Viatris offered little in the way of detail as it announced a setback for its Mapi Pharma-partnered proposed once-monthly glatiramer acetate product for relapsing forms of multiple sclerosis. The firm has previously shouted from the rooftops about Mapi’s Phase III clinical study and the potential to establish a new standard of care for glatiramer acetate patients.
Viatris and its partner Mapi Pharma will have to wait a little longer before they can move ahead with their proposed once-monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for relapsing forms of multiple sclerosis, after the firms’ ‘GA Depot 40mg’ asset received a US Food and Drug Administration complete response letter.
Viatris offered scant detail on the FDA’s rejection for its application, stating: “The companies are reviewing the content of the CRL and
Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.
With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.
Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.
