Biogen and Sage Therapeutics are halting additional growth of their drug Zurzuvae as a possible therapy for depressive issues, a transfer that follows the FDA's rejection of the remedy for that indication final 12 months.

The regulator had requested the businesses to supply extra proof of efficacy based mostly on further medical testing. In its third-quarter 2024 monetary outcomes report launched Wednesday, Biogen stated the choice to discontinue was based mostly on the “important new investments and the time we anticipate can be required to conduct further research.” Going ahead, the 2 Cambridge, Massachusetts-based firms plan to focus their efforts on commercializing this drug for postpartum melancholy, for which it was accepted final 12 months. However postpartum melancholy is a a lot smaller market than depressive issues, that means Zurzuvae is unlikely to realize the excessive gross sales as soon as anticipated for the capsule.

With the renewed concentrate on Zurzuvae for postpartum melancholy, Sage will discontinue Zulresso, a product that grew to become the primary FDA-approved drug for postpartum melancholy in 2019. Zulresso is run as a 60-hour infusion, a difficult dosing routine that has restricted market uptake of this Sage drug. Zurzuvae, however, is a capsule taken as soon as a day for 14 days. For the 9 months ended September 30, Sage reported that Zulresso accounted for $3.1 million in income, a decline of 63% in comparison with the identical interval in 2023. Sage stated Zulresso can be commercially out there till December 31.

The collaboration between Biogen and Sage dates again to 2020. Biogen has dedicated $1.5 billion prematurely to begin the R&D alliance, targeted on melancholy and motion issues. The outcomes have been disappointing. Along with Zurzuvae's rejection within the discipline of depressive issues, the collaboration on the motion issues program SAGE-324 is coming to an finish. In July, the businesses reported that this oral drug failed a Section 2 trial in important tremor. Biogen gave Sage a discover of termination for SAGE-324 final month. When the termination takes impact in February, Sage will grow to be absolutely chargeable for this system. In its quarterly report, Sage stated it plans to guage different potential indications for this drug.

In a letter to buyers, Leerink Companions analyst Marc Goodman stated the halt to additional growth of Zurzuvae in depressive issues was anticipated. Whereas Leerink expects the drug may attain peak gross sales of $200 million to $300 million in postpartum melancholy, docs have advised the corporate they’re skeptical of a paradigm shift in therapy and that the black field warning on the product's label may additional restrict its use.

Sage has different applications within the pipeline, however the firm could have fewer staff to assist them. In its quarterly report, the corporate stated it is going to provoke a company restructuring to strengthen its stability sheet and concentrate on the continued launch of Zurzuvae for postpartum melancholy. Sage stated it is going to shed about 33% of its workforce. With the restructuring, the corporate expects to have ample capital to assist operations till 2026.

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