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