PR93268

SINGAPORE, Nov. 25, 2021 /PRNewswire=KYODO JBN/ --

- 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