth over US$30 billion   [3]   . Drug repurposing is where existing approved drugs are developed into new drugs targeting different indications or a different route of administration, at a lower development cost and risk. Other than Wafermine, iX Biopharma's portfolio includes among others, medicinal cannabis, sildenafil and buprenorphine sublingual wafers.

  

  Contact for media   :  

 
 
    
 

   Yee Chia Hsing
Director of Corporate Affairs
E: chiahsing.yee@ixbiopharma.com  
     

 
 

   

 

   Eva Tan
 
  Chief Commercial Officer
  E: eva.tan@ixbiopharma.com   

 
 

   Alvina Tan   

 

  Media & Investor Relations Consultant
  E: alvina.tan@arkadvisors.com.sg   

 
 
 
 
 
 

 

View original content to download multimedia: https://www.prnewswire.com/news-releases/ix-biopharma-signs-exclusive-license-agreement-for-wafermine-and-other-sublingual-ketamine-wafer-products-301432286.html  

 

SOURCE iX Biopharma Ltd

 
 

News Provided by PR Newswire via QuoteMedia

The Conversation (0)
Glowing mushrooms with colorful graphs in the background on a dark surface.

US Policy Momentum, Clinical Progress Fueling Psychedelics Market in 2025

When the US Food and Drug Administration (FDA) rejected Lykos Therapeutics’ new drug application for MDMA-assisted therapy last August, the initial disappointment cast a shadow over the psychedelics industry.

However, the sector is seeing a resurgence of optimism in 2025 on the back of various US developments.

“The psychedelic industry in 2025 will likely see significant advancements in clinical applications, particularly in treating PTSD, depression, and addiction, as research continues to validate their therapeutic potential,” Dr. Markus Ploesser, chief innovation officer at Open Mind Health, told Microdose in January.

Keep reading...Show less
AVECHO BIOTECHNOLOGY

Avecho and Sandoz enter Exclusive License and Development Agreement to Commercialise CBD for Insomnia in Australia

Avecho Biotechnology Limited (ASX: AVE) (“Avecho” or the “Company”) today announced it has signed an exclusive ten-year development and licensing agreement with Sandoz Group AG (“Sandoz”) for the commercial rights to Avecho’s Phase III cannabidiol (“CBD”) capsule for insomnia in Australia. Avecho retains the rights to commercialise the product in all other territories, with Sandoz granted a first right of refusal for these markets. Avecho’s CBD capsule aims to be the first pharmaceutical CBD product registered with the Therapeutic Goods Administration (“TGA”) as an over-the-counter medicine, which market forecasts predict could generate sales surpassing US$125M per annum in Australia2.

Keep reading...Show less

Compass Pathways to announce fourth quarter and year-end financial results on February 27th, 2025

 

  Compass management will host a conference call at 8:00 am ET (1:00pm UK)  

 

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Emyria Limited

Emyria and UWA in Partnership to Commercialise Novel Serotonin-Releasing Agents for Mental Health and Neurology

Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) has signed an exclusive licence agreement with UWA, granting worldwide rights to a rapidly growing portfolio of selective serotonin-releasing agents. (See Appendix for Key Commercial Terms). These novel compounds, realised through a UWA–Emyria research partnership launched in 2021,2 include potential next-generation treatments for mental health and neurological conditions such as PTSD and Parkinson’s disease.

Keep reading...Show less
Quantum Biopharm (CSE: QNTM)

Quantum BioPharma Files a US Federal Lawsuit Against CIBC World Markets, RBC Dominion Securities and Others, Seeking Damages in Excess of $700,000,000 USD, for Possible Stock Price Manipulation/Spoofing

Christian Attar Law Firm and Freedman Normand Friedland LLP, in conjunction with forensic investigators, have uncovered evidence of a potential multi-year market manipulation scheme that has caused substantial damages to the Company and its shareholders


Keep reading...Show less

Latest Press Releases

Related News

×