US-based biopharmaceutical Sage Therapeutics has partnered with Japanese pharmaceutical firm Shionogi over clinical development and commercialisation of its drug candidate, SAGE-217.

The partners will advance the product for a variety of indications, including mood and movement disorders such as major depressive disorder (MDD), in Japan, Taiwan and South Korea.

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SAGE-217 is a positive allosteric modulator formulated to selectively target synaptic and extrasynaptic GABAA receptors involved in the functioning of the central nervous system (CNS).

Sage Therapeutics CEO Jeff Jonas said: “By working together, we believe we can expand the global footprint for SAGE-217 alongside our ongoing efforts in the US and EU.

“As we have always said, our goal is to build a fully-integrated, multi-national biopharmaceutical company and this collaboration moves us another step closer to achieving the goal.”

Under the terms of the strategic alliance, Shionogi will pay $90m upfront to Sage, which is additionally eligible for another $485m in development and commercial milestone-based payments.

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Shionogi will carry out clinical development, regulatory filings and commercialisation activities for all of SAGE-217’s indications in Japan, Taiwan and South Korea.

“By working together, we believe we can expand the global footprint for SAGE-217.”

Meanwhile, Sage will obtain potential tiered royalties on sales of SAGE-217 in these countries. The company also received select rights from Shionogi to co-promote the drug candidate in Japan.

Sage retains exclusive rights to develop and commercialise the product outside of Japan, Taiwan and South Korea.

In February this year, SAGE-217 secured the US Food and Drug Administration (FDA) breakthrough therapy designation for the MDD treatment.

Sage has already initiated a placebo-controlled trial to investigate SAGE-217 in US women with postpartum depression.

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