Jazz Pharmaceuticals plc has secured exclusive worldwide rights to develop and commercialize SAN2355, a preclinical epilepsy drug candidate, through a global licensing agreement with Danish biotech company Saniona. The deal includes an upfront payment of $42.5 million and positions Jazz to advance what could become a best-in-class treatment for epilepsy.
Novel Mechanism Addresses Previous Limitations
SAN2355 represents a significant advancement in epilepsy treatment as a highly differentiated, subtype-selective Kv7.2/Kv7.3 potassium channel activator. The compound is designed to overcome critical limitations that have hampered previous Kv7-targeting agents, which demonstrated clinical efficacy but faced dosing restrictions due to adverse events associated with off-target activation.
"SAN2355 is uniquely selective for Kv7.2/Kv7.3, the Kv7-subtypes responsible for seizure suppression, and avoids activation of other Kv7-subtypes," according to the companies. This selectivity enables optimal dosing for efficacy and supports the compound's potential as a best-in-class epilepsy treatment.
Substantial Financial Commitment
Under the licensing agreement terms, Saniona is eligible to receive up to $192.5 million in development and regulatory milestones, including a $7.5 million payment upon initiation of the first Phase 1 clinical study. Commercial milestone payments could reach up to $800 million based on achieving significant pre-specified annual net sales thresholds. Additionally, Saniona will receive tiered royalties ranging from mid-single digits to low-double digits on net sales of commercial products.
Strategic Alignment for Both Companies
"Our collaboration with Jazz leverages their leading position in epilepsy and their strong track record of rapidly advancing clinical development programs and effectively commercializing novel therapies in neuroscience," said Thomas Feldthus, CEO of Saniona. The partnership enables Saniona to advance other valuable pipeline programs while positioning SAN2355 for optimal development.
Robert Iannone, executive vice president, global head of R&D, and chief medical officer of Jazz Pharmaceuticals, emphasized the strategic fit: "This transaction further expands our early-stage neuroscience pipeline building on our existing expertise in the treatment of epilepsy and our R&D team remains committed to developing novel approaches to improving treatment options for people living with epilepsy and other neurologic conditions."
Validated Mechanism with Enhanced Selectivity
The Kv7.2/Kv7.3 potassium channel mechanism targeted by SAN2355 has been validated for seizure suppression through previous clinical studies. However, earlier Kv7-targeting agents faced limitations due to their non-selective nature, which led to off-target effects and dosing constraints. SAN2355's selective approach specifically targets the Kv7 subtypes responsible for seizure suppression while avoiding other subtypes that contribute to adverse events.
Jazz will assume responsibility for all further development activities, regulatory submissions, and global commercialization efforts for SAN2355 in epilepsy and other potential neurological indications. The agreement represents a significant expansion of Jazz's early-stage neuroscience pipeline and builds upon the company's established expertise in epilepsy treatment.
