US-based Flexion Therapeutics has signed an agreement with Canadian Xenon Pharmaceuticals to acquire worldwide rights for the development and commercialisation of a NaV1.7 inhibitor, XEN402, to treat post-operative pain.
In addition to the global licence, the deal covers related patents, non-clinical, clinical and manufacturing components of the product.
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Flexion plans to develop XEN402 as an extended-release formulation from a thermosensitive hydrogel, under a preclinical programme named FX301.
Initially, FX301 will serve as a peripheral nerve block to control post-operative pain.
The thermosensitive formulation was observed to convert from a liquid to a gel within minutes of administration, allowing local delivery of the therapeutic near target nerves for up to seven days.
XEN402’s selective pharmacology is expected to offer pain relief and also preserve motor function. Additionally, it is believed to have the potential for ambulation, fast discharge and rehabilitation after musculoskeletal surgery.
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By GlobalDataFlexion plans to start clinical trials to evaluate FX301 in 2021.
Flexion Therapeutics president and CEO Michael Clayman said: “FX301 is a natural fit for Flexion, as it leverages our deep understanding of musculoskeletal pain and our demonstrated formulation expertise.
“We believe FX301 may directly address a substantial medical challenge by potentially providing durable and meaningful post-operative pain relief, while sparing motor function.”
Under the terms of the agreement, Flexion made a $3m upfront payment to Xenon. The company is also eligible for milestones of up to $9m through the launch of a Phase II proof-of-concept study.
After successful completion of the study, Xenon may receive up to $40.75m in clinical development and global regulatory approval milestones, as well as up to $75m in commercialisation milestones.
The company will also receive royalties on future sales.
Moreover, the agreement will see Flexion assume Xenon’s obligation to pay sales royalty to Teva Pharmaceuticals International.
