- 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
SINGAPORE, Nov. 29, 2021 /PRNewswire/ -- 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
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[2] https://www.imarcgroup.com/depression-drugs-market
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[3] https://www.intechopen.com/books/drug-repurposing-hypothesis-molecular-aspects-and-therapeutic-applications/drug-repurposing-dr-an-emerging-approach-in-drug-discovery
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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
|
|
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SOURCE iX Biopharma Ltd