Roivant Halts Lung Disease Drug Development as Bio-Thera and Intas Forge Biosimilar Partnership

Roivant Sciences discontinues development of namilumab for pulmonary sarcoidosis after Phase 2 trial failure136.

The RESOLVE-Lung study failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis38.

Bio-Thera Solutions and Intas Pharmaceuticals sign an exclusive license and commercialization agreement for BAT2506, a golimumab biosimilar, in the United States24.

Bio-Thera will receive an upfront payment of $21 million and potential milestone payments up to $143.5 million from Intas24.

Intas' US specialty division, Accord BioPharma, will be responsible for commercializing BAT2506 in the United States29.

BAT2506 is a proposed biosimilar to Simponi (golimumab), used for treating various inflammatory conditions9.

The partnership aims to expand access to immunology biosimilars for patients in the USA29.

Roivant's CEO, Matt Gline, emphasized the importance of risk-taking in clinical development despite the disappointing results38.

Sources:

1. https://endpts.com/roivant-discontinues-lung-disease-drug-bio-thera-intas-make-biosimilar-deal/

2. https://www.pharmajournalist.com/bio-thera-solutions-signs-exclusive-license-deal-with-intas-for-bat2506-biosimilar-in-the-u-s/

3. https://www.fiercebiotech.com/biotech/roivant-spinout-ends-development-lung-disease-asset-after-phase-2-fail

4. https://www.pharmaceutical-technology.com/news/bio-thera-intas-biosimilar/

6. https://investor.roivant.com/news-releases/news-release-details/roivant-announces-topline-results-phase-2-resolve-lung-study

8. https://www.globenewswire.com/news-release/2024/12/03/2990444/34323/en/Roivant-Announces-Topline-Results-from-Phase-2-RESOLVE-Lung-Study-of-Namilumab-in-Chronic-Active-Pulmonary-Sarcoidosis.html

9. https://www.biospace.com/press-releases/accord-biopharma-strengthens-pipeline-through-exclusive-u-s-licensing-agreement-with-bio-thera-for-bat2506-a-proposed-golimumab-biosimilar