- 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.

[1] https://www.imarcgroup.com/pain-management-drugs-market
 
[2] https://www.imarcgroup.com/depression-drugs-market
 
[3] 
https://www.intechopen.com/books/drug-repurposing-hypothesis-molecular-aspects-and-therapeutic-applications/drug-repurposing-dr-an-emerging-approach-in-drug-discovery

 

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 
 
Source: iX Biopharma Ltd