Takeda and Neurocrine Amend Collaboration on Depression Drug Osavampator

Takeda Pharmaceutical Company and Neurocrine Biosciences have announced a significant amendment to their multi-asset collaboration agreement, focusing on the development of osavampator, a promising phase 3-ready depression drug. This modification marks a pivotal shift in the companies' approach to bringing a potential new treatment option to patients with major depressive disorder (MDD).

Revised Licensing Agreement

Under the terms of the amended agreement, Takeda will regain the home license rights for osavampator in Japan, while Neurocrine Biosciences will retain rights for the rest of the world. This strategic realignment allows both companies to leverage their respective strengths in different markets:

• Takeda will be responsible for development costs and commercialization efforts in Japan.
• Neurocrine will oversee development and potential commercialization in all other global markets.
• Both companies will share royalty payments from each other's sales in their respective territories.

This restructuring of the collaboration aims to streamline the development process and potentially accelerate the drug's path to market.

Osavampator: A Novel Approach to Treating Depression

Osavampator, formerly known as NBI-1065845 or TAK-653, represents a new class of antidepressants with a unique mechanism of action:

• It functions as an AMPA potentiator, enhancing signaling through AMPA receptors.
• The drug has shown promise in treating patients with MDD who have not responded adequately to at least one previous antidepressant.
• In a phase 2 trial, osavampator demonstrated significant efficacy in reducing depression severity among adults with treatment-resistant MDD.

Future Development Plans

Neurocrine Biosciences has announced its intention to initiate a phase 3 program for osavampator in the first half of 2025. This move signifies confidence in the drug's potential and a commitment to advancing its development:

• Kyle Gano, Ph.D., CEO of Neurocrine, emphasized the company's focus on bringing osavampator to patients as quickly as possible.
• Sarah Sheikh, Head of Neuroscience Therapeutic Area Unit at Takeda, expressed confidence in Neurocrine's expertise in developing therapies for serious psychiatric disorders.

The companies believe that osavampator has the potential to become a meaningful new treatment option for patients with MDD, addressing an significant unmet need in the field of psychiatry.