|Finally, iX Biopharma (SGX:42C) has clinched an outlicensing deal for its proprietary sublingual drug delivery technology.
It's been more than 2 years since the Singapore-listed specialty pharmaceutical company sought out a licensee, a process that it had said would require up to 18 months.
Subsequently, it was hampered by Covid-related travel restrictions (see: iX BIOPHARMA: Ready to monetise drug via out-licensing).
iX Biopharma today said its WaferiX technology has been exclusively licensed to Seelos Therapeutics (Nasdaq: SEEL), a US-200 million 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.
iX Biopharma will receive:
|• a US$9 million (SGD 12 million) upfront payment to be satisfied in cash and shares -- US$3.5 million cash and US$6.5 million in Seelos shares.
• up to US$239 million (SGD 323 million) in milestone payments upon achievement by Seelos of certain development milestones and product sales thresholds.
• double-digit percentage royalties on future net sales of any Licensed Product.
Seelos will fund all future development, manufacturing and commercialisation of the Licensed Products.
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).
"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.”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.
Raj Mehra, Ph.D., Chairman and CEO of Seelos, said: “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.”
“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.