On November 24, 2021 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, reported it has entered into an exclusive license agreement (License Agreement), whereby it acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Ltd (iX Biopharma) for Wafermine, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX (Press release, Apricus Biosciences, NOV 24, 2021, View Source [SID1234596014]).
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Seelos plans to evaluate sublingual ketamine, now named SLS-003, in pain indications such as chronic neuropathic pain and Complex Regional Pain Syndrome (CRPS) and in additional psychiatric disorders, including post-traumatic stress disorder (PTSD).
The US Food and Drug Administration (FDA) has granted Wafermine Orphan Drug designation for the treatment of CRPS.
"Our licensing of this new program broadens Seelos’ ketamine franchise with a formulation that we believe will be more suitable for chronic dosing in indications like CRPS and PTSD, which are both very difficult indications to treat effectively," said Raj Mehra, Ph.D., Chairman and CEO of Seelos. "The pharmacokinetic, pharmacodynamic and safety profiles of SLS-003 that have been demonstrated to date suggest a formulation with the potential of being prescribed with less restrictions than current formulations. Our team is very excited to be developing both acute, in SLS-002, and a potentially chronic, in SLS-003, ketamine-based therapy programs. We look forward to initiating studies with SLS-003 in 2022 and our recent capital raises have accounted for the expected development costs for initiating studies."
"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," said Eddy Lee, Chairman and CEO of iX Biopharma. "Licensing our WaferiX-based pharmaceutical drugs to suitable third parties for development and commercialization 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."
Pursuant to the License Agreement, Seelos will pay iX Biopharma a one-time, upfront fee of $9,000,000, comprised of $3,500,000 in cash and $5,500,000 in restricted shares of Seelos’ common stock for the worldwide license for Wafermine (excluding China, Taiwan, Macau and Hong Kong), the worldwide license for WaferiXTM in other ketamine formulations, and clinical supplies. Seelos will also pay iX Biopharma certain milestone payments contingent on achievement by Seelos of certain development, regulatory and commercial milestones and a low double-digit royalty on future net sales of certain licensed products.