Takeda secures global rights to develop and commercialise soticlestat

Takeda Pharmaceutical Company has entered into an exclusive agreement to secure global rights from Ovid Therapeutics to develop and commercialise the investigational medicine soticlestat (TAK-935/OV935) for the treatment of developmental and epileptic encephalopathies, including Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).

Takeda’s Shonan, Japan research center discovered soticlestat, which is a potent, highly selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H).
Under the terms of the exclusive agreement, Takeda will be responsible for further worldwide development and commercialisation.

Ovid will not any longer have financial obligation to Takeda under the original collaboration agreement, including for milestone payments or any future development and commercialisation costs.

Ovid will receive an upfront payment of $196m at closing of the deal and is eligible to receive up to an additional $660m on achieving development, regulatory and sales milestones.

Furthermore, Ovid will secure tiered royalties starting in the low double-digits and up to 20% on sales of soticlestat, if approved and commercialised.

The new agreement is expected to complete by end of this month, subject to the satisfaction of customary closing conditions, including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

Takeda president of research and development Andy Plump said: “I would like to thank Ovid for their thoughtful and productive collaboration. Together we generated positive Phase 2 ELEKTRA study data, and as a result, soticlestat is poised to enter two pivotal trials.

“Our work together demonstrates the strength of Takeda’s partnership model and our commitment to delivering transformative medicines to patients with neurological diseases.”

As per the 2017 collaboration agreement, Takeda secured equity in Ovid and was eligible to get up to $85m as payments for regulatory milestones, including the initiation of Phase 3 clinical trials.

Ovid led development of soticlestat at global level through the successful demonstration of proof-of-concept in multiple rare epilepsies.

Ovid Therapeutics CEO Jeremy Levin said: “This new agreement is a positive outcome for patients, for Ovid and for Takeda. Jointly, we have set the stage, optimized the program and enabled it to accelerate.

“Ovid may benefit significantly, but without the obligation to commit the substantial capital needed over the coming years as soticlestat completes pivotal trials and, if successful, enters the global market. Importantly, with the resources this agreement delivers, Ovid is strategically and financially positioned well into the future. We will advance and enrich our pipeline while continuing to build a leading company in rare diseases of the brain. We would like to thank Takeda, who has been a superb partner, and we look forward to further successes for this program in the future.”

Takeda Neuroscience Therapeutic Area Unit head Sarah Sheikh said: “Soticlestat has emerged as an important late-stage molecule in our portfolio, which focuses predominantly on rare neurological and neuromuscular diseases with great unmet need.

“We are working diligently and expediently to initiate and execute upon the Phase 3 studies in children and young adults with DS and LGS. Our goal is to one day bring new treatment options that provide greater seizure control, tolerability and function to DS and LGS patients around the world.”